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580-52576-005 XR Avanti User Manual

The RTVue XR Avanti User Manual provides comprehensive instructions for the use, maintenance, and troubleshooting of the RTVue XR Avanti System, intended for trained medical personnel. It includes sections on patient information management, scan acquisition, review and reporting, system maintenance, and technical specifications. The manual emphasizes the importance of certified service technicians for repairs and adherence to warranty guidelines.

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Yoshiaki Hara
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© © All Rights Reserved
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0% found this document useful (0 votes)
355 views451 pages

580-52576-005 XR Avanti User Manual

The RTVue XR Avanti User Manual provides comprehensive instructions for the use, maintenance, and troubleshooting of the RTVue XR Avanti System, intended for trained medical personnel. It includes sections on patient information management, scan acquisition, review and reporting, system maintenance, and technical specifications. The manual emphasizes the importance of certified service technicians for repairs and adherence to warranty guidelines.

Uploaded by

Yoshiaki Hara
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 451

RTVue XR Avanti System

User Manual

RTVue XR Avanti User Manual Page 1 of 451 P/N 580-52576-005 Rev. A


Optovue, Inc.

2800 Bayview Drive

Fremont, CA 94538, USA

Phone: (510) 623-8868

Fax: (510) 623-8668

www.optovue.com

E-mail: [email protected]

Telephone: (866) 344-8948

For Customer Service or Technical Support: (510) 623-8868 or (866) 941-9240.

Revision Control

Part Number Revision Software Version Description Release Date

580-52576-005 A 2018.1 Reference ECR02679 06/2019

Federal (U.S.A.) law restricts this device to sale, distribution and use by or
on the order of a physician. Proper procedures and techniques are the
responsibility of the medical professional.

License and use of the RTVue XR Avanti System is intended only for trained
medical personnel in accordance with the license agreement – all other usage is
prohibited – warranty restrictions and possible claim limitations apply.

Standard Warranty Information

See the warranty section of Optovue.com for all product warranty and customer
licensing agreements.

RTVue XR Avanti User Manual Page 2 of 451 P/N 580-52576-005 Rev. A


Service Policy

Only those service technicians certified by Optovue, Inc. are authorized to service or
repair this device. Only those replacement parts approved by Optovue, Inc. may be
used in this device. Parts approved by Optovue, Inc. are available only through service
technicians certified by Optovue, Inc. Any service or repair by an unauthorized service
technician or use of unapproved parts will void the Optovue, Inc. product Warranty, and
may increase risk of product failure. For any problem, for technical assistance or to
arrange for service, contact: Optovue Technical Support or Optovue Customer Service
at the numbers listed below; your local Optovue, Inc. company or authorized distributor.

If the device is to be returned, Optovue or your authorized distributor will provide


instructions for returning the device and will issue a Returned Material Authorization
(RMA) number. For contaminated devices, request the appropriate Product Return
Safety Pack. Returned devices must be packaged with adequate protection against
shipping damage. Include a note describing the problem, stating the RMA number, and
giving the name, address, and telephone number of a person to contact for additional
information.

Copyright © 2018 Optovue, Incorporated. All rights are reserved. No part of this
publication may be stored in a retrieval system, transmitted or reproduced in any way,
including but not limited to photocopy, photograph, magnetic or other record, without the
prior agreement and written consent of Optovue, Inc.

Trademarks

RTVue XR, RTVue XR Avanti, AngioVue, AngioAnalytics, and Optovue are either
trademarks or registered trademarks of Optovue, Inc. Other trade names are the
property of their respective owners and are hereby acknowledged.

RTVue XR Avanti User Manual Page 3 of 451 P/N 580-52576-005 Rev. A


RTVue XR Avanti User Manual Page 4 of 451 P/N 580-52576-005 Rev. A
Table of Contents
1 Introduction ............................................................ 21
General ........................................................................................................... 21
1.1.1 Proper Instrument Use ................................................................................ 21
1.1.2 Indications for Use ....................................................................................... 22
1.1.3 Equipment Classification ............................................................................. 23
1.1.4 Certification ................................................................................................. 23
System Overview ............................................................................................ 23
1.2.1 System Components ................................................................................... 23
1.2.2 System Configurations ................................................................................ 27
1.2.3 Power On and Launch the System .............................................................. 27
System Warnings Avertissements du Système ............................................... 28
General Warnings ........................................................................................... 29
1.4.1 WARNING: User Changes to Software or Hardware .................................. 32
1.4.2 WARNING: Phototoxicity ............................................................................. 32
Power and Electrical Safety ............................................................................ 34
Alternate Power and Electrical Safety ............................................................. 35
Safety with Moving Parts ................................................................................ 36
Standard Accessories ..................................................................................... 39
1.8.1 Standard Accessories ................................................................................. 39
1.8.2 Cabling ........................................................................................................ 40
Product Compliance ........................................................................................ 41
1.9.1 CB Certification: Under IEC 60601-1-2 4th Ed. ............................................ 41
Radio Interference .......................................................................................... 41
1.10.1 Canadian Regulations ................................................................................. 41
1.10.2 Electromagnetic Compatibility (EMC): EN 60601-1-2 4th Ed. ..................... 42
Symbols Explained ......................................................................................... 47
1.11.1 Protective Packing Symbols ........................................................................ 49
Product Labels ................................................................................................ 50
Disposal .......................................................................................................... 51
1.13.1 Waste Electrical and Electronic Equipment (WEEE) Recycling Instructions 51

2 Manage Patient Information .................................. 52


Patient Search ................................................................................................ 53
2.1.1 Basic Search ............................................................................................... 53
2.1.2 Advanced Search ........................................................................................ 54
2.1.3 Patient, Visit and Scan Lists ........................................................................ 56
Add a New Patient .......................................................................................... 58
Edit Patient Information ................................................................................... 60
Correct Visit Linked to the Wrong Patient ....................................................... 60

RTVue XR Avanti User Manual Page 5 of 451 P/N 580-52576-005 Rev. A


3 Capture Scans ........................................................ 62
Steps to Acquire Scans ................................................................................... 62
3.1.1 Instructions for Successful Tracking ............................................................ 71
3.1.2 Tips for Scanning Difficult Patients .............................................................. 72
3.1.3 Tips to Optimize OCT results ...................................................................... 73
3.1.4 Joystick button Functionality........................................................................ 76
Scanning Options ............................................................................................ 78
3.2.1 Scan Types and Protocols........................................................................... 78
3.2.2 Scan Window Buttons ................................................................................. 79
3.2.3 Change Default Scan Settings .................................................................... 80
3.2.4 Auto Tab: Automated Scan Settings ........................................................... 81
3.2.5 Manual Tab: Manually Adjust Scan Settings ............................................... 84

4 Review and Edit Scans .......................................... 86


Review Window .............................................................................................. 86
4.1.1 Patient, Visit and Scan ................................................................................ 88
4.1.2 Signal Strength Index .................................................................................. 89
4.1.3 Change Analysis Button .............................................................................. 89
4.1.4 Comparison Button ...................................................................................... 89
4.1.5 OU Report Button ........................................................................................ 89
4.1.6 Comment Field ............................................................................................ 90
4.1.7 Print Button.................................................................................................. 90
Tool Pane........................................................................................................ 90
4.2.1 Tool Pane Measuring Tab Functions ........................................................... 92
4.2.2 Tool Pane Editing Tools .............................................................................. 96

5 Scan Reports .......................................................... 99


Scan Registration for Comparison .................................................................. 99
5.1.1 3D Widefield Scan for Retina Map Display .................................................. 99
5.1.2 3D Disc Scan for ONH Registration .......................................................... 100
Retina Line Scan Reports ............................................................................. 102
5.2.1 Line Scan Report....................................................................................... 103
5.2.2 Cross Line Report ..................................................................................... 104
5.2.3 Grid Scan Report....................................................................................... 105
5.2.4 Raster Scan Report ................................................................................... 106
5.2.5 Radial Lines............................................................................................... 110
5.2.6 Enhanced HD Line .................................................................................... 112
Retina Map Report ........................................................................................ 113
5.3.1 Retina Map Portrait Print Report ............................................................... 115
5.3.2 NDB References ....................................................................................... 116
5.3.3 Reference Image (Item 1).......................................................................... 116

RTVue XR Avanti User Manual Page 6 of 451 P/N 580-52576-005 Rev. A


5.3.4 Retinal Thickness Map and Chart Overlay (Item 2) ................................... 117
5.3.5 Thickness Map (Item 3) ............................................................................. 118
5.3.6 Thickness and Volume Parameter Table (Item 7) ..................................... 121
5.3.7 ETDRS Chart (Item 8) ............................................................................... 122
5.3.8 NDB Reference or RPE Elevation Map (Item 9) ........................................ 122
5.3.9 B-Scan Display (Item 10)........................................................................... 123
5.3.10 OU Retina Map Portrait Print Report ......................................................... 124
Retina Map Change Analysis Report ............................................................ 125
3D Report Options ........................................................................................ 127
5.5.1 Retina OverVue Report (3D Widefield and 3D Retina) .............................. 128
5.5.2 Retina OverVue Portrait Report................................................................. 130
5.5.3 En Face Report (All 3D Scans) ................................................................. 131
5.5.4 3D Display (All 3D Scans) ......................................................................... 134
5.5.5 3D Widefield and 3D Retina Report .......................................................... 141
5.5.6 3D Clinical Scan ........................................................................................ 143
5.5.7 3D Disc Report .......................................................................................... 144
ONH Report .................................................................................................. 148
5.6.1 RNFL and ONH Analysis Table ................................................................. 149
5.6.2 RNFL Circle B-Scans ................................................................................ 150
5.6.3 TSNIT RNFL Thickness Graph.................................................................. 150
5.6.4 RNFL Thickness Map ................................................................................ 151
5.6.5 Hemisphere and Quadrant Maps .............................................................. 152
5.6.6 Vertical and Horizontal B-Scans ................................................................ 152
5.6.7 Baseline Image and RNFL Thickness Map Overlay .................................. 153
5.6.8 ONH Change Analysis Report ................................................................... 153
5.6.9 ONH OU Report ........................................................................................ 154
5.6.10 Defining the Baseline Optic Disc Margin ................................................... 155
Assessing the GCC ....................................................................................... 157
GCC Report .................................................................................................. 158
5.8.1 Thickness Map or Deviation Map .............................................................. 159
5.8.2 B-Scan Display .......................................................................................... 159
5.8.3 NDB Reference Map ................................................................................. 160
5.8.4 Thickness and Volume Parameters Table ................................................. 160
5.8.5 GCC Change Analysis .............................................................................. 160
Nerve Fiber ONH/GCC Change Analysis Report .......................................... 161
5.9.1 Interpreting Change Report ....................................................................... 162
ONH/GCC OU Report ................................................................................... 164

6 Main Menu ............................................................. 167


File Menu ...................................................................................................... 167
6.1.1 Print Options.............................................................................................. 167
6.1.2 Data Transfer ............................................................................................ 169

RTVue XR Avanti User Manual Page 7 of 451 P/N 580-52576-005 Rev. A


6.1.3 Export (Advanced GUI Only) ..................................................................... 170
6.1.4 Import ........................................................................................................ 171
6.1.5 Archive ...................................................................................................... 173
6.1.6 Data Backup .............................................................................................. 175
6.1.7 Batch Process ........................................................................................... 176
6.1.8 Clean Diagnosis Data ................................................................................ 177
6.1.9 Clean and Batch Process All Patients ....................................................... 178
6.1.10 Delete Unused Visits (0 Scans) ................................................................. 179
6.1.11 Exit 179
Tools Menu ................................................................................................... 179
6.2.1 Scan Pattern Management ........................................................................ 180
6.2.2 Protocol Management ............................................................................... 181
6.2.3 Clear Log File (Advanced GUI only) .......................................................... 181
6.2.4 Enter Calibration Password ....................................................................... 182
6.2.5 User Preference ........................................................................................ 182
6.2.6 Reset System (Advanced GUI Only) ......................................................... 184
OCT Image Menu ......................................................................................... 185
6.3.1 Modify Baseline ......................................................................................... 185
6.3.2 Modify Boundary ....................................................................................... 185
6.3.3 Reload Baseline ........................................................................................ 185
6.3.4 Scan Parameter Setting ............................................................................ 186
Database Management Menu ....................................................................... 187
6.4.1 Protocol ..................................................................................................... 188
6.4.2 Physician ................................................................................................... 190
6.4.3 Operator .................................................................................................... 191
6.4.4 Disease ..................................................................................................... 193
6.4.5 Move a visit to another patient................................................................... 194
Home Menu .................................................................................................. 194
Help Menu..................................................................................................... 194

7 System Maintenance ............................................ 195


Routine Cleaning .......................................................................................... 195
7.1.1 Prevent Dust Accumulation ....................................................................... 195
7.1.2 Clean the Ocular (Front Objective) Lens ................................................... 195
7.1.3 Clean the Head and Chin Rest .................................................................. 195
System Computer Maintenance .................................................................... 195

8 Scan Pattern Specifications ................................ 196


9 Technical Specifications ..................................... 201
Scanner......................................................................................................... 201

RTVue XR Avanti User Manual Page 8 of 451 P/N 580-52576-005 Rev. A


Fundus Imager .............................................................................................. 201
Patient Interface ............................................................................................ 201
Computer ...................................................................................................... 201
Display Unit ................................................................................................... 202
Power Table .................................................................................................. 202
Circuit Breaker and Fuse .............................................................................. 202
Compliance ................................................................................................... 203
Operating Environment ................................................................................. 204
9.11.1 Additional Technical Specifications ........................................................... 204
Cybersecurity Information ......................................................................... 205
9.12.1 Objective ................................................................................................... 205
9.12.2 System Overview ...................................................................................... 205
9.12.3 General Principles ..................................................................................... 205
Cybersecurity Functions ............................................................................... 205
9.13.1 Limit Access to Trusted Users Only .......................................................... 205
9.13.2 Ensure Trusted Content ............................................................................ 206
9.13.3 Detect, Respond, Recover ........................................................................ 206
9.13.4 Other implemented mechanisms ............................................................... 207

10 AngioVue® Software ............................................. 209


Introduction ................................................................................................... 209
10.1.1 General...................................................................................................... 209
10.1.2 Scan Pattern Specifications....................................................................... 210
Manage Patient Information .......................................................................... 210
AngioVue Scan Acquisition and Review ....................................................... 211
10.3.1 Acquiring AngioVue Scans ........................................................................ 211
10.3.3 Acquisition Alerts ....................................................................................... 220
10.3.4 Tips for Scanning Difficult Patients ............................................................ 221
10.3.5 Tips to Optimize OCT results .................................................................... 222
Scan Quality Indicator (SQ) .......................................................................... 226
Examples of Artifacts .................................................................................... 227
10.5.1 MCT Motion Artifacts ................................................................................. 228
10.5.2 Local Weak Signal ..................................................................................... 228
10.5.3 Excessive Motion Not Correctable by AngioVue Software ........................ 231
10.5.4 Cropped Image .......................................................................................... 232
Segmentation Retina .................................................................................... 232
10.6.1 Predefined Angio Retina En Face Slabs ................................................... 233
10.6.2 Custom Angio Retina Slab ........................................................................ 233
Segmentation Disc ........................................................................................ 234
10.7.1 Predefined Angio Disc En Face Slabs ....................................................... 234
10.7.2 Custom Angio Disc Slab ............................................................................ 234
Optic Disc Margin .......................................................................................... 236

RTVue XR Avanti User Manual Page 9 of 451 P/N 580-52576-005 Rev. A


Segmentation Correction and Propagation Tool ........................................... 237
Projection Artifact Removal (PAR) ................................................................ 240
10.10.1 Examples of PAR vs No-PAR ............................................................ 242
AngioVue Reports ......................................................................................... 244
10.11.1 AngioVue Reports List........................................................................ 244
10.11.2 Angio Retina Essential ....................................................................... 244
10.11.3 Angio Retina OverVue Report ............................................................ 246
10.11.4 Angio Retina Main Report .................................................................. 252
10.11.5 Angio Retina Multiple Visits Report .................................................... 258
10.11.6 Angio Montage Report ....................................................................... 261
10.11.7 Angio Disc OverVue Report ............................................................... 265
10.11.8 Angio Disc Main Report...................................................................... 269
10.11.9 Angio Disc Multiple Visits Report ....................................................... 275

11 AngioAnalytics™.................................................. 277
Angio Retina vs GCC Scan Thickness .......................................................... 278
AngioAnalytics™ Composition ...................................................................... 279
11.2.1 Angio Retina .............................................................................................. 279
11.2.2 Angio Disc ................................................................................................. 279
11.2.3 Scan Centering and AngioAnalytics Measurements .................................. 280
Angio Retina Analytics .................................................................................. 281
11.3.1 Fovea Center Detection ............................................................................ 281
11.3.2 ETDRS Grid Centration ............................................................................. 281
11.3.3 Angio Retina Measurement Zones and Parameters .................................. 282
11.3.4 Angio Retina Vessel Density and Retinal Thickness ................................. 284
11.3.5 Foveal Avascular Zone (FAZ).................................................................... 289
11.3.6 Angio Retina QuickVue Report .................................................................. 293
11.3.7 Angio Retina Trend Report ........................................................................ 294
11.3.8 Flow ........................................................................................................... 295
11.3.9 Non-Flow ................................................................................................... 299
11.3.10 Information Display for Saved Analytics Result .................................. 301
Angio Disc Analytics ..................................................................................... 303
11.4.1 Optic Disc Parameters............................................................................... 303
11.4.2 Comparison of Optic Disc Parameters Between OCT and OCTA Scans. . 304
11.4.3 Angio Disc Measurement Zones and Parameters ..................................... 304
11.4.4 Eight Sector Peripapillary Grid . ................................................................ 305
11.4.5 Angio Disc RPC Vessel Density and RNFL Thickness .............................. 306
11.4.6 Angio Disc QuickVue Report ..................................................................... 310
11.4.7 Angio Disc Trend Report ........................................................................... 310

RTVue XR Avanti User Manual Page 10 of 451 P/N 580-52576-005 Rev. A


12 Appendix A: Printer Installation .......................... 313
13 Appendix B: Normative Database (NDB) ............ 313
13.1.1 Data Collection Sites ................................................................................. 314
13.1.2 Methods:.................................................................................................... 315
13.1.3 Results ...................................................................................................... 316
13.1.4 RNFL Thickness ........................................................................................ 318
13.1.5 Optic Disc Parameters............................................................................... 320
13.1.6 GCC Parameters ....................................................................................... 321
13.1.7 Retina Thickness ....................................................................................... 322
13.1.8 Summary ................................................................................................... 328

14 Appendix C: Motion Correction Technology (MCT)


328
15 Appendix D: Repeatability and Reproducibility. 331
16 Appendix E: AngioVue Performance Testing .... 343
Non-clinical Performance Testing ................................................................. 343
16.1.1 3 mm AngioRetina Scan ............................................................................ 343
16.1.2 6 mm HD AngioRetina Scan...................................................................... 344
16.1.3 4.5 mm HD AngioDisc Scan, with and without Large Vessel Masking ...... 345
Clinical Performance Testing ........................................................................ 346
16.2.1 Evaluation of the Repeatability and Reproducibility (“R&R”) of AngioVue in
Normal Subjects, Retinal Patients, and Glaucoma Patients ................................. 346
16.2.2 FAZ Parameter Validation (for non-vascular FAZ Parameters) ................. 362
16.2.3 FAZ Parameters Agreement between 3 mm AngioRetina and 6 mm HD
AngioRetina Scans ............................................................................................... 363
16.2.4 Retinal Thickness, RNFL Thickness and Disc Measurements Agreement
between OCT and OCTA scans ........................................................................... 364
16.2.5 Thickness Measurements Agreement between 3 mm AngioRetina Scan and
6 mm HD AngioRetina Scan ................................................................................ 367

17 Appendix F: Signal Strength Index (SSI) ............ 369


18 Appendix G Cornea Anterior Module (CAM) .... 375
Safety Notes ................................................................................................. 375
Instrument Description .................................................................................. 378
XR/CAM System Configuration: .................................................................... 378
Getting Started .............................................................................................. 380

RTVue XR Avanti User Manual Page 11 of 451 P/N 580-52576-005 Rev. A


18.4.1 Mounting the Lens Adapters...................................................................... 380
Patient Menu ................................................................................................. 381
Examine Menu .............................................................................................. 382
18.6.1 Scan Patterns ............................................................................................ 382
18.6.2 Scan Acquisition: ....................................................................................... 382
18.6.3 Scan Alignment ......................................................................................... 384
18.6.4 Technical Note Regarding Dewarp ............................................................ 386
Review Menu ................................................................................................ 387
18.7.1 Review Layout ........................................................................................... 387
18.7.2 Measurement ............................................................................................ 387
18.7.3 Review Result Layout ................................................................................ 387
18.7.4 Line 387
18.7.5 Cross Line Scan ........................................................................................ 388
18.7.6 Scan with Thickness Measurement Tool ................................................... 388
18.7.7 Angle ......................................................................................................... 390
18.7.8 TISA/AOD Measurement Tool ................................................................... 390
18.7.9 3D Cornea ................................................................................................. 391
18.7.10 Pachymetry ........................................................................................ 392
18.7.11 Pachymetry Assessment .................................................................... 394
18.7.12 Symmetry and Change Analysis ........................................................ 395
18.7.13 Wide Field Pachymetry (9mm) ........................................................... 396
18.7.14 Corneal Power ................................................................................... 398
18.7.15 Summary Description ......................................................................... 399
18.7.16 Summary Report ................................................................................ 400
18.7.17 Repeatability ...................................................................................... 401
18.7.18 Validation ........................................................................................... 402
18.7.19 References: ........................................................................................ 402
18.7.20 Epithelium Thickness Mapping ........................................................... 403
File Management Menu ................................................................................ 406
Maintenance and Troubleshooting ................................................................ 406
Scan Pattern Specifications .......................................................................... 407
Technical Data .............................................................................................. 408
18.11.1 System Specifications ........................................................................ 408
Performance Specifications Summary: ................................................................ 408
Cornea Imager: .................................................................................................... 408
Patient Interface: .................................................................................................. 408
Measurement Features: ....................................................................................... 408
Corneal Power .............................................................................................. 410
18.12.1 Validating Corneal Power Calibration Tool ......................................... 410
18.12.2 Corneal Power Scan and Calculations ............................................... 413
18.12.3 Samples of Poor or Borderline Quality Corneal Power Scan ............. 414
Pachymetry & Epithelium Mapping ............................................................... 422
1.1 Detection of Epithelial Boundaries ................................................................ 422

RTVue XR Avanti User Manual Page 12 of 451 P/N 580-52576-005 Rev. A


18.13.1 Identification of Segmentation Error and Manual Correction .............. 424
Clinical Validation Study 6mm Pachymetry scan .......................................... 426
18.14.1 Enrollment Criteria.............................................................................. 426
18.14.2 Normal................................................................................................ 426
18.14.3 CL....................................................................................................... 426
18.14.4 LASIK ................................................................................................. 427
18.14.5 PRK .................................................................................................... 427
18.14.6 KCN.................................................................................................... 427
18.14.7 Study Subject Demographics and Characteristics ............................. 428
Evaluation of the Repeatability and Reproducibility of PachymetryWide 9mm
Corneal Epithelial Thickness Mapping with SD-OCT .................................................. 430
18.15.1 Clinical Performance Testing ............................................................. 430
18.15.2 Evaluation of the Repeatability and Reproducibility of Corneal Epithelial
Thickness Mapping with SD-OCT ........................................................................ 430
Results 430
18.15.3 Normal Group R&R ............................................................................ 433
18.15.4 Contact Lens Group R&R................................................................... 434
18.15.5 Dry Eye Group R&R ........................................................................... 435
18.15.6 Post-LRS Group R&R ........................................................................ 436
18.15.7 KCN Group R&R ................................................................................ 437
Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with
SD-OCT 438
18.16.1 Results ............................................................................................... 440
Normal Group Agreement .................................................................................... 440
Contact Lens Group Agreement........................................................................... 441
Dry Eye Group Agreement ................................................................................... 442
Post-LRS Group Agreement ................................................................................ 443
Keratoconus Group Agreement............................................................................ 444

19 Glossary ................................................................ 446


Index ............................................................................. 448

RTVue XR Avanti User Manual Page 13 of 451 P/N 580-52576-005 Rev. A


List of Figures
Figure 1 System Hardware ............................................................................................ 25
Figure 2 Alternate System Hardware ............................................................................ 26
Figure 3 PATIENT Window Items ................................................................................. 52
Figure 4 Basic Search Area .......................................................................................... 53
Figure 5 Advanced Search Area ................................................................................... 54
Figure 6 Sample Patient List ......................................................................................... 56
Figure 7 Selections Made in PATIENT Window ............................................................ 57
Figure 8 Delete Current Patient Warning ...................................................................... 57
Figure 9 Add New Patient Dialog .................................................................................. 58
Figure 10 Add New Patient Optional Fields................................................................... 59
Figure 11 Select Move a visit to another patient ........................................................... 60
Figure 12 Confirm Intent to Move Selected Visit ........................................................... 60
Figure 13 Select Patient to Move Visit To ..................................................................... 61
Figure 14 Confirm Move to Selected Patient ................................................................. 61
Figure 15 SCAN Window AngioVue Comprehensive .................................................... 62
Figure 16 AngioVue Comprehensive scans & protocols ............................................... 63
Figure 17 AngioVue Retina Scan Selection Options ..................................................... 63
Figure 18 Scan Adjustment Options (Auto Tab) ............................................................ 64
Figure 19 Manual Tab to Customize Scan .................................................................... 65
Figure 20 Video Image Progression as Scanner Approaches Eye ................................ 66
Figure 21 Eye alignment ............................................................................................... 66
Figure 22 Auto Adjust fail .............................................................................................. 67
Figure 23 Auto Adjust focus .......................................................................................... 67
Figure 24 Optimize Working Distance ........................................................................... 68
Figure 25 Auto Adjust Combines Auto Z, Auto F and Auto P ........................................ 69
Figure 26 Example of Scan Centered Vertically ............................................................ 70
Figure 27 Tips to Optimize OCT results ........................................................................ 73
Figure 28 A Captured Scan (Save Button Active) ......................................................... 74
Figure 29 Fast-X Scan Captured ................................................................................... 75
Figure 30 Active Fast-Y Scan ........................................................................................ 76
Figure 31 Select Scan Type or Protocol ........................................................................ 78
Figure 32 SCAN Window Buttons ................................................................................. 79
Figure 33 User Preference Dialog ................................................................................. 80
Figure 34 Scan Adjustment Options (Auto Tab) ............................................................ 81
Figure 35 Follow-up and Tracking Mode Buttons .......................................................... 82
Figure 36 Followup and Tracking status indicators ....................................................... 83
Figure 37 Good IR Image (Left) and Poor IR Image (Right) .......................................... 83
Figure 38 Manual Tab Selected .................................................................................... 84
Figure 39 Review Window Components ....................................................................... 86
Figure 40 Patient Visit and scan list .............................................................................. 88
Figure 41 Measuring Tools............................................................................................ 90
Figure 42 A Sample B-Scan Window ............................................................................ 91
Figure 43 Right-Click Options on B-Scan Image ........................................................... 91
Figure 44 Segmentation line correction ......................................................................... 91
Figure 45 Line Right-Click Options ................................................................................ 92

RTVue XR Avanti User Manual Page 14 of 451 P/N 580-52576-005 Rev. A


Figure 46 Line Properties Dialog ................................................................................... 92
Figure 47 Area Fill Options............................................................................................ 93
Figure 48 Example B-Scan with Area, Line and Annotation .......................................... 94
Figure 49 CAM Measuring Tools ................................................................................... 95
Figure 50 Editing Tools ................................................................................................. 96
Figure 51 Right-Click Options When Editing Segmentation Lines ................................. 97
Figure 52 Widefield registration ................................................................................... 100
Figure 53 Baseline Disc Boundary Dialog ................................................................... 100
Figure 54 Optic Disc Margin in 3D Disc Report ........................................................... 101
Figure 55 3D Widefield Reference Scan on Reference Tab........................................ 102
Figure 56 Line Scan Report ........................................................................................ 103
Figure 57 Cross Line Scan Report .............................................................................. 104
Figure 58 Grid Scan Report ........................................................................................ 105
Figure 59 Raster Scan Report ..................................................................................... 106
Figure 60 Second page of Raster Report. ................................................................... 107
Figure 61 Raster Portrait Print page 1 ......................................................................... 108
Figure 62 Raster Portrait Print page 2 ......................................................................... 109
Figure 63 Radial Lines Report ..................................................................................... 110
Figure 64 Sample Radial Line Report Comparing B-Scans from Two Visits ............... 111
Figure 65 Enhanced HD Line Report, Vitreous Sample .............................................. 112
Figure 66 Retina Map Components............................................................................. 113
Figure 67 Retina Map Portrait Print Report ................................................................. 115
Figure 68 Retina Map Presentations that Include NDB Reference ............................. 116
Figure 69 Retina Map Reference Image Options with 2D Map and Chart On) ........... 117
Figure 70 Retina Map with Auto-Drawn Contour ......................................................... 119
Figure 71 Select Draw Contour ................................................................................... 120
Figure 72 Drawing a Contour Line .............................................................................. 121
Figure 73 Retina OU Report ........................................................................................ 123
Figure 74 OU Retina Map Portrait Print Report ........................................................... 124
Figure 75 Retina Map Change Analysis Report .......................................................... 125
Figure 76 Retina OverVue Report ............................................................................... 128
Figure 77 Retina OverVue Portrait Report .................................................................. 130
Figure 78 En Face Report with Tint Selected .............................................................. 131
Figure 79 En Face Report, Layers Shown as 3D Images ........................................... 132
Figure 80 3D Display, 3D Volume Checkbox Selected ............................................... 134
Figure 81 3D Display with 3D Volume Checkbox Selected ......................................... 136
Figure 82 3D Volume, All 4 Layers Selected ............................................................... 137
Figure 83 3D Volume, ILM Selected ........................................................................... 137
Figure 84 3D Volume with Vitreous Selected .............................................................. 138
Figure 85 3D Volume Image Options ......................................................................... 138
Figure 86 3D Preferences Dialog ................................................................................ 139
Figure 87 3D Widefield Report .................................................................................... 141
Figure 88 3D Retina Report ........................................................................................ 142
Figure 89 3D Disc Report ............................................................................................ 144
Figure 90 Optic Disc Margin in 3D Disc Report ........................................................... 145
Figure 91 A 3D Disc Scan Showing Eye Motion ......................................................... 146

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Figure 92 3D Disc Comparison Report........................................................................ 147
Figure 93 ONH Report Layout ..................................................................................... 148
Figure 94 RNFL and ONH Analysis Table................................................................... 149
Figure 95 RNFL Circle B-Scan .................................................................................... 150
Figure 96 TSNIT RNFL Thickness Graph ................................................................... 150
Figure 97 RNFL Thickness Map .................................................................................. 151
Figure 98 Hemisphere and Quadrant Maps ................................................................ 152
Figure 99 Vertical and Horizontal B-Scans.................................................................. 152
Figure 100 Baseline Image with RNFL Thickness Map Overlay ................................. 153
Figure 101 ONH OU Report ........................................................................................ 154
Figure 102 Verify RPE Tips ......................................................................................... 156
Figure 103 The GCC and Its Layers ........................................................................... 157
Figure 104 GCC Report Layout ................................................................................... 158
Figure 105 GCC Thickness Maps: Healthy Eye (Left), Glaucoma Eye (Right) ............ 159
Figure 106 Nerve Fiber ONH/GCC Change Analysis Report ...................................... 161
Figure 107 Marginally Significant Change ................................................................... 163
Figure 108 Statistically Significant Change ................................................................. 163
Figure 109 ONH/GCC OU Report ............................................................................... 164
Figure 110 ONH/GCC OU Portrait Report.................................................................. 165
Figure 111 Wellness Report ........................................................................................ 166
Figure 112 Wellness Report with vessel Density and FAZ .......................................... 166
Figure 113 Main Menu ................................................................................................ 167
Figure 114 File Menu .................................................................................................. 167
Figure 115 Print Setup Dialog ..................................................................................... 168
Figure 116 Print Header Dialog ................................................................................... 168
Figure 117 Output Selection Dialog............................................................................. 169
Figure 118 Export Options .......................................................................................... 170
Figure 119 Dialog for Image Import ............................................................................. 172
Figure 120 Archive Selection Dialog ........................................................................... 174
Figure 121 Secondary Backup Drive in User Preference Dialog ................................. 175
Figure 122 Batch Process Options .............................................................................. 176
Figure 123 Clean Diagnosis Data Options .................................................................. 178
Figure 124 Confirm Cleaning and Reprocessing ......................................................... 179
Figure 125 Tools Menu ............................................................................................... 179
Figure 126 Scan Pattern Management Dialog ............................................................ 180
Figure 127 Protocol Management Menu ..................................................................... 181
Figure 128 User Preference Dialog ............................................................................. 182
Figure 129 OCT Image Menu ...................................................................................... 185
Figure 130 Scan Parameter Setting Dialog ................................................................. 186
Figure 131 Database Management Menu ................................................................... 187
Figure 132 Protocol Editor Dialog ............................................................................... 188
Figure 133 Protocol Builder Dialog .............................................................................. 189
Figure 134 Physician Editor Dialog ............................................................................. 190
Figure 135 Dialog to Add or Edit Physician Name ...................................................... 191
Figure 136 Operator Editor Dialog .............................................................................. 191
Figure 137 Dialog to Add or Edit Operator Name ........................................................ 192

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Figure 138 Disease Editor Dialog ................................................................................ 193
Figure 139 Dialog to Add or Edit Disease Name ......................................................... 193
Figure 140 Help Menu ................................................................................................. 194
Figure 141 About RTVue XR Dialog............................................................................ 194
Figure 142 Select or Add Patient ............................................................................... 212
Figure 143 SCAN Window AngioVue Comprehensive ............................................... 212
Figure 144 Scan Selection Options AngioVue Comprehensive .................................. 213
Figure 145 Scan Adjustment Options (Auto Tab) ........................................................ 214
Figure 146 Manual Tab: Customize Scan ................................................................... 214
Figure 147 Video Image Progression as Scanner Approaches Eye ............................ 215
Figure 148 Auto Adjust Fail ......................................................................................... 216
Figure 149 Auto Focus Fail ......................................................................................... 216
Figure 150 Active AngioVue Scan Window ................................................................. 217
Figure 151 Auto Adjust Combines Auto Z, Auto F and Auto P .................................... 218
Figure 152 Examples of Scan Quality Alerts During Acquisition ................................. 221
Figure 153 Tips to Optimize OCT results .................................................................... 222
Figure 154 Fast-X Scan Captured ............................................................................... 223
Figure 155 Active Fast-Y Scan .................................................................................... 224
Figure 156 Fast-Y Scan Captured ............................................................................... 224
Figure 157 AngioVue Scan Complete ......................................................................... 225
Figure 158 Gray Scale and Color Viewing Options ..................................................... 226
Figure 159 Examples of Scans with SQ<6 .................................................................. 227
Figure 160 Saccadic Motion ........................................................................................ 228
Figure 161 Floaters ..................................................................................................... 229
Figure 162 Blink .......................................................................................................... 230
Figure 163 Excessive Motion ...................................................................................... 231
Figure 164 Image Crop ............................................................................................... 232
Figure 165 Retina Segmentation Layers ..................................................................... 232
Figure 166 Disc Segmentation Layers ........................................................................ 234
Figure 167 Disc Margin and Margin Correction ........................................................... 236
Figure 168 Incorrect IPL segmentation ....................................................................... 238
Figure 169 IPL Boundary Selected, Anchor Points Activated ...................................... 239
Figure 170 Single B-Scan Corrected (IPL Line Turned Purple), not Propagated ........ 239
Figure 171 Segmentation Correction and Propagation Applied .................................. 240
Figure 172 PAR Off and PAR On (same Outer Retina Slab) ...................................... 241
Figure 173 Example: 3 mm AngioRetina Scan of Patient with Diabetic Retinopathy, with
and without PAR ......................................................................................................... 242
Figure 174 Example: 3 mm AngioRetina Scan of Patient with CNV, with and without
PAR ............................................................................................................................. 243
Figure 175 Example:4.5 mm HD AngioDisc Scan, with and without PAR ................... 243
Figure 176 Angio Retina Essential Report .................................................................. 245
Figure 177 Essential Report with Choroidal Capillary en face selected ...................... 245
Figure 178 Essentials Report with segmentation raised to evaluate flow .................... 246
Figure 179 Angio Retina OverVue, Angio Selection .................................................... 247
Figure 180 Angio Retina OverVue Portrait Report, Angio Selection ........................... 249
Figure 181 Angio Retina OverVue Report, OCT/OCTA Selection ............................... 250

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Figure 182 Angio Retina OverVue Report, OCT/OCTA Selection ............................... 251
Figure 183 Angio Retina Main Report ......................................................................... 252
Figure 184 3-D Retina Image ...................................................................................... 253
Figure 185 Top Center Image Tabs, Thickness Tab Selected .................................... 254
Figure 186 Angio Retina Main Report, En Face Tab Selected .................................... 255
Figure 187 Angio Retina Main Report, Color Overlay Tab Selected (Default to Movie)
.................................................................................................................................... 257
Figure 188 Movie Paused Between Deep and Outer Reina ........................................ 257
Figure 189 Angio Retina Multiple Visit Report ............................................................. 259
Figure 190 Montage showing Vitreous/Retina layers ................................................. 261
Figure 191 Montage Edit Screen ................................................................................. 262
Figure 192 Example of Type 2 CNV ............................................................................ 264
Figure 193 Angio Disc OverVue, Angio Selection ....................................................... 265
Figure 194 Angio Disc OverVue Report, Angio Selection, Portrait View ..................... 267
Figure 195 Angio Disc OverVue Report, OCT/OCTA Selection .................................. 268
Figure 196 Angio Disc Main Report, En Face Tab Selected ....................................... 269
Figure 197 Angio Disc Central Image Tabs................................................................. 270
Figure 198 Angio Disc Main Report, SLO Tab with Color Selected ............................ 272
Figure 199 Angio Disc Main Report, En Face Tab Selected ....................................... 273
Figure 200 Angio Disc Main Report, Color Overlay Tab with Movie Selected ............. 274
Figure 201 Angio Disc Multiple Visit Report ................................................................ 275
Figure 202 Angio Retina vs GCC Scan Comparison ................................................... 278
Figure 203 Sector Crop >30% Marked NA .................................................................. 280
Figure 204 Grid centration........................................................................................... 281
Figure 205 Angio Retina Measurement Zones and Parameters ................................. 283
Figure 206 6 mm HD Angio Retina, Main Report ........................................................ 285
Figure 207 Measurement Window Slection ................................................................. 285
Figure 208 Superficial and Deep Vessel Density Measurements ................................ 287
Figure 209 Angio Retina Main Report, Thickness Tab with Full Retina Thickness
Selected ...................................................................................................................... 288
Figure 210 Retina Multi Scan Showing Superficial Density ......................................... 288
Figure 211 FAZ Parameters ........................................................................................ 289
Figure 212 Examples of FAZ Detection based on Angio Retina 3mmx3mm scan. ..... 290
Figure 213 Examples of FAZ Detection based on Angio Retina HD 6mmx6mm scan. 290
Figure 214 FAZ Editing ............................................................................................... 292
Figure 215 FAZ Multiscan Report ............................................................................... 293
Figure 216 6 mm HD AngioRetina, QuickVue Report ................................................. 293
Figure 217 Angio Retina Trend Report, Superficial Vessel Density selected. ............. 294
Figure 218 Flow .......................................................................................................... 296
Figure 219 Circle Flow ................................................................................................ 297
Figure 220 Circle Flow, Moved and Reduced ............................................................. 297
Figure 221 Contour Area of Flow Highlighted Yellow and Measured .......................... 298
Figure 222 Angio Retina Multiscan Report, Outer Retina Slab and Flow Selection .... 299
Figure 223 Select NonFlow in Measurement Window ................................................. 300
Figure 224 Area of Non-Flow Highlighted Yellow and Measured ................................ 300
Figure 225 Additional Non-Flow Areas Selected and Measured ................................. 301

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Figure 226 Flow and NonFlow Indicators on the Scan List ......................................... 302
Figure 227 Disc Parameters........................................................................................ 303
Figure 228 Disc Parameters Comparison between ONH OCT and AngioDisc Scans 304
Figure 229 Angio Disc Measurement Zones and Parameters ..................................... 305
Figure 230 Eight Sector Peripapillary Grid .................................................................. 306
Figure 231 Angio Disc, Main Report with En Face Tab and Density Selected ............ 307
Figure 232 Large Vessels Mask .................................................................................. 308
Figure 233 Angio Disc Multi Scan Report, RPC Slab and Vessel Density Selected ... 309
Figure 234 Angio Disc Main Report, Thickness Tab Selected .................................... 309
Figure 235 Angio Disc QuickVue Report ..................................................................... 310
Figure 236 Angio Disc Trend Report, Vessel Density Selected. ................................. 311
Figure 237 Angio Disc Tren Report, RNFL Thickness Selected .................................. 312
Figure 238 MCT Scan Acquisition and Effect in 3D Volumes, En Face Views ............ 329
Figure 239 MCT Scan Acquisition and Effect in 3D Volumes, Cross-Sectional Views 329
Figure 240 3D Widefield MCT Scan Example Covering Both Macula And Optic Disc 330
Figure 241 Scanner head with fixation and cornea illumination lights ......................... 379
Figure 242 Scan pattern selection ............................................................................... 382
Figure 243 B scan between red lines .......................................................................... 384
Figure 244 Iris image................................................................................................... 384
Figure 245 Iris and B scan image for Angle ................................................................ 385
Figure 246 Cross line centering .................................................................................. 385
Figure 247 Line scan report ........................................................................................ 387
Figure 248 Cross line report ........................................................................................ 388
Figure 249 B scan with Measurement tool .................................................................. 388
Figure 250 B scan with artifact .................................................................................... 389
Figure 251 B scan of angle ......................................................................................... 390
Figure 252 Four scan display page ............................................................................. 390
Figure 253 3D Cornea report ...................................................................................... 391
Figure 254 3D Cornea Volume presentation ............................................................... 392
Figure 255 Illustration of Pachymetry scan pattern, 8 meridians, 6mm long ............... 392
Figure 256 Pachymetry report ..................................................................................... 393
Figure 257 Pachymetry report with epithelial thickness/Stroma map .......................... 394
Figure 258 Symmetry Analysis for Pachymetry Results (Normalized) ........................ 395
Figure 259 Change Analysis Results for Pachymetry, Cornea Power and
Epithelial/Stroma Map ................................................................................................. 395
Figure 260 9mm Widefield Pachymetry with Epithelial/Stroma thickness ................... 396
Figure 261 Widefiled Pachymetry with normalized Epithelial scale ............................. 397
Figure 262 Widefield Pachymetry Change Analysis .................................................... 397
Figure 263 Widefield Pachymetry OU report with Epithelial/Stroma maps .................. 398
Figure 264 Pachymetry report with Corneal power values .......................................... 400
Figure 265 Pachymetry & Epithelial change analysis with Corneal Power values ...... 401
Figure 266 repeatability (standard deviation) of the corneal power scan .................... 402
Figure 267 Pachymetry report displaying Epithelial thickness map ............................. 403
Figure 268 Pachymetry Change Analysis with Epithelial Thickness/Stroma and Corneal
Power .......................................................................................................................... 404

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Figure 269 Pachymetry OU Report With Epithelial Mapping/Stroma and Corneal Power
.................................................................................................................................... 405
Figure 270 Mounting of Corneal power validation tool ................................................ 410
Figure 271 Validation message ................................................................................... 411
Figure 272 Validation screen ....................................................................................... 411
Figure 273 OCT Reflection signal ............................................................................... 412
Figure 274 Validation failure message ........................................................................ 412
Figure 275 Curvature illustration ................................................................................. 413
Figure 276 Invalid scan. No corneal power measurements are calculated ................. 414
Figure 277 Poor reliability index. ................................................................................. 415
Figure 278 Scan out of range ...................................................................................... 416
Figure 279 Eyelid blocking more than 1 mm of the image........................................... 417
Figure 280 Eyelid blocking between 0.5 mm ~ 1 mm of the image. ............................ 418
Figure 281 Eyelid / Eyelash artifact ............................................................................. 419
Figure 282 Misalignment on pupil between 0.5 mm ~ 1 mm. ...................................... 420
Figure 283 Pupil blocked by eyelid in the video image and alignment cannot be
assessed. .................................................................................................................... 421
Figure 284 Automatic segmentation boundaries Lasik ................................................ 422
Figure 285 Automatic segmentation boundaries PRK ................................................. 423
Figure 286 Segmentation error ................................................................................... 424
Figure 287 Reprocessed Map ..................................................................................... 425

_______________End of section_______________

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1 Introduction
General
Optovue, Inc. has developed and tested the RTVue XR Avanti System (Avanti System)
with DualTrac and AngioVue software in accordance with Optovue, Inc. safety
standards, as well as national and international regulatory guidelines and all applicable
safety standards to ensure a high degree of instrument safety. Please observe all
labeling related to safety, including information and notes in this manual and on the
device labels. This device does not produce any waste that needs disposal. This
product contains no material that presents a chemical hazard concern.

Section 10 of this manual contains information for AngioVue Software on the RTVue XR
Avanti System. It offers further information on acquisition and review of only the
AngioVue scans, which are a subset of the scans available with the Avanti
Comprehensive, or the Avanti Retina System.

1.1.1 Proper Instrument Use


• Always enter patient information first.

• Clean patient contact surfaces (forehead and chin rest, according to the cleaning
method in this manual in chapter 7).

• The power cord is the only way to disconnect the system completely from the
power source. For any emergency, turn the system power OFF, then immediately
unplug the power cord from the wall or from the system.

• Clean the ocular lens frequently to ensure good image quality.

• Adjust power table height properly to ensure patient comfort during the examination.

• Raise or lower the patient’s head so the eye aligns with the canthus mark on the chin
and forehead rest assembly.

• Dim the room lights to allow natural dilation of the patient’s pupil, and to reduce glare
and provide comfortable visualization of the fixation target.

+ Note: Chemically induced pupil dilation is not normally needed.

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• Warn others not to sit or stand on any part of the table,
including the base and the top.

• When lowering the table, make sure that pinch point areas are clear of people and
articles; do not store articles in these areas.

• To avoid pinching the patient, check the patient’s head position before raising the chin
rest.

1.1.2 Indications for Use


The Avanti is an optical coherence tomography system indicated for the in vivo imaging,
axial cross-sectional, and three-dimensional imaging and measurement of anterior and
posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell
complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma, pachymetry,
corneal power, and anterior chamber of the eye. With the integrated normative
database, Avanti is also a quantitative tool for the comparison of retina, retinal nerve
fiber layer, and optic disc measurements in the human eye to a database of known
normal subjects. It is intended for use as a diagnostic device to aid in the detection and
management of ocular diseases.

The Avanti with the AngioVue software feature is indicated as an aid in the visualization
of vascular structures of the retina and choroid in normal subjects, and in subjects with
glaucoma and retina diseases. The AngioAnalytics software feature of AngioVue is
indicated for the measurement of vascular density, the foveal avascular zone, the
thickness of retinal layers, and nerve fiber layer, and measurement of optic disc
parameters in normal subjects, and in subjects with glaucoma and retinal diseases .

Contraindications
Contre-indications

This device is not designed, sold or intended for use except as


indicated.

Cet appareil n'est pas conçu ni vendu pour être utilisé de toute autre
manière que celle spécifiée.

+ Note: The RTVue XR Avanti System is not intended to be used as the sole
diagnostic aid in disease identification, classification or management. The system
provides data to be used in conjunction with other information, intended to assist an eye

RTVue XR Avanti User Manual Page 22 of 451 P/N 580-52576-005 Rev. A


care clinician in determining a diagnosis. Patient diagnosis is the sole domain of a
licensed eye care clinician.

+ Remarque : Le systéme RTVue XR Avanti n'est pas destiné à être utilisé comme
seul outil de diagnostic pour l'identification, le classement ou le traitement des maladies.
Les données produites par le systéme peuvent être utilisées de pair avec d'autres
données destinées à aider le clinicien des soins oculaires à établir un diagnostic. Le
diagnostic du patient est le domaine exclusive linicien de soins oculaires qualifié.

+ Note: The RTVue XR Avanti System with AngioVue software is not intended as a
substitute for fluorescein angiography.

+ Remarque : Le systéme RTVue XR Avanti avec AngioVue logiciel ne vise pas


comme un substitut pour angiographie à la fluorescéine.

1.1.3 Equipment Classification


• Type of protection against electric shock: Class 1

• Degree of protection against harmful ingress of water: IPX0

• Class of operation: Continuous

1.1.4 Certification
To ensure full system quality, the RTVue XR Avanti System has been manufactured in
a registered ISO 9001 or 13485 facility. It has been designed and tested to be compliant
when used with the laboratory equipment requirements of applicable regulatory
agencies. Declarations of conformity and certificates of compliance are available at
www.optovue.com.

System Overview
1.2.1 System Components
The system ships in one palletized box, which contains the following hardware.

• Scanner: This is the main component of the System. It is used to view and scan the
patient’s eye, collect the OCT signal, and send it to the computer for processing.

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• Computer: The system computer supports scanner operation, and processes, stores
and displays exam data through the application software. The searchable RTVue
database stores and organizes patient and exam data.

• Monitor: A 21.5 in. LCD widescreen flat panel monitor provides the graphical user
interface (GUI).

+ Note: The monitor resolution is set at the factory to 1920 X 1080. We


recommend you confirm this setting before first use.

• Keyboard and Mouse: Standard USB-connected input devices

• System Table: The system table holds all system components and powers them
through a medical grade isolation transformer, which prevents current leakage from
main AC power. It rests on lockable wheels, making the system portable, and its height
is adjustable through a medical grade telescopic lift.

+ Note: Optovue recommends connecting the system via an uninterruptible power


supply (UPS) to the wall outlet.

+ Note: The Avanti Comprehensive has Retina, Nerve fiber, Cornea, and AngioVue
scans. The Avanti Retina is a simplified version with AngioVue scans for OCTA
imaging and only Retina scans for OCT imaging.

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The system hardware appears below from the operator’s perspective. The following
legend identifies the callouts.

13
14

1
2
12

11 4
3

10

9
8
5

6
6

Figure 1 System Hardware

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13
14

1
2
12

11

10

9 8
4

3 5

6
7 6

Figure 2 Alternate System Hardware

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Figure 1&2 Legend:

1. 1 Scanner 8. 8 Keyboard and mouse (enclosed in


retractable shelf)
2. 2 Monitor
9. 9 System table
3. 3 Power switch
10. 10 Chin rest up/down switch
4. 4 Table up/down switch
11. 11 Joystick
5. 5 Computer
12. 12 Forehead rest
6. 6 Wheels and locks (x4)
13. 13 External fixation light
7. 7 Warning, RTVue, and serial number
labels 14. 14 Red LED to illuminate eye for CAM (x2)

1.2.2 System Configurations


• Model: RTVue XR-100-1: 110 VAC

• Model: RTVue XR-100-2: 230 VAC

• Model: RTVue XR-100

1.2.3 Power On and Launch the System


Follow these steps to power on and launch the system:

1. Turn on the system table using its power switch.

2. Turn on the system computer using its power switch.

3. After the computer operating system has fully launched (can take up to a minute),
double-click the RTVue XR Avanti desktop icon to launch the system software.

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System Warnings
Avertissements du Système

WARNING: During normal use, software periodically polls the system


status through the USB. Whenever software detects abnormality in status,
it halts operation and flags error messages to warn users. Upon seeing the
error messages, please exit the RTVue application and reboot the system.

WARNING: No modification of this equipment is allowed.

WARNING: Do not modify this equipment without authorization of the


manufacturer.

WARNING: If this equipment is modified, appropriate inspection and


testing must be conducted to ensure continued safe use of the equipment.

WARNING: Optovue recommends that no accessories other than those


specifically called out in this user manual may be connected to the system.
Any customer accessory equipment connected to the interface ports must
be certified according to the respective IEC standards (for example, IEC
60950 for data processing equipment and IEC 60601-1 for medical
equipment) Also, all configurations shall comply with the system standard
IEC 60601-1:2005. Any person who connects or installs accessories to the
system has the responsibility to verify the compliance. If in doubt, consult
an Optovue representative.

Avertissement : Il est recommandé de ne pas brancher sur l'instrument


d'autres accessoires que ceux expressément mentionnés dans ce mode
d'emploi. Tout équipement accessoire client branché aux ports d'interface
doit être certifié selon les normes CEI respectives (p. ex. la norme CEI
60950 pour le matériel informatique et la norme CEI 60601-1 pour
l'équipement médical). En outre, toutes les configurations doivent être
conformes à la norme système IEC 60601-1: 2005. Il incombe à toute
personne qui branche ou qui installe des accessoires à l'appareil de vérifier
la conformité de ces accessoires. En cas de doute, parlez à un
représentant d'Optovue.

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General Warnings

ESD WARNING: Before assembly, installation or interconnection of the


system, Optovue recommends that any staff (that is, biomedical engineers and
health care staff) that could touch connectors identified with the ESD warning
symbol undergo electrostatic discharge (ESD) training. At minimum, ESD
training should include an introduction to the physics of electrostatic charge,
the voltage levels that can occur in normal practice and the damage that can
be done to electronic components if they are touched by an operator who is
electrostatically charged. Furthermore, an explanation should be given of
methods to prevent build-up of electrostatic charge, and how and why to
discharge one’s body to earth or to the frame of the equipment or system, or
bond oneself by means of a wrist strap to the equipment or system or to earth,
before making a connection. Finally, staff must be made aware that accessible
pins of connectors identified with the ESD warning symbol should not be
touched with the fingers or with a handheld tool, unless proper precautionary
procedures have been followed.

WARNING: Do not connect the instrument with anything other than those
connections specified. Otherwise, it may result in fire or electric shock. For
details of purchasing accessories, please contact an Optovue representative or
distributor. To avoid risk of electric shock, this equipment must be connected
only to supply mains with protective earthing.

+ Note: Avoid the use of extension cords or a power strip.

WARNING: The use of accessories, transducers and cables other than those
specified may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the system.

WARNING: Components of the system should not be used adjacent to or


stacked with other equipment, and, if adjacent or stacked use is necessary, the
system should be observed to verify normal operation in the configuration in
which it will be used.

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WARNING: The system cannot replace clinical judgment and is intended
to be used only in conjunction with other clinical tools considered to be
the standard of care for diagnosis of eye health and disease.

The system is not intended to be used as the sole diagnostic aid in disease
identification, classification or management. The system provides data to be
used in conjunction with other information, intended to assist an eye care
clinician in determining a diagnosis. A patient diagnosis is the sole domain of a
licensed eye care clinician.

WARNING: Equipment is not suitable for use in the presence of a Flammable


Anesthetic Mixture with Air, Oxygen, or Nitrous Oxide.

WARNING: The system has no special protection against harmful ingress of


water or other liquids (classified IPX0). To avoid damage to the instrument and
cause a safety hazard, the cleaning solutions, including water, should not be
directly applied to the device. Using a dampened cloth (without dripping) is a
good method to clean the exterior surface of the enclosure. The table can be
cleaned in the same manner as the system. Care should be taken to avoid
excess fluid near any of the system components.

WARNING: While being examined, the patient must not touch any part of his or
her body to an electrical device that is not powered by the system. In addition,
while examining the patient, the system operator must not touch at the same
time the patient and any electrical device that is not powered by the system.
Failure to observe these warnings could result in electrical shock to the patient
and/or operator.

WARNING: Use power cords provided only by Optovue. Do not block access
to unplug the power cord.

To remove power from the system, you must disconnect the mains plug
from the wall outlet. Do not position the system where plugs are
inaccessible during operation.

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Caution: The Normative Database and the results displayed based on
estimated percentiles should be used only as an aid for making clinical
decisions. The results from the normative database comparison should never
be used in isolation, but only as one part of the entire clinical armamentarium.
Patients who are not represented by the patients in the normative database
may not be suitable for comparison to the normative database. In these
patients, the normative database results should be used with caution, if at all.
This includes patients outside the age range of the normative database, that is,
outside 18 – 82 years of age; or patients outside the range of refractive error,
that is, more than 8 diopters spherical error or 2 diopters cylindrical error.
Results in patients 30 years of age or younger, and 80 years of age or older,
should be interpreted with caution, since only 4 subjects below the age of 30
and three subjects above the age of 80 were included in the normative
database. It should be noted that this normative database does not have any
subject younger than 18 years of age. The color categorization of a pixel
presents the percentile with regard to the distribution of thickness at the
specific location of a given pixel.

Caution: The color normative maps provide a way to represent whether a


given patient is similar or dissimilar to a “Normal” patient. This information does
not provide further diagnostic information beyond representing whether a given
patient is similar or dissimilar to a “Normal” patient.

Caution: Normative database comparisons are based on statistical


comparisons only, and there are possible normal outliers.

Caution: OCT image is a plot of optical path length. Depending on the optical
design and scanning location, the image can be distorted from its actual
physical shape. For example, a relatively flat retinal OCT image might not
reflect the true curvature of the retina.

Caution: The OCT image can be affected by the optical pathway, that is, by
corneal opacity, cataract or eye shape.

Caution: Federal law restricts this device to the sale by or on the order of a
Physician or Practitioner (CFR 801.109(b) (1).

Mise en garde: La loi fédérale américaine limite la vente de cet appareil


directement aux médecins ou praticiens ou sur ordonnance (CFR 801.109 (b)
(1)).

RTVue XR Avanti User Manual Page 31 of 451 P/N 580-52576-005 Rev. A


1.4.1 WARNING: User Changes to Software or Hardware

The RTVue XR Avanti System is a medical device. The software and


hardware has been designed in accordance with U.S., European and other
international medical device design and manufacturing standards.
Unauthorized modification of the system software or hardware, or any
addition or deletion of any application in any way, can jeopardize the safety
of operators and patients, the performance of the instrument, and the
integrity of patient data.

Any changes, additions or deletions to factory installed applications,


the operating system, or modifications to hardware in any manner
VOIDS the warranty completely and can cause SAFETY HAZARDS.

Avertissement : Modifications apportées par l'utilisateur au logiciel


ou au matériel informatique.

Le systéme RTVue XR Avanti est un instrument médical. Le logiciel et le


matériel informatique ont été conçus conformément aux normes de
conception et de fabrication des appareils médicaux en vigueur aux É.-U.,
en Europe et ailleurs. Toute modification non autorisée du logiciel ou du
matériel informatique du systéme, ou tout ajout ou suppression d'une
application de quelque manière que ce soit peut présenter un risque pour
la sécurité des opérateurs et des patients, le fonctionnement de
l'instrument et l'intégrité des données des patients.

Tout changement, ajout ou suppression aux applications installées en


usine et au système d'exploitation et toute modification au matériel
informatique, de quelque manière que ce soit, ANNULERONT
complètement la garantie et pourraient présenter un DANGER.

1.4.2 WARNING: Phototoxicity

Because prolonged intense light exposure can damage the retina, the use
of the device for ocular examination should not be prolonged
unnecessarily, and the brightness setting should not exceed what is
needed to provide clear visualization of the target structures.

The retinal exposure dose for a photochemical hazard is a product of the


radiance and the exposure time. If the value of radiance were reduced in
half, twice the time would be needed to reach the maximum exposure
limit.

RTVue XR Avanti User Manual Page 32 of 451 P/N 580-52576-005 Rev. A


While no acute optical radiation hazards have been identified for direct or
indirect ophthalmoscopes, it is recommended that the intensity of light
directed into the patient’s eye be limited to the minimum level which is
necessary for diagnosis. Infants, aphakes and persons with diseased
eyes will be at greater risk. The risk may also be increased if the person
being examined has had any exposure to the same instrument or any
other ophthalmic instrument using a visible light source during the
previous 24 hours. This will apply particularly if the eye has been exposed
to retinal photography.

Avertissement : Phototoxicité

Du fait que l'exposition prolongée à une lumière intense peut


endommager la rétine, l'utilisation du dispositif pour l'examen oculaire ne
doit pas être inutilement prolongée, et le réglage de la luminosité ne doit
pas dépasser l'intensité nécessaire pour obtenir une visualisation claire
des structures cibles.

La dose d'exposition rétinienne susceptible de présenter un danger


photochimique est le résultat de l'intensité de radiation et de la durée
d'exposition. Lorsque la valeur de rayonnement est réduite de moitié, le
délai nécessaire pour atteindre la limite d'exposition maximale double.

Même si aucune étude ne montre que les rayonnements optiques des


ophtalmoscopes directs ou indirects ont un effet de toxicité aiguë, il est
recommandé de réduire l'intensité de la lumière dirigée dans l'œil du
patient au niveau strictement nécessaire pour établir le diagnostic. Les
nourrissons, les personnes souffrant d'aphakie (absence de cornée) et les
personnes souffrant d'une maladie oculaire sont les plus à risque. Le
risque peut également augmenter lorsque la personne examinée a été
exposée au même instrument ou à tout autre instrument ophtalmique
utilisant une source de lumière visible au cours des 24 dernières heures.
Cela est particulièrement vrai lorsque les yeux ont été exposés à une
photographie rétinienne.

RTVue XR Avanti User Manual Page 33 of 451 P/N 580-52576-005 Rev. A


Do not step on surface.

Ne pas marcher sur la surface.

WARNING: Electricity

Avertissement : Électricité.

Power and Electrical Safety

“Partial On” symbol


above the power switch

ON/OFF - Even with


switch off, there is
power to the table
column.

ON/OFF - La colonne
de la table reste sous
tension même
lorsque l'instrument
est arrêté.
Electrical rating (voltage/current)
and equipment specified for each
exposed socket outlet.

Maximum Permissible
Load (See socket
label. For use by
Optovue personnel
only.)
Charge maximale
admissible (voir
l'étiquette de la prise)

RTVue XR Avanti User Manual Page 34 of 451 P/N 580-52576-005 Rev. A


Alternate Power and Electrical Safety

ON/OFF

UP/DOWN

Maximum
Permissible
Load (For use
by Optovue
personnel
only.)
Charge
maximale
admissible

RTVue XR Avanti User Manual Page 35 of 451 P/N 580-52576-005 Rev. A


Safety with Moving Parts
Table Handling Instructions
Directives de manipulation de la table

Read the warning label on the table


column for instructions to safely
transport the table from room to room.
The instructions tell you to lower the
table to its lowest height before
transport. Observe the pinch point and
foot trap warnings before lowering the
table, to avoid trapping or pinching a
foot, leg, hand or arm.

Pinch Warning Locations

Emplacements pour les avertissements


de risque de pincement.

Please observe pinch warnings before raising and lowering the table.

Veuillez lire les avertissements sur le risque de pincement avant de relever ou


d'abaisser la table.

Foot Rest Trapping Warning

Do not step on table base when


adjusting table height.

Avertissement de risque de
coincement dans le repose-pied

RTVue XR Avanti User Manual Page 36 of 451 P/N 580-52576-005 Rev. A


Ne pas poser les pieds sur base de
table lors de l’ajustement hauteur de
table.

Table Up/Down Label


Étiquette d’abaissement/relèvement de
la table

Table Up/Down Label


Étiquette d’abaissement/relèvement
de la table

Pinch warning label


locations
Emplacements pour les
avertissements de risque
de pincement

Do not step here.


Ne pas pieds ici.

RTVue XR Avanti User Manual Page 37 of 451 P/N 580-52576-005 Rev. A


A.

WARNING: Possible Pinch Locations

Avertissement : Zones de risque de pincement

A. Space between bottom of the table top and base of column


Espace entre le dessous de la plateforme de la table et le col de la colonne

B. Space between bottom of the PC and the base


Espace entre le fond de la PC et à la plateforme de la table

RTVue XR Avanti User Manual Page 38 of 451 P/N 580-52576-005 Rev. A


C. Space between chin rest and forehead rest
Espace entre la mentonnière et l'appui-tête

How to lock wheels:


Étiquette de blocage de roué:

Locked Unlocked Wheel lock label


Verrouillé Déverrouillé

Standard Accessories

1.8.1 Standard Accessories

Description Part No. Quantity

Installation Manual 810-48858-002 1 pc.

Dust Cover 530-42553 1 pc.

Lock cover Plug, Plastic,, 3/8" OD 620-50389-001 1 pc.

Hardware Kit 500-48112-001 1 pc.

Plug, Plastic Push-in Round 5/8 ID 620-47485-001 3 pc.

Mouse 600-44542 1 pc.

USB Keyboard 600-48557-001 1 pc.

RTVue XR Avanti User Manual Page 39 of 451 P/N 580-52576-005 Rev. A


1.8.2 Cabling
System Cabling

Shielded or Cable Max.


Cable Name Cable Type
Unshielded Length

PC AC 3 wire Unshielded 1m

PC DC 2 wire Unshielded 1m

Keyboard, Mouse USB Shielded 1m

RTVue AC 3 wire Unshielded 1m

RTVue PC USB Shielded 1m

RTVue Scan Head Multi wire Shielded 1.5 m

RTVue Optical Fiber Pair Unshielded 2m

RTVue GigE CAT 6 Unshielded 1m

RTVue Chinrest Multi wire Shielded 1.5 m

RTVue Joystick 2 wire Shielded 0.2 m

Column AC 3 wire Unshielded 2m

RTVue XR Avanti User Manual Page 40 of 451 P/N 580-52576-005 Rev. A


Product Compliance
1.9.1 CB Certification: Under IEC 60601-1-2 4th Ed.
This device is classified according to UL/IEC/BS EN 60601-1-2 4th Ed. (2015) as
follows:

Mobile, Continuous Operation, Class 1, Type B.

With respect to electrical shock, fire and mechanical hazards only in accordance with
UL/IEC/BS EN 60601-1-2 4th Ed. (2015) and CAN/CSA C22.2 No. 601.1.

ON for part of the Equipment.


Une partie de l'équipement est en marche (« ON »).

Alternating Current
Courant alternatif

Radio Interference
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of FCC rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with this user manual,
may cause interference to radio communications. Operation of this equipment in a
residential area is likely to cause interference, in which case users will be required to
correct the interference at their own expense.

1.10.1 Canadian Regulations


This equipment does not exceed the Class A limits for radio noise emissions from digital
apparatus as set out in the radio interference regulations of the Canadian Department of
Communications.

Le présent appareil numérique n’émet pas de bruits radioélectriques dépassant les


limites applicables aux appareils numériques de Classe A prescrites dans le reglement
sur le brouillage radioelectrique édicté par le Ministère des Communications du
Canada.

RTVue XR Avanti User Manual Page 41 of 451 P/N 580-52576-005 Rev. A


1.10.2 Electromagnetic Compatibility (EMC): EN 60601-1-2 4th Ed.
The RTVue XR Avanti System has been tested to comply with the emission and
immunity requirements of IEC 60601-1-2 4th Ed. / BS EN 60601-1-2:2007. The system
is intended for use in an electromagnetic environment where radiated RF disturbances
are not beyond the standard defined in IEC 60601-1-2 4th Ed. / BS EN60601-1-2:2007.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC


EMISSIONS

The system is intended for use in the electromagnetic environment specified below. The
system customer or user should ensure that it is used in an appropriate environment.

Test type Test level Compliance Electromagnetic Environment - Guidance

Conducted
Emissions
Class A Class A
EN group 1 group 1 The RTVue uses RF energy only for its internal function.
55011:2009+A Therefore, its RF emissions are very low and are not likely
1:2010, CISPR 150 kHz to 150 kHz to to cause any interference in nearby electronic equipment.
11:2009+A1:2 30 MHz 30 MHz
010

Radiated
Emissions
Class A
Class A The system is suitable for use in all establishments other
EN
group 1
group 1 than domestic, and may be used in domestic
55011:2009+A establishments and those directly connected to the public
1:2010, CISPR 30 MHz to low-voltage power supply network that supplies buildings
11:2009+A1:2 1 GHz 30 MHz to
used for domestic purposes, provided the following
010 1 GHz
WARNING is heeded:

Harmonics WARNING: This equipment/system is intended for use by


Per Clause healthcare professionals only. This equipment/ system may
IEC/EN Class A
5 of the cause radio interference or may disrupt the operation of
61000-3- Device
Standard nearby equipment. It may be necessary to take mitigation
2:2014

RTVue XR Avanti User Manual Page 42 of 451 P/N 580-52576-005 Rev. A


Flicker measures, such as re-orienting or relocating the system, or
Per Clause Per Clause shielding the location.
IEC/EN
5 of the 5 of the
61000-3-
Standard Standard
3:2013

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should assure that it is used in such an environment.

IEC 60601
Immunity test Compliance level Electromagnetic environment guidance
test level

While the 15 kV ESD air discharge IMMNITY


8 kV TEST LEVEL specified in this collateral
8 kV
Electrostatic contact standard for the professional healthcare
contact facility environment and the HOME
discharge (ESD) discharge
discharge HEALTHCARE ENVIRONMENT is higher
 2, 4, 8
 2, 4, 8 &15kV than the ESD air discharge IMMUNITY TEST
IEC/EN 61000-4-2 &15kV
LEVEL specified in IEC 60601-1-2:2007,
air discharge MANUFACTURERS should determine if even
air discharge
15 kV is adequate for the environments of
INTENDED USE..

2 kV AC
Mains
2 kV AC Mains
Electrical fast
1 kV I/O
transient/burst 1 kV I/O Lines
Lines Mains power quality should be that of a
5/50
5/50 typical commercial or hospital environment.
IEC/EN 61000-4-4
5kHz &100 kHz
5kHz &100
kHz

RTVue XR Avanti User Manual Page 43 of 451 P/N 580-52576-005 Rev. A


GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

1 kV
Surge Line to 1 kV
Line Line to Line
Line to Line Mains power quality should be that of a
(AC Power) 2 kV
2 kV typical commercial or hospital
environment.
IEC/EN 61000-4-5 Line to
Line to Ground
Ground

The MANUFACTURER should


consider reducing the minimum
80 MHz - 2.7 80 MHz - 2.7 separation distance, based on
GHz GHz
3 V/m 80% 3 V/m 80% @ 1 RISK MANAGEMENT and using
higher IMMUNITY TEST LEVELS that
Radiated RF @ 1 kHz kHz are appropriate for the reduced
minimum separation distance.
IEC/EN 61000-4-3 Minimum separation distances for
Spot Spot frequencies higher IMMUNITY TEST LEVELS
frequencies 385MHz – 5.750 shall be calculated using the following
385MHz – GHz Pulse equation:
5.750 GHz Modulation
Pulse E = (6/d)P
Modulation Where P is the maximum power in W,
d is the minimum separation distance
in m, and E is the
IMMUNITY TEST LEVEL in V/m.
Proximity field
from RF wireless See EN If the ME EQUIPMENT or ME SYSTEM
communications 60601-1- See EN 60601-1- complies with higher IMMUNITY TEST
equipment 2:2014 Table 2:2014 Table 9 LEVELS for this test, the 30 cm minimum
9 separation distance in 5.2.1.1 f) may be
IEC 61000-4-3
replaced with minimum separation distances
calculated from the higher IMMUNITY TEST
LEVELS.

RTVue XR Avanti User Manual Page 44 of 451 P/N 580-52576-005 Rev. A


GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The ISM (industrial, scientific and medical)


0.15 - 80 bands between 0,15 MHz and 80 MHz are
Conducted MHz 0.15 - 80 MHz 6,765 MHz to 6,795 MHz; 13,553 MHz to
Immunity 13,567 MHz; 26,957 MHz to 27,283 MHz;
3 Vrms & 3 Vrms & 6Vrms
and 40,66 MHz to 40,70 MHz. The amateur
(AC Power) 6Vrms in in ISM &
radio bands between 0,15 MHz and 80 MHz
ISM & amateur bands
(I/O Lines) amateur 1 kHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz,
5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1
bands 1 kHz
IEC/EN 61000-4-6 AC Mains MHz to 10,15 MHz, 14 MHz to 14,2 MHz,
AC Mains 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4
MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to
29,7 MHz and 50,0 MHz to 54,0 MHz.

This test level assumes a minimum distance


between the ME EQUIPMENT or ME
SYSTEM and sources of power frequency
Magnetic Immunity magnetic field of at least 15 cm. If the RISK
ANALYSIS shows that the ME EQUIPMENT
30 A/m 30 A/m
IEC/EN-61000-4-8 or ME SYSTEM will be used closer than 15
cm to sources of power frequency magnetic
field, the IMMUNITY TEST LEVEL shall be
adjusted as appropriate for the minimum
expected distance

Voltage dips, short


interruptions and 0% UT .5 cycle 0% UT .5 cycle
If the user of InZone requires continued
voltage variations on 0% UT 1 cycle 0% UT 1 cycle
operation during power mains interruptions, it
power supply input 70% UT 25 70% UT 25 is recommended that the InZone be powered
lines
cycles cycles from an uninterruptible power supply or a
battery.
IEC/EN 61000-4-11 0% UT5 Sec 0% UT5 Sec

Power frequency
(50/60 Hz) Power frequency magnetic fields should be at
magnetic field 3 A/m 3 A/m levels characteristic of a typical location in a
typical commercial or hospital environment.
IEC/EN 61000-4-8

NOTE UT is the a.c. mains voltage before application of the test level.

RTVue XR Avanti User Manual Page 45 of 451 P/N 580-52576-005 Rev. A


General Requirements Summary

Severity Level
Standards Description Criteria Results
or Limit

Verification of
Risk Management Process for ME Per Section Electromagne
IEC 60601-1-2:2014
equipment and ME System One, tic
Complies
Clause 4 Disturbance
Clause 4.1
Risk
Management
See
ME Equipment and ME System
IEC 60601-1-2:2014 requirement
Identification, marking and
s called out Review Complies
Clause 5 documents
in standard.

RTVue XR Avanti User Manual Page 46 of 451 P/N 580-52576-005 Rev. A


Symbols Explained

Refer to or read user manual first

Electrical shock hazard: Voltage present inside the instrument. Do


not remove the instrument cover or parts.

WARNING symbol indicates a potentially hazardous situation which, if


not avoided, could result in death or serious injury. May be used to
indicate the possibility of erroneous data that could result in an
incorrect diagnosis (does not apply to all products).

Caution symbol indicates a potentially hazardous situation, which, if


not avoided, may result in minor or moderate injury. It may also be
used to alert against unsafe practices. May be used to indicate the
possibility of erroneous data that could result in an incorrect diagnosis
(does not apply to all products).

+ Note: Calls attention to important information for the user.

European Conformity Mark for TUV Rheinland


European Notified Body:
TÜV Rheinland LGA Products GmbH
Tillystrasse 2
90431 Nuremburg Germany

RTVue XR Avanti User Manual Page 47 of 451 P/N 580-52576-005 Rev. A


Type B applied part: This instrument complies with the specified
requirements to provide protection against electrical shock,
particularly regarding allowable patient leakage current.

Manufacturer
Optovue, Inc.
2800 Bayview Drive,
Fremont, CA., USA, 94538

General mandatory action sign

Authorized European Community Representative


Medical Device Safety Services (MDSS) GMbH
Schiffgraben 41
30175 Hannover, Germany

Serial number

Catalog number / part number

Do not sit on

Do not step on

RTVue XR Avanti User Manual Page 48 of 451 P/N 580-52576-005 Rev. A


Do not push

WARNING: Hand crush hazard

1.11.1 Protective Packing Symbols


The protective packing symbols specify handling requirements and transport and
storage conditions.

Fragile, handle with care

Keep dry

This side up

Environmental conditions during transport: Relative humidity


(10% to 100%, including condensation)

Environmental conditions during transport: Temperature range


(-40 C to +70 C) and atmospheric pressure range (500 hPa to
1060 hPa)

RTVue XR Avanti User Manual Page 49 of 451 P/N 580-52576-005 Rev. A


Product Labels
The RTVue XR Avanti model product labels appear below. These labels are examples
only.

RTVue XR Avanti User Manual Page 50 of 451 P/N 580-52576-005 Rev. A


Disposal
Dispose of the equipment per local regulations.

1.13.1 Waste Electrical and Electronic Equipment (WEEE) Recycling


Instructions

When the device is ready for disposal, it is to be recycled according to


local (including institutional and national) policies and procedures. Do not
dispose of the device as general waste.

Déchets d'équipements électriques et électroniques (DEEE)


Instructions de recyclage

Lorsque l'instrument est considéré prêt à l'envoi au rebut, il doit être


recyclé conformément aux politiques et procédures en vigueur dans le
pays. L'instrument à éliminer ne doit pas être traité comme un déchet
ordinaire.

Recycling Label

This symbol is required in accordance with the Waste Electrical and


Electronic Equipment (WEEE) Directive of the European Union. The
presence of this marking on the product indicates:

4. The device was put on the European market after August 13, 2005.

5. The device is not to be disposed of via the municipal waste collection


system of any member state of the European Union. It is very important
that customers understand and follow all laws regarding the proper
decontamination and safe disposal of electrical equipment.

_______________End of section_______________

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2 Manage Patient Information
The system application opens by default to the PATIENT window. The application also
has a SCAN window (see chapter 3) and a REVIEW window (see chapter 5). The figure
below calls out PATIENT window items.

4 5
3

6 7

1 2

9
13 10

12 11
8

Figure 3 PATIENT Window Items

Figure 3 Legend:

1. 1 PATIENT tab (highlighted) 8. 8 Review button

2. 2 Basic or Advanced Search area 9. 9 OverVue buttons ( Retina Wellness)

3. 3 Selected patient in list and on title bar 10. 10 Scan button

4. 4 Patient list 11. 11 Edit button

5. 5 Patient Detail area 12. 12 Add Patient button

6. 6 Visit list (for selected patient) 13. 13Advanced or Basic Search link

7. 7 Scan list (for selected visit)

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+ Note: The selected tab is highlighted as shown for the PATIENT tab in Figure 3.

See chapter 6 for information regarding the main menu.

Use the PATIENT window to create, find, select, edit and delete patients, visits and
scans, and to initiate scanning or scan review. Features of the PATIENT window help
you enter patient information in advance, preview today’s scheduled patients, and
search for patients using a specified date range or other search criteria. The Patient list
displays search results.

Patient Search
To find patients in the database, you can perform a Basic Search or an Advanced
Search.

2.1.1 Basic Search

Figure 4 Basic Search Area

RTVue XR Avanti User Manual Page 53 of 451 P/N 580-52576-005 Rev. A


• Click Show Today to list patients scheduled for today. Click Show All to list all patients
in the database.

• To search for a patient by name (first or last), enter the name in the Basic Search field
and make sure Name (default) is selected in the Search by field, and click the Search
button.

• To search by patient ID, enter the ID in the Basic Search field and use the down arrow
in the Search by field to select EMR ID (Electronic Medical Records ID), and then click
the Search button.

2.1.2 Advanced Search


Click the Advanced Search link at lower left to open the Advanced Search area.

Figure 5 Advanced Search Area

RTVue XR Avanti User Manual Page 54 of 451 P/N 580-52576-005 Rev. A


In the Search By field, click the down arrow to select one of the following search
parameters.

• Disease • Name (first or last)

• EMR ID • Operator

• First Name• Physician

• Last Name • Scan Type

Then, in the field at the top, enter the search text for the chosen parameter (for
example, name or ID number) and click the Search button. If your search returns no
patients or not the ones you wish to find, search by another parameter. If you specified
a date range (as described next), searching with no date range, or a broader range, will
broaden your search.

To narrow any search by date range, select the Specify Date checkbox and click the
down arrow next to the From and To fields to select dates using the calendar that
appears. Use the left and right arrows on the month to change the month. You can use
the date range to find all patients with visits in the specified date range—if you do not
enter text in the field at the top, or to find patients in the specified date range that also
match the search text for the chosen search parameter.

RTVue XR Avanti User Manual Page 55 of 451 P/N 580-52576-005 Rev. A


2.1.3 Patient, Visit and Scan Lists
The Patient list displays results of a search. Before a search, the Patient list says There
are no items to show and the title bar says No patient selected.

Figure 6 Sample Patient List

Click to select a name in the Patient list. When you do:

• The selected name is highlighted in the list and appears in the title bar on top of the
window.

• The Patient Detail area shows the patient information previously entered for this
patient: Name, Gender, Birth Date, Ethnicity, EMR ID, and Comment. (To enter or
edit patient details, see sections 2.2 and 2.3.)

• The Visit list displays all visits for the selected patient, by date and showing the number
of scans on that visit.

Click to select a visit in the Visit list. When you do, the Scans list displays all scans
from that visit by type icon, name, and time of scan. Click to select a scan in the Scan
list.

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When a visit containing a retinal scan and/or a specific retinal scan is selected, the
application enables the OD Retina OverVue and/or OS Retina OverVue button,
according to the eye (left or right, or both with a visit that has both). The Wellness
protocol enables the Wellness OverVue button

Figure 7 shows portions of the screen affected by your selections.

Figure 7 Selections Made in PATIENT Window

Patient and Visit Shortcuts

Right-click on a Patient name to access the Delete Patient option, which is used to
permanently delete the selected patient. A warning message appears asking you to
confirm deletion.

Figure 8 Delete Current Patient Warning

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Right-click on a Visit date to access these options:

• Add Visit: Create a new visit with the current date for the selected patient.

• Delete Visit: Permanently delete the selected visit.

To confirm, click OK. Click Cancel to cancel deletion.

Add a New Patient


To add a new patient, click the Add Patient button. The Add New Patient dialog
appears, as shown in Figure 9.

Click to show more


optional fields

Figure 9 Add New Patient Dialog

Required fields are in bold. Enter the required information and enter other information
as desired. You must enter the birth date in the indicated format.

+ Note: You can use symbols in the name fields, but these may interfere with the
system’s screen capture function.

+ Note: Enter birth date in the indicated format. You can change the default birth
date format in the User Preferences dialog (go to Tools > User Preferences and
choose the format in the Date Format field). However, if you change the birth date
format, note that the system computer date format must match it. Follow the
instructions below to change the computer date format:

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1. On the computer, select Start > Control Panel > Region and Language.

2. Select the matching date format in the Short date field.

You can enter more optional information for the patient by clicking the green down
arrow to expand the dialog.

Green arrow

Figure 10 Add New Patient Optional Fields

Use the Optional area to enter:

• Physician: Use the down arrow to select one or more physicians to associate with this
patient, or select Add New to enter a new physician name and associate it with this
patient.

• Operator: Use the down arrow to select one or more operators to associate with this
patient, or select Add New to enter a new operator name and associate it with this
patient.

• Visit Comment: Enter desired comments for this patient.

+ Note: You can also create, edit and delete physicians, operators or diseases by
selecting Physician, Operator or Disease from the Database Management menu.

Use the Disease Category area to associate one or more user-defined diseases with
this patient. Once they are created, you can search for patients by disease category. To
create disease categories, click Add New to display the Disease Category Editor
dialog, enter a disease name and click OK.

When you finish entering information for the new patient, click Save to save the new
patient and close the dialog, or click Scan to initiate scanning for this new patient. Click
Cancel to discard entered information and close the dialog.

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Edit Patient Information
To edit patient information, select the patient name from the Patient list and click the
Edit button. The Edit Patient/Visit Info dialog appears. Edit the fields as desired. Click
Save to save your changes. Click Cancel to discard the edits and close the dialog.

Correct Visit Linked to the Wrong Patient


Follow these steps to move a visit—a complete visit only, not specific scans—from the
wrong patient to the right patient. If the patient you move the visit to already has a visit
on that date, the scans will be combined under the one visit date.

+ Note: To avoid having visits associated with the wrong patient, make sure you
have selected or added the name of the patient you are about to scan.

1. From the Patient and Visit lists, select the patient and visit to be moved. Then select
Move a visit to another patient from the Database Management menu.

Figure 11 Select Move a visit to another patient

A confirmation dialog appears.

Figure 12 Confirm Intent to Move Selected Visit

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2. Select Yes to confirm. A list of patients appears.

Figure 13 Select Patient to Move Visit To

3. Select the patient you wish to move the visit to and click OK. A second confirmation
dialog appears.

Figure 14 Confirm Move to Selected Patient

4. Select Yes to confirm the move to the selected patient.

_______________End of section_______________

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3 Capture Scans
This chapter shows you how to acquire OCT scans. First, it provides all the steps of the
general scan acquisition procedure, as a sort of quick guide. Then it provides more
detail about available options during the procedure.

Steps to Acquire Scans

+ Note: We recommend you clean the chinrest and forehead rest between patients
with a disinfectant. For example, wipe with an isopropyl alcohol pad or with another
germicide using a clean cloth.

Use the following procedure to acquire OCT scans:

1. From the PATIENT window, select an existing patient (see section 2.1.3) or add a new
patient (see section 2.2), then click the Scan button to go the SCAN window.

Infrared (IR)
video image OCT image area
area

Scan Selection

En face OD and OS
image area completed scans
lists

Scan button

Figure 15 SCAN Window AngioVue Comprehensive

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2. In the SCAN window, select the patient eye to be scanned. Both / OU is selected by
default. To change, click the Right / OD or Left / OS button.
Scans and Protocols

Select
Eye

Cancel

Start
Scan
Figure 16 AngioVue Comprehensive scans & protocols

Figure 16
17 Avanti
AngioVue
Retina
Retina
Scan
Scan
Selection
Selection Options

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3. Select the desired scan type from the Retina, Nerve Fiber, or Cornea lists, or select a
scan protocol from the Protocol list. You can select multiple scans to do the selected
scans in succession. When you finish your selections, click the Scan button to
begin scanning or click the joystick button.

• Alternatively, you can repeat any previous scan for a patient by double-clicking on the
scan name in the Scans list of the PATIENT window.

When you start scanning, the Scan Selection options are replaced by scan adjustment
options on the Auto tab (default) or Manual tab. (The available parameters and their
ranges depend on the scan type.)
Gray OCTA color
Light eye Dark eye Color
scale
Zoom OCT

Capture Cancel

Figure 18 Scan Adjustment Options (Auto Tab)

To customize scan parameters, select the MANUAL tab.

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Figure 19 Manual Tab to Customize Scan

4. Position the patient correctly as follows:

• Chin on the system chin rest with teeth together

• Forehead against the forehead rest

• Eye to be scanned aligned vertically with the canthus mark on the side of the forehead
and chin rest assembly.

• Ask the patient to look at the fixation target, a blue dot in the red field.

5. Center the video image on the pupil and move the scan head towards the patient,
controlling it so that the video image passes through the pupil. Carefully advance until

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the fundus comes into view (for Retina and Nerve Fiber scans). The figure below shows
the progression of views as you move the scan head forward.

Figure 20 Video Image Progression as Scanner Approaches Eye

6. Adjust the working distance between the scan head and patient eye to optimize the
video image. Optimized fundus images should be illuminated evenly from edge to edge.
Optimized optic disc images may contain dark areas on either side. For cornea scans,
an optimized video image shows iris detail.

+ Note: For fundus imaging, make sure to set the working distance first. If a live
OCT scan appears in the scan window, do not stop forward movement of the camera
until you achieve a good infrared (IR) video image of the fundus. For cornea scans, the
OCT image in the scan window indicates the correct working distance.

Note: On each patient, the first scan of each eye, of that day, the OCT image will
not appear until the Auto Adjustment has been performed. A message will appear
over the OCT window telling the operator to optimize the IR image then to select
auto adjust.

Figure 21 Eye alignment

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If the Auto Adjust fails, the live OCT B-scan window is active but no or poor B scan,

then the following message is displayed.

Figure 22 Auto Adjust fail

The operator should try to optimize the IR image and Auto Adjust again, if the image
cannot be improved the operator may decide to capture the image

If the Auto Focus portion only fails, the following message will be displayed.

Figure 23 Auto Adjust focus

The operator should try to optimize the IR image and Auto Adjust/focus again, if the
image cannot be improved the operator may decide to capture the image

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IR video image showing
scan pattern overlay Green bar
shows good IR
Quality

Green bar
shows good
signal strength

Optimization tips
Follow up & Tracking on/off

En face
image

Figure 24 Optimize Working Distance

7. When the video image is optimized, use the scan pattern overlay in the live video image
to center the scan pattern over the area of interest (fovea or disc). You can either:

a. Double-click in the video image where you want to position the center of the scan
pattern.

OR

b. Click, hold and drag the scan pattern to the desired location, then release.

To adjust video brightness and contrast, click in the live video, hold and move the cursor
up and down for brightness, left and right for contrast.

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8. Click Auto Adjust—or double-click on the scan image—to optimize scan signal
strength and image quality.

Figure 25 Auto Adjust Combines Auto Z, Auto F and Auto P

Auto Adjust executes Auto Z, Auto F and Auto P in combination. (Only the Auto P
option is available for cornea scans.) Auto Adjust also tries to place the scan image in
the target area between the red dashed lines. Figure below shows an example of a
scan centered vertically. If the scan is not between the red dashed lines but visible in
the window, click once in the scan window and scroll the mouse wheel to bring the OCT
scan between the red dashed lines.

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Figure 26 Example of Scan Centered Vertically

Figure Note: For scans that include the optic disc, it is OK—and expected—to have the
disc portion of the scan below the lower red line.

On the right side of each live scan, a green bar indicates a good signal strength index
(SSI) value. If the bar is red, you can manually optimize scan signal strength and image
quality as instructed in the next step below.

+ Note: In most normal patients, the OCT (SSI) indicator should be green.
However, individual patient variability and the light absorption properties of some
pathologies can sometimes make it impossible to achieve a green signal. If the OCT
(SSI) indicator is not green over a range of patients, including normals, contact Optovue
Technical Support for assistance.

9. If the OCT (SSI) indicator is red, use one or more of the following functions on the
Manual tab to manually optimize scan signal strength and image quality.

• Select the Manual tab (at upper left) and adjust the Z Motor, Focus or P Motor
settings, or scroll the mouse wheel in the scan image to move the scan image between
the red dashed lines.

• Click and hold in the live video image, then drag up or down to adjust video brightness,
or left and right to adjust video contrast.

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3.1.1 Instructions for Successful Tracking
• On fundus image

• Check good, homogeneous illumination by alignment to the center of pupil

• Bring optical disc in the field of view

• Avoid glare by adjusting the scan-head alignment to pupil center

• In follow-up mode, adjust the image to ensure green cross (“good tracking”) shows up in
the target zone in fundus image.

• On OCT image

• Target tissues should fall between two red lines

• Tracking (green light indicator) and start scanning

• Good Image

Poor due to glare

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Blocked or blurry

3.1.2 Tips for Scanning Difficult Patients

Note: After scanning and the patient starts to drift always remind the patient to look at
the blue dot before attempting to reposition the camera. Often the patient will return to
the correct position.

Pupil or fixation drift during scan acquisition may cause tracking to stall.

• Tip: Re-align the scan by slightly shifting the joystick towards the direction of the drift.
This will allow tracking to resume and enable the scan to complete.

Patients with poor vision still need to maintain some level of fixation for tracking
to be successful.

• Tip: Use the external fixation light to help keep the eye being scanned in the correct
location.

• Tip: If the eye moves outside of the trackable area (no disc in IR image), stop tracking
and help the patient fixate before resuming the scan or re-scan the patient.

Nervous patients can have excessive up-and-down movement of the B-scan


within the scan window

• Tip: This movement will not always affect tracking but will reduce the quality of the scan
image. Take action to minimize movement and keep the B-scan in the scan window.

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• Tip: Push the joystick slightly towards or away from the patient to keep the B-scan from
moving up and down excessively or out of the scan window altogether.

• Tip: Take advantage of the stability of the table. Position the table low enough that the
patient can lean into the headrest, put their arms on the table and hug the base of the
machine.

3.1.3 Tips to Optimize OCT results

Figure 27 Tips to Optimize OCT results

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10. To capture the scan, either press the joystick button or click the checkmark button.

Figure 28 A Captured Scan (Save Button Active)

After scan capture, review the scan images for quality and completeness. If you want to
save the images, click the Save button or press the joystick button again. Pressing
the Scan button again without saving discards the images and restarts the same
scan.

When you are done scanning, use one of these methods to review scans:

a. Click the REVIEW tab on the left to review the scan just completed.

b. Go back to the PATIENT window, select the desired patient, visit and scan, and click
the Review button.

Note: Certain scans like the Widefield MCT and AngioVue scans require the acquisition
of a Fast-X scan and a Fast-Y scan in consecutive steps. On first capture, the system
acquires a Fast-X scan. Review the scan for severe eye movement. Then capture the
Fast –Y.

See Chapter 11 on AngioVue for more information on OCTA scan capture.

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Figure 29 Fast-X Scan Captured

If you are satisfied with the captured scan, click Continue or joystick button to
proceed to the Fast-Y scan. Or Click Rescan to retake the Fast-X scan. Click Cancel to
discard the Fast-X scan and start over.

When you continue, the Fast-Y scan begins automatically. The orange overlay in the
video image (upper left) shows the large vessels from the optic disc as captured in the
Fast-X scan, which assists in recognizing whether alignment has been maintained.

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Figure 30 Active Fast-Y Scan

11. If necessary, adjust scan placement and optimize scan quality again. It is optimal to
capture the second scan with minimal adjustment, so ask the patient not to move
between scans. When ready, capture the Fast-Y scan.

3.1.4 Joystick button Functionality


Joystick button is capable of closing few message boxes which appear while capturing
scans. These specific message boxes are closable by joystick button:
1. Eye blink:

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2. Low signal strength:

3. Enface registration failure:

4. Continue scan with Fast Y and reduce artifacts (during MCT scans):

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Scanning Options
3.2.1 Scan Types and Protocols

Figure 31 Select Scan Type or Protocol

The initial SCAN window presents scan types grouped in the categories Retina, Nerve
Fiber, Cornea and Protocol.

+ Note: See chapter 8 Scan Pattern Specifications for a description of available


OCT scan types.

Scan Protocols

Scan protocols group a set of scan types for sequential capture with a particular clinical
purpose, or to apply a customized scan regimen. See section 6.4 Database
Management Menu for instructions to create, edit or delete scan protocols.

+ Note: It is recommended to contact Optovue Technical Support before selecting


scans or establishing a protocol with the methods described in this manual.

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+ Note: Optovue recommends that each practice either use the pre-installed
protocols or set up its own protocols based on patient demographics. This enables you
to select a protocol to capture all desired scan types sequentially. See section 6.4
Database Management Menu for instructions to create protocols.

3.2.2 Scan Window Buttons


Scan window buttons. The Save button is unavailable until you capture a scan.

Start Capture Save Cancel

Figure 32 SCAN Window Buttons

+ Note: To repeat a scan, double-click on the desired scan type in the list of
completed scans.

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3.2.3 Change Default Scan Settings
Use the User Preference dialog to change the default scan settings (among other
things). From the main menu, click Tools > User Preference to open the User
Preference dialog. The lower area of the dialog has three tabs, RT Scan Pattern,
Average# and Cornea, to set the default scan settings.

Figure 33 User Preference Dialog

Use the RT Scan Pattern tab to set the default length (and width for Raster and Grid)
for the line scan types. Use the Average# tab to adjust the number of averaged scans
used when tracking is on during scan acquisition. The values you set here become the
default values in the Auto tab of the SCAN window. For more information, see section
6.2.5 User Preference.

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3.2.4 Auto Tab: Automated Scan Settings
After starting a scan, the Auto tab opens. (The available parameters and their ranges
can depend on which scan type you are using.)

Figure 34 Scan Adjustment Options (Auto Tab)

The Auto tab helps you acquire good scans with minimal adjustments. (The Manual
tab, covered in section 3.2.5 below, helps you make detailed manual adjustments to
many scan and video parameters.) It provides the following functions:

• Eye Color: According to iris color, click the light eye or dark eye button, to optimize in
one step the video image for illumination, brightness, and contrast. If you click neither
button, the system defaults to the average of the dark and light eye settings.

• Gray Scale or Color: Click one or the other to display the live OCT image in gray scale
or color.

+ Note: From the main menu bar, select OCT Image > Scan Parameter Setting to
set the default scan image to either gray scale or color. For detais, see section 6.3.4.

• Illumination: Enter a value in the Illumination field or drag the slider to adjust
illumination manually.

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• Auto Adjust: By default, clicking Auto Adjust executes Auto Z, Auto F and Auto P in
combination. (You can select which functions to execute when you click Auto Adjust in
the Auto Adjust Setting field in the User Preference dialog—see section 6.2.5.) You
can also execute Auto Adjust by double-clicking in the OCT scan window.

• Auto Z: Automatically adjusts axial length.

• Auto F: Makes automatic spherical adjustments to offset refractive error.

• Auto P: Automatically adjusts polarization.

• Capture: Use the green checkmark button to capture the scan.

• Cancel: Use the red X button to cancel the scan.

For the Line, Cross Line, Raster, Grid, and Enhanced HD Line scans, you can
customize the scan using the Scan# and Size options.

• Scan #: Sets the number of scans used for averaging. Averaging reduces the noise in
the OCT image and yields a B-scan with reduced speckling. Eye or operator motion can
limit the number of frames that are used in this process. Quick eye motion can also
smear the OCT image and reduce quality.

• Size (scan length): Adjusts B-scan length. For the Line scan, radio buttons enable you
to select the Standard (9 mm) and Widefield (12 mm) options.

Followup Mode

Figure 35 Follow-up and Tracking Mode Buttons

Followup mode is selected when the box is checked, and off when it is blank. When you
are repeating a scan done on a previous visit for this patient, you can use Followup to
repeat the scan location and rotation of the previous scan. Repeat scans using
Followup cannot be moved or rotated. Turning Followup off allows you to move or rotate
the scan. Followup mode does not take into account changes in fixation relative to the
previous scan.

+ Note: You may have to guide the patient’s fixation to achieve alignment of the
scan to the previous visit.

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Figure 36 Followup and Tracking status indicators

In Followup mode, the cross-hair on the IR image is red if alignment is not correct, and
green when alignment is correct. The capture button turns green when the cross-hair is
green a majority of the time, indicating correct, or close to correct alignment. If the
check mark stays red the operators still has the option to capture but with the
understanding the location is not confirmed. If you want to scan a different location, turn
off followup mode to allow the scan are to be dragged.

Tracking Mode

Tracking helps to maintain scan placement when the patient blinks or moves their eye.
Tracking is selected when its box is checked, and off when it is blank. Check the color
of the indicator lights; red not collecting, or green collecting for. Tracking is available for
the following scans: Line, Cross Line, Raster, Grid, Enhanced HD Line and Radial
Lines and all 3D cubes including AngioVue scans.

A good IR image of the fundus is important for followup and when tracking is on,
because the system tracks image details to maintain scan placement. Image below
shows examples of good and poor IR fundus images.

Figure 37 Good IR Image (Left) and Poor IR Image (Right)

The capture button turns green only when a good fundus image is present. A small
green cross on the IR image indicates good followup, and a red cross indicates poor
followup. The cross will be gray if followup is not active. During scan capture, there are
two quality bar one for the IR image and one for the OCT image. Try to maximize the
green in both. The progression bar at the bottom shows scan collection progress. If
scan capture takes longer than expected because tracking is on, you can turn tracking
off during scan capture, and the system captures remaining scans with tracking off.

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3.2.5 Manual Tab: Manually Adjust Scan Settings
The figure below shows the Manual tab.

Figure 38 Manual Tab Selected

Use the available fields, arrow buttons or sliders to manually adjust scan and video
parameters listed below. If a parameter is not available for adjustment, it is because that
parameter is not applicable to the current scan type.

• Length (mm): Adjusts length of scan line(s).

• Width (mm): Adjusts the width of applicable scans, spacing the lines of the scan evenly
within the selected width.

• Angle (degrees): Rotates the scan pattern relative to the center. You can also rotate the
scan by clicking on the scan graphic in the video window and scrolling the mouse wheel
up or down.

• Video Brightness: Adjusts brightness of the video image (not the OCT scan).

• Contrast: Adjusts contrast of the video image (not the OCT scan).

• Z Motor: Click Auto Z or use the slider to vertically center the OCT scan in the scan
window (between the dashed red lines). You can also center the scan by clicking in the
scan window and scrolling the mouse wheel up or down.

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• Focus (diopters): Click Auto F or use the slider to adjust focus of the OCT scan and
thereby improve signal strength.

• P Motor: Click Auto P or use the slider to adjust scan polarization and thereby improve
signal strength.

• Vitreoretinal or Chorioretinal radio buttons: Vitreoretinal presets the scan parameters


to achieve highest signal strength above the RPE. Chorioretinal presets the scan
parameters to achieve highest signal strength below the RPE. Note that the red dashed
lines in the scan window shift up for a vitreoretinal scan; they shift down for a
chorioretinal scan.

_______________End of section_______________

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4 Review and Edit Scans
This chapter describes review of OCT scans, including editing and measurement
functions. Click the REVIEW tab to open the Review window.

Review Window

Title Bar
Scan type 4

Reference
1 Video
Image

2 5

3
6 8
7 9

10 11

Figure 39 Review Window Components

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Legend:

1. 1 -Patient list 7. 7- Print button

2. 2- Visit list 8. 8- Change Analysis button

3. 3- Scan list 9. 9- OU Report button

4. 4- Signal Strength Index value 10. 10- Comparison button

5. 5- B-scan windows 11. 11- Comment button

6. 6- Tool pane

Each scan type has its own report that opens in the Review window when you select the
scan. Descriptions of the reports for each scan type are in Chapter 5 Scan Reports. (For
review of anterior segment scans, see the RTVue XR CAM User Manual.) This section
describes features of the Review window common to many scan types. Other features
and options of the Review window are available with reports of specific scan types.

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4.1.1 Patient, Visit and Scan

Figure 40 Patient Visit and scan list

The left side of the Review window provides a list of patients, visits and
scans to choose for display, and a set of tools to use with the currently displayed scan.
Patient list can be concealed using user preference selection

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4.1.2 Signal Strength Index
The Signal Strength Index (SSI) value appears near top center of each report. It helps
you determine whether the scan quality is acceptable or not. The SSI is based on the
intensity, or brightness, of reflected light during scanning. Greater intensity corresponds
with a higher SSI. The SSI is based on a global average over the entire scan pattern.
The SSI is not intended to be used alone to determine image quality. However, when
the SSI is lower than the minimum recommended values given in table below, Optovue
recommends that you re-take the scan to achieve an SSI value above the minimum
recommended, if possible.

Table 1 Minimum Recommended SSI for Each Scan Type

Scan Type Minimum Recommended SSI

Retina Map SSI > 39

ONH SSI > 28

GCC SSI > 32

See Appendix F: Signal Strength Index (SSI) for further detail on the SSI.

4.1.3 Change Analysis Button


The Change Analysis button is available when map scans like Retina Map, GCC and
ONH have been taken on two or more visits. Click this button and the system displays
up to six visits on the change report that appears.

4.1.4 Comparison Button


The Comparison button is available for certain scan types when the same scan has
been taken on two or more visits. Comparison applies to display of B-scans.

4.1.5 OU Report Button


The OU Report button is available for certain scan types when scans for both eyes
have been taken. Click this button and the system automatically displays the most
recent scan for each eye, but you can choose a specific scan for each eye.

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4.1.6 Comment Field
The Comment field is at the bottom of the report. Enter text here and it is saved when
you exit the REVIEW window. The information you enter appears only with this specific
scan; it does not appear with other scans or visits from this patient. Comments entered
do appear on printed and PDF reports of the scan.

4.1.7 Print Button


Click Print to print the current report either to an electronic file (PDF) or to hard copy,
depending on the printer you choose.

Tool Pane
The Tool pane provides various tools on its Measuring and Editing tabs. Image below
shows the Measuring tools. Callouts identify each icon. Functions not currently
available are grayed out.

Figure 41 Measuring Tools

+ Note: You must click the View B-scans icon (right end of second row) to use the
first four tools, which are specifically for measurement and annotation of B-scans.
Clicking View B-scans opens a new window that displays B-scans along with the same
Tool pane at upper right.

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Figure 42 A Sample B-Scan Window

If you right-click on the image, a menu gives you options to adjust its scale and zoom.

Figure 43 Right-Click Options on B-Scan Image

After you make measurements and annotations as described below, click Save to save
your changes with the B-scan and return to the report where you started. If you make
changes to the segmentation lines, click Save and Reprocess to recalculate
measurements (such as thickness) based on the revised segmentation. Right click also
provides an option to “Undo manual curves”.

Figure 44 Segmentation line correction

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4.2.1 Tool Pane Measuring Tab Functions

• Distance: To measure distances in an open B-scan, select this tool, click on the
scan at the starting point and drag the endpoints. The distance in mm appears next to
the line. Right-click on a line to access these options:

Figure 45 Line Right-Click Options

• Cut deletes the line.

• Order > [selection] changes the front-back order of overlays.

• Properties… gives access to change color, style and width of the line.

Figure 46 Line Properties Dialog

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• Area: Use this tool to draw a polygon and measure its area. To draw the polygon,
click once to make each corner point, and double-click to close the shape. The area in
mm2 appears next to it. The same right-click options are available: Cut, Order >
[selection] and Properties…. Area has the same Line options plus Fill options,
including Foreground Color, Background Color and Hatch style.

Figure 47 Area Fill Options

• Line: Select this tool to draw a line on the B-scan, but note that this line serves as
an annotation or indicator only; no measurement appears.

• Text Annotation: Select this tool, click the image and type to annotate. Right-click
on the text to change the font color, style and size.

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Figure 48 Example B-Scan with Area, Line and Annotation

• Color/Gray Scale: Toggles scan display between pseudo-color and gray scale.

• Save Report as JPG: This option is available in the Review window, but not in the
B-scan window. Like a screen capture, click to save an image of the current report in
.jpg format. You can choose where to save the image and what to name it in the Save
As dialog that appears.

+ Note: Images made with the Save Report as JPG (camera) icon do not include
patient and practice information. To include this information, use the Print button in the
Review window, which prints the report either to an electronic file (PDF) or to hard copy,
depending on the printer you choose.

• Darken: Darkens OCT images.

• Brighten: Brightens OCT images.

• Video Reset: This option is available in the Review window, but not in the B-scan
window. Resets video image brightness and contrast.

• Video Auto: Automatically optimize video image brightness and contrast.

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• Inverse OCT Image: Inverts grayscale OCT images.

• View B-scans: This option is available in the Review window, but not in the B-
scan window. Displays all B-scans in a new window and enables you to modify the
segmentation tracing (lines), and to make measurements and annotations.

• Export as PNG: This option is available in the Review window if you have selected
the Auto saving PNG checkbox and specified an export destination in the PNG
directory field of the User Preference dialog—see section 6.2.5. This option is never
available in the B-scan window. Like a screen capture, click Export as PNG to save an
image of the current report in .png format. The system exports the report image
automatically.

• Show/Hide Boundaries: Toggle to show or hide segmentation lines on the


OCT image.

Optional Anterior Segment Measuring Tools

Special measuring tools for anterior segment scans are available when the optional
corneal anterior module (CAM option) has been installed.

Figure 49 CAM Measuring Tools

• Left Angle and Right Angle: Use these tools to measure the angle opening. Click in
the angle recess or scleral spur (your preference) to create the angle vertex. Click again
to place angle lines along the surfaces of the iris and posterior cornea. The angle
measurement appears next to the angle drawn.

• Left and Right TISA 500 and 750: Measures the trabecular iris surface area (TISA) at
500 µm or 750 µm from the scleral spur.

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• Angle Caliper: Draw a line within the angle and measure its length. For example, use it
to measure angle opening distance (AOD).

• Corneal Thickness: Draws and measures a line between the anterior and posterior
cornea surfaces. Drag the line to measure at the point of interest, for example, to make
a post-LASIK flap measurement.

4.2.2 Tool Pane Editing Tools


Click the Editing tab to display the editing tools. Use these tools on the B-scan images
to edit the layer segmentation lines and to zoom the view. Click Save or Save and
Reprocess to save the boundary changes; reprocessing, when applicable, implements
the boundary changes into the report measurements.

Show/Hide
Pan Boundaries
Select

Zoom Zoom
Undo Redo In/Out to Fit

Figure 50 Editing Tools

• Select: Click to select a segmentation line for editing or to deselect a zoom tool in
use.

• Edit Segmentation Lines: When you select a segmentation line, its anchor points
appear. To edit the line, click and drag anchor points. Right-click on the line to add or
delete anchor points using the menu that appears. Right click to undo segmentation
changes.

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Modify point

Figure 51 Right-Click Options When Editing Segmentation Lines

• When you select Modify Point, drag each point where you want it to be.

• When you select Del Point (Del for delete), double click the point you want to delete.

• Properties… opens the dialog to change line properties, as shown in the image above.
The Save button saves any changes you made to the B-scan, but does not recalculate
measurements based on segmentation changes.

• Click Save & Reprocess—when available—to recalculate measurements based on


segmentation changes you made. One you make segmentation changes, you cannot
reprocess scans to revert to the automatic segmentation and measurements. Automatic
segmentation and measurements occur only upon first processing after scan capture.

+ The Clean Diagnosis Data function does not affect manually edited
segmentation but it does reset fovea position and previous manual fovea correction will
be lost. Please verify fovea location and manually adjust if needed.

• Pan: Select this tool, click and drag to move the OCT image in the window.

• Show/Hide Boundaries: Toggle to show or hide segmentation lines on the


OCT image.

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• Undo and Redo: Click to undo or redo last edit. Use it repeatedly to make
multiple steps back or forward.

• Zoom In/Out: Select this tool and left-click to zoom in, right-click to zoom out, or
zoom to the size of the box you draw on the image.

• Zoom to Fit: Zooms out to fit all B-scans in the window.

_______________End of section_______________

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5 Scan Reports
Scan Registration for Comparison
In some reports, you can compare multiple scans of the same type over time. To enable
accurate comparison, these multiple scans must be accurately aligned, or registered,
with each other. The system uses a baseline scan, also called a reference scan, for
registration of multiple scans. Specifically, it uses for registration particular features,
such as blood vessels or the fovea, in the SLO-like image. The Retina Map scan can
overlay on the SLO-like image of the 3D Widefield scan using the fovea for registration.
If no widefield scan, the initial Retina map is used as the reference, utilizing the fovea.
The ONH scan uses the SLO-like image of the 3D Disc scan as baseline for
registration.

Registration of multiple scans enables clinicians to compare scans over time and
thereby track progression of retinal diseases and glaucoma. When multiple scans of
eligible scan types have been acquired, the Change Analysis or Comparison button is
present on the scan report.

Retinal morphology can change over time due to disease progression or surgery. In
such cases, the clinician can acquire a new baseline scan. Subsequent scans from that
point would use the new baseline scan. Scans prior to the new baseline scan continue
to be registered against their original baseline scan.

5.1.1 3D Widefield Scan for Retina Map Display


The Widefield scan is not required for thickness evaluation of macula or optic nerve. It
will affect the scan display but will not change the quantitative analysis and will not
impact the change analysis report. If the Widefield scan is available, the Retina Map or
the ONH scan will be overlaid on the Widefield scan. The 3D Widefield scan
encompasses both the macula and the optic nerve in an approximately 40o view of the
fundus. The scan produces a 12 mm x 9 mm SLO-like reference image, which is used
for display of scans. Specifically, it uses the fovea for registration. It also produces
detailed en face images of the retina surface, and a 3D cube of image data of the entire
retina. See section 5.5.5 for information on the 3D Widefield report.

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

+ Note: When you repeat a 3D Widefield scan and click the Save button, a dialog
asks you whether to use the new scan image as the new baseline for registration.

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Select Yes to use the new image for registration, or No, use the existing one. Exit the
visit to see “baseline” indicator in scan list change to the new scan.

Figure 52 Widefield registration

5.1.2 3D Disc Scan for ONH Registration


The system uses the SLO-like image of the 3D Disc scan as baseline for registration of
ONH scans. Specifically, it uses the disc margin, disc center and vessels for
registration. It finds the disc center by first tracing the disc boundary (disc margin) on
the 3D Disc scan image. If you acquire an ONH scan before the 3D Disc scan for that
eye, the system prompts you to capture the 3D Disc scan in the Baseline Disc Boundary
dialog.

Figure 53 Baseline Disc Boundary Dialog

Click Capture New to acquire a baseline 3D Disc scan.

+ Note: If you do not capture a 3D Disc scan, you must manually draw the disc
margin on the ONH scan image. A baseline 3D Disc scan is required to display
Normative Database (NDB) comparisons for RNFL measurements, and optic disc
metrics for ONH scans.

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To show the disc margin on the 3D Disc report, click the Show button. Click the Auto
button for the system to automatically draw the disc margin.

Disc margin in orange

Figure 54 Optic Disc Margin in 3D Disc Report

You can edit the disc margin by clicking and dragging any of the white anchor points to
the desired location.

Click Draw to draw the disc boundary manually, then click to place anchor points
around the disc margin. See section 5.5.7 for information on the 3D Disc report.

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Retina Line Scan Reports
Six scan types designed to scan the retina use line scans (of adjustable length) singly or
in combination. These are the Line, Cross Line, Grid, Raster, Radial Line, and
Enhanced HD Line scans. As a reference for registration, the system aligns each of
these scans to the 3D Widefield scan (see sections 5.1.1 and 5.5.5), when one has
been acquired for this eye. The reports for each of these retina line scan types show the
3D Widefield reference scan, when taken, on the default Reference tab. (You can also
select the En Face or IR tab to display those images.)

Figure 55 3D Widefield Reference Scan on Reference Tab

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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5.2.1 Line Scan Report
The Line Scan averages multiple frames of the single line scan in its report, and reports
the number of frames used in averaging, as shown in the image below. The scan length
in mm, which is adjustable, appears beneath the B-scan image. Click the Comparison
button to compare any two scans for this eye.

Number of frames
used in averaging

Figure 56 Line Scan Report

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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5.2.2 Cross Line Report
The Cross Line scan averages multiple frames of the vertical and horizontal line scans
and reports the number of frames used in the averaging for each line—for the B-scan
shown above and the one below, in that order, as shown in the image below. The scan
length (same for both lines, but adjustable) in mm appears between the B-scans on the
right. Click the Comparison button to compare any two scans for this eye.

Number of frames
(above, below) used
in averaging

Figure 57 Cross Line Scan Report

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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5.2.3 Grid Scan Report
The Grid scan report shows the grid of five horizontal and five vertical line scans
overlaid on the 3D Widefield reference image, as shown in the image below. The length
and width of the scan pattern are adjustable. The B-scans at the top and bottom
correspond to the top and bottom line scans highlighted in red on the reference image
at upper left. Use the mouse wheel or the arrow keys to scroll through each of the
scans. The scan size in mm appears between the B-scan images at the right. Select the
1x1, 1x2 or 2x2 radio buttons to change the number of B-scans shown on the report.
Click the Comparison button to compare any two scans for this eye.

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

Figure 58 Grid Scan Report

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5.2.4 Raster Scan Report
The Raster scan report shows a stack of 21 horizontal line scans overlaid on the 3D
Widefield reference image, as shown in the image below. The length and width of the
scan pattern are adjustable. The B-scans are for the currently selected line scans,
which are highlighted in red on the reference image. Use the mouse wheel or the arrow
keys to scroll through each of the scans. The scan size in mm appears between the B-
scan images at the right. Select the 1x1, 1x2 or 2x2 radio button to change the number
of B-scans shown on the report. Click the Comparison button to compare any two
scans for this eye.

A second print page maybe selected and printed to show more scans.

Figure 59 Raster Scan Report

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Figure 60 Second page of Raster Report.

Select button marked “Back to First page” to return to original page.

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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Raster Portrait Print page 1

Figure 61 Raster Portrait Print page 1

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Raster Portrait Print page 2

Figure 62 Raster Portrait Print page 2

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5.2.5 Radial Lines
The Radial Lines scan report shows line scans arranged like spokes on a wheel
overlaid on the 3D Widefield reference image, as shown below. The B-scans are for the
currently selected line scans, which are highlighted in red on the reference image. Use
the mouse wheel or the arrow keys to scroll through each of the scans. The scan size in
mm, which is adjustable, appears between the B-scan images at the right. Click the
Comparison button to compare any two scans for this eye. The software allows you to
compare radial line scans of different sizes.

Figure 63 Radial Lines Report

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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Figure 64 Sample Radial Line Report Comparing B-Scans from Two Visits

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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5.2.6 Enhanced HD Line
The Enhanced HD Line scan acquires a single high-definition line of adjustable length.
Its position shows as an overlay on the 3D Widefield reference image. The scan is
designed to show detail either in the vitreous or in the choroid; you select which using
the corresponding radio button on the AUTO tab before scan acquisition. In addition, the
report for Enhanced HD Line enhances detail in the vitreous or the choroid, depending
on whether you select the Vitreous (default) or Retina radio button below the scan
image.

The Vitreous radio button results in brighter colors with greater color contrast, to more
easily see details in the vitreous that would otherwise be subtle. The Retina radio
button results in less-bright colors with less color contrast, to tone down brightness in
the retinal layers and make retinal details more discernible. The slider below the radio
buttons also enhances the color intensity as you move it from left to right. The image
below shows a sample Enhanced HD Line report captured in Vitreoretinal mode. Click
the Comparison button to compare up to six scans for this eye.

Figure 65 Enhanced HD Line Report, Vitreous Sample

Note; In the event of registration failure the selected scan will not show on top of the
Widefield image.

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Retina Map Report
The Retina Map report provides image displays, charts, tables and interactive maps to
enable qualitative and quantitative assessment of the retina. The image below and its
legend below identify the components of a Retina Map report. The subsections following
explain each component. To select editable center B-scans deselect the “Show HR
Frames” check box.

3 7

1 4

2 5

6 11

10
0

Figure 66 Retina Map Components

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Retina Map Components Legend:

1. 1 Reference image 6. 6 Thickness at a single point

2. 2 Map/chart overlay 7. 7 Thickness and volume parameter table

3. 3 Thickness map 8. 8 ETDRS chart

4. 4 Map display options 9. 9 NDB reference map or RPE elevation map

5. 5 Volume contouring and threshold10. 10 B-scan display


selection
11. 11 HR Frames check box

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5.3.1 Retina Map Portrait Print Report

Figure 67 Retina Map Portrait Print Report

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5.3.2 NDB References
NDB references are available only for full retinal thickness. The Retina Map report
includes three possible presentations of retinal thickness with respect to the normative
database, as shown in the image below.

Figure 68 Retina Map Presentations that Include NDB Reference

NDB references can appear in the ETDRS Chart (lower right), the NDB Reference Map
(bottom center) and the retinal parameters table (upper right). The NDB color key above
the ETDRS chart explains that green indicates “Within normal limits” “ (the
measurement is between the 5th percentile to 95th percentile of the NDB); yellow
indicates “Borderline” thick (the measurement is between the 95th percentile to the 99 th
percentile of the NDB); red indicates “Outside normal limits” thick (the measurement is
above the 99th percentile of the NDB); blue indicates “Borderline” thin (the
measurement is between the 5th percentile to the 1st percentile of the NDB); and dark
blue indicates “Outside normal limits” thin (the measurement is below the 1 st percentile
of the NDB). See Appendix B for more detail on the Normative Database.

+ Note: The normative database embedded in system software enables


comparison of measured retinal thickness with that of patients in the normal range. NDB
comparison provides an objective metric for a clinician to use in making an overall
diagnosis.

5.3.3 Reference Image (Item 1)


The reference image at upper left shows the SLO-like image from the reference scan
(by default) on the Reference tab, or the video image acquired during scan acquisition
on the IR tab.

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5.3.4 Retinal Thickness Map and Chart Overlay (Item 2)
When the Retina Map report opens, by default the retinal thickness map and ETDRS
thickness chart values both overlay the 3D Widefield reference image at upper left.
These are the same color-coded maps next to the reference image at upper center
(thickness map, item 3) and lower right (ETDRS chart, item 8). Right-click on the
overlay to toggle 2D Map Off and Chart Off individually. See below. The right-click
options change to turn one or both on again.

Figure 69 Retina Map Reference Image Options with 2D Map and Chart On)

The 2D Map overlay shows Full Retinal, Inner Retinal or Outer Retinal thickness, according
to the radio button selected in the Thickness box left of the Thickness Map at top center.

• When the 2D (Thickness) Map is on, the overlay shows only its colors, which indicate
thickness. When the 2D (Thickness) Map is off, the overlay shows the ETDRS chart
colors, which are based on the normative database.

Adjust Fovea Location, if Necessary

If the ETDRS chart overlay seems not to be centered on the fovea, check to see if the
fovea location indicated by the yellow dot on the Thickness Map (at top center) is
accurate. If not, you can move the fovea location in two ways:

• Right-click on the Thickness Map and select Move Fovea, then click and drag the
yellow dot to where the fovea should be. When you release, the system asks if you want
to reprocess the data based on the new foveal location. Click Yes and the system saves

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the fovea location change and reprocesses the data, which changes the measurements
and colors. Click No and the fovea location reverts to where it started.

• Open the 3D Widefield (or 3D Widefield MCT) reference image and go to the 3D
Widefield report. Right-click on the white space in the report and select Move Fovea,
then click the location where the fovea should be. Now open the retina map again and
confirm the ETDRS map appears in the expected location.

5.3.5 Thickness Map (Item 3)


The Thickness Map at top center reports retinal thickness, using a color code, over the
5 x 5 mm square centered on the fovea. The system finds the fovea location
automatically. If the system cannot find the fovea, it places it in the center of the scan.
Review the fovea location indicated by the yellow dot in the thickness map, and move it
if necessary, as instructed above.

Thickness Map Colors

The color key next to the map explains the thickness values (in µm) associated with the
colors. Warmer colors, from yellow, orange and red to white, represent increasing
thickness. Cooler colors, from green to blue to black, represent decreasing thickness.

Show Lines Checkbox

When the Show Lines checkbox is selected (as it is by default), grid lines overlay the
map. The grid lines show placement of the scan lines of the Retina Map scan pattern.
The grid lines must be on to change the currently selected point and the B-scans shown
at lower left.

Thickness Box (Item 4)

The Thickness box next to the map has radio buttons to select display of Full Retinal,
Inner Retinal or Outer Retinal thickness on the thickness map, in the thickness and
volume parameter table (upper right) and on the ETDRS chart (lower right).

• Full Retinal Thickness measures from ILM (inner limiting membrane) to RPE (retinal
pigment epithelium).

• Inner Retinal Thickness measures from ILM to IPL (inner plexiform layer).

• Outer Retinal Thickness measures from IPL to RPE.

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Threshold and Volume Fields (Item 5)

Below the Thickness box are the Threshold and Volume fields, which interact to show
volume values relative to the currently selected radio button in the Thickness box. (The
options are Full Retinal, Inner Retinal and Outer Retinal.) Use the Threshold field to
set a threshold thickness value: the Volume field reports the volume of retinal tissue
above the threshold thickness value, for the retinal segment selected in the Thickness
box. Only when Full Retinal thickness is selected, the map draws contours to indicate
areas that exceed the threshold.

Use Threshold field to set a threshold


thickness value (in µm) to assess
edema or elevated pathologies. For full
retinal thickness only, the map draws
contours around tissue exceeding the
threshold.
Volume field reports retinal volume (in
mm3) exceeding the threshold value for
the current segment (Full, Inner or
Outer).

Click Save to save the values for the


current segment. Retinal thickness and
volume parameters appear in the table
at upper right.

Contours indicate areas that exceed


the threshold thickness value.
(Contours are drawn only for the full
retinal thickness map.)

Figure 70 Retina Map with Auto-Drawn Contour

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Draw Contours Manually

Manually draw a contour to measure full retinal thickness within the contour. The
volume value (in mm3) appears inside (or next to) the contour as you draw and when
complete. Follow these steps to draw a contour:

1. Right-click the Thickness Map and select Contour > Draw Contour.

Figure 71 Select Draw Contour

2. Each click you make on the map creates a contour anchor point. The contour line
follows the cursor as you move it between clicks. After the third click, the volume value

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appears and updates continuously while you draw. The contour line is black while
drawing. To complete the contour, double-click. It turns red when complete.

Figure 72 Drawing a Contour Line

Intersecting Red (or Blue) Lines and Single Point Thickness (Item 6)

The red lines on the Thickness Map indicate the currently selected scan lines of the
retina map pattern, which correspond to the B-scans shown at lower left (item 10).

• Below the Thickness Map on the left, the software reports Thickness (in µm) at the point
of intersection of the red lines. In parentheses below the Thickness value are x-y
coordinates (in mm) with respect to the center of the retina map pattern.

• When you click on the Thickness Map, the red lines change to blue and move to
intersect where you click. The lines then follow the pointer until you click again, and they
turn back to red. When the lines are blue and you move the pointer, the Thickness value
updates to show thickness at the exact pointer location. While you move the blue lines,
the x-y coordinates update to the nearest point of scan line intersection, and the
corresponding B-scans also update.

5.3.6 Thickness and Volume Parameter Table (Item 7)


The table at upper right reports retinal thickness (in µm) and volume (in mm 3) for the
superior and inferior hemispheres and for the nine ETDRS-like sectors. The values
displayed correspond to the current selection in the Thickness box to the left of the
Thickness Map: Full Retinal, Inner Retinal or Outer Retinal. Color-coding with respect
to the normative database appears only for full retinal thickness values. (See section
5.3.1 regarding the significance of the colors.)

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5.3.7 ETDRS Chart (Item 8)
The ETDRS Chart at lower right reports average thickness in each of nine ETDRS-like
sectors, both numerically (in µm) and in color with respect to the normative database.
The nine sectors consist of the central 1 mm circle centered on the fovea, and the eight
zones defined by the two concentric circles 3 mm and 5 mm from the fovea divided into
the four quadrants: superior (S), nasal (N), inferior (I) and temporal (T). (The chart is
based on the original four macular regions as defined in Stereoscopic Atlas of Macular
Diseases Diagnosis and Treatment, J Donald M. Gass, Mosby, 3rd edition, Volume 1,
Page 3).

The NDB color key above the ETDRS chart explains that green indicates “Within
normal limits” “ (the measurement is between the 5th percentile to 95th percentile of the
NDB); yellow indicates “Borderline” thick (the measurement is between the 95th
percentile to the 99th percentile of the NDB); red indicates “Outside normal limits” thick
(the measurement is above the 99th percentile of the NDB); blue indicates “Borderline”
thin (the measurement is between the 5th percentile to the 1st percentile of the NDB);
and dark blue indicates “Outside normal limits” thin (the measurement is below the 1 st
percentile of the NDB). See Appendix B for more detail on the Normative Database.

5.3.8 NDB Reference or RPE Elevation Map (Item 9)


The map at bottom center shows either the NDB Reference map (default) or the RPE
Elevation map, based on the selected radio button in the Map Option box above it.

NDB Reference Map

The NDB Reference map shows retinal thickness relative to the normal distribution.

RPE Elevation Map

The RPE elevation map shows elevation of the RPE relative to a normalized plane. The
color key next to the map explains the thickness values (in µm) associated with the
colors. Warmer colors from yellow, orange and red to white represent increasing
thickness. Cooler colors from green to blue to black represent decreasing thickness.

The RPE tracing is compared to a normalized RPE ellipse fit. Disruption (D) is based
upon +\-80% of the RPE (24 µm), and amplitude of +\- 150% of the RPE thickness (45
µm).

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5.3.9 B-Scan Display (Item 10)
The red (or blue) lines on the Thickness Map indicate the currently selected scan lines
of the retina map pattern, which correspond to the B-scans shown at lower left.

• Show Boundary Curves Checkbox: Select this checkbox above the B-scans to show
segmentation lines on the B-scans.

• Deselect HR frames to edit center cross line

Retina OU Report

Figure 73 Retina OU Report

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5.3.10 OU Retina Map Portrait Print Report

Figure 74 OU Retina Map Portrait Print Report

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Retina Map Change Analysis Report
The Change Analysis button is available on the Retina Map report when two or more
Retina Map scans have been taken. Click this button and the system displays the
Retina Map Change Analysis report; it automatically selects up to six scans (a baseline
scan and up to five subsequent scans) for the current patient eye. When a 3D Widefield
scan has been acquired, the system uses it as baseline for registration of Retina Map
scans. (When no 3D Widefield scan has been acquired, the system uses the first Retina
Map scan as baseline.)

Figure 75 Retina Map Change Analysis Report

The Retina Map scan uses the fovea in the baseline scan (3D Widefield, if available) for
registration. (See section 5.1.1 for details.) If the system cannot identify the fovea, it
places it in the center of the scan. For a valid comparison, the fovea location on each
Retina Map scan must be correct, so it is important that fovea location be reviewed after
capture of each scan. Review individual scans as necessary and adjust the fovea
location of those with an incorrectly placed fovea. See instructions to adjust the fovea
location in section 5.3.4.

+ Note: If the scans are manually adjusted, make sure the foveal adjustments are
consistent. The Clean Diagnosis Data function does not affect manually adjusted
segmentation but will reset foveal position.

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The Change Analysis report includes:

• Across the top, a full retinal thickness map (default) or an RPE elevation map. Select
the RPE Elevation checkbox at top left to switch to display of RPE elevation maps.

• When the retinal thickness maps are displayed, you can use the Threshold field at
upper right to automatically draw contours around areas above the threshold thickness
value on all maps. The volume of retinal tissue above the threshold value appears
within the contour. This assists in identifying areas of greater thickness that may be due
to pathology.

• When the RPE elevation maps are displayed, you can use the Ref field at upper right to
display elevation (in µm) relative to the reference value you entered, using the color
code at upper right. The Ref range is from -25 to 25.

• In the second row are horizontal and vertical B-scans that correspond to the indicated
scan lines on each map. The currently selected B-scan, highlighted in red around its
perimeter, is shown in larger size at bottom left.

• The ETDRS chart for each scan appears in the third row. The chart furthest left, for the
baseline scan, always shows full retinal thickness values and includes the normative
reference colors. By default, the ETDRS charts after the baseline scan show the change
in retinal thickness (in µm) relative to the baseline scan, and do not include normative
reference colors.

• When you deselect the ETDRS Change checkbox at top left, the ETDRS charts show
full retinal thickness for each scan and include the normative reference colors.

• At bottom center and right are graphs that plot Foveal Thickness and Macular Volume,
creating a line that traces change from scan to scan.

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3D Report Options
The Avanti System has three types of 3D scan, and provides multiple report options for
each scan type, as shown below.

3D Widefield 3D Retina
Scan Scan 3D Disc Scan

Retina OverVue Report X X

En Face Report X X X

3D Display X X X

Scan Specific Report X X X

The system generates all applicable report options when you select a 3D scan for
review, and you can move between the report options using buttons on each report. (3D
features introduced in this version are intended for the XR PC system. PC systems that
do not adhere to the RTVue XR specifications may exhibit reduced performance when
using 3D features. 3D Volume views are memory-intensive functions and frequent
usage of these features may slow scan processing.)

+ Note: In the User Preference dialog (see section 6.2.5 User Preference on page
182), you can select which types of 3D report opens by default.

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5.5.1 Retina OverVue Report (3D Widefield and 3D Retina)
The system generates a Retina OverVue report only for the 3D Widefield and 3D Retina
scans. When you select one of these scans for review, the Retina OverVue report
opens first.

Figure 76 Retina OverVue Report

In addition to the 3D Widefield or 3D Retina scan, the Retina OverVue report uses data
from the Retina Map, Cross Line and Grid scans, when they have been acquired. The
system constructs the Retina OverVue report as follows:

• Across the top are en face images at four depths taken from the 3D Retina or 3D
Widefield scan, in that order of preference

• At lower left is the SLO-like image from the 3D Widefield or 3D Retina scan, in that
order of preference.

• Overlying the image is a thickness map from the Retina Map, 3D Widefield, or 3D
Retina scan, in that order of preference. The overlay is either an NDB Reference map
(default) or a Full Thickness map, according to the radio button selected beneath it.

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• At lower right are horizontal and vertical B-scans from the Cross Line, Grid, 3D Retina,
or 3D Widefield scan, in that order of preference.

When you click the Exit button at upper right, the scan specific report opens, (either the
3D Widefield report or the 3D Retina report—see section 5.5.5). When you click the En
Face button, the En Face report opens.

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5.5.2 Retina OverVue Portrait Report

Figure 77 Retina OverVue Portrait Report

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5.5.3 En Face Report (All 3D Scans)
The En Face report applies to all 3D scans (Widefield, Retina and Disc). The En Face
button is available in the Retina OverVue report and in the scan specific reports.

En Face Report with Tint Selected

Figure 78 En Face Report with Tint Selected

In the middle appears a single horizontal B-scan that corresponds to the green line
across all four en face images. Click and drag the green line to change which B-scan is
displayed. By default, this report displays en face images at different depths
corresponding to the relevant retinal or disc layers.

• For retina scans, the default layers shown are ILM, IPL, RPE, and RPE Reference.

• For 3D Disc scans, the default layers are ILM, NFL, and RPE.

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• You can select the Show 3D checkbox at middle right to display the same layers using
a 3D image.

Figure 79 En Face Report, Layers Shown as 3D Images

Next to each image are three fields that enable you to change:

• The layer displayed in each image, such as ILM, IPL, RPE and RPE Ref

• The Offset (in µm) of the layer. To change the offset is to change the layer depth
relative to the default layer depth.

• The Thickness (in µm) of the given layer.

These options also define the layers displayed in the 3D Volume report (see section
5.5.4).

Click and hold over an image, then drag up or down to adjust video brightness, or left
and right to adjust video contrast. Click and scroll over an image to adjust zoom.

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At upper right are the following controls:

• Exit: Exits the en face report and returns to the scan specific
report.

• Print: Prints the current report either to an electronic file or to hard


copy, depending on the printer you choose.

• OverVue: Return to OverVue screen.

• Reset View: Resets offset and thickness to standard values.

• Set Defaults: Sets the default offset and thickness values to the
current values for each image.

• Tint EnFace: Tints each en face image for better contrast.

• Show Bnd (Boundary): Shows segmentation lines on the B-scan.

• Show 3D: Shows en face layers in 3D.

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5.5.4 3D Display (All 3D Scans)
The 3D Display button is available in the scan specific reports of all 3D scans. When
you click 3D Display the system presents a 3D image of the OCT scan.

3D Display, 3D Volume Checkbox Selected

Scan Orientation Icon

Figure 80 3D Display, 3D Volume Checkbox Selected

• Scan Orientation Icon: Shows orientation of the image using TSNI indicators.

• Click and drag on the image to rotate it. Scroll on the image to zoom. Click and drag on
the green corner handles to move the SLO image relative to the 3D image.

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To the right of the 3D image are the following controls.

• Exit: Closes the 3D display window.

• Play: Sequentially plays through the B-scans. Click Pause to


pause.

• Record: Click Record to save a recording of the sequential display


of B-scans: a dialog prompts you to choose a folder where the
recording will be saved, in .avi format, and recording begins. To
finish recording, click Stop Recording.

• Reset View: Resets the image to a top-down view.

• Cut 3D: Shows the cut 3D image. Click Play to change the cut
planes and Pause to stop.

• 3D Volume: Presents the entire 3D volume captured, including the


vitreous tissue just above the ILM plane.

• Layer Selection field: Select to display the chosen layer. When the
3D Volume checkbox is clear, the options are:

• SLO 3D: Entire 3D volume with SLO image on top

• Full Thick: Retina from ILM to RPE

• Inner Thick: ILM to IPL

• Outer Thick: IPL to RPE

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3D Volume Checkbox

Select the 3D Volume checkbox to display the Full 3D volume image (by default) with
the SLO image below.

Figure 81 3D Display with 3D Volume Checkbox Selected

When the 3D Volume checkbox is selected, the layer options are:

• Full 3D: Entire 3D volume (default)

• Layer 1, Layer 2, Layer 3, Layer 4: Select to display the chosen


layer as defined in the En Face report (see section 5.5.3).

• All 4 Layers: Displays all 4 layers.

• Vitreous: Displays the vitreous and retina.

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The following figures give examples of the available 3D Volume display options.

Figure 82 3D Volume, All 4 Layers Selected

Figure 83 3D Volume, ILM Selected

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Figure 84 3D Volume with Vitreous Selected

(White Background Used For Better Vitreous Particles View)

3D Volume Image Adjustment

Layer Selection
drop-down menu

Image Brightness Image Contrast

3D Transparency 3D Volume Low Cutoff

Figure 85 3D Volume Image Options

• 3D Volume Low Cutoff: Filters additional noise from 3D image.

• Shading checkbox: Select to switch shading on/off on the 3D image. When not
selected, the SLO image is not present.

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• Preferences button: Click Preferences to open the 3D Preferences dialog. Use this
dialog to adjust the default display of 3D images.

Figure 86 3D Preferences Dialog

Layer 1, 2, 3, 4 Defaults: Select default layer and set default offset and thickness for each
layer.

• Background Color: Click to change the background color of the 3D image. It changes
from black to gray to white.

• Advanced: Click Advanced to adjust Z Sample Distance, Interactive Z Sample


Distance, X,Y Sample Distance and Interactive X,Y Sample Distance. These adjust
3D volume rendering when static (motionless) or dynamic (moving, for example, being
dragged or rotated). Higher values yield 3D images of lower resolution, but are
processed faster. Lower values yield 3D images of higher resolution, but take longer to
process. Optovue sets the factory default values to optimally balance resolution and
processing time. Table below shows the range of input values for each parameter.

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Table Sample Distance Adjustment Ranges with CPU and GPU

GPU (Hardware
CPU Acceleration Option
Selected)

Z Sample Distance 1.0 < X < 10 0.4 < X < 10

Interactive Z Sample Distance 2.5 < X < 10 2.5 < X < 10

X,Y Sample Distance 0.7 < X < 10 N/A

Interactive Z Sample
0.7 < X < 10 N/A
Distance

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5.5.5 3D Widefield and 3D Retina Report
The 3D Widefield report and 3D Retina report share a common layout as described
below, the difference being the size of the scan pattern. Each has an image with four
display option tabs at upper left, a horizontal B-scan at lower left and vertical B-scan on
the right.

Figure 87 3D Widefield Report

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Figure 88 3D Retina Report

The green horizontal line and red vertical line on the upper left image correspond with
the horizontal and vertical B-scans currently displayed. Click on the upper left image to
select the B-scans where the lines intersect. Drag on the sliders for the green or red line
to scroll through the corresponding B-scans.

The upper left image has four tabs to display the following optional images:

• SLO: Shows the SLO-like image.

• En Face: Shows the en face image. Use the radio buttons to the right to select one of
four different layers for display: ILM, IPL, RPE, or RPE Ref. Use the Upper Offset,
Thickness and Lower Offset fields (all in µm) to adjust these parameters for the
current layer.

• Thickness (default): Shows the SLO image overlaid with retinal thickness using a color
scale. The color key next to the map explains the thickness values (in µm) associated
with the colors. Warmer colors from yellow, orange and red to white represent
increasing thickness. Cooler colors from green to blue to black represent decreasing
thickness.

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• Use the radio buttons to select Full (ILM to RPE), Inner (ILM to IPL) or Outer (IPL to
RPE) thickness for display.

• Select the Edit Bnd (Boundaries) checkbox to show and edit the layer boundaries on
the horizontal B-scan.

• RPE Elevation: Shows elevation of the RPE relative to a normalized plane. The color
key next to the map explains the thickness values (in µm) associated with the colors.
Warmer colors from yellow, orange and red to white represent increasing thickness.
Cooler colors from green to blue to black represent decreasing thickness.

At upper right are the following controls:

• 3D Display: Opens the 3D Display.

• En Face: Opens the En Face report.

• OverVue: Opens the Retina OverVue report.

• Play: Plays through the horizontal and vertical B-scans.

• Record: Records as you play through the B-scans.

• Show Bnd (Boundaries): Shows the segmentation boundaries on the B-


scans.

5.5.6 3D Clinical Scan


The 3D Clinical scan is a 513 x 101 3D cube covering 6 mm x 6 mm. This scan is
designed for use primarily in clinical studies.

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5.5.7 3D Disc Report
The 3D Report has an image with three display option tabs at upper left, a horizontal B-
scan at lower left and vertical B-scan on the right.

Figure 89 3D Disc Report

The green horizontal line and red vertical line on the upper left image correspond with
the horizontal and vertical B-scans currently displayed. Click on the upper left image to
select the B-scans where the lines intersect.

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To show the disc margin on the 3D Disc report, click the Show button.

Disc margin in orange

Figure 90 Optic Disc Margin in 3D Disc Report

You can edit the disc margin by clicking and dragging any of the white anchor points to
the desired location.

To draw the disc margin manually, select the Draw right-click option, then click once to
make each anchor point on the margin, and double-click to complete the margin.

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Disc Margin Drawing Controls

• Auto: Automatically detects the disc margin.

• Show: Displays the disc margin.

• Draw: Click Draw to manually draw the disc margin, then click around the
disc margin to place each anchor point.

• Save: Saves the disc margin as the ONH baseline.

Excessive eye motion during a 3D Disc scan can cause image registration and disc
margin detection to fail. The telltale sign of eye movement during scanning is
discontinuity of blood vessels. The image below shows such an example. In these
cases, you should retake the scan.

Eye movement indicated


by blood vessel pattern
breaks

Figure 91 A 3D Disc Scan Showing Eye Motion

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Comparison

If more than one 3D Disc scan has been acquired for this eye, the Comparison button
will be present on the report. Click Comparison and the report shows a reference
image and a B-scan window for each compared scan in rows, as shown in the image
below. Use the slider next to the reference image to select the B-scans to compare at
right.

Figure 92 3D Disc Comparison Report

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ONH Report
The ONH report provides images, charts, tables and maps to enable qualitative and
quantitative assessment of the retinal nerve fiber layer (RNFL) and the optic disc. The
image below and its legend below identify the components of an ONH report. The
subsections following explain each component in order.

9
1 2

3
8

4
7
5

Figure 93 ONH Report Layout

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ONH Report Layout Legend:

1. 1 RNFL and ONH Analysis Table 6. 6 Hemisphere and Quadrant Maps

2. 2 RNFL Circle B-scan 7. 7 Vertical and Horizontal B-scans

3. 3 TSNIT RNFL Thickness Graph 8. 8 RNFL Thickness Map Overlay

4. 4 RNFL Thickness Map 9. 9 Image Tabs (Baseline default)

5. 5 Normative Database legend

5.6.1 RNFL and ONH Analysis Table

Figure 94 RNFL and ONH Analysis Table

At top center is the RNFL and ONH Analysis table, which reports the parameters shown
above. Cell coloring reflects comparison of each value with the normative database. As
the legend at bottom center shows regions where thickness is within normal range
(green, the measurement is between the 5th percentile to 95th percentile of the NDB,
borderline (yellow, the measurement is between the 5th percentile to the 1st percentile of
the NDB, and outside normal range (red, the measurement is below the 1 st percentile of
the NDB).

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5.6.2 RNFL Circle B-Scans

Figure 95 RNFL Circle B-Scan

One of the circle B-scans centered on the optic nerve is shown at top right of the report.

5.6.3 TSNIT RNFL Thickness Graph

Figure 96 TSNIT RNFL Thickness Graph

At middle right is a graph with the black line depicting RNFL thickness (in µm) along a
calculated 3.4 mm diameter circle centered on the optic nerve head. The red, yellow
and green background on the graph represents the normative distribution of RNFL
thickness, enabling you to see the measured RNFL thickness relative to normal.

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5.6.4 RNFL Thickness Map
At lower right is a color-coded RNFL thickness map of 5 mm diameter. Warmer colors
from yellow, orange and red to white represent increasing thickness. Cooler colors from
green to blue to black represent decreasing thickness. Disc margin (green line) and cup
margin (red line) are traced at the center of the map. The space between the cup and
disc margins is the rim area.

RNFL measurement location


(black line at 3.4 mm diameter)
Disc margin (red line)

Average thickness in
this sector

Cup margin (green line)

Figure 97 RNFL Thickness Map

Average RNFL thickness for each of eight sectors appears in a ring at the outer edge of
the map. Each measurement appears against a green, yellow or red background,
indicating whether the measurement is within normal (green), borderline (yellow) or
outside normal (red). The RNFL thickness measurement at 3.4 mm diameter is sampled
relative to the disc center, not the scan beam center, so minor de-centering of the disc
relative to the scan beam does not affect the measurement.

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5.6.5 Hemisphere and Quadrant Maps

Figure 98 Hemisphere and Quadrant Maps

The hemisphere and quadrant maps show average RNFL thickness in the indicated
hemispheres (left) and quadrants (right). Each measurement appears against a green,
yellow or red background, indicating whether the measurement is within normal (green),
borderline (yellow) or outside normal (red).

5.6.6 Vertical and Horizontal B-Scans

Figure 99 Vertical and Horizontal B-Scans

At lower left are vertical and horizontal B-scans through the optic disc. Click on the IR
tab at upper left to see the scan lines on the IR video image.

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5.6.7 Baseline Image and RNFL Thickness Map Overlay

Figure 100 Baseline Image with RNFL Thickness Map Overlay

By default, the RNFL thickness map overlays the Baseline image at upper left. Right-
click on the image and select 2D Map Off to turn off the map overlay. Select the IR tab
to display the IR video image with scan pattern lines overlaid.

5.6.8 ONH Change Analysis Report


The Change Analysis button is available on the ONH report when ONH scans have
been taken on two or more visits. Click this button and the system displays the ONH
Change Analysis report; when the patient record includes both ONH and GCC scans,
the system displays the Nerve Fiber ONH/GCC Change Analysis Report (see Section
5.9). The system automatically selects up to six scans for the current patient eye. The
system uses a 3D Disc scan as baseline for registration of ONH scans.

The Change Analysis report includes most elements of the ONH report side by side for
each scan, and adds a plot of RNFL thickness versus age, and reports the resulting
RNFL rate of (thickness) change per year, its 95% confidence interval (CI) in brackets,
and its p-value.

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5.6.9 ONH OU Report
The OU Report button is available when the ONH scan has been taken for both eyes.
Click this button and the system displays the ONH OU report; when the patient record
includes both ONH and GCC scans, the system displays the ONH/GCC OU Report (see
section 5.10). OU reports are useful to assess symmetry between eyes.

Figure 101 ONH OU Report

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5.6.10 Defining the Baseline Optic Disc Margin
The system uses the optic disc margin to calculate measurements of the optic disc, cup
and rim. To define the baseline optic disc margin used in the ONH report, the system
automatically traces the disc margin using the SLO image from the 3D Disc scan (when
it is available). This is called 3D Baseline mode. It is possible to use one of two
alternative modes to define the baseline optic disc margin, though Optovue does not
recommend them; you should use an alternative mode only if you cannot capture
a useful 3D Disc scan. The three modes are:

• 3D Baseline mode (default): The system automatically traces the disc margin using the
SLO image of the 3D Disc scan

• Video Baseline mode: The user draws the disc margin manually. Right-click and select
Draw Disc.

• No Baseline mode: In this mode, the system does not calculate disc measurements
and so reports all metrics as zero.

Caution: Optovue does NOT RECOMMEND using No Baseline mode, for


several reasons:

• Successful results require great skill to center the scan pattern on the optic
disc.

• No Baseline mode precludes scan registration between visits, and therefore


precludes change analysis.

• In this mode, the system does not calculate disc measurements and so
reports all metrics as zero.

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Modify RPE Anchor Points

RPE tips are relevant in ONH reports only. The system places anchor points on the
RPE tips to define the disc and cup, and to center ONH scans on the optic nerve.

1. To verify end point placement on ONH reports, right-click on white space or on the
RNFL thickness map and select Modify RPE Anchor Points.

2. Drag the yellow dots as desired to adjust placement of one set of RPE anchor points.

Figure 102 Verify RPE Tips

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Assessing the GCC

Figure 103 The GCC and Its Layers

The ganglion cell complex (GCC) encompasses three layers of ganglion cells in the
retina:

1. The retinal nerve fiber layer (RNFL) is made up of the ganglion cell axons,

2. The ganglion cell layer (GCL) is made up of the ganglion cell bodies,

3. The inner-plexiform layer (IPL) is made up of the ganglion cell dendrites.

The GCC becomes thinner as ganglion cells die from glaucoma. By measuring GCC
thickness, the GCC scan supports clinicians who diagnose and track glaucoma and
other diseases that affect the GCC layer.

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GCC Report
The GCC report provides image displays, charts, tables and interactive maps to enable
qualitative and quantitative assessment of the GCC. Figure 104 and its legend below
identify the components of a GCC report. The following subsections explain each
component in order.

Figure 104 GCC Report Layout

GCC Report Components Legend:

1. 1 Thickness Map 5. 5 NDB Reference Map

2. 2 Thickness and Deviation radio buttons 6. 6 Table of thickness and volume


parameters
3. 3 B-scan display
7. 7 Normative database legend
4. 4 Show Lines and Show Boundary Curves
checkboxes

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5.8.1 Thickness Map or Deviation Map
At upper left appears a GCC Thickness Map by default. The Thickness Map is 6 mm
diameter and uses a color scale to indicate thickness (in µm). Use the Thickness and
Deviation radio buttons below the map to choose which type of map to display. The
Deviation Map uses a color scale to indicate percent deviation (-50% to +50%) from
normal thickness. The color key next to the maps explains the values (in µm) associated
with the colors. Warmer colors from yellow, orange and red to white represent greater
values. Cooler colors from green to blue to black represent lesser values.

The GCC map for a normal eye shows a broad sweep of bright color around the fovea,
indicating a GCC with healthy ganglion cells (healthy eye at left in Figure 105). (The
fovea has no ganglion cells and therefore shows darker color.) In glaucoma, the GCC
thins as ganglion cells are lost; consequently, the extent of bright color around the fovea
contracts (glaucoma eye at right in Figure 105).

Figure 105 GCC Thickness Maps: Healthy Eye (Left), Glaucoma Eye (Right)

5.8.2 B-Scan Display


The red lines on the NDB Reference Map at upper right indicate the currently selected
scan lines of the GCC scan pattern, which correspond to the B-scans shown at lower
left and center.

• Select Show Lines to show scan pattern lines on the thickness map and NDB
reference map. Select Show Boundary Curves to show the segmentation lines on the
B-scans.

• When you click on the NDB Reference Map, the red lines change to blue and move to
the vertical scan where you click. The vertical line then follows the pointer until you click
again, and the lines turn back to red. While you move the blue lines, the corresponding
B-scan also updates.

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5.8.3 NDB Reference Map
The color-coded NDB Reference Map shows regions where thickness is within normal
range (green, the measurement is between the 5th percentile to 95th percentile of the
NDB, borderline (yellow, the measurement is between the 5th percentile to the 1st
percentile of the NDB, and outside normal range (red, the measurement is below the 1st
percentile of the NDB). The grey circle around the fovea is to exclude reference to
normative data colors because this region lacks ganglion cells.

5.8.4 Thickness and Volume Parameters Table


The table at lower right reports GCC thickness and volume parameters. Applicable
measurements appear against a green, yellow or red background, indicating whether
the measurement is within normal (green), borderline (yellow) or outside normal (red).
Parameters include:

• Average GCC thickness (in µm) overall (Total) and in the superior and inferior
hemispheres. GCC thickness is measured from ILM to IPL. Each measurement appears
against a green, yellow or red background, indicating whether the measurement is
within normal (green), borderline (yellow) or outside normal (red). Intra-eye Difference
(S-I) is difference of thickness value between hemispheres.

• FLV (%) Focal Loss Volume quantifies the amount of significant GCC loss. FLV is
expressed as a percentage of the map area with significant ganglion cell loss (by
volume).

• GLV (%) Global Loss Volume quantifies the average amount of GCC loss over the
entire GCC map. GLV is the sum of the pixels where the fractional deviation map value
is < 0, divided by the total map area to give a percent loss of GCC thickness.

5.8.5 GCC Change Analysis


The Change Analysis button is available on the GCC report when GCC scans have
been taken on three or more visits. Click this button and the system displays the GCC
Change Analysis report; when the patient record includes both ONH and GCC scans,
the system displays the Nerve Fiber ONH/GCC Change Analysis Report (see section
5.9). The system automatically selects up to six visits for the current patient eye.

The GCC Change Analysis report includes most elements of the GCC report side by
side for each scan, and adds a plot of RNFL thickness versus age, and reports the
resulting RNFL rate of (thickness) change.

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Nerve Fiber ONH/GCC Change Analysis Report
When both ONH and GCC scans were acquired for an eye on three or more visits, the
Change Analysis button on the ONH and GCC reports generates a Nerve Fiber
ONH/GCC Change Analysis report. This report automatically displays ONH and GCC
thickness maps (and data for up to six visits for the current patient eye).

Figure 106 Nerve Fiber ONH/GCC Change Analysis Report

• Thickness Maps: At upper left, the report shows thickness maps for up to six GCC
scans and six RNFL scans. The software automatically selects for display the earliest
two visits and the latest two visits. If desired, you can use the list of visits in the column
at left to select which scans to display.

• GCC Thickness Maps support evaluation of GCC thickness distribution (color, pattern,
and fovea centering) for consistency, scan quality, and obvious measurement artifacts.
Usually, the first two visits should be reasonably consistent with each other and the last
two visits should be reasonably consistent with each other, unless a confirmed condition
exists to explain rapid change between two adjacent visits. Scans with clearly identified
image quality problems should be deleted to avoid inclusion in change analysis.
Compare images to the GCC trend to rule out contradictory images or those that prompt
data quality concerns.

• RNFL Thickness Maps support evaluation of RNFL thickness distribution (color and
pattern) and disc/cup shapes for consistency, scan quality, and obvious measurement

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artifacts. Usually, the first two visits should be reasonably consistent with each other
and the last two visits should be reasonably consistent with each other. Scans with
clearly identified image quality problems should be deleted to avoid inclusion in change
analysis. Compare images to the RNFL trend to rule out contradictory images or those
that prompt data quality concerns.

• Comparison to NDB Table: At upper right, a table reports GCC and RNFL
measurements for the first and last visits. Table cells are color-coded with respect to the
normative database.

• TSNIT Graph: At middle right is a TSNIT graph displaying RNFL thickness at each
visit. The TSNIT graphs help you visualize regions of change and the shape of the
RNFL distribution, and to judge test consistency.

• Rate of Change Graphs: At bottom are graphs that plot RNFL thickness (left) and GCC
thickness (right) versus age. Above each graph appears the estimated rate of change
(in µm) per year, as well as the range of the 95% confidence interval in brackets, and its
p-value. Different from other threshold-based change detection methods, this change
analysis does not apply a fixed threshold for change detection, and makes no
assumption of test-retest variability. The rate of change estimate uses simple linear
regression. It fits a straight line to a graph of thickness data points versus age, and
calculates the slope of the line to determine whether it indicates a statistically significant
change in thickness.

5.9.1 Interpreting Change Report


• For the estimated rate of thickness change, the report automatically includes thickness
measurements from all visits. Including more data with a longer period of follow-up
tends to increase the accuracy of the estimate. Optovue recommends that you delete
poor quality ONH and GCC scans to exclude them from the analysis.

• The 95% Confidence Interval indicates the range of slope within which the true slope is,
with 95% probability. The narrower the range, the more reliable the slope estimate.
When the range includes zero, it means the estimated slope is not significantly different
from zero statistically. Factors affecting the confidence interval include measurement
variability, duration of follow-up, and number of tests performed.

• The p-value indicates whether the estimated slope is statistically different from zero. A
smaller p-value means it is less likely the true slope is zero.

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When the p-value is between 0.1 and 0.05, the slope and p-value appear with black text
against a light purple background, indicating marginal statistical significance.

Figure 107 Marginally Significant Change

When the p-value is 0.05 or less, the slope and p-value appear with white text against a
dark purple background, indicating statistical significance.

Figure 108 Statistically Significant Change

The rate of change, if estimated with high reliability, could be used to estimate RNFL
and GCC thickness measurements in future years. For example, a rate of -3 µm/year
could mean loss of 30 µm of thickness in 10 years if it continues at the same rate. For
reference, based on the OCT normative database (cross-sectional data set), the
estimated age-related loss of average RNFL and average GCC is less than 0.2
µm/year. It is likely that an individual’s age-related loss may have a different rate from
the average value. However, if a much higher rate of change is detected in an eye,
further clinical evaluation may be necessary.

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ONH/GCC OU Report
When the patient record includes both ONH and GCC scans for both eyes, clicking the
OU Report button generates an ONH/GCC report.

Figure 109 ONH/GCC OU Report

This report includes the elements of the ONH and GCC report for both eyes side by
side, for analysis of symmetry. For details, see sections 5.6 ONH Report and 5.8 GCC
Report.

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ONH/GCC OU Portrait Report

Figure 110 ONH/GCC OU Portrait Report

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Avanti OU Wellness Report

The Avanti OU Wellness report is derived from the Avanti Wellness protocol. It is a
combination of the values from the Retina scan and the GCC scan for both eyes. It
displays 4 B scans with retina and GCC thickness compared to NDB.

Figure 111 Wellness Report

If the AngioVue Retina scan has been taken in the same visit the Wellness report will also
show the Retinal vessel density and FAZ for each eye.

Figure 112 Wellness Report with vessel Density and FAZ

_End of section_______________

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6 Main Menu
The options available in the main menu depend on the current user interface setting,
which you can select in the User Interface Setting field of the User Preference dialog
(see section 6.2.5). The default setting is Advanced, which includes all available menu
options. Other settings include a subset of the Advanced settings. This chapter
addresses the Advanced menu options.

Figure 113 Main Menu

File Menu
Click File to open the File menu.

Figure 114 File Menu

6.1.1 Print Options


• Print: Prints the current report either to an electronic file or to hard copy, depending on
the printer you choose. Make sure the chosen printer is connected and ready to print.

• Print Preview: Opens a preview of the printout.

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• Print Setup: Opens the Print Setup dialog, where you can select the printer and adjust
print preferences.ie Portrait or Landscape. If printing to PDF increase the DBI setting to
get clearer printouts. The default is usually low resolution.

Figure 115 Print Setup Dialog

• Print Header Info: Opens the Print Header dialog. Use it enter practice information to
be included on all printouts. Name is required, others are optional. If no name has been
entered previously, the Print Header dialog also appears when you click Print.

Figure 116 Print Header Dialog

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6.1.2 Data Transfer
Data Transfer enables you to transfer scan data from the system database to another
local file directory or networked computer. Follow these steps to transfer data:

1. Select Data Transfer > Output Data. A Save As dialog opens, enabling you to select
the target location.

2. OutputDB is the default file name; give the output file a unique name in the File name
field and click Save. The Output Selection dialog appears.

Figure 117 Output Selection Dialog

3. To find specific patients, use the search options at upper right. Select the checkboxes of
scans you wish to transfer and click the Start Output button. A progress bar shows

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output progress. When complete, a dialog informs you and prompts you to do the next
step.

4. You must click the Save and Exit button to save transferred data. Click OK to close the
dialog and then click Save and Exit back in the Output Selection dialog.

6.1.3 Export (Advanced GUI Only)


Data export is available only when using the Advanced GUI; it is only intended to
support research using third party analysis applications. Export enables you to export
the current scan or all scans from the current visit.

Figure 118 Export Options

+ Note: The export format is XML. For detailed XML specifications, contact
Optovue Technical Support.

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1. Select Export and then Current Visit, Current Scan, or XML, as shown in Figure 118.

• If you select XML, the XML Export Selection dialog opens. Much like the Output
Selection dialog, it enables you to search for and to choose scans for export.

• If you choose Current Visit or Current Scan, a Browse dialog opens. Select the target
directory for export and click OK.

6.1.4 Import
Import enables you to import saved images one at a time from a local or networked
directory to the currently selected patient record. You can import any image file,
including .bmp, .jpg, .gif, .png and .tif files. Optovue recommends using a common
image format for imported and exported images, and suggests use of .jpg files. Images
can be from any system that saves image files, such as fundus photographers, corneal
topographers, visual field analyzers, wavefront systems, and OCT, SLO and SLP
imaging systems.

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Follow these steps to import images:

1. Select Import > Import Image. An Open dialog appears.

2. Find and select the desired image for import and click Open. A dialog opens showing
the selected image. The currently selected patient name, visit date and the imported
image name appear below the image.

Figure 119 Dialog for Image Import

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3. To the right of the image, select the eye (OD or OS) and specify the type of image using
the radio buttons and click Save. The image is saved with the specified visit and
available for viewing on the system. The Image Type radio buttons are:

Fundus Image Types

• Color Image

• Red free Image

• FA Image (Fluorescein Angiogram)

• IA Image (Indocyanine Green)

Exam Result Types

• WF Wavefront

• VF Visual Field

• CT Corneal Topography

• SCODI Scanning Computerized Ophthalmic Diagnostic


Instrument (per Medicare nomenclature)

When an imported image is saved to a visit, and you open any scan from that visit, if its
report includes an image display with tab options, a new tab will appear named with the
image type you specified when importing. Select that tab to view the imported image.

6.1.5 Archive

+ Note: Always contact Optovue Technical Support department before attempting


to archive any patient data. It is a complex procedure requiring technical assistance to
perform successfully.

Archiving removes data from the internal hard drive. The purpose of archiving is to free
space to save new exams on the internal drive while maintaining access to archived
patient records. Archived scans are still displayed in the patient list, but the archive drive
must be connected to the system to review archived scans.

+ Note: Archiving is not a method to back up the database. Archiving removes


data from the internal hard drives to free space, while backing up copies data for

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recovery in the event of data loss. It is important to maintain a backup of both the
internal hard drive and the archive drives in case either is lost or damaged.

Before attempting to archive, you must designate the archive drive in the User
Preference dialog (see section 6.2.5). Select User Preference from the Tools menu to
open the User Preference dialog; then designate the archive drive in the Primary
Archive Drive field.

+ Note: You must use an external USB hard drive or network drive to archive
data. Do not archive to the system hard drive. Archive drives must support NTFS
format.

Select Archive from the File menu to start the archive process. The Archive Selection
dialog opens.

Patient Search
Visit list options

Start Archive
button

Figure 120 Archive Selection Dialog

To find specific patients, use the search options at upper right. Select the checkboxes of
the visits you wish to archive and click the Start Archive button. A dialog reports
progress until archive is complete. After archiving, the small letter ‘a’ appears next to
the number of scans for that visit date, indicating that the visit is archived. However,
when you select a scan from an archived visit for review, the system automatically
retrieves the data and opens the scan report as normal, as long as the archive drive is
connected.

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+ Note: The archive drive must be connected to the system to review scans from
archived visits.

6.1.6 Data Backup


Data backup is an automatic background function performed during normal system
operation. There are two hard drives supplied in all XR systems, the C drive (main) and
D drive (primary backup drive). The application automatically copies scan data to both
drives as each scan capture session is finished.

+ Note: The automatic backup does not cover archive drives.

You can add an additional backup target in the form of an external USB drive or a
network address (folder, drive, etc.). Simply add the appropriate drive letter (assigned
automatically by Windows when connected, or determined by an IT person) in the
Secondary backup drive field in the User Preference dialog.

Figure 121 Secondary Backup Drive in User Preference Dialog

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6.1.7 Batch Process
To batch process means to process a set of scans you choose in the way they are
processed the first time you open the scans in the Review window. In this way, these
scans are already processed and open more quickly in the Review window. It is
advisable to clean diagnosis data on all scans and then batch process all scans after
installing a software update from Optovue. To do this in one step, select Clean and
Batch Process All Patients from the File menu. This can take up to several hours if
the database is large.

Batch Process Options

Optovue strongly recommends using Batch Process only when the system is not
otherwise needed. Start it at the end of the day if you choose to batch process all
patients, since it can take up to several hours if the database is large.

Figure 122 Batch Process Options

Select File > Batch Process and then the option of your choice.

• Current Visit: Processes all scans of the currently selected visit.

• Current Patient: Processes all scans of the currently selected patient.

• Today’s Patients: Processes all scans acquired today.

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• All Patients: Further select the option of your choice.

• All: Processes all scans in the database. This can take considerable time to complete.

• Cornea: Further select the option of your choice.

▪ All: Processes all cornea scans

▪ 3D Cornea: Processes all 3D cornea scans

▪ Pachymetry: Processes all pachymetry scans

• Nerve Fiber: Further select the option of your choice.

▪ All: Processes all nerve fiber scans

▪ 3D Disc: Processes all 3D Disc scans

▪ GCC: Processes all GCC scans

▪ ONH: Processes all ONH scans

• Retina: Clicking this option displays these submenu options:

▪ All: Processes all retina scans

▪ 3D Retina: Processes all 3D retina scans

▪ 3D Widefield: Processes all 3D Widefield scans

▪ Retina Map: Processes all retina map scans

6.1.8 Clean Diagnosis Data


The Clean Diagnosis Data process undoes previous scan processing. Scans are then
reprocessed as usual when opened in the Review window, or when you run a batch
process. If a software update requires reprocessing of certain type of scans, it is
advisable to clean diagnosis data on all scans of the scan type and then batch process
all scans of the scan type after installing a software update from Optovue. To do this in
one step, select Clean and Batch Process All Patients and select the scan type from
the File menu. This can take up to several hours if the database is large.

+ Note: Manual segmentation edits are preserved when you clean diagnosis
data. Retina Map foveal position will reset and previous manual fovea
correction will be lost. Please verify fovea location and manually adjust if needed.

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Clean Diagnosis Data Options

Select Clean Diagnosis Data from the File menu. This process has all the same
submenu options as the batch process—see section 6.1.7 above for details.

Figure 123 Clean Diagnosis Data Options

6.1.9 Clean and Batch Process All Patients

+ Note: Manual segmentation edits are preserved when you clean diagnosis data.
Retina Map foveal position will reset and previous manual fovea correction will be
lost. Please verify fovea location and manually adjust if needed.

This is a one-click solution to clean and reprocess all scans for all patients. Depending
on the size of the database, this can require up to several hours. Optovue recommends
starting this process only at the end of the day.

1. Select Clean and Batch Process All Patients from the File menu. A dialog informs
you it can take several hours and asks if you want to continue.

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Figure 124 Confirm Cleaning and Reprocessing

2. Click OK to proceed. Click Cancel to cancel. If you proceed, a dialog shows progress
until it completes.

6.1.10 Delete Unused Visits (0 Scans)


Select this option to delete visits that have no scans.

6.1.11 Exit
Exits the software application, like clicking the X button in the upper right corner.

Tools Menu
Click Tools to open the Tools menu.

Figure 125 Tools Menu

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6.2.1 Scan Pattern Management
Select Scan Pattern Management in the File menu. The Scan Pattern Management
dialog opens; it lists the available scan patterns. Select the checkboxes of those scan
patterns you wish to have available during scan acquisition.

Figure 126 Scan Pattern Management Dialog

Click Done to implement your selections.

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6.2.2 Protocol Management
Select Protocol Management in the File menu. The Protocol Management dialog
opens; it lists the available protocols. Select the checkboxes of those protocols you wish
to have available during scan acquisition. Scan protocols group a set of scan types for
sequential capture with a particular clinical purpose, or to apply a customized scan
regimen. You can create and edit custom protocols by selecting Protocol from the
Database Management menu (see section 6.4.1).

Figure 127 Protocol Management Menu

Click Done to implement your selections.

6.2.3 Clear Log File (Advanced GUI only)

+ Note: Use Clear Log File only when so directed by an Optovue representative.

Clear Log File clears the system event log file.

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6.2.4 Enter Calibration Password

+ Note: Only Optovue-trained personnel should use this function.

6.2.5 User Preference


Select User Preference from the Tools menu to open the User Preference dialog. Use
it to specify various system settings, default views and scan parameters, as explained
below.

Figure 128 User Preference Dialog

• Date Format: Specifies the date format for the system application, which should match
the system computer date format.

• Allow to save eye blink data: Select YES to save scan data even if the system detects
patient blinks during scanning. Select NO to discard scan data and prompt to rescan
when the system detects patient blinks.

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• Fixation LED Current (0-1000): Adjusts the LED current—and thus the light intensity—
of the fixation target (default is 700).

• Video Enhancement: Select YES to automatically apply contrast enhancement to the


IR video reference image captured with the scan.

• Primary Archive Drive: Select the drive letter of the primary drive used to save
archived data.

• Secondary Archive Drive: Select the drive letter of the secondary drive used to save
archived data. Using a secondary drive is optional.

• Primary Backup Drive: By factory default, the system uses its own second internal
hard drive (the D drive) as the primary backup drive used to save an automatic backup
copy of scan data. (A backup is used to recover data in the event of damage or loss of
the primary internal system drive or an archive drive.) Use this field to specify a different
drive as the primary drive.

• Secondary Backup Drive: Enables you to specify a second drive to be used for
backup, usually an external USB drive or network drive

• Enable Joystick to Save Scan checkbox: Selected by default, this means that
pressing the joystick button after scan capture saves the scan and the system
automatically goes to the next scan (if any). Clear this checkbox to disable this feature,
which means you must click the Save button on screen to save.

• User Interface Setting: Select the user interface, Clinical or Advanced.

• Clinical Tab Setting: Select Auto or Manual to set the default layout of scan controls.

• Auto Adjust Setting: Defines the functions that occur when you press the Auto Adjust
button or double-click in the live scan area.

• Auto Play/Scan Video Quality Settings: Sets the level of quality and the file size of
the AVI file created by recording the animation of 3D scans, Range: Low = 25 MB (1
loop/cycle) and High = 125 MB (1 loop/cycle)

• 3D OCT Sum (µm): Default starting value for en face presentation in 3D analysis
display.

• Default 3D View: Sets the default report view for 3D Widefield scan and 3D Clinical
scan (used at research sites only).

• Default 3D Retina View: Sets the default report view for 3D Retina scan.

• Default 3D Disc View: Sets the default report view for 3D Disc scan.

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• Default 3D Retina Display: Sets the default type of image to display in the 3D Retina
report.

• Default 3D Glaucoma Display: Sets the default type of image to display for the 3D
ONH presentation.

• Default 3D Retina Enface Layer: Sets the default layer to display in the 3D Retina
Enface presentation.

• Default 3D Glaucoma Enface Layer: Sets the default layer to display in the 3D ONH
Enface presentation.

• MCT Load Both Volumes: When sending scans over an office network, this option
enables you to select whether both source scan data sets are sent when transferring
scans that have had MCT (motion correction technology) applied, or only the final MCT
scan data. Sending both data sets takes more time and requires sufficiently fast
computers to do.

• Followup, Tracking and Show Patient list checkboxes: Select to enable, deselect to
disable the tracking, followup, or list features.

• Auto saving PNG checkbox: Select to enable, deselect to disable the Export as PNG
button in the Tool pane of the Review window. Default is disabled (unchecked).

• PNG directory: When you select the Auto saving PNG checkbox, the PNG directory
field opens, prompting you to choose where PNG report images will be saved. Click the
button to the right of the field to find and select the target folder, or type in the path. If
you do not specify a directory, the system displays an error message when you click the
Export as PNG button in the Tool pane of the Review window.

• RT Scan Pattern Tab: Adjust the default length and width of the Line, Cross Line,
Raster, and Grid scans.

• Average # Tab: Enter for each scan type the number of scans to be averaged.

• Cornea Tab: Adjust the default length of each cornea scan type.

• OK and Cancel buttons: Click the OK button to save user preference changes. Click
Cancel to discard changes and close the dialog.

6.2.6 Reset System (Advanced GUI Only)


Contact Optovue technical support to perform this function.

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OCT Image Menu
Click OCT Image to open the OCT Image menu.

Figure 129 OCT Image Menu

6.3.1 Modify Baseline


Select to modify the disc margin baseline shown on the video (IR) image. This feature
applies only to baselines drawn on the video (IR) image. The drawing saved as the
baseline may or may not have been drawn on the currently displayed IR image.

6.3.2 Modify Boundary


Opens the B-scan window so you can review and edit segmentation boundaries on
individual B-scans.

6.3.3 Reload Baseline


Places the existing baseline disc margin drawing on the video (IR) image in the upper
left corner of the review screen for reference (use the Modify Baseline function to edit).
This feature applies only to baselines drawn on the video (IR) image.

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6.3.4 Scan Parameter Setting
Use the Scan Parameter Setting dialog to set the default parameters for display of
images during scan acquisition.

Figure 130 Scan Parameter Setting Dialog

• Dark Eye and Light Eye field groups: Specify the default IR video settings to be used
when you click the Dark Eye or Light Eye button during scan acquisition. The
parameters you can adjust are:

• Illumination

• Video Brightness

• Video Contrast

• Black Level

• Dark/Light Eye Method: Select Fixed or Black Level to specify the whether or not to
adjust the above video settings based on the black level. Fixed means the dark and
light eye settings do not adjust based on the black level. Black Level means they do
adjust based on the black level.

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• Automatic Usage: Select Never, AA + Illumination (Auto Adjust plus Illumination), or
Continuous to specify whether and how the black level automatically adjusts based on
the settings reached when you click the Auto Adjust button while scanning.

• Examine OCT Image: Select Gray Scale or Color Scale to set the default way to
display OCT images during scanning.

• Diagnosis OCT Image: Select Gray Scale, Color Scale or Same as Examine to set
the default way to display OCT images during review.

• Image Quality Signal Strength Index: Sets the minimum SSI threshold below which
the system will not show a green bar during scanning.

Database Management Menu


Click Database Management to open the Database Management menu.

Figure 131 Database Management Menu

+ Note: Once you associate scans with an item (such as physician, protocol,
disease, etc.) from the database management menu, you cannot delete that item unless
you delete all associated scans first.

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6.4.1 Protocol
Click Protocol in the Database Management menu. The Protocol Editor dialog
opens. Use this dialog add (create), edit or delete scan protocols. Scan protocols group
a set of scan types for sequential capture with a particular clinical purpose, or to apply a
customized scan regimen.

Figure 132 Protocol Editor Dialog

The system provides a preset list of protocols, but you can add, edit or delete any
protocol. All protocols appear in the scan window when you click the Protocol button
(see section 3.2.1).

+ Note: Adding protocols at any point adds them to the STEP 1 Protocols popup
menu discussed in that section and to the list shown in the Protocol Editor dialog.

Delete Protocols

Select a protocol from the list and click the Delete button. A dialog asks Do you want
to delete [selected protocol]? Click Yes to delete, or No to retain the protocol. The
system does not allow you to delete a protocol that has been used to acquire scans.

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Add Protocols

Add (create) new protocols by combining scan types or even other protocols using the
Protocol Builder dialog. You cannot edit existing protocols, only delete the entire
protocol (and make a new one if you wish).

1. In the Protocol Editor dialog, click the Add button. The Protocol Builder dialog opens.

Figure 133 Protocol Builder Dialog

2. Enter a name in the Examine Protocol Name field.

3. From the tabbed lists for Protocol, Retina, Nerve Fiber and CAM-L on the left, select a
scan type or protocol and click Add to add it to the list on the right.

• To delete a scan type or protocol from the new protocol before saving, select it and click
Delete.

• Click Clear to delete all the scan types and protocols added so far and start over. Click
Save to save the new protocol.

• Click Cancel to exit the Protocol Builder; changes you have already saved will be
retained.

• Note that when you add a scan type, it is added for both eyes. If you wish to make a
protocol for OD or OS only, delete each OD or OS version separately.

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Edit Protocol Name

You cannot edit existing protocols, only delete the entire protocol (and make a new one
if you wish). The Edit button in the Protocol Editor enables you to edit only the name of
the protocol.

In the Protocol Editor dialog, select a protocol and click the Edit button. Edit the name in
the Edit Protocol Name dialog that opens, then click Save to save the name.

6.4.2 Physician
Select Physician from the Database Management menu. The Physician Editor dialog
opens. Use this dialog to create or edit a list of physicians. You can select a physician
from the list you create to associate with his or her patients.

Figure 134 Physician Editor Dialog

• Select a physician from the list and click Delete to delete a physician. The system does
not allow you to delete a name that is associated with any visit or scan.

• Click Add to open a dialog where you can enter the name of a physician, then click OK
to save.

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Figure 135 Dialog to Add or Edit Physician Name

• Select a physician from the list and click Edit to open the same dialog where you can
edit the name, then click OK to save.

6.4.3 Operator
Select Operator from the Database Management menu. The Operator Editor dialog
opens. Use this dialog to create or edit a list of system operators. You can select an
operator from the list you create to associate with patients.

Figure 136 Operator Editor Dialog

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• Select an operator from the list and click Delete to delete an operator. The system does
not allow you to delete a name that is associated with scan data.

• Click Add to open a dialog where you can enter the name of a physician, then click OK
to save.

Figure 137 Dialog to Add or Edit Operator Name

• Select an operator from the list and click Edit to open the same dialog where you can
edit the name, then click OK to save.

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6.4.4 Disease
Select Disease from the Database Management menu. The Disease Editor dialog
opens. Use this dialog to create or edit a list of diseases. You can select a disease from
the list you create to associate with his or her patients.

Figure 138 Disease Editor Dialog

• Select a disease from the list and click Delete to delete a disease. The system does not
allow you to delete a disease that is associated with scan data.

• Click Add to open a dialog where you can enter the name of a disease, then click OK to
save.

Figure 139 Dialog to Add or Edit Disease Name

• Select a disease from the list and click Edit to open the same dialog where you can edit
the name, then click OK to save.

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6.4.5 Move a visit to another patient
If a visit was erroneously created under the incorrect patient, this feature enables you to
correct the error. Select the patient and visit you wish to move, and then select Move a
visit to another patient from the Database Management menu. Follow the steps in
section 2.4.

Home Menu
Select Home from the main menu to open the Avanti home screen.

Help Menu
Select Help to open the Help menu.

Figure 140 Help Menu

• About RTVue XR: Opens the About RTVue XR dialog, which shows the current
software version, the Optovue support email address [email protected], the
Optovue website http://www.optovue.com, and has a link to View All Licenses.

Figure 141 About RTVue XR Dialog

• Upgrade: Select to perform a software upgrade.

_______________End of section_______________

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7 System Maintenance
Routine Cleaning
7.1.1 Prevent Dust Accumulation
To prevent accumulation of dust, place the dust cover over the system when not in use.

7.1.2 Clean the Ocular (Front Objective) Lens


Caution: Make sure the front lens is clean before scanning. An unclean lens
can cause a weak OCT image or a blurry video image and may skew
scanning data. The ocular lens can be unclean due to smudges from contact
with eyelashes, the nose or fingers; or excessive dust or dirt from the
environment.

Optovue recommends cleaning the ocular lens regularly using lens cleaning solution
and lens cleaning paper. Wet the lens paper with cleaning solution and wipe the ocular
lens with one pass in one direction. Discard the used lens paper. Use a new sheet for
each wipe until the lens is clean.

7.1.3 Clean the Head and Chin Rest


Optovue recommends cleaning the head and chin rest between patients using either a
disinfecting agent, such as an anti-germicide or isopropyl alcohol, on a clean, lint-free
cloth or an isopropyl alcohol wipe

System Computer Maintenance


To maintain computer performance, Optovue recommends regular use of the Disk
Cleanup and Disk Defragmenter tools. To access these tools, from the computer
desktop select Start > All Programs > Accessories > System Tools > Disk
Cleanup or Disk Defragmenter. We suggest disk defragmentation monthly, or more
frequently if the system is used heavily.

Optovue suggests major maintenance, including calibration verification, be done once a


year. We further suggest to close the system application when the system has not been
in use for a long period of time, and to shut down the system at the end of each
business day.

_______________End of section_______________

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8 Scan Pattern Specifications

Table 2 Scan Pattern Specifications

# A-Scan
Scan
Description (Without Adjustability Default
Pattern
Averaging)

Transverse:
Single line scan with 2-12 mm (0.1 mm 12 mm, -5o
Line speckle elimination 1024 X 1 increment) Angle: (monitor screen
process option 90 to 90o (1o left to right)
increment)

Transverse:
Cross Single line scan with 2-10 mm (0.1 mm 10 mm, 0o
speckle elimination 1024 X 2 increment) Angle: (monitor screen
Line process option 90 to 90o (1o left to right)
increment)

2-12 mm length 10 mm length x


5 vertical, 5 horizontal
Grid 1024 X 10 0-8 mm width
lines
adjustment 2 mm width

12 mm length x
21 parallel line scans; 6-12 mm length
Raster 1024 X 21
averaged 1-8 mm zone
7 mm width

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# A-Scan
Scan
Description (Without Adjustability Default
Pattern
Averaging)

6 mm x 6 mm

outer region

13 horizontal lines with


6 mm scan length, 0.5 4 mm x 4 mm
mm interval; + 8
horizontal lines with 4 inner region
mm scan length, 0.5
mm interval; 13 vertical (803 x 26) +
Retina Map Fixed
lines with 6 mm scan (535 x 16)
length, 0.5 mm 250 μm interval
interval, + 8 vertical in central 4 mm
lines with 4 mm scan & 500 μm
length, 0.5 mm interval, separation
all centered at fovea
outside 1 mm

(each side &

top/bottom)

141 B-scans equally


spaced to cover 7 mm
3D Retina 385 X 141 Fixed 7 mm X 7 mm
x 7 mm volume. Center
fixation

320 B-scans equally


spaced to cover 9 mm
y-axis (slow transverse
3D Widefield axis). Each B-scan has 320 X 320 Fixed 12 mm X 9 mm
320 A-scans covering
12 mm x-axis (fast
transverse axis).

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# A-Scan
Scan
Description (Without Adjustability Default
Pattern
Averaging)

3D Widefield Same as 3D Widefield


(320 X 320) X
but with Motion Fixed 12 mm X 9 mm
4
With MCT Correction Technology

Radial Lines 18 radial lines 1024 X 18 2 – 12 mm length 12 mm

Transverse: 2-12
12 mm, -5o
Enhanced mm (0.1 mm
Single line scan 1024 X 1 (monitor screen
HD Line increment) Angle:
left to right)
90 to 90o

1 horizontal line with 7


mm scan length,
933 x 1
followed by 15 vertical
horizontal Line,
GCC lines with 7 mm scan Fixed 7 mm X 7 mm
933 x 15
length & 0.5 mm
vertical lines
interval, centered 1 mm
temporal to fovea

965 x 3 ring
(4.9, 4.6, 4.3),
12 radial line scans 3.4 775 x 3 ring
mm length & 13 (4.0, 3.7, 3.4), 4.9 mm diameter
ONH concentric rings (1.3- 587 x 3 (3.1, Fixed centered on optic
4.9 mm diameter) all 2.8. 2.5), 425 x disc
centered on disc 4 ring (2.2, 1.9,
1.6, 1.3), 12 x
455/radial line

101 B-Scans equally Transverse: 3-8


spaced covering 6 mm mm (1 mm
3D Disc y-axis, each 513 X 101 increment) Width: 6 mm X 6 mm
with 513 A-scans 3-8 mm (1 mm
covering 6 mm x-axis. increment)

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# A-Scan
Scan
Description (Without Adjustability Default
Pattern
Averaging)

8 radial lines with 6 mm


scan length (1020
Pachymetry 1020 X 8 Fixed 6 mm radial scan
A-scans/line), 22.5 o
interval

8 radial lines with 9 mm


scan length (1020
Pachymetry
1020 X 8 Fixed 9 mm radial scan
Wide o
A-scans/line), 22.5
interval

8 radial scans with 6


Pachymetry mm scan length (1020 (1020 x 8) x 5
+ Corneal A-cans/line) & 22.5 o per 5 repeated Fixed 6 mm radial scan
Power interval. 5 repeated sets
sets taken

1020 A-scans/line Transverse: 2-8


mm (0.5 mm
Cornea Line with adjustable 1020 X 1 increment) Angle: 8 mm, 0 o
90 to 90o (1o
scan length increment)

Transverse: 2-8
2 scan lines each
Cornea mm (0.5 mm
orthogonal with
1020 X 2 increment) Angle: 8 mm, 0 o
adjustable scan length
Cross Line 90 to 90o (1o
at 1020 A-scans/line
increment)

Transverse: 2-6
1 scan line with mm (0.5 mm
Angle adjustable scan length 1021 X 1 increment) Angle: 3 mm, 0 o
o o
(1020 A-scans/line) 90 to 90 (1
increment)

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# A-Scan
Scan
Description (Without Adjustability Default
Pattern
Averaging)

101 horizontal scan


Transverse: 2-8
lines, 2-8 mm scan
mm (1 mm
3D Cornea length at 513 A- 513 X 101 4 mm
increment) Angle:
scans/line & 0-8 mm
fixed at 0o
width

Transverse: 2-10
101 frames equally
mm (0.1 mm
spaced B-scans over a
3D Clinical 513 X 101 increment) Angle: 6 mm X 6 mm
square volume.
0 to 180o
Fixation at center
Width:1-6 mm

Notes: Cornea and anterior segment scans are available only with the purchase of the CAM (Cornea and
Anterior Module) option.

_______________End of section_______________

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9 Technical Specifications
Scanner
• OCT Image Acquisition Rate: 70,000 A-scans/second

Axial Resolution (in tissue):

• Depth: 5 μm

Scan Range:

• Depth: 2 mm to 3 mm

• Transverse: 2 mm to 12 mm

• Scan Beam central Wavelength: λ = 840±10 nm

• Exposure Power at pupil: less than or equal to 750 μW

Fundus Imager
• FOV: 32o (H) x 22o (V)

• Monochrome CCD Camera: WVGA 1/3 in. CCD Format

• NIR Illumination: 735 nm LED

Patient Interface
• Working Distance: 22 mm

• Motorized Focus Range: -15D to +12D

• Internal Fixation: Center, ±3.5° (Horizontal), and ±18° (Horizontal)

• Motorized Chin-Rest adjustable range: 65 mm

• Joystick controlled X-Y-Z adjustment: X-100 mm, Y-85 mm, Z-25 mm

• Lock mechanism: Electro-magnetic activated

Computer
• CPU: 3.3 GHz six-core

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• Hard Disc: 2 TB

• Back up Hard Disc: 2 TB

• Archive: USB or Network Drive

• RAM: 16 GB

• DAQ: Camera link frame grabber

Display Unit
• 21.5 inch Flat Panel LCD Monitor

Power Table
• Power Input: 110 VAC and 230 VAC

• Current: 1.8 A

• Frequency: 50/60 Hz

• Power Rating: 160 W

• Maximum Force: 2500 N

• Motorized adjustment range: 200 mm

• Model: RTVue XR-100-1: 110 VAC

• Model: RTVue XR-100-2: 230 VAC

Alternate Power & Isolation Box


• Power Input: 110-240 VAC

• Current: 1.8 A

• Frequency: 50/60 Hz

• Auto resettable thermal switch on primary + 2 circuit breaker on input side

Circuit Breaker and Fuse


• Thermal circuit breaker (main power entry)

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• Rating: 10 A, 125-250 VAC

• Dielectric Strength: 2500 VAC/1 minutes

• Operating Temperature: –10 °C to 60 °C

• Fuse (Power supply in Scanner)

• Rating: 4 A/250 V

• Package: 5 mm x 20 mm

• Type: Fast Acting, Short Time Lag

WARNING: Do not use fuses that are not approved by Optovue. Optovue
provides approved fuses.

Compliance
• General Medical EN 60601-1

• Medical System EN 60601-1-1

• EMC of Medical System EN 60601-1-2

• ITE (Computer) EN 60950

Circuit Breaker and Fuse


• Fuse (Power supply in Scanner)

• Rating: 4 A/250 V

• Package: 5 mm x 20 mm

• Type: Fast Acting, Short Time Lag

• WARNING: Do not use fuses that are not approved by Optovue. Optovue
provides approved fuses.

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Operating Environment
Operating Conditions:

• Temperature: 10 °C to 35 °C

• Relative Humidity: 30% to 90%

• Atmospheric pressure: 800 – 1060 hPa

Storage Conditions:

• Temperature: –10 °C to 55 °C

• Relative Humidity: 10% to 95%

• Atmospheric pressure: 700 to 1060 hPa

• Altitude: < 3000 m

Transport Conditions:

• Temperature: -40 °C to 70 °C

• Relative Humidity: 10% to 95%

• Atmospheric pressure: 500 hPa to 1060 hPa

• Vibration, Sinusoidal: 10 Hz to 500 Hz, 0.5 g

• Shock: 30 g, duration 6 ms

• Bump: 10 g, duration 6 ms

9.11.1 Additional Technical Specifications


• Electrical Supply: Class 1

• Installation Category: II

• Pollution degree: 2

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Cybersecurity Information
9.12.1 Objective
The purpose of this section is to summarize the cybersecurity controls for the Avanti
system with embedded Windows 10 operating system.

9.12.2 System Overview


The Avanti device has the following interfaces that are critical for cybersecurity:

• ETHERNET port for DICOM/PACS interface and Optovue Remote Service

• USB ports for connecting to various USB devices

9.12.3 General Principles


Cybersecurity risk management is a shared responsibility among stakeholders including
the medical device manufacturer, the user, and the health care facility. Failure to
maintain cybersecurity can result in compromised device functionality, loss of data
availability or integrity, or expose other connected devices or networks to security
threats.

Cybersecurity Functions
9.13.1 Limit Access to Trusted Users Only
Authentication of Users

• Avanti device uses Microsoft Windows 10 as the main operating system. The operating
system itself allows the end user to establish and configure “User Accounts” (example:
standard users, power users, administrators) and “User Passwords” so that
authentication is performed by password.

Auto-Logoff

• The operating system has the ability to prevent access and misuse by unauthorized
users if the device is left idle for a period of time. The length of inactivity time before
auto-logoff/screen lock is user/administrator configurable.

• The auto-logoff/screen lock can be manually invoked by the user.

Layered Authorization Based on User Role

• Users can be assigned different privilege levels within an application based on ‘roles.’

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Appropriate Authentication

• “IT Admin” and “Optovue Service” require password authentication.

User Authentication for Software or Firmware Updates

• Software and firmware updates require Privileged account access.

9.13.2 Ensure Trusted Content


Restrict Software of Firmware Updates to Authenticated Code

• Software and firmware updates are performed by Optovue Field Service or Customer
Service personnel from a protected source.

• All updates require a Privileged account.

9.13.3 Detect, Respond, Recover


Features that allow for security compromises to be detected, recognized, logged,
timed, and acted upon during normal use.

• System, security and anti-virus logs are implemented.

• Log files can be accessed by or exported to Optovue Service.

Provide information to the end user concerning appropriate actions to take upon
detection of a cybersecurity event.

• Disconnect the Avanti device from any network

• Contact the IT Administrator at the user facility for on-site evaluation

• Run a scan using the anti-virus software

• Quarantine and delete any identified threats using the anti-virus software

• Restore the database

• Reconnect to the network

• Contact Optovue Technical Services if additional assistance is required

Device features that protect critical functionality, even when the device’s
cybersecurity has been compromised.

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• The Avanti safety circuit for light hazard exposure is designed in the device hardware
and will continue to operate during a power surge even when the device’s cybersecurity
has been compromised.

Methods for retention and recovery of device configuration by an authenticated


privileged user.

• The Avanti device comes with a built-in primary backup hard-drive and all data are
backed up to this hard-drive.

• The device also provides an option for a secondary data backup.

• The device provides for archiving of old data to external storage.

• The device configuration data is backed up automatically at each launch of the


application.

• Optovue Clinical Applications, Field Service, or Technical Services personnel can


restore to a previous backup.

9.13.4 Other implemented mechanisms


Institutional IT Infrastructure

• The Avanti device uses the Windows 10 operating system and supports integration into
the IT infrastructure and domain at the institution or facility where the device is installed.
Some facilities/institutions will have their own cybersecurity infrastructure, such as
remote control of User Accounts, firewalls, encryption, and so forth. The Avanti device
will support these site-specific IT systems and this is verified during the installation
process by Optovue personnel.

Stand Alone Mode

• The Avanti system can be run completely without internet connection. There is no
specific requirement to be connected to the internet for the device to operate properly.

Cybersecurity and Data Back-up Configurations

• The device is manufactured with anti-virus protection provided by “Microsoft Security


Essentials”

• The device is manufactured the device with “Windows Firewall” enabled

• Data encryption can be added by a third-party tool

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• The Avanti device comes with a built-in primary backup hard-drive and all data are
backed up to this hard-drive.

• The device also provides an option for a secondary data backup.

• The device provides for archiving of old data to external storage.

_______________End of section_______________

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10 AngioVue® Software
Introduction
AngioVue is a licensed software upgrade for the visualization of vascular structures of
the retina and choroid. Once loaded and licensed on the RTVue XR Avanti System, the
AngioVue scan patterns and analysis functions are enabled.

10.1.1 General
Optovue, Inc. has developed and tested AngioVue software and the RTVue XR Avanti
System in accordance with Optovue, Inc. safety standards, as well as national and
international regulatory guidelines and all applicable safety standards to ensure a high
degree of instrument safety. Please observe all labeling related to safety, including
information and notes in this manual and on the device labels. This device does not
produce any waste that needs disposal. This product contains no material that presents
a chemical hazard concern.

This chapter contains complete safety and use information for AngioVue Software on
the RTVue XR Avanti System. Therefore, this chapter only addresses acquisition and
review of AngioVue scans, which are a subset of the scans available with the Avanti
System.

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10.1.2 Scan Pattern Specifications

# A-Scan
Scan
Description (Without Default
Pattern
Averaging)

304 B-scans equally spaced


on X-axis and on Y-axis. 3 X 3 mm
Angio
Each B-scan has 304 A- 304 X 304
Retina 8 X 8 mm (no quantitative
scans. analysis)
640 pixels in Z-axis

400 B-scans equally spaced


on X-axis and on Y-axis.
HD
Angio Each B-scan has 400 A- 400 X 400 6 X 6 mm
Retina scans.

640 pixels in Z-axis

400 B-scans equally spaced


on X-axis and on Y-axis. 4.5 X 4.5 mm
HD
Angio Each B-scan has 400 A- 400 X 400 6 X 6 mm (no quantitative
Disc scans. analysis)
640 pixels in Z-axis

Table 3 Scan Pattern Specifications

Manage Patient Information


The system application opens by default to the PATIENT window. The application also
has a SCAN window (see chapter 3) and a REVIEW window

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See chapter 6 for information regarding the main menu.

AngioVue Scan Acquisition and Review

+ Note: AngioVue software is available as part of AngioVue Comprehensive or


Essential, as an upgrade to the RTVue XR Avanti System or as part of the Avanti
Retina system.

AngioVue Software creates a 3D data set that combines the results of multiple repeated
B-scans. Using a motion contrast algorithm, AngioVue Software can aid in the
visualization of vascular structures of the retina and choroid.

We recommend that you read the entire RTVue XR Avanti System User Manual and
this AngioVue Software User chapter before using the system.

10.3.1 Acquiring AngioVue Scans


The AngioVue scans comprise two back to back, 3D scans, each with aiming, capture
and quality review phases in either X (Fx) or Y (Fy) orientation. AngioVue Software
combines the Fx and Fy scans and saves them as one MCT-corrected AngioVue scan.

+ Note: We recommend you clean the chinrest and forehead rest between patients
with a disinfectant. For example, wipe with an isopropyl alcohol pad or with another
germicide using a clean disposable cloth.

Use the following procedure to acquire AngioVue scans. Start from the PATIENT
window.

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Figure 142 Select or Add Patient

4. From the PATIENT window, select an existing patient (see section 2.1.3) or add a new
patient (see section 2.2), then click the Scan button to go the SCAN window.

Infrared (IR)
video image OCT image area
area

Scan Selection

En face OD and OS
image area completed scans
lists

Scan button

Figure 143 SCAN Window AngioVue Comprehensive

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5. In the SCAN window, select the patient eye to be scanned. Both / OU is selected by
default. To change, click the Right / OD or Left / OS button.

Figure 144 Scan Selection Options AngioVue Comprehensive

6. Select the desired scan type from the AngioVue, Retina, Nerve Fiber, or
Cornea lists, or select a scan protocol from the Protocol list. You can select multiple
scans to do the selected scans in succession. When you finish your selections, click the
Scan button or joystick to begin scanning.

• Alternatively, you can repeat any previous scan for a patient by double-clicking on the
scan name in the Scans list of the PATIENT window.

When you start scanning, the Scan Selection options are replaced by scan adjustment
options on the Auto tab (default) or Manual tab. (The available parameters and their
ranges depend on the scan type.)

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Figure 145 Scan Adjustment Options (Auto Tab)

To customize scan parameters, select the MANUAL tab.

Figure 146 Manual Tab: Customize Scan

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7. Position the patient correctly as follows:

• Chin on the system chin rest with teeth together

• Forehead against the forehead rest

• Eye to be scanned aligned vertically with the canthus mark on the side of the forehead
and chin rest assembly.

• Ask the patient to look at the fixation target, a blue dot in the red field.

8. Center the video image on the pupil and move the scan head towards the patient,
controlling it so that the video image passes through the pupil. Carefully advance until
the fundus comes into view (for Retina and Nerve Fiber scans). The figure below shows
the progression of views as you move the scan head forward.

Figure 147 Video Image Progression as Scanner Approaches Eye

9. Adjust the working distance between the scan head and patient eye to optimize the
video image. Optimized fundus images should be illuminated evenly from edge to edge.
Optimized optic disc images may contain dark areas on either side. For cornea scans,
an optimized video image shows iris detail.

+ Note: For fundus imaging, make sure to set the working distance for fundus
video image first. If a live OCT scan appears in the OCT image window, do not stop
forward movement of the camera until you achieve a good infrared (IR) video image
of the fundus

Note: On the first scan of each eye, of that day, the OCT image will not appear
until the Auto Adjustment has been performed. A message will appear over the
OCT window telling the operator to optimize the IR image then to select auto
adjust.

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Figure 148 Auto Adjust Fail

If the Auto Adjust fails the live OCT B-scan is now displayed and the following message
is displayed.

Figure 149 Auto Focus Fail

The operator should try to optimize the IR image and Auto Adjust again, if the image
cannot be improved the operator may decide to capture the image
If only the Auto Focus portion fails, the following message will be displayed.

The operator should try to optimize the IR image and Auto Adjust/focus again, if the
image cannot be improved the operator may decide to capture the image

10. When the video image is optimized, use the scan pattern overlay in the live video image
to center the scan pattern over the area of interest (fovea or disc). You can either:

c. Double-click in the video image where you want to position the center of the scan
pattern.

or

d. Click, hold and drag the scan pattern to the desired location, then release.

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To adjust video brightness and contrast, click in the live video, hold and move the cursor
up and down for brightness, left and right for contrast.

Figure 150 Active AngioVue Scan Window

11. Click Auto Adjust—or double-click on the OCT scan image—to optimize scan signal
strength and image quality.

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Figure 151 Auto Adjust Combines Auto Z, Auto F and Auto P

Auto Adjust executes Auto Z, Auto F and Auto P in combination. Auto Adjust also
tries to place the scan image in the target area between the red dashed lines. If
necessary to bring the OCT scan to the target area, click once in the scan window and
scroll the mouse wheel to bring the OCT scan between the red dashed lines.

+ Note: For scans that include the optic disc, it is OK (and expected) to have the
disc portion of the scan below the lower red line.

On the right side of each live scan, a green bar indicates a good OCT signal strength
index (SSI) value. If the bar is red, you can manually optimize scan signal strength and
image quality as instructed in the next step below.

+ Note: In most normal patients, the OCT (SSI) indicator should be green.
However, individual patient variability and the light absorption properties of some
pathologies can sometimes make it impossible to achieve a green signal. If the OCT
(SSI) indicator is not green over a range of patients, including normal eyes, contact
Optovue Technical Support for assistance.

12. If the OCT (SSI) indicator is red, use one or more of the following functions on the
Manual tab to manually optimize scan signal strength and image quality.

• Select the Manual tab (at upper left) and adjust the Z Motor, Focus or P Motor
settings, or scroll the mouse wheel in the scan image to move the scan image between
the red dashed lines.

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• Click and hold in the live video image, then drag up or down to adjust video brightness,
or left and right to adjust video contrast.

10.3.2 Instructions for Successful Tracking

• To improve the fundus image

• Check good, homogeneous illumination by alignment to the center of pupil, a little


darkening of the corners is normal

• Bring optical disc in the field of view

• Avoid glare by adjusting the scan-head alignment to pupil center

• In follow-up mode, adjust the image to ensure green cross (“good tracking”) shows up in
the target zone in fundus image.

! Fundus features detectable on IR video image serve for tracking. Optimized IR video
image is a key for successful Angio scan tracking and acquisition.

• To improve the OCT image

• Target tissues should fall between two red lines

• Maximize OCT signal as described earlier in chapter 3

• Tracking (green light indicator) and start scanning

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Good Image

Poor due to glare

Blocked or blurry

10.3.3 Acquisition Alerts


If acquired scan is suboptimal, the software may present pop-up alerts, as shown in the
figure below. It is the operator’s choice whether to rescan the last volume before saving
or proceed with acquisition as usual; alerts are recommendation only.

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Figure 152 Examples of Scan Quality Alerts During Acquisition

10.3.4 Tips for Scanning Difficult Patients


Note: After scanning starts always remind the patient to look at the blue dot before
attempting to reposition the camera. Often the patient will return to the correct position.

Pupil or fixation drift or dry cornea surface during scan acquisition may cause
tracking to stall.

• Tip- always ask the person to look at the blue dot before moving the joystick

• Tip: Re-align the scan by slightly shifting the joystick towards the direction of the drift.
This will allow tracking to resume and enable the scan to complete.

• Tip: use artificial tears when needed.

Patients with poor vision still need to maintain some level of fixation for tracking
to be successful.

• Tip: Use the external fixation light in front of the fellow eye to help keep the eye being
scanned in the correct location.

• Tip: If the eye moves outside of the trackable area (no disc in IR image), stop tracking
and help the patient fixate before resuming the scan or re-scan the patient.

Nervous patients can have excessive up-and-down movement of the B-scan


within the scan window from excessive back and forth in the patient chair.

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• Tip: This movement will not always affect tracking but will reduce the quality of the scan
image. Take action to minimize movement and keep the B-scan in the scan window.

• Tip: Push the joystick slightly towards or away from the patient to keep the B-scan from
moving up and down excessively or out of the scan window altogether.

• Tip: Take advantage of the stability of the table. Position the table low enough that the
patient can lean into the headrest, put their arms on the table and hug the base of the
machine.

10.3.5 Tips to Optimize OCT results

Figure 153 Tips to Optimize OCT results

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13. To capture the scan, either press the joystick button or click the checkmark button .
AngioVue scans require acquisition of a Fast-X scan and a Fast-Y scan in consecutive
steps. On first capture, the system acquires a Fast-X scan. Review the scan for severe
eye movement. (Blinks appear as black bands and saccades appear as bright, thin
white lines in the Angio en face image).

Figure 154 Fast-X Scan Captured

14. If you are satisfied with the captured scan, click Continue or click the joystick button
to proceed to the Fast-Y scan. Click Rescan to retake the Fast-X scan. Click Cancel to
discard the Fast-X scan and start over.

When you continue, the Fast-Y scan begins automatically. The orange overlay in the
video image (lower left) shows the large vessels from the optic disc as captured in the
Fast-X scan, which assists in recognizing whether alignment has been maintained.

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Figure 155 Active Fast-Y Scan

15. If necessary, adjust scan placement and optimize scan quality again. It is optimal to
capture the second scan with minimal adjustment, so ask the patient not to move
between scans. When ready, capture the Fast-Y scan.

Figure 156 Fast-Y Scan Captured

16. When you capture the Fast-Y scan, the screen shows you both the Fast-X and Fast-Y
scans, so you can determine if they align well before processing. If you are satisfied,

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click Continue and Save or click the joystick button to combine and process the
Fast-X and Fast-Y scans, and apply motion correction technology. Click Rescan to
retake the Fast-Y scan. Click Cancel to discard both the Fast-X and Fast-Y scans and
start over.

If you select Continue and Save or click the joystick button, the results appear on
screen. Check the final image for horizontal and vertical movement lines and vessel
duplication. The SQ indicator appear to assist with scan quality evaluation. Repeat the
scan if necessary.

Figure 157 AngioVue Scan Complete

To view the AngioVue and OCT images with color, select the AUTO tab and click the
Color (for Angio image, upper left) and/or the OCT Color icons, highlighted below.

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Figure 158 Gray Scale and Color Viewing Options

Click the Gray Scale icon to return both images to gray scale. To zoom in on the OCT
image, select the Zoom OCT checkbox.

The only other active button on this screen is the Start Scanning
button. Use this button to repeat the scan type just completed.

When you are done scanning, use one of these methods to review scans:

a. Click the REVIEW tab on the left to review the scan just completed.

b. Go back to the PATIENT window, select the desired patient, visit and scan, and click
the Review button.

Scan Quality Indicator (SQ)


SQ takes into consideration signal strength, eye motion and focus, providing an
objective image quality index that correlates with qualitative assessment of image
quality. The automatic scan quality ranges from 1~10. The recommended cut off for
AngioAnalytics is a SQ score of 6 and above. Score of 5 and below should be regarded
with more diligence. A Scan Quality (SQ) number (1-10) will appear in the scan list as
the scan saves and will be displayed at the top of the AngioVue reports. The SQ may be

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used as a quick indicator to determine which scan to open, if there are several of the
same area / same scan pattern.

Figure 159 Examples of Scans with SQ<6

From left to right: SQ=5, due to motion, artifact lines (horizontal and vertical) are visible,
as well as distortion of blood vessel pattern; SQ=5, due to low SSI, image is dark and
lacking details of the smaller blood vessels; SQ=2, due to poor focus, blood vessels
appear blurred.

Examples of Artifacts
The following AngioVue image examples illustrate artifacts that are characteristic of
OCTA scans due to movement of the human eye during scanning.

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+ Note: In some cases when artifacts are present, it can be useful to select the No
MCT button to view the Fast-X scan without motion correction, which may show useful
anatomical information. Scans should be retaken if artifacts impair adequate
visualization of structures.

10.5.1 MCT Motion Artifacts


Saccadic Motion

Saccadic eye motion appears as straight white lines parallel to scan line orientation
(horizontal or vertical). Lines due to saccadic motion are easily recognized since they
occur in straight lines. Motion Correction Technology (MCT) minimizes artifacts due to
involuntary motion. The Fast-X and Fast-Y images below illustrate an amount of
saccadic motion that MCT can minimize by integrating data from both scans, as seen in
the MCT Merged scan on the right.

Figure 160 Saccadic Motion

Fx and Fy saccadic motion corrected on MCT Merged image

10.5.2 Local Weak Signal


Regional drop of the signal, either caused by floaters or by media opacity, can be
recognized in the en face images and confirmed in corresponding B-scans.

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Floaters

Floaters are a kind of ocular opacity, all of which partially or completely block the OCT
scan beam and thereby reduce the signal strength reflected from the tissue beneath the
opacity. When a floater has sufficient density and size, the underlying vessels can
appear faint or missing, like a shadow, as illustrated below.

Figure 161 Floaters

You can recognize these “shadows” as floater artifacts by checking for the same pattern
of shadows in the en face scan and B-scan. Thus, you can see that the shadow starts in
the vitreous and proceeds through the retina, which shows that there was an opacity

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between the light source and the tissue. Local signal reduction by the floaters is not
incorporated in the automated SQ calculations but may significantly affect
AngioAnalytics data. AngioAnalytics metrics of scans with large floaters should be
treated with caution.

Blinks

Blockage of the OCT scan beam during patient blinks results in the absence of data
while the eye is closed. Blink artifacts appear as straight black lines, as shown below.
These lines are easily recognized due to the loss of data. These artifacts are extremely
rare if acquisition is performed with active tracking.

Figure 162 Blink

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10.5.3 Excessive Motion Not Correctable by AngioVue Software
Some eye motion is too great to be corrected by AngioVue Software. The two images
below illustrate artifacts due to excessive motion.

Figure 163 Excessive Motion

Double Vessel Artifact (left), Excessive Motion not Correctable by MCT (right)

Duplication of vasculature (left image) - Double Vessel Artifact

The highlighted areas in the left image above illustrate duplication of vasculature. This
happens in cases where the motion correction algorithm is unable to combine the
images because the eye motion was too great. Double vessel artifact is not
incorporated in the automated SQ calculations but may significantly affect
AngioAnalytics data. AngioAnalytics metrics of scans with double vessel artifacts should
be treated with caution.

Muddled image (right image)

The image above on the right illustrates a case where overall eye movement was so
great that it results in a muddled image lacking comprehensible detail. In such cases the
excessive motion is usually captured by the SQ, causing reduction of SQ.

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10.5.4 Cropped Image
Retina placed too high or too low in the OCT window during scan acquisition causes
image cropping. Cropped images can be recognized in the en face image and
confirmed in the corresponding B-scan image as illustrated in 160.

Figure 164 Image Crop

Example of image cropping affecting both the vascular en face image (left), confirmed in
the corresponding B-scan image (right)

Cropping artifact is not incorporated in the automated SQ calculations but may


significantly affect AngioAnalytics data. AngioAnalytics metrics of scans with cropping
should be treated with caution.

Segmentation Retina

Figure 165 Retina Segmentation Layers

The following segmentation boundaries are available for the AngioRetina scans:

ILM, NFL, IPL, INL, OPL, IS/OS, RPE, BRM

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10.6.1 Predefined Angio Retina En Face Slabs
Based on segmentation boundaries as listed above, the following consistent Angio
Retina en face slabs are predefined:

• Superficial (Upper limit = ILM; Lower limit = IPL-10µm)

• Deep (Upper limit = IPL-10µm; Lower Limit = OPL+10µm)

• Outer (Upper limit = OPL+10µm; Lower limit = BRM-10µm)

• Choroid (Upper limit = BRM-10µm; Lower limit = BRM+30µm)

• Retina (Upper limit = ILM; Lower limit = OPL+10µm)

10.6.2 Custom Angio Retina Slab


The custom slab boundaries are user-defined, providing users with the ability to
visualize additional retinal slab based on their preferences. The software allows
selection of upper layer from available segmentation lines, upper layer offset, lower
layer from available segmentation lines and lower layer offset. The slab can also be
renamed

To define custom slab boundaries, go to


“Tools”→”Angio Retina Custom En Face
Slab” and select the boundaries and offsets.

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Segmentation Disc

Figure 166 Disc Segmentation Layers

The following segmentation boundaries are available for the AngioDisc scans:

ILM, NFL, IPL, OPL, IS/OS, RPE, BRM

10.7.1 Predefined Angio Disc En Face Slabs


Based on segmentation boundaries as listed above, the following consistent Angio
Retina en face slabs are predefined:

• Vitreous (Upper limit = ILM-2000µm; Lower limit = ILM)

• Superficial (Upper limit = ILM; Lower limit = IPL-10µm)

• RPC (Upper limit = ILM; Lower Limit = NFL)

• Choroid (Upper limit = BRM-10µm; Lower limit = BRM+30µm)

• Retina (Upper limit = ILM; Lower limit = OPL+10µm)

10.7.2 Custom Angio Disc Slab


The custom slab boundaries are user-defined, providing users with the ability to
visualize additional retinal slab based on their preferences. The software allows
selection of upper layer from available segmentation lines, upper layer offset, lower
layer from available segmentation lines and lower layer offset. The slab can also be
renamed.

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To define custom slab boundaries, go to
“Tools”→”Angio Disc Custom En Face Slab” and select
the boundaries and offsets.

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Optic Disc Margin
The optic disc margin detection by the software shall be reviewed in the SLO view
screen (Main Report, SLO Tab – see Section 10.11.8). Disc margin can be verified by
placing cross-hairs on the disc margin outline by the software and verify in the
corresponding B-scan that the location is aligned with the Bruch’s membrane opening
(BMO).

If the location is not aligned with the BMO, the disc margin outline should be manually
adjusted until it matches the anatomy. To do that, the mouse is placed on the incorrectly
placed “anchor” point, which is then dragged to the correct location where BMO is
identified

Automatic segmentation update and recalculation of disc center as well as all


peripapillary and disc metrics is performed by the software once modified disc margin
boundary is saved by the user.

Figure 167 Disc Margin and Margin Correction


Left – Incorrect disc margin detected (red a-scan vertical line through the disc margin
point) and confirmed on the corresponding b-scan (yellow arrow points to the correct
BMO). Middle – “Anchor” point is dragged to correct location at the BMO, as confirmed
by corresponding b-scan. Right – Fully corrected disc margin, as confirmed by selecting
additional point of the disc margin and demonstrating its location on the b-scan at the
BMO (yellow arrow).

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Segmentation Correction and Propagation Tool
Incorrect segmentation of one or more of the segmentation boundaries can be identified
either on OCT or OCTA windows.

In the event of a segmentation error the user can manually correct the segmentation
lines on a single b-scan and propagate the change throughout the entire scan or a
selected segment (Region of Interest (ROI).

In the image below (Figure 168) a red box has been drawn around the incorrect
segmentation area on the OCT Inner Thickness map.

The following steps describe the segmentation editing and propagation process.

1. To access the “segmentation edit” screen, check the Edit Bnd checkbox to the right of
the screen (inside red rectangle). The screen as in Figure 168 will appear.

2. To edit specific segmentation line, click the check-box near the line name on the left to
the b-scan. The chosen line will appear on the b-scan image,

(If you’d like to visualize your edits on the thickness map, on the right to the OCT window
choose the layer that is defined by that line. For example, if you wish to edit IPL, choose Inner
layer (ILM to IPL) or Outer layer (IPL to RPE). Once the layer defined by IPL line is chosen
(Inner layer in Fig.164), only the two segmentation lines defining the Inner layer are displayed
(ILM and IPL), and the ILM and IPL lines indicators to the left of the b-scan window become
active.)

3. Define ROI for segmentation correction and propagation. There are several ways to
define ROI to propagate the modified curve:

a. Use mouse to click on the OCT enface window and continue to drag to the
desired Region. There is red dot boundary to indicate the user specified region to be
propagated.

b. Move the B scan to the start desire location and click “Seed Region Start”→
“Set” button to set the start position. Move the B scan to the end desire location and
click “Seed Region End”→ “Set” button to set the end position.

c. If no region is specified, start seed should be the first frame and end seed should
be the last frame – the curve edit will be propagated thorough the entire scan.

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Figure 168 Incorrect IPL segmentation

4. Correct the segmentation of the single selected b-scan inside the ROI.

In Figure 169 the b-scan through the incorrectly segmented area is selected. By clicking
on the IPL line in the OCT window, the anchor points are activated on the curve (Figure
169, one anchor point is encircled in red).

The segmentation correction of single B-scan can be performed in two ways:

a. Drag the anchor points to the desired location – the line color will become purple➔
“edited B-scan”, Figure 170

b. Right-click and choose to “Reselect All Points”. The green curve will disappear, and by
clicking along the correct segmentation location from one side of the B-scan to another
and double-clicking at the end, the new segmentation line will be created, and will
appear purple ➔ “edited B-scan”, Figure 170

In the example below the IPL layer has dropped below the inner nuclear layer (see
green line in B-scan) in the lower right corner of the scan (as illustrated by the red
thickness area.)

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Figure 169 IPL Boundary Selected, Anchor Points Activated

Figure 170 Single B-Scan Corrected (IPL Line Turned Purple), not Propagated

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5. Propagation.

Clicking on the Propagate button (red rectangle on Figure 171) to the right of the B-
scan window will apply the correction to the neighboring b-scans located in the defined
ROI, or throughout entire image if no boundary of ROI is drawn. Figure 171 shows the
propagated map.

Figure 171 Segmentation Correction and Propagation Applied

The procedure can be performed more than once if needed, and can be either repeated
over the same ROI, or different ROI/s. Following segmentation update, software
automatically updates all the measurements data.

Projection Artifact Removal (PAR)


OCTA techniques are based on the principle of motion contrast. Visualization of the
deeper vascular layers is affected by flow projection artifacts form fluctuating shadows
of the flowing blood cells in the more superficial blood vessels that create “false flow” in
the deeper layers. This phenomenon is called “projection artifacts”. On cross-sectional
OCTA projection artifacts are seen as elongated signal tail. On en face OCTA images
the more superficial blood vessels network gets duplicated on the deeper slabs. Without
PAR the superficial plexus would project onto the deep plexus, then superficial and

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deep would project onto Outer and all three would project onto the choroid. PAR
suppresses locations of artifacts to the background OCT noise.

PAR algorithm removes projection artifacts from deeper layers. Figure 172
demonstrates outer retinal slab without PAR application – all Superficial and Deep
vessels are “imprinted”, and after PAR application - void of vessels projections from the
Superficial and Deep vascular plexuses.

Figure 172 PAR Off and PAR On (same Outer Retina Slab)

+ Note: that vessel density measurements are determined only with PAR
correction. Therefore, the precision data of vessel density measurements from the
AngioAnalytics R&R study (Section 16.2) reflects measurements only with PAR on.

+ Note: It is recommended that the PAR-corrected images are inspected and


compared to PAR-uncorrected images prior to interpreting vessel density measurement
values to determine if there has been extensive removal of non-artifactual signal.

+ Note that vessel density measurements are less accurate in locations where
there are both projection artifacts and in-situ signal (e.g., deep plexus locations with
projection artifacts from the overlying superficial plexus). Refer to Section 11.3.4 and
11.4.5 for more information on the vessel density measurement feature.

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10.10.1 Examples of PAR vs No-PAR

Figure 173 Example: 3 mm AngioRetina Scan of Patient with Diabetic Retinopathy, with
and without PAR
Superficial and deep en face slabs, and horizontal angio B-scans of the same scan are
presented; without application of PAR (left panel) and following PAR (right panel).

Clear imprint of superficial plexus blood vessels can be seen on the deep plexus en face
image with no PAR (left). Following PAR, the projections of the superficial plexus are
removed, providing better visualization of the deep plexus vasculature (right). The yellow
arrow points to the flow detected in the superficial plexus vessel (the b-scan shows the
flow signal appearing in the superficial slab), with the tail projecting into deep slab and
beyond if no PAR applied (left b-scan). Following PAR, the flow signal is detected in the
superficial slab, however the projection into the deep slab and further is removed.

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Figure 174 Example: 3 mm AngioRetina Scan of Patient with CNV, with and without PAR
Superficial, deep, outer retina and choriocapillaris en face slabs of the same scan are
presented; with PAR (upper panel) and without PAR (lower panel).

Figure 175 Example:4.5 mm HD AngioDisc Scan, with and without PAR

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RPC en face slab and horizontal b-scan of the same scan are presented; without
application of PAR (left panel) and following PAR (right panel). Vascular plexus of RPC
slab is superficial, and therefore is not significantly affected by PAR application, as can
be seen on the en face images of RPC slab before and after PAR. Horizontal angio b-scan
demonstrates “projection tails” removal following PAR in the deeper layers of the retina
(yellow boxes).

AngioVue Reports
AngioVue integrates the Fast-X and Fast-Y scans in 3D reports that provide many
options for presentation. The operator should assess the quality of en face images for
excessive motion not correctable by the software. Retake the scans if necessary in
order to obtain results without excessive motion. The operator should also assess the
images for artifacts. The user should interpret such images with caution.

10.11.1 AngioVue Reports List


Angio Retina Reports

• Angio Retina Essential (requires Essential license)

• Angio Retina QuickVue report (with AngioAnalytics)

• Angio Retina Main report

• Angio Retina OverVue report

• Angio Retina Trend report (with AngioAnalytics)

Angio Disc Reports

• Angio Disc QuickVue report (with AngioAnalytics)

• Angio Disc Main report

• Angio Disc OverVue report

• Angio Disc Trend Report (with AngioAnalytics)

Angio Montage report

10.11.2 Angio Retina Essential


The Essential Report is a simplified approach to OCTA analysis and requires separate
license. The report has the 4-layer en face segmentation presented along the top:
Superficial, Deep, Outer Retina and Choriocapillaries. Moveable B-scan indicators are

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red and green. The upper B-scan is horizontal (green) the lower B-scan is vertical (red).
The lower left en face display default is Superficial.

Figure 176 Angio Retina Essential Report

Clicking/selecting on any of the 4 top en face images will change the display in the left
lower corner to the selected slab. Selecting the Choroidal Capillary en face enables the
choroidal segmentation adjustment slider. The operator can move the segmentation
up/down to visualize the vasculature.

Figure 177 Essential Report with Choroidal Capillary en face selected

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Figure 178 Essentials Report with segmentation raised to evaluate flow

Selecting Angio, OCT or Angio/OCTA button on the right will bring the corresponding en
face images to display.

Clicking on Angio Overlay will display OCTA overlay on B-scan image.

10.11.3 Angio Retina OverVue Report


Angio Retina OverVue report is presented below with the Angio radio button selected
(red square). There are two additional radio buttons—OCT and Angio/OCT —each of
which presents different images and associated functionality. (Note: additional Montage
button appears only if the scan is 6 mm HD Angio Retina, and there is 6 mm HD
AngioDisc scan available from the same visit)

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Figure 179 Angio Retina OverVue, Angio Selection

The default Retina OverVue is gray scale and includes:

Across the top, four Angio en face images at different depths shown in gray scale. Click
on an image and scroll the mouse wheel to zoom the image.

• The left-most image in the top row is selected by default, which means it is displayed on
the lower left image. Click to select one of the other images above and that one
becomes the overlay, plus the segmentation lines on the B-scans change to show the
layer of the selected image. (If no OCT image larger than the scan area exists for this
patient, the currently selected image fills the space at lower left.)

• At lower right, horizontal and vertical B-Scan images. Each Angio en face image has
green (horizontal) and red (vertical) lines that indicate the current B-scan location. You
can drag these lines to select which horizontal and vertical B-scan displays.

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Angio Retina OverVue Controls

At upper right, the screen provides the following options.

• Exit: Exits screen and goes to the main report.

• QuickVue: redirects to QuickVue report (with


AngioAnalytics)

• Montage: Displays the AngioVue montage image, which


overlays the aligned AngioVue Retina and AngioVue Disc
images on the 3D Widefield image.

• Print: Prints the current display.

• Save Angio: Saves the current AngioVue images in the


folder you choose in the Save As dialog that appears.

• Reset View: Resets view to the default settings.

• Invert: Inverts the gray scale in the images.

• Color: Displays images in color.

• Show Lines: Displays horizontal (green) and vertical


(red) lines that indicate the current B-scan locations.

• Show Bnd: Displays segmentation boundaries on B-


scans.

• Angio: Shows AngioVue images at 4 depths.

• OCT: Shows OCT images at 4 depths.

• Angio / OCT: Shows 4 AngioVue and 4 OCT images

• Auto Zoom: Selected by default, auto zoom applies to


the B-scans shown. Clear checkbox to turn off auto
zoom.

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Angio Retina OverVue, Portrait Report

Figure 180 Angio Retina OverVue Portrait Report, Angio Selection

Below is how the report looks when you select the Angio / OCT radio button. Above are
the Angio en face images at different depths, and below are the four corresponding
OCT en face images at the same depths. The B-scan shows the Outer Retina slab
boundaries, since the outer retina slab was selected (blue frame around the third image
in the upper panel)

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Figure 181 Angio Retina OverVue Report, OCT/OCTA Selection

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Angio Retina OverVue. Structure Function Portrait Report

Figure 182 Angio Retina OverVue Report, OCT/OCTA Selection

Report showing corresponding OCT and OCTA en face images.

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10.11.4 Angio Retina Main Report

Figure 183 Angio Retina Main Report

The Angio main report is the working report, which means that the options you select
here affect display of the OverVue and QuickVue reports. The default Angio Retina
main report includes:

• At top left, an AngioVue image. Above it is an Export Angio button to export the
AngioVue image to a file. You can choose where to save the image and what to name it
in the Save As dialog that appears.

• At top center, an OCT image showing retinal thickness using a color scale and ETDRS
grid. This image has five tabs to display optional images. It also has sliders to change
which B-scans are shown, no matter which tab is selected.

Along the bottom horizontal B-scan are presented, with and without Angio overlay .
Unclick Large Angio checkbox below the AngioVue image to enable display of the
vertical B-scan on the right side of the screen.

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Angio Retina Main Report Controls

At upper right, the screen provides the following options, no matter which tab is selected
above the top center image.

• 3D Display: Opens the 3D Display.

• OverVue: Return to the OverVue screen.

• QuickVue: en face and measurements display display (with


AngioAnalytic licence)

• Play: Plays through the B-scans.

• Show Bnd: Traces boundaries with colored lines.

• Color: Displays images in color

• Show Line: Displays horizontal & vertical lines.

At the bottom of the screen are buttons to Print and Comment on the report.

Figure 184 3-D Retina Image

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Top Center Image Tabs

Thickness Tab

Figure 185 Top Center Image Tabs, Thickness Tab Selected

The top center image has five tabs to display the following optional images:

• SLO: Shows OCT and AngioVue images of the full scan thickness.

• En Face: Shows the en face OCT image of the retina and the corresponding AngioVue
image to the left.

• Thickness: Shows an OCT image overlaid with retinal thickness using a color scale
(and ETDRS overlay), and the corresponding AngioVue image to the left. (ETDRS is
based on fovea center, and is adjustable by user by dragging the mouse; available with
AngioAnalytics)

• RPE Elevation: Shows AngioVue and OCT images of the layers between RPE_Ref
and RPE.

• Color overlay: allows static or movie color presentation

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Thickness Tab Controls

• Use the radio buttons to the right to select Full (ILM to RPE), Inner (ILM to
IPL), Outer (IPL to RPE), thickness.

• Click the Edit Bnd checkbox to edit the boundaries shown on the B-scans
and thereby adjust the thickness.

En Face Tab

The figure below shows the AngioVue and OCT images when the En Face tab is
selected. In the example, the Outer Retina option is selected as reference, in the
controls at right. The following section explains the controls.

Figure 186 Angio Retina Main Report, En Face Tab Selected

The example shows the AngioVue image in color because the Color checkbox (red
rectangle at far right) is selected

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En Face Tab Controls

• Brightness Icon: Click to adjust.

• Contrast Icon: Click to adjust contrast.

• Edit Bnd: Redirects to segmentation edits screen

• Restore Settings: Restores to original settings

• En Face Slab

• Superficial

• Deep

• Outer Retina

• Choriocapillaris

• Retina

• Custom

▪ Upper – ILM Offset (µm): Displays the name and offset of upper boundary for the
selected slab

▪ Lower – IPL Offset (µm): Displays the name and offset of lower boundary for the
selected slab.

Note: for custom slab only, the boundary can be adjusted by user and saved.

Color Overlay Tab

When the Color Overlay tab is selected, the image shows the AngioVue and OCT
images. An overlay pull down selection is available on the left, default is Movie. When
play is selected the screen will display the retinal slabs by colors and track the level by
the moving indicator to the left. There is also static selection for Vitreous, Superficial,
Deep, Outer and Choroid. All static layers have adjustable opacity to enable the user to
highlight the pathology.

Note: En face Images show small icon with slab indicator, using the same colors as the
movie legend.

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Color Overlay, Movie

Figure 187 Angio Retina Main Report, Color Overlay Tab Selected (Default to Movie)

This image illustrates the screen as the


movie transitions from the Deep layer into
the Outer layer showing a Type 2 CNV in
yellow.

Figure 188 Movie Paused Between Deep and Outer Reina

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Movie Layers Boundaries

• Vitreous (Upper limit: = -2000; Lower Limit = ILM); Color= Green

• Superficial (Upper limit = ILM; Lower limit = IPL-10µm): Color= GrayScale

• Deep (Upper limit = IPL-10µm; Lower Limit = OPL+10µm); Color= Purple

• Outer (Upper limit = OPL+10µm; Lower limit = BRM-10µm); Color = Yellow

• Choroid (Upper limit = BRM-10µm; Lower limit = BRM+30µm); Color = Red

Color Overlay, Static

Static images are available for all 5 layers listed above, with corresponding color-
coding. Color layer adjustment information available in section 10.11.6.

10.11.5 Angio Retina Multiple Visits Report


Use this report to visualize en face images and the corresponding B-scans. The B-
scans location is “linked” (registered) across visits to display same anatomical location.
The system displays scans from up to eight visits, with default display of last two visits.
Select or deselect visits to display using the list at upper left. One of the five standard en
face layers, or custom layer can be selected for display. If AngioAnalytics™ license is
activated measurement parameters can be displayed as well such as vessel density or
FAZ. Utilize the multi-scans view button to refresh the page after reselections.

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Figure 189 Angio Retina Multiple Visit Report

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Angio Retina Multiple Visit Report Controls

En Face Slab: Select a radio button to display the desired slab

• Superficial

• Deep

• Outer Retina

• Choriocapillaris

• Retina

• Custom

Measurement: Select a radio button to display the desired


measurement

• None

• Vessel Density

• FAZ

• Flow Area

• Non Flow Area

• Reset View: reverts to original

• Link B-scans: links B-scans from multiple images to display same


anatomical location

• Invert: Select to invert the gray scale shading or color of the


images.

• Color: Select color image

• Show Bnd (Boundaries) in the B-scans.

Use the radio buttons at lower right to show either Angio or OCT
images for comparison.

Auto zoom: for B scans

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10.11.6 Angio Montage Report
The Montage radio button is available in the OverVue report screen for both Angio
Retina and Angio Disc, if both these scans are available for the visit. When you select
the Montage radio button in either the Angio Retina OverVue or the Angio Disc
OverVue, the same AngioVue montage opens on screen. The montage image
combines the aligned and partially overlapping 6 mm HD Angio Retina and 6 mm HD
Angio Disc images.

Figure 190 Montage showing Vitreous/Retina layers

Vitreous/Retina Display

• Vitreous (Upper limit: = -2000; Lower Limit = ILM); Color= Green

• Superficial (Upper limit = ILM; Lower limit = IPL-10µm): Color= GrayScale

• Deep (Upper limit = IPL-10µm; Lower limit = OPL+10µm): Color= Purple

Outer/Choroid Display

• Superficial (Upper limit = ILM; Lower limit = OPL+10µm): Color= GrayScale

• Outer (Upper limit = OPL+10µm; Lower limit = BRM-10µm); Color = Yellow

• Choroid (Upper limit = BRM-10µm; Lower limit = BRM+30µm); Color = Red

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Manual Adjustment of Enface Images

Figure 191 Montage Edit Screen

• Check edit box

• Drag center or corners of each scan to align vessels (holding the shift key slows
movement on screen)

• Uncheck edit box to finish

• Reset returns both images to original positions

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Montage Controls

At right, the Montage Display Mode area assists you to


understand what you are viewing in the montage.

• Exit: Exits screen and goes to the main report.

• OverVue: Redirects to OverVue report

• QuickVue: Redirects to QuickVue report (6mm HD


Angio Retina)

• Print: Prints the current display.

• Reset View: Resets view to the default settings.

• Edit: Redirects to montage edit screen

• Vitreous/Retina: Displays Vitreous/Retina slabs

• Outer/Choroid: Displays Outer/Choroid slabs

• Grayscale: Presents images in grayscale if checked

Auto Zoom: Selected by default, auto zoom applies to the B-


scans shown. Clear checkbox to turn off auto zoom.

Montage Layers Boundaries and Color Legend

• Vitreous (Upper limit: = -2000; Lower Limit = ILM); Color= Green

• Superficial (Upper limit = ILM; Lower limit = IPL-10µm): Color= GrayScale

• Deep (Upper limit = IPL-10µm; Lower Limit = OPL+10µm); Color= Purple

• Outer (Upper limit = OPL+10µm; Lower limit = BRM-10µm); Color = Yellow

• Choroid (Upper limit = BRM-10µm; Lower limit = BRM+30µm); Color = Red

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Layers Adjustment on Montage Image

AngioVue images are 3D images. To view every available layer of AngioVue image data
stacked in an image, click on an image → an outer frame color will appear indicating at
what depth the screen is currently, then scroll the mouse wheel to change the level of
opacity. AngioVue software assigns colors to the borders of the image data at each
depth to enable you to identify the layer in which you are viewing specific anatomy.

Levels adjusted so superficial vessels indicate


location of lesion, and the outer color (yellow)
indicates CNV above the RPE while red shows
choroidal layer.

Figure 192 Example of Type 2 CNV

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10.11.7 Angio Disc OverVue Report
When you begin review of an AngioDisc scan, the system displays an Angio Disc
OverVue report.

Figure 193 Angio Disc OverVue, Angio Selection

The default Disc OverVue is gray scale and includes:

• Across the top, four en face Angio slabs images at different depths are presented. Click
any of the four images to display it at lower left. Click and drag the horizontal (green
line) and vertical (red line) to show the corresponding horizontal and vertical B-scan
images at lower right.

• At lower left, selected OCTA en face image is presented. If wider field OCT baseline
image has been acquired, an OCT en face image overlaid with selected Angio en face
image will display.

• At lower right, the currently selected horizontal and vertical B-scan images.

Use the Patient, Visit and Scan lists at left to select AngioDisc scans for review.

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Angio Disc OverVue Controls

At upper right, the screen provides the following options.

• Exit: Exits screen and goes to the main report.

• QuickVue: en face and measurements display

• Print: Prints the current display.

• Export Angio: Exports the current display settings

• Reset View: reverts display to original

• Invert: Inverts the gray scale in the images.

• Color: Displays images in color

• Show Lines: Displays horizontal & vertical lines.

• Show Bnd: Traces boundaries with colored lines.

• Angio: Shows 4 AngioVue images.

• OCT: Shows 4 OCT images.

• Angio / OCT: Shows 4 AngioVue and 4 OCT images.

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Angio Disc OverVue, Portrait Report

Figure 194 Angio Disc OverVue Report, Angio Selection, Portrait View

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If you select the Angio / OCT radio button, the OverVue report shows four Angio slabs
images and four OCT images at each depth, as shown below.

Figure 195 Angio Disc OverVue Report, OCT/OCTA Selection

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10.11.8 Angio Disc Main Report

Figure 196 Angio Disc Main Report, En Face Tab Selected

The Angio Disc main report is the working report, which means that the options you
select here affect display of the OverVue, QuickVue and other report. The Angio Disc
main report includes:

• At top left, an AngioVue image. Above it is an Export Angio button to export the
AngioVue image to a file. You can choose where to save the image and what to name it
in the Save As dialog that appears.

• At top center, an OCT image showing RNFL thickness using a color scale. It also has
sliders to change which B-scans are shown, no matter which tab is selected.

• Along the bottom horizontal B-scans are presented, with and without Angio overlay.
Unclicking the “Large Angio” button will bring the vertical b-scan along the right side of
the screen.

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Angio Disc Main Report Controls

At upper right, the screen provides the following options, no matter which tab is selected
above the top center image.

• 3D Display: Opens the 3D Display.

• OverVue: Return to the OverVue screen.

• QuickVue: en face and measurements display (with AngioAnalytic


license)

• Play: Plays through the B-scans.

• Show Bnd: Traces boundaries with colored lines.

• Color: Displays images in color

• Show Line: Displays horizontal & vertical lines.

At the bottom of the screen are buttons to Print and Comment on the report.

Top Center Image Tabs

Thickness Tab

Figure 197 Angio Disc Central Image Tabs

The top center image has four tabs to display the following optional images:

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• SLO: Shows OCT and AngioVue images of the full scan thickness

• En Face: Shows the en face OCT image of the disc and the corresponding AngioVue
image to the left.

• Thickness: Shows an SLO OCT image overlaid with retinal nerve fiber thickness using
a color scale (and peripapillary grid if AngioAnalytics™ license enabled). There is also
an outline of cup/disc. The cup/disc measurement uses Bruch’s membrane opening
(BMO) as the determining reference plane (see Section 11.4.1).

• Color Overlay: allows static or movie color presentation

+ Note: This is different than the previous structural only scans which use BMO
plus 150µm anterior shift as reference plane. See Section 11.4.2.

Note: Peripapillary (adjacent to the disc boundary) 100 µm wide ring region is displayed
with mesh pattern to remind the user that no quantitative analysis is performed for this
area.

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Thickness Tab Controls

• Click the Edit Bnd checkbox to edit the boundaries shown on the B-
scans and thereby adjust the thickness.

• Note: segmentation of ILM can be edited similarly to AngioRetina scan


(section 10.8), however for any other segmentation boundaries the
editing of b-scan should avoid disc region. Propagation region should
avoid disc region as well.

SLO Tab

The figure below shows Angio Disc main report when the SLO tab is selected. The
example shows the AngioVue image in color because the color checkbox is selected at
far right. SLO screen is used to edit optic disc boundaries if needed (see Section 10.8)

Figure 198 Angio Disc Main Report, SLO Tab with Color Selected

En Face Tab

The figure below shows the AngioVue and OCT images when the En Face tab is
selected. In the example, the RPC option is selected in the controls at right. The
following section explains the controls.

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Figure 199 Angio Disc Main Report, En Face Tab Selected

En Face Tab Controls

• Brightness Icon: Click to adjust.

• Contrast Icon: Click to adjust contrast.

• Edit Bnd: Clicking this checkbox will take you to the


segmentation editing and propagation screen

• En Face Slab: Use the radio buttons to display the retinal


segment indicated.

• Vitreous

• Superficial

• RPC

• Choroid

• Retina

• Custom

▪ Upper – ILM Offset (µm): Displays the name and offset of upper
boundary for the selected slab

▪ Lower – IPL Offset (µm): Displays the name and offset of lower
boundary for the selected slab.

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Color Overlay Tab, Movie

When the Color Overlay tab is selected, the image shows the AngioVue and OCT
images. An overlay pull-down selection is available on the left, default is Movie. When
play is selected the screen will display the retinal slabs by colors and track the level by
the moving indicator to the left. There is also static selection for Vitreous, Superficial,
Deep, Outer and Choroid. All static layers have adjustable opacity to enable the user to
highlight the pathology.

Note: En face images show a small icon with color slab indicator, using the same colors
as the movie legend.

Figure 200 Angio Disc Main Report, Color Overlay Tab with Movie Selected

Movie Layers Boundaries

• Vitreous (Upper limit: = -2000; Lower Limit = ILM); Color= Green

• Superficial (Upper limit = ILM; Lower limit = IPL-10µm): Color= GrayScale

• Deep (Upper limit = IPL-10µm; Lower Limit = OPL+10µm); Color= Purple

• Outer (Upper limit = OPL+10µm; Lower limit = BRM-10µm); Color = Yellow

• Choroid (Upper limit = BRM-10µm; Lower limit = BRM+30µm); Color = Red

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Color Overlay, Static

Static images are available for all 5 layers listed above, with corresponding color-
coding.

10.11.9 Angio Disc Multiple Visits Report


Use this report to visualize en face disc images and the corresponding B-scans. The b-
scans location is “linked” (registered) across visits to display same anatomical location.
The system displays scans from up to eight visits. Select or deselect visits to display
using the list at upper left. Utilize the multi-scans view button to refresh the page after
selections. One of the five standard en face layers, or custom layer can be selected for
display. If AngioAnalytics™ license is activated, vessel density for RPC slab can be
displayed.

Figure 201 Angio Disc Multiple Visit Report

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Angio Disc Multiple Visits Report Controls

En Face Slab: Use the radio buttons to display the retinal slab
indicated.

• Vitreous

• Superficial

• RPC

• Choroid

• Retina

• Custom

Measurement

• None

• Vessel Density

• Reset View: reverts to original

• Link B-scans: links B-scans from multiple images to display


same anatomical location

• Invert: Select to invert the gray scale shading or color of the


images.

• Color: Select color image

• Show Bnd (Boundaries) in the B-scans.

Use the radio buttons at lower right to show either Angio or OCT
images for comparison.

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11 AngioAnalytics™
AngioAnalytics™ is a licensed upgrade that enables measurement of retinal vessel
density, FAZ, flow area and non-flow area as well as retinal layer thickness to the 3 mm
Angio Retina and 6 mm HD AngioRetina scans. It also enables the measurement of
RPC density and RNFL thickness and optic disc measurements for 4.5 mm HD
AngioDisc scans.

This measurement functionality is available in the Angio Retina and Angio Disc Main
Reports. The Measure field (next to the AngioVue image) at upper left is Off by default.
Use the down arrow to select to measure Vessel Density, FAZ, Flow and NonFlow
parameters. Some functionality is also displayed in the Multiscan and QuickVue reports.
These options are described below.

+ Note: All quantitative analysis for the vasculature are based on en face images
after removing projection artifacts. Deselecting artifact removal deactivates the
Measure field.

+ Vessel density is quantitation of the proportion of pixels representing vessels) out


of total number of pixels for regions in the en face images of the Superficial plexus, the
Deep plexus, and the RPC respectively. Due to the difference in sampling density
between the 3 mm AngioRetina scan and the 6 mm HD AngioRetina scan, the vessel
density measurements between the 2 scans of the same eye are not interchangeable.

+ Optic disc parameters (e.g., cup area, cup volume, rim area, rim volume, and
cup-to-disc ratio parameters) derived from the 4.5 mm HD AngioDisc scans are based
on the BMO plane, while the corresponding measurements derived from the ONH scan
are based on BMO plane with 150 µm anterior shift. Therefore, these two sets of
measurements are not interchangeable.

The device software also allows for structural measurements from both the 3 mm
AngioRetina scan and the 6 mm HD AngioRetina scan. Measurements include Full
Retina thickness, Inner Retina thickness, and Outer Retina thickness based on the scan
area, with measurements for the central 3 mm available in both scans.

Comparison of the Inner Retinal thickness of the 6 mm HD AngioRetina scan to the


GCC thickness of GCC scan, and comparison of the RNFL thickness measurements
and optic disc parameters between the 4.5 mm HD AngioDisc scan and the ONH scan
are provided in Table 19 of Appendix E.

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Angio Retina vs GCC Scan Thickness
Caution: The analysis region of the GCC scan is offset 1 mm temporally while
the analysis region of the AngioRetina scan is centered over the fovea.
Therefore, be advised that GCC measurement values (the parameters GCC Average,
GCC Inferior Average, and GCC Superior Average) from the AngioRetina scan are not
interchangeable with those of the GCC.

Figure 202 Angio Retina vs GCC Scan Comparison

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AngioAnalytics™ Composition
AngioAnalytics™ is composed of 3D segmentation and quantitative analysis of posterior
ocular structures based on OCTA scans:

11.2.1 Angio Retina


• AngioRetina scan segmentation (8-layer)

• Automatic fovea center detection.

• Measurements of the vessel density within AngioRetina scan measurement areas

• Measurement of the thickness of the retina and layers of retina in the macula within
measurement areas

• Automatic FAZ margin detection and FAZ parameters calculations

• Flow and Non-Flow tool

Note: AngioRetina scan segmentation (8-layer) supports the thickness


measurement of full retina, inner retina, and outer retina, similar to thickness
measurements before with OCT scans. The 8-layer segmentation only applies to
OCTA scans and have no impact to OCT scans.

11.2.2 Angio Disc


• AngioDisc scan segmentation (7-layer)

• Automatic optic disc margin detection

• Measurements of the vessel density within AngioDisc scan measurement areas

• Measurement of the thickness of the retinal nerve fiber layer (RNFL)

• Measurement of the optic disc parameters, including disc area, rim area, cup area, cup-
to-disc ratio.

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11.2.3 Scan Centering and AngioAnalytics Measurements
AngioRetina scans should be centered on the fovea and AngioDisc scan should be
centered on the optic disc to minimize truncation of the measurement areas, such as
ETDRS grid and Garway-Heath grid.

If due to scan de-centration one of the measurement sectors is lacking more than 30%
of pixels as calculated by the software, the metrics for that sector are marked as “NA”

Figure 203 Sector Crop >30% Marked NA

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Angio Retina Analytics
11.3.1 Fovea Center Detection
The fovea center is an important anatomical landmark. Accurate identification of fovea
center allows placement of fovea-centered measurement grids such as the early
treatment diabetic retinopathy study (ETDRS) grid, as well as registration across
multiple visits.

The subject device identifies fovea center automatically by searching for the thinnest
part of the inner retina slab (ILM to IPL) generated from the automatic segmentation.

11.3.2 ETDRS Grid Centration


ETDRS grid misplacement can affect vessel density and retinal thickness
measurements.

ETDRS grid centration adjustment can be performed by simple dragging of the grid to
the required position. All metrics are recalculated by the software following grid
replacement.

Figure 204 Grid centration


Left - ETDRS grid is not precisely centered on fovea on this 3 mm AngioRetina scan. By
simple dragging of the grid and dropping it at the desired location, the placement of the

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grid can be changes, and the action will require confirmation from the operator, by
providing response to the pop-up icon – Right

11.3.3 Angio Retina Measurement Zones and Parameters


Below is schematic presentation of the measurement zones and their report
nomenclature for the 3.0mm Angio Retina and 6.0mm HD AngioRetina scans.

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Whole Image Whole Image
Quadrants Hemispheres
Parameters

G11 G12 G13


WI_S_Hemi
3mm scan G21 G22 G23 WI
WI_I_Hemi
G31 G32 G33

G11 G12 G13


WI_S_Hemi

6mm scan G21 G22 G23 WI

WI_I_Hemi
G31 G32 G33

Figure 205 Angio Retina Measurement Zones and Parameters


The ETDRS grid is comprised of 3 concentric rings: 1 mm center (green), 1-3 mm
(parafovea, blue), and outer ring of 3-6 mm diameters (perifovea, gray). The outermost
rings are further divided into 4 sectors for Quadrant analysis (temporal (T), superior (S),
nasal (N) and inferior (I)) or 2 Hemispheres (Superior (S_Hemi) and Inferior (I_Hemi),
divided by horizontal line through the foveal center. Right (3 mm partial ETDRS grid) and
Left eye (6 mm full ETDRS grid) are illustrated here to show mirrored display of T and N
sectors between right and left eyes. The whole image parameters are also subdivided

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further into Superior and inferior halves and 9 equal squares, however naming of the
sectors remains constant in relation to the right /left eye.

As shown in Appendix E, tables 21~24, comparing the full retina thickness and inner
retina thickness measurements in the fovea and para-fovea zone between the 3 mm
AngioRetina scan and 6 mm HD AngioRetina scan, the mean of differences does not
exceed 1µm and the Deming regression analysis slope ranges from 0.99 to 1.03.

The retina layers thickness measurements from the OCTA scan are similar to those of
the Retina map scan within the ETDRS grid, centered on the fovea. For full retinal
thickness, the mean thickness difference between the scans is -1.7 µm for fovea center,
3.8 µm for inner (para fovea) zone, and -4.7 µm for outer (peri fovea) zone. For
information relating the Inner retinal thickness of 6 mm HD AngioRetina scan and the
GCC scan thickness, and the RNFL thickness measurements and optic disc parameters
see reference (Appendix E Tables 19 and 20).

11.3.4 Angio Retina Vessel Density and Retinal Thickness


Vessel density analysis computes the percentage of area occupied by OCTA detected
vasculature.

+ Note: that vessel density measurements from the 6 mm HD AngioRetina scans


are not interchangeable with those of the 3 mm AngioRetina scans because of the
differences in sampling density between the two scan patterns. Therefore, when
assessing for change in measurement values from successive scans over time, the
same scan pattern should be used in follow-up.

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Figure 206 6 mm HD Angio Retina, Main Report

Select Density in the Measure field next to the AngioVue image at upper left.
Concentric blue circles indicating the ETDRS sectors overlay appear on the selected
retina slab of the image. The ring diameters appear above the image.

Select Density in
Measure field

Figure 207 Measurement Window Slection

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Note: All density measurements are calculated with PAR on. Turning off PAR allows for
visualization of vessels with projection artifacts. No quantitative analysis allowed in this
mode.

+ Note: It is recommended that the PAR-corrected images are inspected and


compared to PAR-uncorrected images prior to interpreting vessel density measurement
values to determine if there has been extensive removal of non-artifactual signal.

+ Note: that vessel density measurements are determined only with PAR
correction. Therefore, the precision data of vessel density measurements from the
AngioAnalytics R&R study (Section 16.2) reflects measurements only with PAR on.

+ Note that vessel density measurements are less accurate in locations where
there are both projection artifacts and in-situ signal (e.g., deep plexus locations with
projection artifacts from the overlying superficial plexus). Refer to Section 11.3.4 and
11.4.5 for more information on the vessel density measurement feature.

It is recommended that the PAR-corrected images are inspected and compared to PAR-
uncorrected images prior to interpreting vessel density measurement values to
determine if there has been extensive removal of non-artifactual signal.

The system measures vessel density of the selected slab (Superficial or Deep) and
presents it in tables at upper right, as in the example below.

The blue, concentric ETDRS grid overlay on the Angio image indicates the sections
measured.

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Figure 208 Superficial and Deep Vessel Density Measurements

The large table displays vessel density in % on the left and OCT full retinal thickness on
the right for the listed sections of the current layer – superficial on the left, and deep on
the right.

The lower table reports the 3x3 grid-based vessel area density in % that matches the
color image below.

Under Enface Slab is the radio button showing the displayed and measured layer,
“Superficial” or “Deep”.

A color overlay indicates vessel density over the AngioVue image area. The color scale
legend at right associates the colors on the map with percent density in ten percent
increments.

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Figure 209 Angio Retina Main Report, Thickness Tab with Full Retina Thickness Selected

→ Vessel density and thickness measurements are available on the Main, Multiscan,
Trend and QuickVue reports.

Figure 210 Retina Multi Scan Showing Superficial Density

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11.3.5 Foveal Avascular Zone (FAZ)
In fluorescein angiographic analysis of the retina, the center of the macula is generally
capillary-free, this area being named the foveal avascular zone (FAZ).

Foveal avascular zone (FAZ) measurements are based on AngioRetina scan – either 3
mm or 6 mm and are generated based on the Retina slab (ILM to OPL+10µ).

The following parameters are provided: (Fig. 174):


• FAZ: FAZ area in mm2 (3 mm and 6 mm OCTA scans)
• PERIM: FAZ perimeter in mm (3 mm and 6 mm OCTA scans)
• FD: vessel density of the 300µ width ring surrounding the FAZ, in %. (3 mm and 6
mm OCTA scans). FD is calculated by dividing the number of vessels pixels by the
total number of pixels, multiplied by 100%. The foveal vessel density measurement
(FD) is not interchangeable between 3 mm and 6 mm OCTA scans.

FAZ

FD

Figure 211 FAZ Parameters

Automated FAZ boundary detection is provided by the AngioVue software, applied on


Retina slab (ILM to OPL+10um) and can be reviewed on the En Face screen, under
“FAZ” measurement.

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Figure 212 Examples of FAZ Detection based on Angio Retina 3mmx3mm scan.

Figure 213 Examples of FAZ Detection based on Angio Retina HD 6mmx6mm scan.

+ The comparison between the 3 mm AngioRetina scan and the 6 mm HD


AngioRetina scan for the FAZ measurements (FAZ area, FAZ Perimeter, and FD-300
vessel density) is provided in Appendix E, Tables 18a and 18b. There is a difference of

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approximately 2.5% on average in FD-300 vessel density measurements between the 2
scan patterns.

FAZ Controls

• User may change FAZ boundary by dragging the anchor point and the 300μm ring boundary
follows automatically

• Select ”Clear” to clear FAZ region

• Select “Draw” to manually select FAZ region

• Select “Auto” to call algorithm to detect FAZ region

• Select “Save Analytics” on the right to save any manual modifications

FAZ Edit

Over- or under-detection of the FAZ can be noted following automated FAZ boundary
drawing by the software. Correction of FAZ boundary can be performed by dragging the
“anchor” point to the correct location of the FAZ boundary as detected form the Retina
(ILM to OPL+10µ) en face slab.

Automatic recalculation of all FAZ metrics is performed by the software once modified
FAZ boundary is saved by the user by clicking on “Save Analytics” button on the right.

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Figure 214 FAZ Editing

Upper left – Retina slab (ILM to OPL+10) of 3 mm AngioRetina scan. Upper right –
Imprecisely automatically detected FAZ margin (pointed by red arrow). Lower left – FAZ
margin correction by dragging the “anchor” point to the correct location (pointed by red
arrow). Lower right – Corrected FAZ

→ FAZ measurements are available on Main, Trend and Multiscan reports.

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Figure 215 FAZ Multiscan Report

11.3.6 Angio Retina QuickVue Report

Figure 216 6 mm HD AngioRetina, QuickVue Report

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The Retina QuickVue report shows the 4 default OCTA segmentations along the top. B-
scan is fovea centered by default, unless flow is detected in Outer Retina slab – in such
case the B-scans will be defaulted to the flow area. The lower 4 displays are Superficial
Vessel Density, Inner Retina Thickness, SLO like image and Full Retina thickness map.

11.3.7 Angio Retina Trend Report


The purpose of Angio Retina Trend report is to provide the user with evaluation of rate
of change in AngioAnalytics global parameters that are available for AngioRetina scans.
Trend Report button on Main Report screen becomes available, if there are 3 or more
visits of the same scan type available.

Trend report displays parameters of both eyes over time to aid in the assessment of
longitudinal change. The trend report requires five visits before a regression line is
drawn. A tentative regression line is drawn once three visits are available, and rate of
change metrics are marked “NA” if less than five visits are recorded.

The following parameters can be presented on trend report: Retinal Thickness – Inner
(GCC) and Full, Vessel Density – Superficial and Deep, and FAZ parameters.

Figure 217 Angio Retina Trend Report, Superficial Vessel Density selected.

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The report displays superficial vessel density color-coded map along with the B-scans
and ETDRS metrics for the first and the last visit of both eyes (top row). The graphs
show Superior Hemifield (of the Whole Image), Inferior Hemifield (of the Whole Image)
and ETDRS Grid vessel density over three available visits for each eye, including the
tentative trend line. The table on the right provides tabular view of the metrics.

To view different parameter, i.e. FAZ, select FAZ on the right side of the report.

Interpreting trend report values

Note: The trend will be graphed as solid line (with rate of change and its confidence
interval noted above the graph) if 5 or more scans are available. The trend will be
graphed as dotted line (with no metrics available) if at least 3 visits are available.

To interpret the graph:


1. Look at the trend line – horizontal line indicates stable values, positive slope indicates
increasing values, negative slope indicates decreasing values.
2. Look at the confidence interval of the estimated rate between brackets on the report
(provided if at least 5 visits are available):
a. if zero value is included in the confidence intervals, the trend may not be
different from zero
b. if zero value is not included in the confidence intervals, there is likely a
change; check the estimated rate of change for clinical significance

11.3.8 Flow
Flow area measurement is based on AngioRetina scans, detecting the flow in the pre-
defined Outer Retina slab (OPL+10µm to BRM-10µm) and Choriocapillaris slab (BRM-
10µm to BRM+30µm).

Flow detection can be performed either by using the circle, manually placed on the
image slab of the outer retina, or by drawing a closed contour around the region of
interest. In such cases selected area and flow area parameters will be provided (mm 2).

No quantitative evaluation for these parameters was performed in the AngioAnalytics


study.

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Figure 218 Flow
Left – flow area measured within the circle, right – flow area measured within the
delineated contour, measurements are provided at the top of the image

Flow Tool Use

Go to “EnFace” tab of the OCT, then select Flow in the Measure field next to the
AngioVue image at upper left. It is available for the outer retina and choroid layers.
When selected, a pull-down menu appears below the field. A 2mm diameter circle is
placed in the center of the image

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1. Select Flow in
Measure field

2. Circle

Figure 219 Circle Flow

Using the left mouse key, click in the center to drag the position of the circle, left click on
the circle line and adjust the circle size.

Figure 220 Circle Flow, Moved and Reduced

Click the Pull down and select Contour. Then click Draw, this allows the operator to
outline the area of interest. Each click places an anchor point and the software
automatically creates an arch by connecting each anchor point to the last. Close the

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area by clicking on the first anchor point again. The yellow-highlighted flow areas and
measurements appear automatically when you close the shape.

Selected area Vessel area


(yellow)

Shape you drew


in orange

Areas of flow
(yellow) within
orange shape

Figure 221 Contour Area of Flow Highlighted Yellow and Measured

To adjust the size and shape of the area, click and drag an anchor point. You can also
delete an anchor point by clicking it and pressing the Delete key (on your keyboard),
and the shape adjusts accordingly. Click Clear to clear the shape you drew and start
over again by clicking Draw.

When you close the area by clicking on the first anchor point again, the software
automatically highlights in yellow the areas of flow within the shape you drew. Above the
AngioVue image, the software reports measurements (in mm 2) of the area you selected,
the Select Area, and the total flow area, the Vessel Area.

Click Save Analytic on the right side to save the measurement


with the report.

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+ Note: The system saves the measurements (including delineated shape and
detected vessels area) for each layer if you click Save Analytic before exiting the
screen. In such case “F” will appear near the scan at the scan list.

• Remove Artifacts Checkbox: This checkbox activates Projection artifact removal


(PAR) and is selected by default. Its purpose is to remove artifacts from the measured
area, thus reducing the area highlighted yellow and corresponding vessel area
measurement. If you clear this checkbox, the software restores projection artifacts and
removes the option of any measurements, including the Flow tool.

+ Once Flow measurements are saved (by clicking Save Analytic button) it will
become available on Main and Multiscan reports review.

Figure 222 Angio Retina Multiscan Report, Outer Retina Slab and Flow Selection

11.3.9 Non-Flow
The Non-Flow tool is available for application on Superficial retinal slab. It can be used
for semi-automatic quantification of non-perfused areas.

No quantitative evaluation for Non-Flow parameters was performed in the


AngioAnalytics study.

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Non-Flow Tool Use

Go to En Face OCT tab, then select NonFlow in the Measure field next to the AngioVue
image at upper left. When you do, the instruction “Use Left Mouse Button to Drop
Seed” appears below the field, and Undo and Clear buttons.

Select NonFlow in
Measure field

Figure 223 Select NonFlow in Measurement Window

Click inside in a dark area, without vessels, and the software automatically highlights
yellow all the contiguous dark area. The yellow-highlighted non-flow area and
measurements appear automatically.

Non-Flow Area Measurement

Area of non-flow

Figure 224 Area of Non-Flow Highlighted Yellow and Measured

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You can select additional non-flow areas by clicking in them also, and the additional
area is added to the measurement. Click Undo to undo your last selection. Click Clear
to clear the highlighted area and start over again.

Non-Flow Area Increased

Areas of non-flow added

Figure 225 Additional Non-Flow Areas Selected and Measured

Click Save Analytic on the right side to save the measurement


with the report.

+ Note: The software automatically clears yellow-highlighted areas and


measurements each time you exit the Non-Flow screen. The system saves the
measurements (including yellow areas) if you clicked Save Analytic before changing
the layer. In such case “NF” will appear near the scan at the scan list.

+ Once Non-Flow measurements are saved (by clicking Save Analytic button) it will
become available on Main and Multiscan reports review.

11.3.10 Information Display for Saved Analytics Result


The Review Scan list shall display information regarding saved Analytics results

F = Flow measurement

NF = NonFlow Measurement

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Figure 226 Flow and NonFlow Indicators on the Scan List

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Angio Disc Analytics
Angio Disc enables the measurement of RPC density and structural thickness values of
RNFL for 4.5 mm HD Angio Disc.

11.4.1 Optic Disc Parameters


The following parameters are provided based on 3D OCTA intensity images of the disc,
derived from RNFL slab of the 2~4 mm diameter ring.

✓ Cup/Disc Area Ratio – cup to disc area ratio


✓ Cup/Disc V. Ratio – cup to disc vertical ratio
✓ Cup/Disc H. Ratio – cup to disc horizontal ratio
✓ Rim Area (mm2)
✓ Disc Area (mm2)
✓ CupArea (mm2)
✓ CupVolume (mm3)

Figure 227 Disc Parameters

For AngioDisc scans the disc margin (A) is automatically detected based at Bruch’s
Membrane Opening (BMO) (B), and both cup and rim are measured within the BMO
plane: the portion above the BMO plane is “rim”, while the portion below the plane is a
“cup” (C).

Note: Peripapillary (adjacent to the disc boundary) 100 µm wide ring region is displayed
with mesh pattern to remind the user that no quantitative analysis is performed for this
area.

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11.4.2 Comparison of Optic Disc Parameters Between OCT and OCTA
Scans.
The differences in optic disc parameters are predominantly due to the shift in the disc
analysis plane, as illustrated in the example below. The parameters of the ONH scan
are measured from the plane 150 microns anterior to BMO while the parameters of the
AngioDisc scan are measured from the BMO plane without any offset, and as expected,
the cup will be smaller with the AngioDisc scan.

Figure 228 Disc Parameters Comparison between ONH OCT and AngioDisc Scans

11.4.3 Angio Disc Measurement Zones and Parameters


The figure below provides schematic presentation of the vessel density and RNFL
thickness measurement areas and parameters nomenclature based on whole image
and Garway-Heath based peripapillary grid.

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Figure 229 Angio Disc Measurement Zones and Parameters
Schematic presentation of the peripapillary grid and grid sectors naming for the left eye.
Peripapillary region is defined by two rings of 2mm and 4mm centered on disc center
(blue area).

Upper panel: Left – Peripapillary (2-4) grid. Middle - Superior and Inferior Hemi-sectors.
Right – Disc and 8 equal sectors. Disc – inside disc (grey area outlined by the yellow
boundary) 2mm circle centered on disc center; 8 peripapillary sectors - nasal superior
(NS), nasal inferior (NI), inferior nasal (IN), inferior temporal (IT), temporal inferior (TI),
temporal superior (TS), superior temporal (ST), superior nasal (SN).

Lower panel: Left – whole image of 4.5X4.5 mm of disc scan. Right - 9 sectors grid

11.4.4 Eight Sector Peripapillary Grid .


The grid consists of two concentric circles of 2mm and 4mm diameter, centered on the
center of the optic disc, as determined by BMO fitted circle. The modified grid aims to
follow RNFL distribution and sectored to provide easier correlation with visual field
testing.

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Figure 230 Eight Sector Peripapillary Grid
The eight sectors grid overlaid on and 4.5 mm HD Angio Disc En Face RPC Slab.The
inner circle has a diameter of 2 mm and the outer circle has a diameter of 4 mm.

11.4.5 Angio Disc RPC Vessel Density and RNFL Thickness


Vessel density analysis computes and displays the percentage of area occupied by
OCTA detected vasculature for RPC slab (ILM to NFL). Peripapillary RNFL thickness is
calculated for RNFL layer (ILM to NFL).

The HD Angio Disc main report below with EnFace tab and Density measurement
selected shows an OCTA image with peripapillary grid overlayed on RPC slab, a
structural image with SLO, EnFace, Thickness, and Color Overlay tabs with EnFace tab
selected; charts for regional RPC vessel density and RNFL thickness parameters;
horizontal B scans with/without flow patterns and vessel density 9 square grid chart and
color-coded map.

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Figure 231 Angio Disc, Main Report with En Face Tab and Density Selected

The vessel density measurements of small vessels (i.e., with large vessel masking) are
provided in the table with the header of “Vessel Density & RNFL Thickness” from the
peripapillary region (from the 2mm to 4mm ring region) and inside the optic disc. The
vessel density measurements of all vessels (i.e., without large vessel masking) is
displayed below with the header of “Grid-based Vessel Density (%)” for parameters
derived from the 3x3 square sectors grid of the vessel density map. While end-user may
be interested in assessing both small vessel density and all vessels density, the
peripapillary ring region centered on the disc center is a clinically more relevant for disc
scans.

+ Note: All density measurements are calculated with projection artifacts removed
(PAR applied). RPC is the most superficial plexus and therefore minimally affected by
projection artifacts.

+ Turning off PAR allows for visualization of vessels and projection artifacts. No
quantitative analysis is available with “PAR off”.

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Threshold for Small Vessel

The large-vessel masking is a software-based feature when a pre-determined cutoff is


used to distinguish between ‘large vessels’ and ‘small vessels’ (see Figure below). This
cutoff is fixed and does not change by en face slab or individual scan.

Figure 232 Large Vessels Mask


Example of large vessel mask for 4.5 mm HD AngioDisc scan. (Left) RPC en face image.
(Middle) Extracted large vessel mask. (Right) Extracted large vessel mask overlaid on the
RPC face image.

The small vessels density is measured with the application of large vessel mask which
has threshold of ≥ 3 pixels (approximately ≥ 33µm for the 4.5 mm HD AngioDisc scans).
Following mask application, only the “small vessels” density is measured.

Vessel density is also available on Main, QuickVue, Multi Scan and Trend reports.

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Figure 233 Angio Disc Multi Scan Report, RPC Slab and Vessel Density Selected

→RNFL Thickness is available on Main, QuickVue and Trend reports

Figure 234 Angio Disc Main Report, Thickness Tab Selected

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11.4.6 Angio Disc QuickVue Report

Figure 235 Angio Disc QuickVue Report

The Angio Disc QuickVue Report has the 4 OCTA default segmentations with horizontal
and vertical B-scan through the disc. The left lower part displays structural information
including Optic Disc parameters, RNFL thickness global parameters and Garway-Heath
based grid, well color-coded thickness RNFL thickness map. The right lower part
provides vessels density information including RPC slab global vessel density
parameters (small vessels and all vessels) and Garway-Heath based regional vessel
density parameters (small vessels only) as well as color-coded vessel density map.

11.4.7 Angio Disc Trend Report


The purpose of Angio Disc Trend report is to provide the user with evaluation of rate of
change in AngioAnalytics global parameters that are available for AngioDisc scans.
Trend Report button on Main Report screen becomes available, if three or more visits of
the same scan type are available.

Trend report displays parameters of both eyes over time to aid in the assessment of
symmetry and longitudinal change. The trend report requires five visits before a
predictive line is drawn. A tentative predictive projection line is drawn once three visits

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are available, and rate of change metrics are marked “NA” if less than five visits are
recorded.

The following parameters can be presented on Angio Disc Trend report: Retinal Nerve
Fiber Layer (RNFL) Thickness and Radial Peripapillary Capillaries (RPC) Vessel
Density.

Figure 236 Angio Disc Trend Report, Vessel Density Selected.

The report displays RNFL thickness color-coded map along with the B-scans and
peripapillary grid metrics for the first and the last visit of both eyes (top row). The graphs
show Superior (Hemifield) RNFL (of the Whole Image), Inferior (Hemifield) RNFL (of the
Whole Image) and Average RNFL thickness (of the Whole Image) over five available
visits for right eye, and three visits for left eye, including trend line, rate of change and
confidence interval for the right eye, and tentative trend line for the left eye. The table on
the right provides tabular view of the metrics. Including optic disc parameters.

To view RNFL Thickness, select RNFL on the right side of the report.

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Figure 237 Angio Disc Tren Report, RNFL Thickness Selected

Interpreting trend report values

Note: The trend will be graphed as solid line (with rate of change and its confidence
interval noted above the graph) if five or more scans are available. The trend will be
graphed as dotted line (with no metrics available) if at least three visits are available.

To interpret the graph:


3. Look at the trend line – horizontal line indicates stable values, positive slope indicates
increasing values, negative slope indicates decreasing values.
4. Look at the confidence interval of the estimated rate between brackets on the report
(provided if at least five visits are available):
a. if zero value is included in the confidence intervals, the trend may not be
different from zero
b. if zero value is not included in the confidence intervals, there is likely a
change; check the estimated rate of change for clinical significance

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12 Appendix A: Printer Installation
WARNING: When using a printer connected directly to the system via USB,
Optovue recommends that you plug the printer into the designated power outlet
in the system PC compartment. This outlet is isolated from the wall plug (building
power) through the RTVue isolation transformer. If you plug the printer into any other
power outlet, place the printer at least 1.5 meters away from the patient to avoid electric
shock.

AVERTISSEMENT : Lorsque l'alimentation d'une imprimante USB provient de


l'instrument XR, il est recommandé de brancher le cordon d'alimentation de l'imprimante
dans la prise de courant conçue à cette fin dans le compartiment PC. Cette prise est
isolée de la prise murale (réseau d'alimentation du bâtiment) par le transformateur
d'isolement de l'instrument XR. Si l'alimentation de l'imprimante provient d'une autre
source que la prise d'alimentation conçue à cette fin, l'imprimante doit être placée à
1,5m au moins du patient, pour éviter tout risque d'électrocution.

13 Appendix B: Normative Database (NDB)


A normative database (NDB) is an integral part of an imaging device. The RTVue NDB
was cleared by the FDA for use on September 15th, 2010 (K101505). It provides a
statistical benchmark of normality by comparing an eye to a group of known healthy
eyes. The results are labeled as within normal, borderline, or outside normal
depending on where the patient value is relative to the normal distribution. If they are
within the 5%~95% range of all normals in the distribution, they are labeled within
normal range. If they are within the 1%~5% range or the 95%~99% range of all
normals in the distribution, they are labeled borderline. If they are less than 1% or
greater than 99% of all normals in the distribution, they are labeled outside normal.
The applicable label, based on comparison of the subject eye to the normative
database, is not meant to serve as a diagnosis, and should not be used in isolation for
clinical decisions. Rather, it is an aid to be taken into consideration, with all other
available clinical information, in making an overall diagnosis. It provides an important
piece of clinical information to the clinician, by providing a statistical reference for the
patient’s structural measures compared to a group of known healthy eyes.

Several factors were found to influence the RTVue measurements. Age was found to
affect thickness values: older age associated with lesser thickness. Optic disc size was
also a significant factor correlated to RNFL thickness: the larger the optic disc, the
thicker the RNFL. Furthermore, retinal thickness correlates to gender: retinal thickness
in males is greater than in females. Comparisons of thickness measurements of a
subject eyes to the RTVue normative database (NDB) automatically take into account
these three factors, adjusting for age, gender and optic disc size. This means that the

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final label, within normal, borderline or outside normal, reflects the patient’s status
relative to NDB adjusted for these factors.

The RTVue normative data was collected at 11 clinical sites following an IRB approved
protocol and enrolled known healthy eyes from 480 individuals with a wide age range of
age (ages 18-84) from various ethnic backgrounds including African Americans, Asians,
Caucasians, Hispanics, Indians, and other.

All data was carefully reviewed for completeness and quality. Subjects not meeting
study criteria, and scans not meeting image quality criteria, were excluded. The final
RTVue normative database consists of 649 eyes from 366 subjects for the ONH scan,
644 eyes from 364 subjects for the EMM5 scan (that is, the retina map scan), and 656
eyes from 364 subjects for the GCC scan.

13.1.1 Data Collection Sites


Eleven clinical sites worldwide participated in the data collection, all following the
approved protocol. These sites were:

US sites:

• Christopher Girkin - University of Alabama at Birmingham, Birmingham, Alabama

• Gadi Wollstein - University of Pittsburgh Medical School, Pittsburgh Pennsylvania

• Rohit Varma - University of Southern California, Los Angeles California

• Jeffrey Liebmann - New York Eye and Ear Infirmary, New York City, New York

• Murray Fingeret - New York VA Hospital, St. Alban’s, St. Albans, New York

• David Greenfield - Bascom Palmer Eye Institute, Palm Beach Gardens, Florida

International sites:

• David F. Garway-Heath - Moorfields Eye Hospital, London, England

• Makoto Araie - Tokyo University, Tokyo, Japan

• Yasuo Tanno - Osaka University, Osaka, Japan

• Goji Tomita - Toho University, Tokyo, Japan

• G.S. Sekhar - LV Prasad Eye Institute, Hyderabad, India

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13.1.2 Methods:
All subjects enrolled had a complete eye exam and were confirmed to be free of any
ocular pathology. All subjects had normal visual fields and normal IOP.

The following inclusion/exclusion criteria were followed in the NDB data collection.

Inclusion Criteria:

a) At least 18 years of age

b) Able and willing to provide consent

c) Able and willing to complete the required examinations and visits

d) Signature on the Informed Consent Form

e) Refractive error within +/- 8 diopters sphere and within +/- 2 diopters cylinder in each
eye

f) Best corrected visual acuity of 20/30 or better in each eye

Exclusion Criteria:

a) History of leukemia, AIDS, dementia, or multiple sclerosis

b) Concomitant use of hydroxychloroquine or chloroquine

c) Family history of glaucoma among first degree relatives

d) Intraocular pressure of 22 mm Hg or greater in either eye

e) A visual field test showing one or more of the following:

• An unreliable visual field test result (>30% false negative responses or >30% false
positives or >30% fixation losses)

• Pattern Standard Deviation (PSD) of p<5% or worse

• Glaucoma Hemifield Test (GHT) result of Outside Normal Limits

f) Active ocular disease including degenerative myopia (for example, AMD, DME)

g) Previously diagnosed with glaucoma or glaucoma suspect

h) Congenital ocular abnormalities

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i) Previous intra-ocular surgery or laser treatment (other than refractive surgery

j) or uncomplicated cataract surgery greater than 6 months previously)

k) Anatomical narrow angle

13.1.3 Results
The breakdown of the final normative database by age range and ethnicity group, as
well refractive error range, is provided in Table 4. The database covers a wide age
range of adults and a wide range of ethnic groups.

Table 4 Normative Database Breakdown by Age and Ethnicity with Refractive Error
Range

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Age Breakdown 100%

18-29 14.50%

30-39 13.10%

40-49 18.90%

50-59 25.40%

60-69 17.50%

70+ 10.70%

Ethnicity Breakdown 100%

Caucasian 34%

Asian 22%

Hispanic 12%

African Descendant 19%

Indian/Middle East 12%

Pacific Islander 0%

Other 1%

Refraction Error Range

Sphere (Mean ± SD) ‐ 0.46 D ± 1.9 D

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Range (‐ 7.75 D ~ + 5.50 D)

13.1.4 RNFL Thickness


The retinal nerve fiber layer thickness is obtained from the ONH scan. The parameters
are derived from a 3.45 diameter circle centered on the optic disc and are shown in
Table 5.

Table 5 Normal Subjects Retinal Nerve Fiber Layer Thickness Distribution

ONH Scan – Retinal Nerve Fiber Layer Thickness

N
Parameter Mean SD Min Q1 Median Q3 Max
(Subjects)

Age 49.9 15.6 18.9 37.1 50.8 61.1 83.9 366

SSI 55.3 9.8 31.6 48.2 54.7 62.3 80.3 366

discArea (mm2) 2.117 0.368 1.330 1.850 2.065 2.328 3.580 366

Avg_RNFL (µm) 101.1 9.0 66.6 95.3 101.3 106.9 126.3 366

Sup_RNFL (µm) 103.3 10.2 65.5 97.0 103.6 110.1 144.8 366

Inf_RNFL (µm) 98.9 9.1 67.7 92.9 99.0 105.0 126.5 366

Tempo (µm) 75.3 9.2 44.4 70.2 74.8 81.1 109.6 366

Superior (µm) 123.8 14.1 73.4 113.2 125.2 132.7 171.3 366

Nasal (µm) 79.3 10.9 48.6 72.6 79.4 86.0 147.4 366

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ONH Scan – Retinal Nerve Fiber Layer Thickness

N
Parameter Mean SD Min Q1 Median Q3 Max
(Subjects)

Inferior (µm) 126.1 13.2 85.0 117.7 124.9 135.5 165.2 366

TU (µm) 81.8 11.0 45.6 74.9 81.5 88.7 121.6 366

ST (µm) 135.0 15.9 62.4 124.9 135.9 146.3 176.8 366

SN (µm) 112.7 17.8 66.7 100.5 112.1 123.6 178.2 366

NU (µm) 83.8 13.1 47.0 75.5 83.2 91.3 172.2 366

NL (µm) 74.7 10.5 45.6 67.8 74.7 811 122.6 366

IN (µm) 114.2 17.4 68.1 102.7 114.4 125.5 167.9 366

IT (µm) 137.9 16.7 83.9 126.4 138.7 149.6 188.9 366

TL (µm) 68.9 9.2 43.3 63.6 68.4 73.9 107.0 366

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13.1.5 Optic Disc Parameters
Optic disc parameters, including neuro-retinal rim, optic nerve head cup, and cup-to-
disc ratio, etc., are also obtained from the ONH scan. ONH disc, rim, and cup
measurement parameters are shown in Table 6.

Table 6 Normal Subjects: Distribution of Optic Nerve Head Measurements

ONH Scan – Disc, Rim, & Cup

N
Parameter Mean SD Min Q1 Median Q3 Max
(Subjects)

Age 49.9 15.6 18.9 37.1 50.8 61.1 83.9 366

SSI 55.3 9.8 31.6 48.2 54.7 62.3 80.3 366

discArea (mm²) 2.117 0.368 1.330 1.850 2.328 2.065 3.580 366

Area_C_D_ratio 0.321 0.172 0.000 0.210 0.320 0.440 0.770 366

H_C_D_ratio 1.413 0.363 0.650 1.190 1.370 1.628 2.680 366

V_C_D_ratio 0.181 0.120 0.016 0.100 0.145 0.228 0.721 366

CupArea (mm²) 0.704 0.447 0.000 0.393 0.680 0.950 2.200 366

RimArea (mm²) 0.179 0.195 0.000 0.029 0.120 0.262 1.122 366

RimVolume (mm³) 0.328 0.186 0.053 0.203 0.269 0.412 1.066 366

Nervehead_Volume
0.584 0.225 0.000 0.480 0.630 0.750 0.990 366
(mm³)

CupVolume (mm³) 0.521 0.203 0.000 0.430 0.570 0.660 0.910 366

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13.1.6 GCC Parameters
The following results are from the GCCTM scan. The GCC scan provides inner retinal
thickness values from the ILM to the inner plexiform layer, called the ganglion cell
complex (GCC). It is centered 1 mm temporal to the fovea in order to emphasize the
temporal retina region, which corresponds to the nasal visual field (area most
susceptible to early glaucomatous damage). In addition to the thickness parameters
shown in Table 7 below, the GCC also provides two important parameters, the FLV and
GLV.

Table 7 Normal Subjects: Distribution of GCC Measurements

GCC Scan – Ganglion Cell Complex

Parameter Mean SD Min Q1 Median Q3 Max N (Subjects)

Age 49.8 15.5 18.9 37.4 50.8 61.1 83.9 364

SSI 62.0 8.5 39.3 56.1 61.9 67.9 83.3 364

GCC_Average (μm) 98.8 7.2 78.3 93.9 98.7 103.2 119.6 364

GCC_Superior_Avg (μm) 98.2 7.3 80.6 93.5 97.8 102.4 122.9 364

GCC_Inferior_Avg (μm) 99.4 7.4 75.5 94.1 99.2 104.3 120.8 364

GCC_FLV (%) 0.546 0.693 0.000 0.081 0.324 0.730 4.356 364

GCC_GLV (%) 2.101 2.706 0.000 0.353 1.046 2.856 17.270 364

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13.1.7 Retina Thickness
The following results are from the EMM5 scan pattern (that is, Retina Map scan). The
EMM5 scan provides full retinal thickness values from the ILM to the RPE layer. It is
centered on the fovea. Thickness values for the fovea region and surrounding
parafovea and perifovea are provided.

Table 8 Normal Subjects Retinal Thickness Distribution

Retina Map Scan – Retinal Thickness

N
Parameter Mean SD Min Q1 Median Q3 Max
(Subjects)

Age 49.8 15.5 18.9 37.4 50.8 61.1 80.1 364

SSI 63.4 8.3 42.6 58.1 63.2 69.0 85.4 364

Fovea (μm) 255.2 22.0 191.9 239.2 254.9 270.4 320.7 364

ParaFovea (μm) 319.6 16.6 267.0 309.0 320.0 330.2 362.0 364

Para S Hemisphere
320.7 17.1 269.0 310.0 321.0 332.0 365.0 364
(μm)

Para I Hemisphere
318.6 16.6 261.0 307.0 319.0 330.0 362.0 364
(μm)

Para Tempo (µm) 312.0 17.0 255.0 301.0 313.0 324.0 354.0 364

Para Superior (µm) 323.2 17.3 270.0 312.0 324.0 334.0 373.0 364

Para Nasal (µm) 324.3 17.7 274.0 312.0 326.0 336.0 365.0 364

Para Inferior (µm) 319.0 16.6 259.0 307.8 320.0 330.0 367.0 364

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Retina Map Scan – Retinal Thickness

N
Parameter Mean SD Min Q1 Median Q3 Max
(Subjects)

Perifovea (µm) 288.9 14.3 246.0 278.0 288.0 298.2 330.0 364

Peri S Hemisphere
292.3 14.5 247.0 282.0 291.0 301.2 334.0 364
(µm)

Peri I Hemisphere (µm) 285.5 14.8 241.0 275.0 284.5 296.0 329.0 364

Peri Tempo (µm) 280.1 15.3 238.0 269.0 279.0 290.0 330.0 364

Peri Superior (µm) 291.5 14.7 243.0 281.0 291.0 302.0 337.0 364

Peri Nasal (µm) 304.2 15.9 258.0 294.0 304.0 315.0 350.0 364

Peri Inferior (μm) 319.6 16.6 267.0 309.0 320.0 330.2 362.0 364

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Gender difference was observed with the retinal thickness measurement in the normal
subjects. Table 9 provides retinal thickness distribution by gender. On average, male
subjects measures approximately 9 µm thicker in central retinal thickness than female
subjects.

Table 9 Normal Subjects: Retinal Thickness Distribution by Gender

Male Female

Parameter (all μm) Mean SD N (Subjects) Mean SD N (Subjects)

Fovea 259.7 21.5 195 250.1 21.6 169

ParaFovea 322.4 16.5 195 316.5 16.2 169

Para S Hemisphere 323.3 16.8 195 317.7 16.9 169

Para I Hemisphere 321.5 16.8 195 315.2 15.9 169

Para Tempo 315.0 16.8 195 308.6 16.6 169

Para Superior 325.6 17.2 195 320.6 17.1 169

Para Nasal 327.2 17.5 195 320.9 17.4 169

Para Inferior 321.8 17.0 195 315.7 15.6 169

Perifovea 289.3 15.1 195 288.5 13.5 169

Peri S Hemisphere 292.5 15.2 195 292.0 13.8 169

Peri I Hemisphere 286.0 15.5 195 284.9 14.0 169

Peri Tempo 281.3 15.8 195 278.7 14.5 169

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Male Female

Parameter (all μm) Mean SD N (Subjects) Mean SD N (Subjects)

Peri Superior 291.2 15.4 195 291.8 13.9 169

Peri Nasal 304.6 16.8 195 303.8 14.8 169

Peri Inferior 280.0 15.3 195 279.6 14.1 169

Age-related thinning was found with GCC thickness measurements, although the rate of
age-related loss is small as shown in Table 10. On average, GCC
age-related thinning is approximately -0.1 μm/year, which means 1 μm thinning per
decade.

Table 10 Normal Subjects: Age-Related Loss of GCC Thickness

Slope (μm/yr.)

GCC_Average ‐0.093

GCC_Superior_Avg ‐0.086

GCC_Inferior_Avg ‐0.100

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The RNFL thickness measurements were found to be significantly correlated with age
and disc size (area). The age-related thinning is small and the RNFL thickness
increases with increasing disc size. While the rate of change with age may appear
small, but over the wide age range (60~80 years), the impact over the full range is
similar to that of disc size which has a much higher rate but small range (1.33 ~ 3.58
mm2).

Table 11 Normal Subjects: Rate of Change in RNFL Thickness by Age and Disc Area

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Slope_age Slope_discArea

Parameter (μm/yr) (μm/mm²)

Avg_RNFL ‐0.118 6.7

Sup_RNFL ‐0.125 8.1

Inf_RNFL ‐0.111 5.3

Tempo ‐0.065 0.3

Superior ‐0.138 11.0

Nasal ‐0.112 7.0

Inferior ‐0.157 7.5

TU ‐0.081 1.9

ST ‐0.126 9.3

SN ‐0.150 12.7

NU ‐0.142 8.2

NL ‐0.082 5.8

IN ‐0.150 9.3

IT ‐0.162 5.7

TL ‐0.030 0.0

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13.1.8 Summary
The OCT measurements of the normal subjects are correlated with age, optic disc size
(ONH and RNFL parameters), and gender (retinal thickness parameters). The
normative limits were established based on multivariate regression analysis to adjust for
the relevant covariant. Therefore, the comparison to the NDB is appropriately accounted
for these covariant.

The EMM5 scan in the RTVue has been renamed to Retina Map in the XR.

14 Appendix C: Motion Correction Technology (MCT)


It is commonly understood that it takes at least a couple of seconds to acquire a 3D
data volume at reasonable density with typical SD-OCT devices. As a result, the 3D
data volume is susceptible to artifacts caused by blinks and eye motion during scan
acquisition. Such artifacts appear as distortion in the retinal blood vessel pattern and/or
dark bands, as viewed in the en face image; they appear as a rippling retinal surface
and/or dark sections, as viewed in the cross-sectional image.

When the two 3D volumes are acquired in orthogonal directions as illustrated in Figure
238 below, the system applies a proprietary software-based motion correction
technology (MCT) to assess and correct motion in each volume. The system performs
motion correction based on minimization of the overall difference between the two
corrected volumes. The system generates the final 3D volume of an MCT scan based
on the weighted average of the horizontal and vertical motion corrected volumes, as
shown in Figure 238 below.

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Figure 238 MCT Scan Acquisition and Effect in 3D Volumes, En Face Views

Figure 239 shows scans before and after motion correction:

• Left: 3D volume acquired in horizontal direction with noticeable motion artifacts.

• Middle: 3D volume acquired in vertical direction with noticeable motion artifacts.

• Right: Merged 3D volume with reduced motion artifacts using MCT.

Figure 239 MCT Scan Acquisition and Effect in 3D Volumes,


Cross-Sectional Views

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The scan shown in Figure 240 covering both macula and optic disc provides image
registration reference for other scan types.

Figure 240 3D Widefield MCT Scan Example Covering Both Macula And Optic Disc

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15 Appendix D: Repeatability and Reproducibility
Clinical Data for the repeatability and reproducibility assessment were collected under
an IRB approved study protocol. Consenting subjects were enrolled in three study
groups, a normal group, a glaucoma group, and a retina group. One eye per qualified
subject was included in the data collection and each study eye was imaged repeatedly
three times with each of the three RTVue/operator pairs for each of the required OCT
scan types.

Inclusion Criteria as Defined in the Data Collection Protocol

All subjects must meet the following criteria:

• At least 18 years of age

• Able and willing to provide consent

• Able and willing to complete the required examinations and visits

In addition, for each respective subject group, the following inclusion criteria were
applied:

• Normal subjects must have normal results from the clinical exam and be free of ocular
pathology

• Glaucoma patients must have clinical exam results consistent with glaucoma

• They must have visual field defects consistent with glaucoma (for example, PSD < 5%
and/or GHT outside normal), and/or structural damage consistent with glaucoma (for
example, neuroretinal rim thinning, notching, RNFL defect, etc.)

• Retina patients must have clinical exam results consistent with retina pathology (for
example, soft drusen, retinal edema, macula hole, etc.)

Exclusion Criteria as Defined in the Data Collection Protocol

• Normal subjects must be free of any ocular pathology

• Glaucoma patients must be free of any ocular pathology except glaucoma

• Retina patients must be free of any ocular pathology except any type of retina pathology

A total of 16 normal subjects, 19 glaucoma patients, and 17 retinal patients qualified


and completed the study. GCC scan and ONH scan were not acquired for retina
subjects and EMM5 scan (that is, retina map scan) was not acquired for glaucoma

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subjects. All three scan types were acquired for Normal subjects. For each subject, nine
scans across three device/operator pairs per required scan type were expected.

Table 12 shows the total number of acquired scans for each scan type. All subjects
completed the required number of scans with the exception of one glaucoma subject,
who was short of two GCC scans in one instrument; therefore the total number of GCC
scans was 169 instead of the expected 171.

Table 12 Number of Scans Acquired by Scan Type and Study Group

Acquired Scans EMM5 GCC ONH

Normal (16 subjects) 144 144 144

Glaucoma (19 subjects) 169 171

Retina (17 subjects) 153

TOTAL 297 313 315

All study scans were reviewed for the following image quality aspects and, if failed any
one factor, was marked as poor scan quality for exclusion from further analysis:

• Overall signal strength

• Blink or locally weak signal

• OCT signal clipped

• Fixation errors

• Optic disc off-center

• Eye motion

• Poor quality 3D-Disc reference

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The rate of scan exclusion from the quality review is summarized in Table 13. All study
groups combined, the image quality based scan exclusion rate was 0.6% (2 out of total
313) for the GCC scan, 2.9% (9 out of total 315) for the ONH scan, and 4.0% (12 out of
297) for the EMM5 scan.

Table 13 Number of Qualified Scans by Scan Type and Study Group

Qualified Scans EMM5 GCC ONH

Normal (16 subjects) 142 144 138

Glaucoma (19 subjects) 167 168

Retina (17 subjects) 143

TOTAL 285 311 306

Disqualified Scans (Rate) 12 (4.0%) 2 (0.6%) 9 (2.9%)

The repeatability and reproducibility were estimated based on the qualified scans and
the results are provided in the tables below as follows: repeatability standard deviation
(SD), reproducibility SD, coefficient of variation (COV) based on reproducibility
(Reproducibility SD/Mean*100), and 95% limits of reproducibility (2.8* Reproducibility
SD), along with the Mean values and SD values of the study group.

Table 14 Repeatability and Reproducibility for Retina Thickness (Normal Eyes)

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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Table 15- Repeatability and Reproducibility of Retinal Thickness (Retina
Disease Eyes)

EMM5 (Retina Map) all μm

Retina Subjects (17 Subjects, 143 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

Fovea 266.7 55.1 6.5 6.5 2.4% 18.0

ParaFovea 322.5 30.6 3.5 3.6 1.1% 9.9

Para S
323.7 30.7 4.3 4.5 1.4% 12.3
Hemisphere

Para I
321.2 32.8 3.2 3.2 1.0% 8.9
Hemisphere

Para Tempo 316.2 38.4 3.8 3.9 1.2% 10.9

Para Superior 330.1 25.2 4.3 4.4 1.3% 12.2

Para Nasal 323.9 17.2 3.2 3.4 1.0% 9.3

Para Inferior 319.0 34.3 3.3 3.3 1.0% 9.1

Perifovea 298.1 29.6 2.5 2.5 0.8% 7.0

Peri S
303.3 29.9 3.0 3.1 1.0% 8.5
Hemisphere

Peri I
293.1 30.4 3.5 3.5 1.2% 9.7
Hemisphere

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Table 15- Repeatability and Reproducibility of Retinal Thickness (Retina
Disease Eyes)

EMM5 (Retina Map) all μm

Retina Subjects (17 Subjects, 143 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

Peri Tempo 294.1 44.6 3.6 3.6 1.2% 10.0

Peri Superior 301.1 31.1 3.2 3.3 1.1% 9.1

Peri Nasal 312.7 20.9 3.7 3.8 1.2% 10.4

Peri Inferior 284.6 32.2 4.2 4.2 1.5% 11.7

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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Table 15 Repeatability and Reproducibility for GCC (Normal Eyes)

GCC

Normal Subjects (16 Subjects, 144 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

GCC_Avg. (μm) 96.2 5.6 1.6 1.6 1.7% 4.5

GCC_Superior
95.8 5.5 1.7 1.7 1.8% 4.8
Avg. (μm)

GCC_Inferior
96.7 6.1 1.6 1.6 1.7% 4.6
Avg. (μm)

GCC_FLV (%) 0.489 0.507 0.182 0.182 37.2% 0.504

GCC_GLV (%) 2.616 2.417 0.754 0.767 29.3% 2.126

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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The high COV values for GCC_FLV and GCC_GLV is due to the highly skewed
distribution near zero values of normal eyes and the denominator for the COV
calculation has a low value. COV is not an appropriate measure of test-retest variability
for such skewed distributions with a large portion of data at or near zero. Please
interpret the data with this information in mind.

Table 16 Repeatability and Reproducibility for GCC (Glaucoma Eyes)

GCC

Glaucoma Subjects (19 Subjects, 167 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

GCC_Avg.(μm) 79.1 10.9 1.3 1.3 1.7% 3.6

GCC_Superior
79.5 12.0 1.4 1.4 1.8% 4.0
Avg. (μm)

GCC_Inferior
78.7 11.9 1.4 1.4 1.8% 4.0
Avg. (μm)

GCC_FLV (%) 5.525 3.948 0.643 0.643 11.4% 1.783

GCC_GLV (%) 16.856 9.959 1.209 1.209 7.1% 3.352

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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Table 17 Repeatability and Reproducibility for Disc Parameters (Normal Eyes)

ONH

Normal Subjects (16 Subjects, 138 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

discArea (mm2) 1.963 0.382 0.078 0.078 4.0% 0.216

Area_C_D_ratio 0.274 0.153 0.023 0.023 8.3% 0.063

H_C_D_ratio 0.554 0.191 0.050 0.050 9.1% 0.140

V_C_D_ratio 0.445 0.190 0.043 0.043 9.8% 0.120

CupArea (mm2) 0.563 0.364 0.042 0.042 7.5% 0.116

RimArea (mm2) 1.400 0.327 0.081 0.081 5.8% 0.226

RimVolume (mm2) 0.167 0.058 0.016 0.016 9.2% 0.043

Nervehead_Volume
0.340 0.135 0.044 0.044 12.8% 0.122
(mm2)

CupVolume (mm2) 0.114 0.141 0.026 0.026 23.8% 0.073

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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Table 18 Repeatability and Reproducibility for Disc Parameters (Glaucoma Eyes)

ONH

Glaucoma Subjects (19 Subjects, 168 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

discArea (mm2) 2.508 0.427 0.067 0.072 2.8% 0.198

Area_C_D_ratio 0.654 0.144 0.022 0.022 3.4% 0.061

H_C_D_ratio 0.863 0.104 0.046 0.046 5.4% 0.128

V_C_D_ratio 0.817 0.121 0.026 0.026 3.2% 0.073

CupArea (mm2) 1.647 0.476 0.052 0.055 3.3% 0.153

RimArea (mm2) 0.861 0.362 0.067 0.067 7.9% 0.186

RimVolume (mm2) 0.039 0.034 0.008 0.008 21.4% 0.023

Nervehead_Volume
0.109 0.093 0.012 0.012 11.5% 0.034
(mm2)

CupVolume (mm2) 0.635 0.275 0.053 0.056 8.6% 0.154

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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Table 20- Repeatability and Reproducibility of RNFL Thickness ( Normal eyes)

ONH (all μm)

Normal Subjects (16 Subjects, 138 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

Avg_RNFL 98.6 10.0 1.5 1.5 1.5% 4.1

Sup_RNFL 100.8 12.0 2.1 2.2 2.2% 6.1

Inf_RNFL 96.5 9.3 2.2 2.3 2.3% 6.3

Tempo 77.6 10.9 3.3 3.3 4.2% 9.0

Superior 121.9 16.2 4.0 4.2 3.4% 11.6

Nasal 71.2 12.5 3.6 3.6 5.1% 10.0

Inferior 123.8 11.2 3.4 3.4 2.8% 9.6

TU 85.0 11.9 3.7 3.7 4.4% 10.3

ST 137.8 14.9 5.0 5.1 3.7% 14.2

SN 106.0 19.1 4.6 4.8 4.5% 13.4

NU 74.4 15.4 3.9 3.9 5.3% 10.9

NL 68.0 10.4 3.8 3.9 5.7% 10.7

IN 108.8 15.8 5.2 5.4 5.0% 15.1

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IT 138.9 16.6 5.6 5.7 4.1% 15.7

TL 70.2 11.8 4.3 4.3 6.2% 12.0

* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

Table 21 Repeatability and Reproducibility of RNFL Thickness (Glaucoma Eyes)

ONH (all μm)

Glaucoma Subjects (19 Subjects, 168 Scans)

Repeatability Reproducibility Reproducibility Reproducibility


Parameter Mean SD
(SD) (SD) COV Limit*

Avg_RNFL 75.3 14.0 1.6 1.6 2.1% 4.5

Sup_RNFL 78.3 16.1 2.2 2.3 2.9% 6.3

Inf_RNFL 72.2 14.4 2.0 2.0 2.8% 5.6

Tempo 61.0 13.4 3.1 3.1 5.1% 8.6

Superior 91.1 20.3 3.7 3.9 4.2% 10.7

Nasal 61.9 12.2 2.8 2.8 4.5% 7.7

Inferior 87.2 19.6 3.2 3.2 3.7% 8.9

TU 65.8 16.7 4.6 4.6 7.0% 12.7

ST 100.4 22.4 4.4 4.4 4.4% 12.3

SN 81.7 21.0 5.3 5.5 6.8% 15.4

NU 65.4 14.1 3.6 3.6 5.5% 10.0

NL 58.5 11.2 2.9 2.9 5.0% 8.2

IN 79.4 17.0 3.3 3.4 4.3% 9.4

IT 94.9 24.4 4.4 4.5 4.7% 12.4

TL 56.2 12.2 4.4 4.6 8.2% 12.7

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* Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility
conditions. Reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.

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16 Appendix E: AngioVue Performance Testing
Non-clinical Performance Testing
A series of 3D phantom models with known ground truth for vessel density
measurements was designed to validate the accuracy of the proposed device software
for measurement of vessel density from 3 mm Angio Retina, 6 mm HD Angio Retina,
and 4.5 mm HD AngioDisc scans. The phantoms were designed to assess the impact of
projection artifacts removal (PAR) on vessel density measurements (especially Deep
vessel density) and large vessel masking for RPC vessel density.

The 3D phantoms were constructed with the same raw data format as that of an OCTA
scan of the eye, containing an OCT volume and an OCTA volume with spatial
colocalization. A series of phantoms containing different wireframe densities and/or
patterns to cover a range of physiologically relevant vascular densities and pathologies,
such as branch occlusions, were designed. Projection artifacts were simulated in the
OCTA volume for each phantom throughout the depth. Larger vessels with varying
diameters (50µm ~ 180µm) were included in the AngioDisc scan 3D phantom design.
Vessel density measurements by the software are based on the RPC en face images
for all vessels and for small vessels (applying large vessel mask to mask the regions
occupied by large vessels).

Phantoms were processed directly with the device software with all the steps that lead
to the generation of vessel density map and associated measurement parameters,
including en face slab generation, projection artifacts removal, image processing to
generate vessel density map/measurements, and detection of large vessel mask for
RPC vessel density analysis.
The agreement between software reported measurements and the expected “vascular”
density values computed directly from the model were used to validate the accuracy of
the software.

16.1.1 3 mm AngioRetina Scan


To evaluate accuracy of measurements of 3 mm AngioRetina scan, 4 phantoms with
various vessel density were used, including one phantom with occlusion (vessel
dropout) pattern.

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The measurement parameters tested included all software density measurement
parameters for Superficial plexus and Deep plexus, as well as the foveal vessel density
(FD-300) based on the Retina slab.

The difference between the software reported vessel density value and the expected
vessel density value of the phantom were evaluated for each parameter and for each of
the 4 phantoms.

The range and accuracy for the 3 mm AngioRetina scan parameters are summarized
below, for Superficial and Deep plexuses.

Accuracy for 3 mm AngioRetina scan (pooled results of 4 individual phantoms and all zonal
parameters)
Superficial SW Deep SW
Expected Difference Expected Difference
Vessel Density (%) Reported Vessel Density (%) Reported
Average 46.5 48.7 2.3 Average 39.8 39.8 0.0
Std Dev 13.0 13.0 1.0 Std Dev 14.3 13.9 1.2
Min 17.2 20.2 -1.0 Min 0.2 0.2 -3.0
Max 73.5 75.7 4.3 Max 50.5 50.9 2.4

FD-300 SW
Vessel Density Expected Difference
Reported
(%)
Average 57.5 55.3 -2.2
Std Dev 2.2 1.5 -0.7
Min 54.7 53.5 -1.2
Max 60.0 57.0 -3.0

Pooling results of the 4 phantoms and both plexuses, the measured vessel density
values cover a broad range (from ~ 20% to ~ 75% as measured by the software).

16.1.2 6 mm HD AngioRetina Scan


To evaluate accuracy of measurements of 6 mm HD AngioRetina scan, 3 phantoms
with various vessel density were used, including one phantom with occlusion (vessel
dropout) pattern.

The measurement parameters tested included all software density measurement


parameters for Superficial plexus and Deep plexus, as well as the foveal vessel density
(FD-300) based on the Retina slab.

The difference between the software reported vessel density value and the expected
vessel density value (i.e., the “known” vessel density value of the phantom) were
evaluated for each parameter respectively and for each of the 3 phantoms.

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The tables below summarize the measurement range for the 6 mm HD AngioRetina
scan parameters, for Superficial and Deep plexuses.

Accuracy for 6 mm HD AngioRetina scan (pooled results of 3 individual phantoms and all zonal parameters)

Superficial Deep
SW SW
Vessel Density Expected Difference Vessel Density Expected Difference
Reported Reported
(%) (%)
Average 49.0 48.7 -0.2 Average 63.0 63.3 0.3
Std Dev 9.8 10.0 1.3 Std Dev 12.5 12.0 2.5
Min 28.6 30.7 -3.7 Min 0.8 1.4 -4.7
Max 62.5 62.8 2.3 Max 68.2 69.2 5.8
FD-300
SW
Vessel Density Expected Difference
Reported
(%)
Average 63.0 62.1 -0.9
Std Dev 3.9 6.1 2.2
Min 60.7 58.5 -1.6
Max 67.5 69.2 2.2

Pooling results of the 3 phantoms and both plexuses, the measured vessel density
values cover a broad range (from ~ 31 % to ~ 69% as measured by the software).

16.1.3 4.5 mm HD AngioDisc Scan, with and without Large Vessel


Masking
To evaluate accuracy of measurements of 4.5 mm HD AngioDisc scan, 3 phantoms with
various vessel density were used, including one phantom with occlusion (vessel
dropout) pattern.

The measurement parameters tested included all software density measurement


parameters for RPC slab, small vessels only vessel density (with applying large vessel
mask) and all vessels density (without large vessel mask), respectively.

The small vessels only vessel density is measured with the application of large vessel
mask which has threshold of 3 pixels (approximately 33µm for the 4.5 mm HD
AngioDisc scans), therefore representing small vessels in the RPC slab.

The difference between the software reported vessel density value and the expected
vessel density value of the phantom were evaluated for each parameter and for each of
the 3 phantoms.

The tables below summarize the measurements range for the 4.5 mm AngioDisc scan
parameters, RPC plexus; small vessels only vessel density (with applying large vessel
mask) and RPC all vessels density, respectively.

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Accuracy for 4.5 mm HD AngioDisc scan (pooled results of 3 individual phantoms and all zonal parameters)

Small Vessel SW All Vessels SW


Expected Difference Expected Difference
Density (%) Reported Density (%) Reported
Average 46.9 47.9 1.0 Average 56.1 55.6 -0.5
Std Dev 10.2 10.3 1.1 Std Dev 9.4 8.6 1.7
Min 7.0 6.3 -1.1 Min 22.4 23.6 -2.9
Max 56.9 57.1 3.4 Max 68.3 65.5 2.9

Pooling results of the 3 phantoms, the measured vessel density values cover a broad
range (from ~ 6.0% to ~ 57% for small vessels only and from ~ 24% to ~ 66% for all
vessels as measured by the software).

Clinical Performance Testing


The repeatability and reproducibility were evaluated for the measurements of vessel
density, retinal thickness, retinal sub-layer thicknesses, and optic disc measurements
based on the AngioRetina scans and AngioDisc scans. Measurement agreement for
structural parameters measured by both devices was also evaluated.

16.2.1 Evaluation of the Repeatability and Reproducibility (“R&R”) of


AngioVue in Normal Subjects, Retinal Patients, and Glaucoma
Patients
This was a prospective, observational study conducted at a single clinical U.S. site.
Eligible participants age 18 or older were enrolled and assigned to one of three study
groups: 1) individuals with no ocular disease; 2) individuals with glaucoma of varying
severity (with confirmed glaucomatous visual field defect and/or glaucomatous optic
nerve changes), and 3) individuals with exudative age-related macular degeneration
(AMD), proliferative and non-proliferative diabetic retinopathy (DR), and other retinal
vascular conditions. Individuals with media opacity or significant refractive error
precluding adequate image quality were excluded. For repeatability/reproducibility and
agreement, the study eye is imaged three times using relevant OCTA scan patterns with
each of three Avanti instrument-operator pairs. For agreement assessment of retinal
thickness and optic nerve head (ONH) parameters, study eyes were also scanned once
with each of four predicate (“legacy”) posterior segment scan patterns. All eligible study
eyes with at least two acceptable scans were included into final statistical analyses. All
scans underwent post-acquisition image quality review. OCTA scans with a SQ score of
less than 6 were excluded from analysis; “legacy” scan SSIs of <39 (Retina Map), <32
(GCC), or <28 (ONH scan pattern) were also excluded. Repeatability and reproducibility
of the measured parameters (new OCTA parameters and non-OCTA thickness
parameters) were calculated using a random-effects analysis of variance (ANOVA)

RTVue XR Avanti User Manual Page 346 of 451 P/N 580-52576-005 Rev. A
model. Agreement was evaluated with calculation of 95% limits of agreement (LOAs)
and Deming regression analyses.

A total of 70 participants were consented and enrolled, 15 “normals,” 16 with glaucoma


(“Glaucoma” sub-group), and 39 with retinal conditions (“Retina” sub-group). Three
participants from the Retina sub-group could not complete the required imaging.
Therefore, a total of 67 eligible participants completed the study. Of the 36 “Retina” sub-
group participants, 12 were assigned to the exudative AMD, DR, and “other” groups
each. The age distribution and clinical characteristics of the study cohort are shown in
Tables 1 through 5.

Table 1. Age Distribution for All Subjects by Enrollment Category

Mean SD Median Min Max

Normal (n=15) 47 21.8 41 19 84

Glaucoma (n=16) 72 7.4 73 62 87

Retina (n=36) 68 16.1 71 21 95

Wet AMD (n=12) 77 9.6 74 66 95

DR (n=12) 56 12.7 57 31 77

Retina other (n=12) 70 18.0 75 21 90

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Table 2. Visual Field and Optic Nerve Head Characteristics Distribution in Glaucoma Group

Glaucoma VF PSD mean VF MD mean VF GHT ONH rim RNFL ONH


Stage (range) dB (range) dB outside normal thinning defect cupping
limits
(Total N=16) (N of (N of (N of eyes)
(N of eyes) eyes) eyes)

Early -1.71
2.69
5 5 0 7
N=7 (-2.71 to -
(1.76 to 3.52)
0.32)

Moderate -3.62
4.74
4 4 1 3
N=4 (-4.42 to -
(3.33 to 6.08)
3.04)

Advanced 11.66 -14.06

5 5 2 5
N=5 (10.72 to (-25.79 to -
12.23) 7.84)

Table 3. Imaging Findings and Treatment in Retina Wet AMD Sub-group

Sub- Type 1 Type 2 CNV seen


Subject Eye IRF SRF PED Treatment
Group CNV CNV on OCTA

SD7529 OS wetAMD 1 1 1
SD7533 OD wetAMD 1 1 1 1
SD7549 OS wetAMD 1 1 1 1
SD7551 OD wetAMD 1 1 1
SD7553 OS wetAMD 1 1
SD7555 OS wetAMD 1 1
SD7557 OD wetAMD 1 1 1
SD7558 OD wetAMD 1 1 1
SD7561 OD wetAMD 1 1 1
SD7563 OS wetAMD 1 1
SD7564 OD wetAMD 1 1 1 1
SD7568 OS wetAMD 1 1 1
Sum 7 5 4 4 1 7 8

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Table 4. Clinical and Imaging Findings, and Treatment in Retina DR Sub-group

Sub- Reduced Retinal Other Vascular


Subject Eye DR Severity w/ DME w/o DME IRF Treatment
Group Vascular Density Change
SD7537 OD DR Moderate NPDR 1 1 1
SD7538 OD DR PDR 1 1 1
SD7539 OS DR Moderate NPDR 1 1 1 IRMA

SD7540 OS DR PDR 1 1 dilation, tortuosity


dilation,
SD7543 OS DR Moderate NPDR 1 1 1 tortuosity, MA
SD7547 OS DR PDR 1 1 1 FAZ Outpouching 1

SD7554 OD DR Moderate NPDR 1 1 1 dilation, tortuosity


SD 7556 OD DR Moderate NPDR 1 1
SD7560 OS DR PDR 1 1 FAZ outpouching 1
SD7565 OS DR PDR 1 1 FAZ outpouching 1
SD7566 OS DR PDR 1 FAZ outpouching 1
SD7567 OD DR Mild NPDR 1 1
Sum 8 3 8 10 4

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Table 5. Clinical and Imaging Findings, and Treatment in Retina Other Sub-group

Sub- CNV on Reduced Retinal Other Vascular


Subject Eye Details IRF SRF Treatment
Group OCTA Vascular Density Change
SD7528 OS Other ERM
SD7534 OD Other BRVO w/CME 1 1
SD7535 OD Other dryAMD
SD7541 OD Other dryAMD
SD7542 OD Other dryAMD
Traumatic
SD7544 OS Other CNV 1
SD7545 OD Other PCV 1 1 1
SD7546 OS Other BRVO 1 1 1
SD7548 OS Other
ERM w/
SD7550 OD Other lamellar hole
SD7559 OD Other BRVO 1 1 1
dilation,
SD7569 OD Other BRVO 1 1 tortuosity 1
Sum 3 1 2 4 5

Results

The frequency of scan exclusion due to insufficient image quality are shown as follows:

• 3 mm AngioRetina scan – 12.9% (77 out of 595 scans)


• 6 mm HD AngioRetina scan – 14.4% (86 out of 598 scans)
• 4.5 mm HD AngioDisc – 3.7% (10 out of 268 scans) (only Normal and Glaucoma
groups)

For the 3 mm AngioRetina scan, the edit rates were: IPL 13.3%, BRM 11.6%, OPL 6%,
RPE 3.5%, and ILM 0% for segmentation, FAZ boundary 10.8%, and ETDRS grid re-
centering 1.5%. For the 6 mm HD AngioRetina scan, the edit rates were: IPL 13.9%,
BRM 10.4%, OPL 5.5%, RPE 2.3%, and ILM 0.6% for segmentation, FAZ
boundary17.7%, and ETDRS grid re-centering 1.8%.

The results are provided below, organized by scan patterns and measurements.

Vascular Parameters of the 3 mm AngioRetina and 6 mm HD AngioRetina


Scans

Tables 6 through 11 summarize the results of the R&R analysis of vascular parameters
of 3 mm Angio Retina and 6 mm HD AngioRetina scans.

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Table 6 Vascular Parameters of AngioRetina Scans, Normal Group

Normal
6-mm HD AngioRetina Scan 3-mm AngioRetina Scan
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
WI 128 50.5 3.2 41.0 56.0 2.3 2.4 4.8% 6.7 129 48.0 3.5 38.3 53.2 1.7 1.9 3.9% 5.2
WI_S_Hemi 128 50.8 3.3 40.8 56.5 2.3 2.5 4.9% 6.9 129 48.7 3.8 38.0 54.4 1.8 2.1 4.2% 5.7
WI_I_Hemi 128 50.3 3.3 41.1 55.9 2.4 2.4 4.9% 6.8 129 47.3 3.5 38.5 54.3 2.0 2.1 4.4% 5.8
All (0-6) 128 50.6 3.3 40.6 56.1 2.3 2.4 4.8% 6.7 129 47.6 3.4 37.9 53.1 1.6 1.8 3.7% 4.9
C (1) 128 27.4 7.1 8.6 44.3 1.9 2.2 8.2% 6.1 129 24.0 6.5 7.9 39.6 1.4 1.5 6.4% 4.2
All (1-3) 128 53.0 3.5 42.7 59.2 2.7 2.8 5.4% 7.9 129 50.7 3.3 41.6 55.7 1.8 1.9 3.7% 5.2
S_Hemi (1-3) 128 53.3 3.4 45.0 60.0 2.4 2.6 4.9% 7.3 129 50.8 3.5 41.3 56.6 1.7 1.9 3.7% 5.2
I_Hemi (1-3) 128 52.7 4.0 36.2 58.5 3.2 3.3 6.4% 9.2 129 50.5 3.4 41.1 55.9 2.1 2.1 4.3% 6.0
T (1-3) 128 53.8 3.4 35.8 60.2 2.7 2.8 5.3% 7.9 129 50.2 2.9 42.3 56.0 1.7 1.9 3.8% 5.3
S (1-3) 128 53.5 3.8 43.6 61.2 2.7 2.9 5.5% 8.1 129 51.5 3.8 40.6 58.2 2.0 2.2 4.2% 6.0
N (1-3) 128 52.2 4.0 40.5 58.7 3.3 3.3 6.4% 9.3 129 49.9 3.6 38.9 56.7 1.9 2.1 4.2% 5.8
Superficial I (1-3) 128 52.5 4.7 30.6 59.0 3.9 4.0 7.6% 11.0 128 51.1 4.0 40.4 57.4 2.5 2.5 4.9% 7.0
(ILM to All (3-6) 128 50.7 3.4 40.7 56.7 2.3 2.4 4.8% 6.8 - - - - - - - - -
IPL-10µm) S_Hemi (3-6) 128 50.9 3.5 40.2 56.3 2.4 2.6 5.1% 7.1 - - - - - - - - -
Vessel I_Hemi (3-6) 128 50.5 3.5 41.2 57.2 2.4 2.5 4.9% 6.8 - - - - - - - - -
Density T (3-6) 128 47.6 3.4 36.7 53.3 2.5 2.7 5.7% 7.5 - - - - - - - - -
(%) S (3-6) 128 51.0 3.8 40.4 57.8 2.6 2.7 5.4% 7.6 - - - - - - - - -
N (3-6) 128 54.1 3.7 44.5 60.3 2.4 2.5 4.6% 6.9 - - - - - - - - -
I (3-6) 128 50.2 3.8 38.3 57.0 2.6 2.6 5.2% 7.3 - - - - - - - - -
G11 128 52.1 6.3 36.8 61.9 2.5 2.5 4.8% 6.9 129 50.7 4.2 37.6 58.9 2.4 2.5 4.9% 6.9
G12 128 51.6 3.7 41.7 58.6 2.6 2.8 5.4% 7.7 129 52.2 3.6 39.7 58.1 2.0 2.1 4.1% 5.9
G13 128 48.9 6.4 33.9 61.4 2.9 3.3 6.7% 9.1 129 49.7 4.9 35.3 59.3 2.4 2.9 5.8% 7.9
G21 128 51.6 4.3 40.1 59.3 2.6 2.6 5.1% 7.3 129 49.7 3.4 38.9 55.8 2.0 2.2 4.4% 6.0
G22 128 48.3 3.5 37.6 54.9 2.4 2.6 5.4% 7.2 129 29.5 5.7 14.2 42.1 1.8 1.9 6.5% 5.3
G23 128 50.8 4.3 38.0 59.9 2.4 2.7 5.3% 7.4 129 49.3 3.1 41.2 55.3 1.6 1.8 3.6% 4.9
G31 128 51.0 6.0 36.1 61.3 2.7 2.7 5.3% 7.4 129 50.5 4.8 30.6 57.4 3.2 3.2 6.4% 8.9
G32 128 50.7 4.0 35.7 58.2 2.9 2.9 5.7% 8.0 129 50.3 4.1 38.6 57.2 2.6 2.7 5.3% 7.4
G33 128 49.6 5.6 35.6 61.3 2.8 2.9 5.9% 8.2 129 50.3 4.2 39.1 57.6 2.3 2.5 4.9% 6.9
WI 128 50.7 4.8 40.4 64.5 3.9 3.9 7.8% 10.9 129 49.5 3.5 42.0 59.2 2.3 2.5 5.0% 6.8
WI_S_Hemi 128 50.9 5.0 40.8 64.9 4.1 4.2 8.3% 11.7 129 50.0 3.7 42.2 60.4 2.4 2.7 5.3% 7.4
WI_I_Hemi 128 50.4 4.9 38.0 64.5 3.8 3.8 7.6% 10.6 129 49.1 3.5 41.6 58.6 2.4 2.4 4.9% 6.7
All (0-6) 128 52.0 4.7 42.3 64.7 3.7 3.8 7.3% 10.5 129 49.4 3.4 43.0 59.9 2.0 2.1 4.3% 5.9
C (1) 128 38.2 7.8 16.8 50.9 1.9 2.0 5.2% 5.4 129 33.0 7.4 13.9 46.2 1.3 1.3 4.1% 3.7
All (1-3) 128 54.0 3.6 46.1 63.5 2.8 2.8 5.2% 7.8 129 51.5 3.5 43.1 62.2 2.2 2.4 4.6% 6.6
S_Hemi (1-3) 128 54.2 3.6 45.6 62.7 2.9 2.9 5.3% 8.0 129 51.6 3.5 43.3 63.2 2.3 2.4 4.7% 6.7
I_Hemi (1-3) 128 53.8 3.9 42.6 64.7 3.0 3.2 5.9% 8.8 129 51.5 3.6 43.0 61.3 2.3 2.5 4.8% 6.8
T (1-3) 128 54.9 3.8 38.9 64.2 2.9 3.0 5.4% 8.2 129 52.1 3.3 45.4 62.2 2.1 2.2 4.3% 6.2
S (1-3) 128 53.3 4.1 43.1 63.4 3.4 3.5 6.5% 9.6 129 51.2 3.9 39.9 64.0 2.6 2.8 5.5% 7.8
N (1-3) 128 55.0 3.8 46.3 64.9 3.1 3.1 5.6% 8.6 129 51.9 3.5 42.8 62.5 2.1 2.3 4.5% 6.4
Deep I (1-3) 128 52.8 4.6 30.0 65.4 3.7 3.9 7.5% 10.9 128 50.8 4.0 41.2 60.2 2.8 2.9 5.6% 7.9
(IPL-10µ to All (3-6) 128 51.9 5.2 39.9 65.9 4.2 4.2 8.2% 11.7 - - - - - - - - -
OPL+10µ) S_Hemi (3-6) 128 52.2 5.3 41.4 66.0 4.3 4.4 8.5% 12.2 - - - - - - - - -
Vessel I_Hemi (3-6) 128 51.6 5.4 36.0 66.5 4.2 4.3 8.3% 11.8 - - - - - - - - -
Density T (3-6) 128 54.8 4.4 43.6 65.0 3.6 3.7 6.7% 10.1 - - - - - - - - -
(%) S (3-6) 128 51.7 5.8 40.8 67.7 4.7 4.8 9.3% 13.3 - - - - - - - - -
N (3-6) 128 50.4 6.0 36.5 66.6 4.9 5.0 9.9% 13.8 - - - - - - - - -
I (3-6) 128 50.7 5.9 32.9 66.4 4.7 4.7 9.3% 13.0 - - - - - - - - -
G11 128 49.0 6.4 37.7 66.6 5.6 5.7 11.6% 15.8 129 50.2 4.3 39.8 60.7 3.6 3.7 7.4% 10.2
G12 128 51.2 5.7 40.4 67.2 4.7 4.8 9.3% 13.2 129 51.1 3.9 40.5 62.1 2.7 2.8 5.5% 7.8
G13 128 49.5 6.7 33.5 65.0 4.9 5.1 10.4% 14.2 129 50.8 4.3 39.2 62.5 3.0 3.4 6.7% 9.5
G21 128 52.8 4.9 42.3 66.4 4.1 4.1 7.8% 11.4 129 52.2 3.3 44.5 60.8 2.1 2.1 4.1% 5.9
G22 128 51.8 3.2 45.2 60.4 2.3 2.3 4.4% 6.3 129 37.5 5.8 20.2 48.9 1.8 2.0 5.4% 5.6
G23 128 53.7 4.8 41.5 64.0 3.8 3.9 7.2% 10.7 129 52.0 3.3 45.0 62.2 2.0 2.1 4.0% 5.8
G31 128 48.1 6.3 31.6 65.8 4.9 4.9 10.2% 13.6 129 50.3 4.4 39.5 60.3 3.5 3.6 7.1% 9.9
G32 128 50.9 5.5 34.9 65.8 4.5 4.6 9.0% 12.7 129 51.3 4.2 41.0 61.6 3.0 3.1 6.0% 8.5
G33 128 49.1 7.3 30.1 64.3 4.6 4.6 9.5% 12.9 129 50.3 4.5 38.7 60.8 3.4 3.6 7.2% 10.0
FAZ (mm2) 128 0.270 0.120 0.069 0.585 0.012 0.012 4.2% 0.032 129 0.284 0.127 0.080 0.582 0.008 0.009 3.0% 0.024
FAZ PERIM (mm) 128 1.975 0.456 0.964 3.080 0.085 0.086 4.3% 0.238 129 2.092 0.494 1.127 3.189 0.063 0.066 3.1% 0.182
FD-300 (%) 128 54.0 4.1 39.6 61.6 2.5 2.6 4.9% 7.3 129 50.7 3.7 41.2 57.7 2.0 2.0 3.8% 5.4

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Table 7. Vascular Parameters of AngioRetina Scans, Glaucoma Group

Glaucoma
6-mm HD AngioRetina Scan 3-mm AngioRetina Scan
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
WI 133 42.6 4.8 30.8 51.2 2.2 2.4 5.7% 6.7 134 42.8 5.3 27.8 53.2 2.1 2.4 5.7% 6.7
WI_S_Hemi 133 43.5 4.8 31.1 53.0 2.3 2.6 5.9% 7.1 134 43.3 5.1 27.6 52.8 2.3 2.7 6.3% 7.5
WI_I_Hemi 133 41.7 5.2 30.0 51.1 2.3 2.4 5.7% 6.6 134 42.4 6.0 28.1 54.7 2.2 2.4 5.7% 6.7
All (0-6) 133 43.0 4.9 30.8 51.4 2.3 2.4 5.7% 6.7 134 43.1 5.3 27.3 53.3 2.0 2.3 5.4% 6.5
C (1) 133 21.2 6.7 7.5 35.4 2.0 2.2 10.2% 6.0 134 20.3 6.4 6.6 35.9 1.4 1.7 8.7% 4.8
All (1-3) 133 47.5 5.3 33.5 56.7 2.7 2.9 6.1% 8.0 134 46.0 5.6 29.5 57.1 2.2 2.5 5.4% 6.9
S_Hemi (1-3) 133 47.7 5.2 33.6 57.6 2.9 3.1 6.5% 8.6 134 46.2 5.5 28.7 57.3 2.3 2.6 5.6% 7.1
I_Hemi (1-3) 133 47.3 6.0 31.7 56.6 2.8 2.9 6.2% 8.1 134 45.8 6.1 30.2 56.9 2.3 2.6 5.6% 7.1
T (1-3) 133 47.0 5.2 33.0 57.3 2.6 2.9 6.1% 7.9 134 44.7 5.1 31.7 57.9 2.3 2.6 5.8% 7.2
S (1-3) 133 48.1 5.6 34.3 58.1 3.4 3.6 7.4% 9.8 134 46.8 5.8 29.6 58.8 2.5 2.8 5.9% 7.7
N (1-3) 133 47.8 6.3 29.2 59.9 3.3 3.5 7.3% 9.6 134 46.5 6.5 24.4 56.8 2.6 2.8 6.1% 7.9
Superficial I (1-3) 133 47.0 6.6 31.2 57.0 3.3 3.4 7.4% 9.6 133 46.0 6.8 28.7 56.3 2.6 2.8 6.1% 7.8
(ILM to All (3-6) 133 42.5 5.0 30.7 51.2 2.3 2.5 5.8% 6.9 - - - - - - - - -
IPL-10µm) S_Hemi (3-6) 133 43.5 5.1 30.5 53.4 2.4 2.6 6.1% 7.3 - - - - - - - - -
Vessel I_Hemi (3-6) 133 41.5 5.6 29.3 51.5 2.5 2.5 6.0% 6.9 - - - - - - - - -
Density T (3-6) 133 39.8 4.7 29.6 50.2 2.4 2.6 6.4% 7.1 - - - - - - - - -
(%) S (3-6) 133 42.7 5.4 30.1 53.2 2.7 2.9 6.8% 8.0 - - - - - - - - -
N (3-6) 133 47.3 5.8 32.4 57.2 2.5 2.7 5.7% 7.5 - - - - - - - - -
I (3-6) 133 40.2 5.9 27.3 52.6 2.7 2.7 6.8% 7.6 - - - - - - - - -
G11 133 43.3 6.3 29.3 56.6 2.6 2.6 6.1% 7.3 134 44.7 6.3 27.5 57.4 3.0 3.2 7.2% 8.9
G12 133 43.5 5.4 29.4 54.5 3.0 3.2 7.3% 8.8 134 47.2 5.9 28.9 59.6 2.7 2.8 6.0% 7.8
G13 133 41.5 7.3 27.7 57.2 2.7 3.0 7.2% 8.2 134 43.7 6.3 30.5 58.7 3.2 3.7 8.4% 10.2
G21 133 45.6 6.4 31.0 57.8 2.4 2.6 5.7% 7.1 134 45.2 6.5 25.2 57.6 2.6 2.9 6.5% 8.1
G22 133 43.6 4.9 29.1 51.3 2.4 2.6 5.9% 7.1 134 25.8 6.2 11.9 39.3 2.2 2.5 9.7% 6.8
G23 133 44.0 5.7 31.2 58.2 2.6 2.9 6.6% 8.0 134 46.0 5.0 33.9 56.4 2.6 2.8 6.2% 7.9
G31 133 41.6 6.8 27.7 52.7 2.3 2.3 5.6% 6.4 134 43.9 7.4 29.2 55.8 2.7 2.8 6.5% 7.9
G32 133 41.7 5.6 28.7 52.5 2.8 2.9 7.0% 8.0 134 45.3 7.1 24.5 56.3 2.9 3.0 6.7% 8.4
G33 133 38.5 6.6 24.6 51.7 2.9 3.0 7.9% 8.4 134 43.6 7.0 25.2 55.6 3.0 3.5 8.1% 9.7
WI 133 47.9 5.1 36.1 61.3 3.3 3.8 7.9% 10.5 134 48.6 3.3 40.5 55.7 2.4 2.6 5.3% 7.1
WI_S_Hemi 133 48.1 5.1 35.8 61.1 3.4 4.1 8.5% 11.3 134 48.9 3.5 40.8 56.7 2.4 2.6 5.4% 7.3
WI_I_Hemi 133 47.7 5.3 35.3 61.5 3.4 3.7 7.7% 10.2 134 48.2 3.3 40.2 55.6 2.5 2.7 5.5% 7.4
All (0-6) 133 49.3 4.9 37.3 62.6 3.2 3.6 7.4% 10.0 134 48.5 3.0 41.5 56.1 2.2 2.3 4.8% 6.4
C (1) 133 33.0 9.2 11.3 53.0 2.3 2.3 7.0% 6.3 134 29.9 8.1 12.9 49.4 1.7 1.7 5.7% 4.6
All (1-3) 133 52.8 3.5 44.1 63.4 2.6 2.9 5.5% 8.1 134 50.9 3.3 43.0 58.8 2.3 2.5 4.9% 6.9
S_Hemi (1-3) 133 52.9 3.6 44.6 63.6 2.7 3.0 5.6% 8.2 134 51.1 3.3 43.6 58.7 2.3 2.4 4.8% 6.8
I_Hemi (1-3) 133 52.6 3.7 42.4 63.2 2.9 3.1 6.0% 8.7 134 50.8 3.3 42.0 58.9 2.6 2.7 5.4% 7.6
T (1-3) 133 53.7 3.6 44.6 62.5 2.6 2.9 5.4% 8.0 134 51.3 3.6 41.3 63.2 2.8 3.0 5.9% 8.4
S (1-3) 133 52.7 4.1 43.4 64.7 3.3 3.5 6.7% 9.8 134 51.2 3.7 41.2 59.0 2.5 2.7 5.3% 7.5
N (1-3) 133 52.8 3.7 35.0 62.4 3.2 3.4 6.4% 9.4 134 50.4 3.0 43.9 58.8 2.3 2.4 4.8% 6.7
Deep I (1-3) 133 51.9 4.3 39.8 64.0 3.5 3.7 7.2% 10.3 133 50.8 3.8 39.8 57.8 2.8 3.0 5.8% 8.2
(IPL-10µ to All (3-6) 133 48.9 5.6 36.0 63.4 3.6 4.0 8.2% 11.1 - - - - - - - - -
OPL+10µ) S_Hemi (3-6) 133 49.3 5.4 36.4 63.4 3.5 4.2 8.5% 11.6 - - - - - - - - -
Vessel I_Hemi (3-6) 133 48.4 5.9 33.1 63.4 3.9 4.1 8.5% 11.4 - - - - - - - - -
Density T (3-6) 133 51.0 5.0 37.5 62.7 3.2 3.6 7.2% 10.1 - - - - - - - - -
(%) S (3-6) 133 48.5 6.2 32.1 63.3 4.1 4.8 10.0% 13.4 - - - - - - - - -
N (3-6) 133 48.7 5.8 29.9 65.0 4.0 4.4 9.1% 12.3 - - - - - - - - -
I (3-6) 133 47.2 7.0 30.4 62.6 4.4 4.5 9.6% 12.5 - - - - - - - - -
G11 133 46.8 6.2 32.2 59.5 4.4 5.0 10.7% 13.9 134 49.6 4.1 38.8 58.1 3.1 3.3 6.6% 9.1
G12 133 48.7 5.9 31.1 63.5 4.0 4.7 9.7% 13.1 134 51.2 3.9 41.4 58.9 2.7 2.8 5.5% 7.8
G13 133 45.2 6.5 28.7 59.3 4.6 5.4 11.9% 14.8 134 49.5 4.6 39.4 57.9 3.5 3.8 7.7% 10.6
G21 133 50.6 5.4 27.8 64.2 3.6 3.9 7.7% 10.8 134 51.0 3.6 40.1 61.5 2.5 2.7 5.3% 7.5
G22 133 50.1 3.2 39.7 58.5 2.2 2.3 4.7% 6.5 134 34.9 6.3 20.9 50.6 1.9 2.0 5.7% 5.4
G23 133 50.7 4.9 40.2 62.5 3.0 3.5 6.9% 9.7 134 51.1 3.6 44.2 67.0 2.6 2.9 5.6% 7.9
G31 133 46.4 6.0 31.4 62.0 4.2 4.4 9.5% 12.2 134 49.6 4.2 38.8 59.4 3.2 3.4 6.9% 9.4
G32 133 48.2 6.3 33.1 63.1 4.1 4.2 8.8% 11.7 134 50.9 3.8 38.6 60.2 3.0 3.1 6.2% 8.7
G33 133 44.6 7.3 26.9 61.3 4.4 4.7 10.7% 13.1 134 49.2 4.5 37.0 58.3 3.4 3.6 7.3% 9.9
FAZ (mm2) 124 0.335 0.127 0.151 0.644 0.010 0.010 3.1% 0.029 125 0.334 0.120 0.148 0.611 0.011 0.011 3.3% 0.032
FAZ PERIM (mm) 124 2.217 0.419 1.471 3.184 0.066 0.066 3.0% 0.182 125 2.293 0.411 1.500 3.122 0.062 0.062 2.7% 0.171
FD-300 (%) 124 50.6 4.9 39.7 63.0 3.1 3.1 6.2% 8.7 125 48.9 4.5 35.3 59.9 2.0 2.1 4.3% 5.9

RTVue XR Avanti User Manual Page 352 of 451 P/N 580-52576-005 Rev. A
Table 8. Vascular Parameters of AngioRetina Scans, Retina Group

Retina
6-mm HD AngioRetina Scan 3-mm AngioRetina Scan
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
WI 251 45.6 3.9 34.2 53.8 1.9 2.0 4.5% 5.6 255 42.1 4.1 33.2 52.8 1.9 2.0 4.9% 5.6
WI_S_Hemi 251 45.7 3.8 33.9 54.3 2.0 2.2 4.9% 6.1 255 42.4 4.2 33.5 54.5 2.0 2.2 5.3% 6.1
WI_I_Hemi 251 45.4 4.3 30.5 54.0 2.0 2.1 4.5% 5.7 255 41.7 4.5 31.2 52.9 2.1 2.2 5.3% 6.1
All (0-6) 251 45.5 4.0 34.6 54.0 2.0 2.1 4.7% 5.9 255 41.8 4.4 31.7 52.9 1.9 2.1 5.0% 5.7
C (1) 251 26.0 8.2 5.7 43.8 2.9 3.0 11.3% 8.2 255 22.6 7.6 6.2 40.9 1.7 1.9 8.5% 5.3
All (1-3) 251 46.9 4.4 35.4 57.9 2.5 2.7 5.8% 7.4 255 44.2 4.6 34.4 55.3 2.0 2.2 5.0% 6.1
S_Hemi (1-3) 251 47.0 4.5 35.2 58.7 2.6 2.8 6.1% 7.8 255 44.3 4.7 34.3 55.5 2.1 2.2 5.1% 6.2
I_Hemi (1-3) 251 46.9 4.9 33.5 57.2 2.9 3.0 6.5% 8.3 255 44.1 4.9 32.1 56.4 2.2 2.4 5.5% 6.6
T (1-3) 251 46.3 6.2 26.7 56.7 3.1 3.1 6.8% 8.7 255 42.6 6.1 24.3 54.1 2.3 2.5 5.9% 6.9
S (1-3) 251 47.7 4.7 32.3 59.0 2.8 3.1 6.6% 8.6 255 45.2 5.2 29.6 57.1 2.3 2.4 5.4% 6.7
N (1-3) 251 46.4 5.0 26.2 57.9 3.3 3.5 7.7% 9.8 255 44.2 4.5 31.9 54.4 2.4 2.6 5.9% 7.1
Superficial I (1-3) 251 47.4 5.3 32.8 59.5 3.4 3.5 7.3% 9.6 249 45.0 5.3 31.0 57.3 2.5 2.6 5.9% 7.3
(ILM to All (3-6) 251 45.8 4.2 33.5 54.6 2.0 2.1 4.7% 5.9 - - - - - - - - -
IPL-10µm) S_Hemi (3-6) 251 45.9 4.0 34.6 55.5 2.1 2.2 4.9% 6.2 - - - - - - - - -
Vessel I_Hemi (3-6) 251 45.8 4.8 28.1 54.2 2.1 2.2 4.9% 6.2 - - - - - - - - -
Density T (3-6) 251 41.7 4.9 25.6 51.7 2.4 2.6 6.2% 7.1 - - - - - - - - -
(%) S (3-6) 251 45.8 4.4 33.2 55.5 2.3 2.5 5.5% 6.9 - - - - - - - - -
N (3-6) 251 50.5 3.7 40.8 58.1 2.1 2.2 4.3% 6.0 - - - - - - - - -
I (3-6) 249 45.2 5.6 24.8 54.6 2.3 2.4 5.2% 6.5 - - - - - - - - -
G11 251 46.7 6.4 31.9 59.1 2.2 2.3 5.0% 6.4 255 44.4 5.3 28.5 57.1 2.7 2.7 6.3% 7.6
G12 251 46.1 4.5 34.6 56.1 2.5 2.7 6.0% 7.6 255 45.2 5.6 25.3 57.5 2.5 2.7 6.0% 7.4
G13 251 45.2 7.3 26.9 59.6 2.4 2.5 5.5% 6.9 255 43.8 5.4 26.3 56.7 2.5 2.7 6.2% 7.4
G21 251 46.0 6.0 25.0 56.3 2.5 2.6 5.7% 7.2 255 42.7 6.0 16.8 55.0 2.6 2.8 6.6% 7.7
G22 251 43.4 4.4 29.5 55.2 2.4 2.6 6.0% 7.1 255 27.2 6.1 12.7 41.7 2.0 2.1 7.9% 5.9
G23 251 46.0 5.8 28.4 60.1 2.4 2.6 5.7% 7.3 255 43.3 5.0 30.9 54.0 2.5 2.8 6.5% 7.7
G31 251 45.6 7.8 20.1 58.1 2.3 2.3 5.1% 6.3 255 43.2 7.3 14.6 56.7 3.0 3.0 7.0% 8.3
G32 251 45.6 5.3 26.6 56.4 2.5 2.5 5.6% 7.1 255 44.7 5.3 28.0 57.5 2.9 3.0 6.7% 8.2
G33 251 45.4 6.4 28.5 59.2 2.5 2.5 5.5% 7.0 255 43.9 5.0 32.0 55.9 2.6 2.7 6.3% 7.6
WI 251 46.9 4.5 30.1 58.1 3.1 3.2 6.8% 8.8 255 43.0 4.7 30.5 55.6 3.4 3.4 7.8% 9.3
WI_S_Hemi 251 47.0 4.6 33.4 58.5 3.4 3.5 7.5% 9.7 255 43.4 4.7 30.3 56.2 3.4 3.4 7.9% 9.6
WI_I_Hemi 251 46.8 4.9 26.8 59.1 3.2 3.2 6.7% 8.7 255 42.7 5.2 30.1 56.3 3.5 3.5 8.1% 9.7
All (0-6) 251 48.0 4.6 30.7 59.3 3.2 3.2 6.7% 8.9 255 42.8 4.8 30.8 55.5 3.3 3.3 7.6% 9.1
C (1) 251 35.9 8.0 14.9 52.5 3.5 3.5 9.7% 9.6 255 30.9 7.4 13.4 53.9 2.7 2.7 8.7% 7.5
All (1-3) 251 49.9 4.6 34.5 62.3 3.5 3.5 6.9% 9.6 255 44.3 5.0 30.9 56.9 3.5 3.5 7.9% 9.8
S_Hemi (1-3) 251 50.2 4.7 37.6 63.7 3.7 3.7 7.4% 10.2 255 44.7 4.9 31.4 57.6 3.5 3.5 7.8% 9.7
I_Hemi (1-3) 251 49.6 5.2 31.5 62.1 3.7 3.7 7.4% 10.2 255 44.0 5.6 29.7 57.2 3.8 3.8 8.4% 10.4
T (1-3) 251 49.9 5.9 29.3 63.0 4.0 4.0 7.9% 11.0 255 44.4 5.6 26.4 58.2 3.3 3.3 7.3% 9.1
S (1-3) 251 49.5 5.5 29.5 63.1 4.2 4.2 8.5% 11.7 255 44.3 5.7 27.8 59.4 3.8 3.8 8.5% 10.6
N (1-3) 251 50.9 5.1 33.2 66.9 4.2 4.2 8.3% 11.7 255 44.7 5.2 29.1 59.2 3.8 3.8 8.5% 10.6
Deep I (1-3) 251 49.1 5.2 34.2 63.2 4.4 4.4 8.9% 12.1 249 44.0 5.5 25.9 58.0 4.1 4.1 9.3% 11.5
(IPL-10µ to All (3-6) 251 47.9 5.0 29.4 59.3 3.3 3.4 7.1% 9.4 - - - - - - - - -
OPL+10µ) S_Hemi (3-6) 251 47.9 5.0 33.0 60.7 3.6 3.7 7.7% 10.2 - - - - - - - - -
Vessel I_Hemi (3-6) 251 47.8 5.5 25.7 61.8 3.4 3.4 7.2% 9.5 - - - - - - - - -
Density T (3-6) 251 49.5 5.5 26.4 60.2 2.9 3.0 6.2% 8.5 - - - - - - - - -
(%) S (3-6) 251 47.4 5.4 30.9 61.8 3.8 3.9 8.3% 10.9 - - - - - - - - -
N (3-6) 251 47.5 6.0 34.3 62.4 4.4 4.4 9.4% 12.3 - - - - - - - - -
I (3-6) 249 47.0 6.3 22.8 62.8 3.8 3.8 8.2% 10.6 - - - - - - - - -
G11 251 46.5 5.8 23.2 59.6 4.4 4.5 9.6% 12.4 255 44.1 5.5 27.0 59.0 4.3 4.3 9.7% 12.0
G12 251 47.4 5.3 34.3 61.2 3.9 4.1 8.6% 11.3 255 44.2 6.5 24.0 58.9 3.9 4.0 8.8% 11.0
G13 251 44.4 6.4 24.3 61.1 4.3 4.6 10.3% 12.6 255 44.0 5.6 26.3 57.3 4.1 4.1 9.3% 11.4
G21 251 49.2 5.6 28.3 63.8 3.8 3.8 7.7% 10.5 255 44.0 6.5 16.8 62.4 3.6 3.7 8.2% 10.1
G22 251 47.8 4.4 35.2 59.0 3.1 3.1 6.6% 8.7 255 34.3 5.9 20.3 53.6 3.0 3.0 8.8% 8.4
G23 251 48.8 5.5 32.4 61.5 3.4 3.5 7.1% 9.6 255 45.5 4.5 32.4 56.6 3.4 3.4 7.5% 9.5
G31 251 45.5 6.6 18.2 61.0 4.0 4.1 8.9% 11.2 255 42.9 7.6 12.1 58.4 4.5 4.5 10.3% 12.5
G32 251 47.0 6.0 25.7 62.0 3.9 3.9 8.4% 10.9 255 44.3 5.9 26.5 60.0 4.3 4.3 9.5% 11.8
G33 251 45.4 5.6 29.3 59.1 4.0 4.0 8.9% 11.2 255 43.9 5.4 29.2 60.7 4.5 4.5 10.1% 12.4
FAZ (mm2) 234 0.259 0.117 0.088 0.576 0.017 0.017 6.6% 0.048 237 0.267 0.12 0.102 0.603 0.010 0.010 3.8% 0.029
FAZ PERIM (mm) 234 1.969 0.446 1.130 3.130 0.092 0.093 4.7% 0.257 237 2.075 0.48 1.276 4.182 0.097 0.097 4.6% 0.270
FD-300 (%) 234 47.1 5.4 18.7 57.9 3.7 3.8 8.1% 10.5 237 43.9 4.8 31.1 54.0 2.1 2.3 5.2% 6.3

RTVue XR Avanti User Manual Page 353 of 451 P/N 580-52576-005 Rev. A
Table 9. Vascular Parameters of AngioRetina Scans, Retina Wet AMD Sub-group

Retina: Wet AMD Sub-group


6-mm HD AngioRetina Scan 3-mm AngioRetina Scan
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
WI 87 46.4 3.2 38.5 53.8 2.2 2.3 5.0% 6.4 89 43.1 2.7 33.2 48.2 1.6 1.7 4.0% 4.8
WI_S_Hemi 87 46.4 3.5 37.4 54.3 2.3 2.4 5.2% 6.7 89 43.5 2.9 34.3 48.6 1.8 1.9 4.5% 5.3
WI_I_Hemi 87 46.3 3.1 39.5 54.0 2.2 2.3 5.0% 6.4 89 42.7 3.0 32.1 48.4 1.8 1.9 4.4% 5.2
All (0-6) 87 46.4 3.3 38.4 54.0 2.3 2.4 5.2% 6.6 89 43.0 2.9 33.0 48.5 1.7 1.8 4.2% 5.0
C (1) 87 24.4 8.6 5.7 43.8 2.6 2.7 10.5% 7.5 89 21.4 8.5 6.3 40.9 1.8 2.1 9.1% 5.7
All (1-3) 87 49.0 3.9 37.3 55.7 2.6 2.7 5.5% 7.4 89 45.7 3.1 34.6 50.1 1.8 1.9 4.2% 5.3
S_Hemi (1-3) 87 48.7 4.1 36.5 55.4 2.8 2.9 6.0% 8.0 89 45.8 3.3 34.6 50.3 1.9 2.0 4.4% 5.6
I_Hemi (1-3) 87 49.3 4.1 38.1 56.3 2.9 2.9 5.9% 8.0 89 45.6 3.2 34.2 50.6 2.0 2.0 4.5% 5.7
T (1-3) 87 49.5 4.2 39.8 56.7 2.7 2.7 5.5% 7.5 89 45.5 3.3 33.7 50.3 2.2 2.4 5.3% 6.6
S (1-3) 87 48.9 4.6 36.5 56.3 3.2 3.3 6.8% 9.2 89 46.5 3.9 32.1 53.7 2.3 2.4 5.1% 6.5
N (1-3) 87 48.0 4.4 34.8 56.3 3.0 3.1 6.6% 8.7 89 45.0 3.2 36.4 51.3 1.9 2.0 4.5% 5.5
Superficial I (1-3) 87 49.6 4.9 36.5 59.5 3.4 3.4 6.9% 9.3 88 46.0 3.9 32.7 52.1 2.3 2.3 5.1% 6.4
(ILM to All (3-6) 87 46.4 3.4 38.4 54.6 2.3 2.4 5.3% 6.8 - - - - - - - - -
IPL-10µm) S_Hemi (3-6) 87 46.3 3.8 38.2 55.5 2.4 2.6 5.6% 7.1 - - - - - - - - -
Vessel I_Hemi (3-6) 87 46.5 3.3 38.5 54.0 2.4 2.5 5.4% 6.9 - - - - - - - - -
Density T (3-6) 87 43.4 3.5 35.3 51.4 2.6 2.7 6.2% 7.4 - - - - - - - - -
(%) S (3-6) 87 45.8 4.1 36.6 55.5 2.7 2.9 6.3% 8.0 - - - - - - - - -
N (3-6) 87 50.4 3.4 42.2 57.9 2.3 2.4 4.7% 6.6 - - - - - - - - -
I (3-6) 87 45.9 3.8 37.9 54.6 2.6 2.7 6.0% 7.6 - - - - - - - - -
G11 87 47.9 5.5 34.3 57.8 2.2 2.3 5.0% 6.5 89 44.9 4.3 29.0 51.4 2.3 2.4 5.4% 6.6
G12 87 46.4 4.3 37.9 55.6 3.0 3.1 6.7% 8.6 89 47.3 4.1 35.0 53.5 2.3 2.4 5.2% 6.7
G13 87 44.8 7.5 29.2 58.0 2.7 2.9 6.4% 8.0 89 44.0 3.9 36.3 54.0 2.3 2.5 5.7% 7.0
G21 87 47.6 3.8 37.4 55.6 2.5 2.6 5.4% 7.1 89 45.2 3.0 35.5 52.4 2.2 2.2 4.9% 6.1
G22 87 45.0 3.6 33.3 52.6 2.4 2.4 5.4% 6.8 89 26.6 6.1 14.1 41.7 2.2 2.3 8.4% 6.4
G23 87 46.9 4.6 36.6 57.4 2.5 2.7 5.7% 7.4 89 45.1 3.2 34.7 49.9 2.2 2.4 5.3% 6.5
G31 87 47.0 5.2 33.8 56.4 2.4 2.4 5.2% 6.7 89 45.0 4.0 33.0 52.1 2.4 2.4 5.4% 6.7
G32 87 46.7 4.0 38.6 56.4 2.8 2.9 6.2% 7.9 89 45.5 4.8 28.0 53.3 2.8 2.9 6.4% 7.9
G33 87 45.0 7.1 31.5 59.2 2.7 2.8 6.2% 7.8 89 44.3 3.9 34.8 52.7 2.7 2.7 6.0% 7.3
WI 87 47.8 4.1 38.0 58.1 3.1 3.1 6.6% 8.7 89 44.2 4.5 34.3 55.6 3.4 3.4 7.7% 9.5
WI_S_Hemi 87 47.5 4.6 35.2 58.5 3.3 3.3 6.9% 9.0 89 44.5 4.4 36.7 55.9 3.4 3.4 7.7% 9.6
WI_I_Hemi 87 48.1 3.9 40.6 59.1 3.2 3.2 6.7% 8.9 89 43.8 4.8 30.3 56.3 3.6 3.6 8.2% 10.1
All (0-6) 87 49.2 4.0 40.1 59.3 3.1 3.1 6.4% 8.7 89 43.7 4.6 33.0 55.5 3.4 3.4 7.7% 9.4
C (1) 87 35.3 8.8 16.1 52.5 2.7 2.7 7.4% 7.6 89 30.7 9.4 13.4 53.9 2.4 2.4 7.4% 6.7
All (1-3) 87 51.3 3.8 41.4 61.8 3.5 3.5 6.8% 9.6 89 45.4 4.5 35.1 56.8 3.7 3.7 8.0% 10.2
S_Hemi (1-3) 87 51.4 3.8 41.3 61.6 3.6 3.6 7.0% 10.0 89 45.6 4.4 37.6 57.6 3.6 3.6 7.8% 10.0
I_Hemi (1-3) 87 51.1 4.2 41.3 62.1 3.6 3.7 7.2% 10.2 89 45.2 4.9 31.1 57.2 4.0 4.0 8.8% 11.2
T (1-3) 87 51.9 3.8 43.4 62.7 3.3 3.3 6.4% 9.2 89 46.1 4.3 32.9 56.8 3.5 3.5 7.5% 9.7
S (1-3) 87 50.9 4.4 37.2 62.7 4.3 4.3 8.5% 11.9 89 45.8 4.9 36.5 59.4 3.8 3.8 8.1% 10.4
N (1-3) 87 51.9 4.6 41.9 66.9 4.0 4.0 7.7% 11.1 89 44.7 5.0 33.2 59.2 4.1 4.1 9.2% 11.5
Deep I (1-3) 87 50.3 4.8 39.2 63.2 4.4 4.4 8.8% 12.3 88 44.9 5.0 34.0 58.0 4.3 4.3 9.5% 11.8
(IPL-10µ to All (3-6) 87 49.1 4.5 37.1 59.3 3.4 3.4 6.9% 9.3 - - - - - - - - -
OPL+10µ) S_Hemi (3-6) 87 48.7 5.1 33.8 60.7 3.6 3.6 7.4% 10.0 - - - - - - - - -
Vessel I_Hemi (3-6) 87 49.5 4.2 40.5 59.8 3.3 3.3 6.8% 9.2 - - - - - - - - -
Density T (3-6) 87 52.0 3.5 42.5 60.1 2.8 2.8 5.4% 7.8 - - - - - - - - -
(%) S (3-6) 87 47.4 5.9 30.9 61.8 4.0 4.0 8.4% 11.0 - - - - - - - - -
N (3-6) 87 48.3 5.8 35.7 62.4 4.1 4.1 8.6% 11.5 - - - - - - - - -
I (3-6) 87 48.7 4.8 34.2 59.4 3.9 3.9 8.1% 10.9 - - - - - - - - -
G11 87 46.3 6.1 23.2 57.7 4.3 4.3 9.4% 12.0 89 44.8 5.5 31.8 59.0 4.3 4.3 9.5% 12.0
G12 87 47.9 5.4 34.3 61.2 3.6 3.6 7.6% 10.0 89 46.4 4.8 35.8 58.6 3.8 3.8 8.0% 10.4
G13 87 44.1 6.5 27.9 58.3 4.0 4.2 9.6% 11.6 89 45.1 5.6 34.4 57.1 4.3 4.3 9.4% 11.9
G21 87 50.9 4.5 39.7 63.8 3.5 3.6 7.0% 9.9 89 45.4 4.9 34.6 58.4 3.7 3.7 7.9% 10.1
G22 87 48.7 3.7 41.6 59.0 3.0 3.1 6.3% 8.5 89 34.4 6.9 20.5 53.6 2.9 2.9 8.0% 8.0
G23 87 50.7 4.9 39.0 61.5 3.2 3.2 6.3% 8.8 89 46.1 4.0 35.6 56.5 3.7 3.7 7.9% 10.2
G31 87 46.9 5.2 34.3 61.0 4.4 4.4 9.4% 12.2 89 45.3 5.2 29.6 58.4 4.5 4.5 9.8% 12.4
G32 87 48.7 4.5 37.4 60.2 3.9 3.9 8.1% 10.9 89 44.9 5.3 30.9 60.0 4.1 4.2 9.3% 11.8
G33 87 45.8 5.4 35.1 58.1 4.1 4.1 8.9% 11.3 89 45.3 5.5 29.2 60.7 4.6 4.6 10.1% 12.8
FAZ (mm2) 79 0.300 0.138 0.119 0.576 0.016 0.016 5.5% 0.044 80 0.310 0.153 0.150 0.603 0.011 0.011 3.6% 0.030
FAZ PERIM (mm) 79 2.116 0.510 1.503 3.130 0.083 0.084 4.0% 0.234 80 2.225 0.605 1.496 4.182 0.129 0.129 5.9% 0.358
FD-300 (%) 79 47.7 4.7 33.8 56.3 3.4 3.4 7.1% 9.3 80 43.7 4.2 31.1 51.6 2.0 2.2 5.1% 6.1

RTVue XR Avanti User Manual Page 354 of 451 P/N 580-52576-005 Rev. A
Table 10. Vascular Parameters of AngioRetina Scans, Retina DR Sub-group

Retina: DR Sub-group
6-mm HD AngioRetina Scan 3-mm AngioRetina Scan
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
WI 76 45.1 2.8 38.2 50.7 1.7 1.7 3.8% 4.8 73 39.3 3.4 33.2 47.1 1.7 1.9 4.83% 5.2
WI_S_Hemi 76 45.0 2.9 39.2 51.3 1.8 1.9 4.2% 5.3 73 39.4 3.3 33.5 46.3 1.8 2.0 5.07% 5.5
WI_I_Hemi 76 45.2 3.0 36.9 50.8 1.8 1.8 4.0% 5.0 73 39.1 3.8 31.2 48.0 2.2 2.3 5.81% 6.3
All (0-6) 76 44.8 2.7 38.0 50.5 1.7 1.8 3.9% 4.9 73 38.6 3.9 31.7 47.6 1.8 1.9 4.92% 5.2
C (1) 76 26.3 8.0 6.6 40.4 3.4 3.4 13.0% 9.4 73 22.0 6.9 7.0 34.2 1.7 1.8 8.43% 5.0
All (1-3) 76 44.3 3.0 35.4 50.5 2.3 2.5 5.6% 6.8 73 40.8 3.8 34.4 49.3 1.8 2.0 4.83% 5.4
S_Hemi (1-3) 76 44.4 3.4 35.2 51.2 2.4 2.8 6.2% 7.6 73 40.8 3.6 34.3 48.3 1.9 2.0 4.83% 5.4
I_Hemi (1-3) 76 44.2 3.3 33.5 53.2 2.8 2.8 6.3% 7.7 73 40.9 4.4 32.6 51.6 2.0 2.1 5.26% 6.0
T (1-3) 76 43.4 4.0 30.8 51.5 3.7 3.7 8.5% 10.2 73 38.6 4.4 31.0 48.1 2.3 2.4 6.26% 6.7
S (1-3) 76 45.4 3.6 36.1 53.3 2.3 2.8 6.2% 7.9 73 41.7 3.3 35.4 49.0 2.0 2.0 4.80% 5.5
N (1-3) 76 43.7 4.9 26.2 54.5 3.7 4.0 9.2% 11.0 73 41.1 4.7 32.3 51.4 2.1 2.4 5.82% 6.6
Superficial I (1-3) 76 44.7 4.0 32.8 53.6 3.2 3.2 7.1% 8.8 68 41.7 5.0 31.0 53.6 2.3 2.3 5.50% 6.4
(ILM to All (3-6) 76 45.7 3.0 39.3 51.4 1.8 1.8 3.9% 5.0 - - - - - - - - -
IPL-10µm) S_Hemi (3-6) 76 45.5 3.2 38.7 51.3 1.7 1.7 3.8% 4.8 - - - - - - - - -
Vessel I_Hemi (3-6) 76 46.0 3.1 38.7 51.5 2.0 2.0 4.4% 5.6 - - - - - - - - -
Density T (3-6) 76 40.3 3.2 32.4 46.4 2.0 2.1 5.3% 6.0 - - - - - - - - -
(%) S (3-6) 76 46.1 3.7 38.0 54.2 2.0 2.0 4.4% 5.6 - - - - - - - - -
N (3-6) 76 50.3 3.3 42.3 56.6 2.2 2.2 4.4% 6.2 - - - - - - - - -
I (3-6) 76 46.2 3.3 38.6 52.9 2.1 2.1 4.6% 5.8 - - - - - - - - -
G11 76 48.5 6.6 34.8 59.1 2.0 2.0 4.1% 5.5 73 42.2 5.5 28.5 52.1 2.6 2.7 6.46% 7.4
G12 76 45.8 4.1 38.1 54.4 2.3 2.4 5.3% 6.7 73 41.9 3.8 33.4 49.7 2.5 2.5 5.94% 6.9
G13 76 43.7 6.2 32.2 59.6 2.5 2.5 5.7% 7.0 73 40.8 3.5 30.8 47.9 2.3 2.6 6.45% 7.3
G21 76 46.0 5.8 29.9 55.7 2.4 2.5 5.4% 6.9 73 39.1 4.9 27.5 49.6 2.5 2.7 6.85% 7.4
G22 76 40.5 3.7 29.5 47.4 2.4 2.4 6.0% 6.7 73 25.7 5.9 12.7 38.9 1.9 1.9 7.64% 5.4
G23 76 43.2 4.0 34.3 53.9 2.3 2.5 5.8% 7.0 73 39.4 4.4 30.9 50.2 2.4 2.8 7.23% 7.9
G31 76 47.6 7.6 32.7 57.5 2.1 2.1 4.5% 5.9 73 42.6 5.6 31.0 56.5 2.6 2.6 6.21% 7.2
G32 76 45.9 3.4 38.1 52.7 2.3 2.3 5.0% 6.4 73 41.0 4.7 29.2 51.6 2.9 2.9 6.95% 7.9
G33 76 44.8 5.4 34.5 56.3 2.4 2.4 5.3% 6.6 73 40.4 3.4 32.0 48.3 2.6 2.6 6.51% 7.3
WI 76 46.8 3.9 38.7 57.5 3.2 3.4 7.3% 9.4 73 41.8 5.3 30.5 51.4 3.9 4.0 9.49% 11.2
WI_S_Hemi 76 46.8 4.1 38.9 57.7 3.7 4.0 8.5% 11.0 73 41.9 5.5 30.3 53.3 4.0 4.1 9.66% 11.4
WI_I_Hemi 76 46.9 4.3 38.5 59.0 3.3 3.3 7.0% 9.2 73 41.7 5.2 30.7 50.9 4.0 4.1 9.64% 11.3
All (0-6) 76 47.8 4.1 39.4 58.5 3.4 3.5 7.3% 9.7 73 41.6 5.1 30.8 50.9 3.8 3.9 9.22% 10.8
C (1) 76 35.3 7.8 14.9 50.3 4.3 4.3 12.2% 11.9 73 29.9 5.6 19.1 45.2 2.9 2.9 9.75% 8.1
All (1-3) 76 49.7 4.4 41.1 62.3 4.0 4.0 8.0% 11.0 73 43.1 5.7 30.9 54.3 4.1 4.2 9.51% 11.6
S_Hemi (1-3) 76 49.4 4.9 40.3 63.7 4.3 4.4 8.9% 12.3 73 43.3 5.8 31.4 54.6 4.1 4.2 9.53% 11.7
I_Hemi (1-3) 76 49.9 4.6 41.4 61.0 4.4 4.4 8.7% 12.1 73 43.0 5.8 30.2 54.0 4.3 4.3 9.87% 12.0
T (1-3) 76 49.1 5.6 29.6 63.0 5.4 5.4 10.9% 14.8 73 42.9 5.0 33.6 55.2 3.8 3.8 8.68% 10.6
S (1-3) 76 49.3 5.5 38.2 63.1 4.6 4.8 9.8% 13.4 73 43.1 6.2 31.2 56.4 4.4 4.6 10.34% 12.6
N (1-3) 76 51.0 6.0 33.2 63.3 5.1 5.1 9.9% 14.1 73 43.8 6.4 29.1 58.6 4.3 4.4 9.88% 12.2
Deep I (1-3) 76 49.4 5.4 34.2 61.0 5.3 5.3 10.7% 14.6 68 43.3 6.2 25.9 54.5 5.0 5.0 11.48% 13.9
(IPL-10µ to All (3-6) 76 47.7 4.2 39.2 58.7 3.4 3.6 7.5% 10.0 - - - - - - - - -
OPL+10µ) S_Hemi (3-6) 76 47.6 4.3 39.9 58.8 3.8 4.0 8.5% 11.2 - - - - - - - - -
Vessel I_Hemi (3-6) 76 47.9 4.8 38.0 61.8 3.6 3.7 7.7% 10.2 - - - - - - - - -
Density T (3-6) 76 48.7 3.8 38.9 57.8 3.2 3.5 7.1% 9.6 - - - - - - - - -
(%) S (3-6) 76 47.2 4.4 38.9 57.2 4.0 4.2 9.0% 11.7 - - - - - - - - -
N (3-6) 76 47.5 6.3 34.6 61.1 5.0 5.1 10.6% 14.0 - - - - - - - - -
I (3-6) 76 47.5 5.4 34.7 62.8 4.0 4.1 8.6% 11.4 - - - - - - - - -
G11 76 45.9 6.2 33.8 59.6 5.2 5.3 11.5% 14.8 73 42.4 6.3 27.0 56.7 4.9 5.1 11.81% 14.0
G12 76 47.1 5.0 36.2 58.7 4.5 4.9 10.5% 13.6 73 42.3 7.7 24.0 58.9 4.5 4.6 10.58% 12.8
G13 76 45.2 5.1 29.6 61.1 4.3 4.6 10.3% 12.7 73 43.6 5.8 30.5 57.3 4.5 4.7 10.60% 12.9
G21 76 48.7 5.1 38.4 61.2 4.6 4.7 9.5% 12.9 73 42.6 6.4 29.8 62.4 4.1 4.2 9.61% 11.7
G22 76 47.6 4.6 37.6 58.0 3.9 3.9 8.1% 10.7 73 33.0 4.8 24.6 48.0 3.1 3.2 9.51% 8.8
G23 76 49.1 4.4 40.0 60.5 3.4 3.5 7.1% 9.7 73 43.8 4.9 32.4 54.9 3.7 3.8 8.57% 10.7
G31 76 45.1 5.7 33.5 58.0 4.1 4.3 9.5% 11.9 73 42.4 6.5 26.7 53.7 5.1 5.1 11.99% 14.3
G32 76 47.5 5.3 34.1 62.0 4.3 4.3 9.1% 12.0 73 42.5 7.0 26.5 56.7 5.1 5.2 11.95% 14.4
G33 76 45.4 5.1 32.5 58.9 3.7 3.8 8.3% 10.4 73 43.4 5.5 29.3 54.4 4.7 4.7 10.73% 13.0
FAZ (mm2) 76 0.272 0.090 0.127 0.462 0.020 0.020 7.3% 0.056 73 0.281 0.092 0.145 0.441 0.010 0.010 3.5% 0.028
FAZ PERIM (mm) 76 2.050 0.361 1.374 2.785 0.095 0.095 4.6% 0.263 73 2.168 0.365 1.481 2.780 0.075 0.077 3.5% 0.212
FD-300 (%) 76 46.8 5.9 18.7 57.9 4.3 4.3 9.3% 12.0 73 43.6 5.1 31.5 54.0 2.2 2.3 5.2% 6.3

RTVue XR Avanti User Manual Page 355 of 451 P/N 580-52576-005 Rev. A
Table 11. Vascular parameters of AngioRetina scans, Retina Other Sub-group

Retina: Other Sub-group


6mm HD Angio Retina Scan 3mm Angio Retina Scan
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
WI 88 45.1 5.0 34.2 53.2 1.7 2.0 4.5% 5.5 93 43.3 4.7 34.8 52.8 2.1 2.4 5.6% 6.6
WI_S_Hemi 88 45.5 4.6 33.9 53.0 1.8 2.2 4.9% 6.1 93 43.7 4.8 34.1 54.5 2.2 2.6 6.1% 7.2
WI_I_Hemi 88 44.7 5.9 30.5 53.6 1.9 2.0 4.5% 5.5 93 42.9 5.3 31.7 52.9 2.3 2.4 5.7% 6.7
All (0-6) 88 45.3 5.2 34.6 52.9 1.9 2.1 4.8% 5.9 93 43.0 4.7 34.5 52.9 2.1 2.4 5.7% 6.7
C (1) 88 27.4 7.6 12.7 42.1 2.7 2.8 10.5% 7.8 93 24.2 6.9 6.2 37.2 1.6 1.8 7.8% 5.1
All (1-3) 88 47.2 4.8 38.0 57.9 2.5 2.9 6.2% 8.0 93 45.5 4.9 36.0 55.3 2.3 2.6 5.8% 7.2
S_Hemi (1-3) 88 47.6 4.7 38.2 58.7 2.4 2.8 6.0% 7.8 93 45.7 5.1 35.0 55.5 2.4 2.6 5.7% 7.1
I_Hemi (1-3) 88 46.9 5.6 33.8 57.2 3.0 3.3 7.1% 9.1 93 45.2 5.6 32.1 56.4 2.4 2.8 6.3% 7.9
T (1-3) 88 45.7 7.8 26.7 56.1 2.8 3.0 6.7% 8.4 93 42.9 7.4 24.3 54.1 2.4 2.6 6.1% 7.2
S (1-3) 88 48.5 4.9 32.3 59.0 2.6 3.1 6.6% 8.7 93 46.6 6.2 29.6 57.1 2.6 2.8 6.0% 7.7
N (1-3) 88 47.1 4.7 31.0 57.9 3.1 3.5 7.6% 9.8 93 45.9 4.3 31.9 54.4 3.0 3.1 6.9% 8.6
Superficial I (1-3) 88 47.5 5.6 33.3 59.3 3.5 3.8 8.0% 10.5 93 46.3 5.8 33.3 57.3 2.7 3.2 6.9% 8.8
(ILM to All (3-6) 88 45.3 5.6 33.5 53.9 1.9 2.1 4.6% 5.7 - - - - - - - - -
IPL-10µm) S_Hemi (3-6) 88 45.9 4.9 34.6 53.6 1.9 2.3 5.0% 6.2 - - - - - - - - -
Vessel I_Hemi (3-6) 88 44.8 6.8 28.1 54.2 2.0 2.1 4.7% 5.8 - - - - - - - - -
Density T (3-6) 88 41.3 6.7 25.6 51.7 2.5 2.8 6.7% 7.6 - - - - - - - - -
(%) S (3-6) 88 45.6 5.1 33.2 55.2 2.1 2.4 5.4% 6.7 - - - - - - - - -
N (3-6) 88 50.7 4.2 40.8 58.1 1.8 1.9 3.8% 5.3 - - - - - - - - -
I (3-6) 86 43.7 7.9 24.8 54.6 2.1 2.1 4.9% 5.9 - - - - - - - - -
G11 88 43.9 6.0 31.9 57.1 2.3 2.5 5.8% 7.0 93 45.6 5.7 33.6 57.1 3.0 3.1 6.8% 8.5
G12 88 46.2 5.0 34.6 56.1 2.2 2.6 5.7% 7.2 93 45.9 6.7 25.3 57.5 2.7 3.1 6.8% 8.5
G13 88 46.9 7.6 26.9 56.1 1.8 1.9 4.2% 5.4 93 46.0 6.5 26.3 56.7 2.7 2.9 6.4% 7.9
G21 88 44.4 7.3 25.0 56.3 2.6 2.7 6.1% 7.5 93 43.2 7.4 16.8 55.0 3.0 3.3 7.7% 9.2
G22 88 44.2 4.4 34.5 55.2 2.4 2.8 6.5% 7.8 93 28.9 6.0 13.6 41.7 2.1 2.1 7.4% 5.7
G23 88 47.6 7.1 28.4 60.1 2.2 2.7 5.7% 7.4 93 44.7 5.1 33.2 54.0 2.7 3.1 6.9% 8.5
G31 88 42.4 9.0 20.1 58.1 2.2 2.3 5.4% 6.3 93 42.1 10.1 14.6 56.7 3.7 3.7 8.9% 10.3
G32 88 44.2 7.2 26.6 54.2 2.3 2.4 5.5% 6.7 93 46.7 4.9 37.3 57.5 2.7 3.3 7.1% 9.0
G33 88 46.3 6.5 28.5 55.3 2.3 2.3 5.0% 6.4 93 46.2 5.5 33.2 55.9 2.6 2.9 6.5% 8.1
WI 88 46.1 5.2 30.1 56.2 3.0 3.0 6.5% 8.3 93 42.9 4.3 33.5 55.5 2.7 2.7 6.4% 7.6
WI_S_Hemi 88 46.6 5.0 33.4 55.8 3.2 3.3 7.0% 9.0 93 43.5 4.1 35.4 56.2 2.7 2.9 6.7% 8.0
WI_I_Hemi 88 45.5 6.0 26.8 57.3 3.0 3.0 6.5% 8.2 93 42.3 5.3 30.1 54.7 2.9 2.9 6.8% 8.0
All (0-6) 88 46.9 5.4 30.7 57.7 3.0 3.0 6.3% 8.3 93 42.8 4.5 33.4 55.5 2.5 2.6 6.1% 7.2
C (1) 88 37.0 7.3 21.2 51.6 3.3 3.4 9.3% 9.3 93 31.9 6.4 14.7 44.8 2.8 2.8 9.0% 7.8
All (1-3) 88 48.6 5.2 34.5 58.9 2.9 2.9 6.0% 8.0 93 44.2 4.6 34.2 56.9 2.7 2.8 6.3% 7.7
S_Hemi (1-3) 88 49.5 5.0 37.6 60.4 3.0 3.0 6.2% 8.4 93 44.8 4.4 33.8 56.8 2.7 2.8 6.2% 7.8
I_Hemi (1-3) 88 47.7 6.0 31.5 59.9 3.1 3.1 6.4% 8.5 93 43.6 6.0 29.7 57.0 3.0 3.0 6.9% 8.4
T (1-3) 88 48.6 7.3 29.3 62.2 3.0 3.0 6.3% 8.4 93 43.9 6.7 26.4 58.2 2.6 2.7 6.1% 7.4
S (1-3) 88 48.3 6.3 29.5 59.9 3.6 3.6 7.4% 9.9 93 43.8 5.8 27.8 55.8 3.2 3.3 7.5% 9.2
N (1-3) 88 49.9 4.6 36.8 59.7 3.5 3.5 7.0% 9.7 93 45.5 4.2 36.6 57.3 3.0 3.0 6.7% 8.4
Deep I (1-3) 88 47.7 5.1 37.2 59.6 3.5 3.5 7.2% 9.6 93 43.7 5.3 34.0 57.8 3.2 3.2 7.4% 9.0
(IPL-10µ to All (3-6) 88 46.8 5.8 29.4 57.8 3.2 3.2 6.8% 8.9 - - - - - - - - -
OPL+10µ) S_Hemi (3-6) 88 47.5 5.5 33.0 57.9 3.3 3.4 7.1% 9.3 - - - - - - - - -
Vessel I_Hemi (3-6) 88 46.0 6.7 25.7 58.0 3.3 3.3 7.1% 9.1 - - - - - - - - -
Density T (3-6) 88 47.6 7.3 26.4 60.2 2.8 2.9 6.0% 7.9 - - - - - - - - -
(%) S (3-6) 88 47.6 5.6 34.0 58.4 3.5 3.6 7.7% 10.1 - - - - - - - - -
N (3-6) 88 46.8 5.8 34.3 59.9 4.1 4.2 9.0% 11.7 - - - - - - - - -
I (3-6) 86 44.8 7.7 22.8 58.5 3.5 3.5 7.7% 9.7 - - - - - - - - -
G11 88 47.1 5.0 30.6 59.3 3.6 3.7 7.9% 10.3 93 44.8 4.5 34.4 56.0 3.6 3.7 8.4% 10.4
G12 88 47.3 5.4 34.3 57.6 3.7 3.7 7.9% 10.4 93 43.8 6.5 26.1 58.0 3.6 3.6 8.2% 10.0
G13 88 44.1 7.3 24.3 56.7 4.7 4.8 10.9% 13.2 93 43.1 5.5 26.3 55.1 3.4 3.4 7.9% 9.5
G21 88 47.9 6.5 28.3 58.1 3.2 3.2 6.6% 8.8 93 43.7 7.7 16.8 58.9 3.0 3.3 7.5% 9.1
G22 88 47.1 4.9 35.2 57.8 2.4 2.4 5.2% 6.8 93 35.3 5.4 20.3 46.2 3.1 3.1 8.8% 8.5
G23 88 46.7 6.2 32.4 60.4 3.7 3.7 7.9% 10.2 93 46.3 4.4 34.9 56.6 2.6 2.9 6.3% 8.1
G31 88 44.4 8.1 18.2 58.1 3.5 3.5 7.8% 9.7 93 41.1 9.6 12.1 53.6 4.0 4.0 9.7% 11.2
G32 88 44.8 7.1 25.7 58.3 3.6 3.6 7.9% 9.9 93 45.0 5.1 36.6 58.6 3.4 3.4 7.6% 9.5
G33 88 45.1 6.2 29.3 59.1 4.2 4.2 9.4% 11.8 93 42.8 5.0 31.6 57.6 4.0 4.1 9.6% 11.4
FAZ (mm2) 79 0.205 0.095 0.088 0.510 0.015 0.016 7.2% 0.044 84 0.215 0.089 0.102 0.504 0.010 0.010 4.3% 0.028
FAZ PERIM (mm) 79 1.745 0.361 1.130 2.799 0.098 0.099 5.4% 0.274 84 1.853 0.339 1.276 2.762 0.075 0.075 3.9% 0.209
FD-300 (%) 79 46.8 5.6 34.5 55.6 3.6 3.6 7.8% 10.1 84 44.5 5.0 32.3 54.0 2.2 2.3 5.1% 6.3

RTVue XR Avanti User Manual Page 356 of 451 P/N 580-52576-005 Rev. A
Vessel Density and RNFL Thickness Results within (2-4) mm, and Disc
Parameters for 4.5 mm HD AngioDisc Scan

Tables 12 and 13 summarize the results of the R&R analysis of vascular and RNFL
thickness parameters of (2-4) mm peripapillary grid, and Disc Parameters of the 4.5 mm
HD AngioDisc scan.

Table 12. Vascular and RNFL Thickness Parameters of (2-4) mm Peripapillary Grid, and Disc
Parameters of the 4.5 mm HD AngioDisc Scan, Normal Group

Normal
repeatability reproducibility Reproducibility 95%_limits_of_
Parameter Scan # Mean SD min max
SD SD CV reproducibility

PP (2-4) 129 108.3 9.9 94.6 125.8 1.6 1.6 1.5% 4.4
S_Hemi (2-4) 129 108.3 11.0 89.1 130.7 2.0 2.0 1.9% 5.6
I_Hemi (2-4) 129 108.3 9.3 87.7 124.6 2.2 2.3 2.1% 6.3
NS (2-4) 129 101.6 13.5 72.4 133.9 3.9 3.9 3.9% 10.9
NI (2-4) 129 90.1 12.5 69.6 113.7 3.0 3.0 3.4% 8.4
RNFL
IN (2-4) 129 138.5 18.0 92.7 173.1 4.7 4.9 3.5% 13.5
Thickness (µm)
IT (2-4) 129 144.7 18.4 97.1 173.0 3.5 3.5 2.5% 9.8
TI (2-4) 129 67.3 11.9 50.1 95.2 2.0 2.0 3.0% 5.6
TS (2-4) 129 76.1 11.9 55.5 108.4 2.4 2.4 3.1% 6.6
ST (2-4) 129 135.9 24.6 75.8 174.8 2.8 2.9 2.1% 7.9
SN (2-4) 129 128.6 19.1 87.3 168.1 3.9 4.0 3.1% 11.1
WI_All Vessels 129 56.8 2.3 46.5 60.4 1.5 1.5 2.7% 4.2
WI_Small Vessels 129 49.7 2.0 40.9 53.0 1.5 1.5 2.9% 4.0
Disc_All Vessels 129 60.0 3.5 44.9 68.0 2.7 2.7 4.5% 7.5
Disc_Small Vessels 129 50.0 4.2 33.0 61.7 2.9 3.0 5.9% 8.2
PP (2-4)_All Vessels 129 58.8 2.5 48.2 62.7 1.5 1.5 2.6% 4.2
PP (2-4)_Small Vessels 129 51.8 2.2 43.1 55.4 1.5 1.5 2.9% 4.1
S_Hemi (2-4)_All Vessels 129 59.1 2.5 49.0 63.7 1.6 1.6 2.7% 4.5
I_Hemi (2-4)_All Vessels 129 58.4 2.6 47.4 62.5 1.6 1.6 2.8% 4.6
S_Hemi (2-4)_Small Vessels 129 51.8 2.2 44.3 55.8 1.6 1.7 3.2% 4.6
I_Hemi (2-4)_Small Vessels 129 51.7 2.6 41.6 55.8 1.6 1.6 3.2% 4.5
NS (2-4)_Small Vessels 129 49.1 3.3 36.2 56.5 2.2 2.2 4.4% 6.0
NI (2-4)_Small Vessels 129 48.3 4.4 32.8 56.4 2.0 2.0 4.1% 5.5
IN (2-4)_Small Vessels 129 50.9 3.8 39.5 60.8 2.4 2.5 4.9% 6.9
RPC Vessel
IT (2-4)_Small Vessels 129 55.4 3.7 39.6 63.0 2.7 2.7 5.0% 7.6
Density (%)
TI (2-4)_Small Vessels 129 52.9 2.8 46.1 60.2 1.8 1.8 3.4% 5.0
TS (2-4)_Small Vessels 129 55.7 2.9 48.8 61.6 1.7 1.7 3.1% 4.7
ST (2-4)_Small Vessels 129 53.6 4.2 43.5 62.4 2.6 2.8 5.1% 7.7
SN (2-4)_Small Vessels 129 49.1 4.0 36.8 56.9 2.1 2.3 4.7% 6.4
G11_All Vessels 129 56.4 4.0 39.7 64.1 2.1 2.1 3.7% 5.8
G12_All Vessels 129 58.9 3.2 45.5 66.2 2.0 2.1 3.5% 5.7
G13_All Vessels 129 56.2 4.9 44.5 65.4 1.9 2.0 3.6% 5.5
G21_All Vessels 129 55.1 4.5 34.8 62.1 2.2 2.3 4.3% 6.5
G22_All Vessels 129 60.3 3.5 45.1 67.4 2.8 2.9 4.8% 8.0
G23_All Vessels 129 54.5 3.6 43.9 62.2 1.8 1.9 3.4% 5.2
G31_All Vessels 129 54.5 4.9 35.3 64.0 1.9 2.0 3.7% 5.6
G32_All Vessels 129 61.5 3.9 48.4 68.6 2.4 2.4 3.9% 6.6
G33_All Vessels 129 54.2 4.6 41.5 61.9 1.7 1.9 3.4% 5.2
Disc_H_Size (mm) 129 1.558 0.094 1.347 1.759 0.051 0.051 3.3% 0.142
Disc_V_Size (mm) 129 1.639 0.134 1.346 1.858 0.054 0.056 3.4% 0.155
DiscArea (mm2) 129 2.011 0.248 1.479 2.567 0.051 0.055 2.7% 0.153
CupArea (mm2) 129 0.274 0.201 0.000 0.766 0.015 0.018 6.6% 0.049
RimArea (mm2) 129 1.737 0.169 1.235 2.014 0.045 0.046 2.7% 0.129
3
Optic Disc CupVolume (mm ) 129 0.040 0.036 0.000 0.129 0.004 0.005 12.1% 0.013
RimVolume (mm3) 129 0.505 0.093 0.343 0.676 0.014 0.014 2.7% 0.038
C_D_Area_Ratio 129 0.130 0.086 0.000 0.305 0.006 0.006 5.1% 0.018
C_D_H_Ratio 129 0.289 0.164 0.000 0.529 0.006 0.006 2.2% 0.018
C_D_V_Ratio 129 0.349 0.189 0.000 0.581 0.015 0.016 4.5% 0.043
DiscElevation (µm) 129 234.6 65.3 102.1 365.8 4.2 4.6 1.9% 12.7
CupDepth (µm) 129 104.5 69.5 0.0 217.7 7.7 7.8 7.7% 21.7

RTVue XR Avanti User Manual Page 357 of 451 P/N 580-52576-005 Rev. A
Table 13. Vascular and RNFL Thickness Parameters of (2-4) mm Peripapillary Grid, and Disc
Parameters of the 4.5 mm HD AngioDisc Scan, Glaucoma Group

Glaucoma
repeatability reproducibility 95%_limits_of_
Parameter Scan # Mean SD min max Reproducibility CV
SD SD reproducibility

PP (2-4) 137 74.4 17.1 42.6 111.2 0.9 0.9 1.2% 2.5
S_Hemi (2-4) 137 77.2 17.8 45.4 111.8 1.1 1.2 1.5% 3.2
I_Hemi (2-4) 137 71.4 18.5 37.6 111.0 1.1 1.1 1.6% 3.1
NS (2-4) 137 79.4 20.3 39.4 110.9 2.4 2.4 3.1% 6.8
NI (2-4) 137 71.3 19.8 34.0 103.7 2.5 2.5 3.5% 6.9
RNFL Thickness
IN (2-4) 137 87.4 28.1 39.0 166.7 2.8 2.8 3.2% 7.8
(µm)
IT (2-4) 137 74.2 30.8 33.7 131.9 2.3 2.3 3.1% 6.4
TI (2-4) 137 53.9 13.5 34.7 88.4 1.1 1.1 2.1% 3.1
TS (2-4) 137 59.7 16.1 34.9 96.4 1.3 1.3 2.2% 3.7
ST (2-4) 137 80.7 29.2 30.8 131.2 2.3 2.3 2.8% 6.3
SN (2-4) 137 91.0 26.4 54.5 147.6 2.7 2.8 3.0% 7.7
WI_All Vessels 137 48.7 5.2 35.7 57.0 1.2 1.3 2.7% 3.6
WI_Small Vessels 137 41.9 5.4 27.8 51.2 1.2 1.3 3.0% 3.5
Disc_All Vessels 137 55.0 6.5 39.6 64.6 2.0 2.3 4.1% 6.3
Disc_Small Vessels 137 47.1 7.5 31.3 59.9 2.0 2.3 4.8% 6.3
PP (2-4)_All Vessels 137 49.8 6.1 33.4 59.1 1.3 1.4 2.8% 3.8
PP (2-4)_Small Vessels 137 43.1 6.2 25.6 52.8 1.4 1.4 3.2% 3.8
S_Hemi (2-4)_All Vessels 137 50.8 6.3 35.4 59.9 1.3 1.4 2.8% 3.9
I_Hemi (2-4)_All Vessels 137 48.8 6.5 31.3 60.2 1.5 1.6 3.3% 4.4
S_Hemi (2-4)_Small Vessels 137 44.0 6.4 26.8 54.1 1.5 1.5 3.3% 4.1
I_Hemi (2-4)_Small Vessels 137 42.0 7.0 24.3 55.0 1.6 1.6 3.9% 4.5
NS (2-4)_Small Vessels 137 42.7 7.7 15.7 52.2 1.9 1.9 4.4% 5.2
NI (2-4)_Small Vessels 137 40.2 7.0 18.3 51.3 2.3 2.3 5.8% 6.4
IN (2-4)_Small Vessels 137 39.5 8.2 18.9 60.9 2.1 2.1 5.2% 5.7
RPC Vessel
IT (2-4)_Small Vessels 137 39.8 12.1 15.2 60.1 2.3 2.4 6.1% 6.7
Density (%)
TI (2-4)_Small Vessels 137 47.6 6.9 28.9 60.1 2.3 2.3 4.7% 6.2
TS (2-4)_Small Vessels 137 50.6 6.1 33.5 59.0 2.2 2.2 4.4% 6.2
ST (2-4)_Small Vessels 137 41.8 9.6 20.7 57.8 2.1 2.1 4.9% 5.7
SN (2-4)_Small Vessels 137 39.6 8.3 20.4 53.5 1.9 1.9 4.8% 5.2
G11_All Vessels 137 47.7 6.1 36.8 59.0 1.6 1.6 3.3% 4.4
G12_All Vessels 137 49.6 7.6 32.4 62.9 1.8 1.9 3.8% 5.2
G13_All Vessels 137 45.3 6.5 30.0 57.4 1.9 1.9 4.3% 5.4
G21_All Vessels 137 49.9 6.4 33.0 61.9 1.8 1.8 3.6% 5.0
G22_All Vessels 137 55.0 6.8 37.5 66.6 2.0 2.4 4.4% 6.7
G23_All Vessels 137 50.0 7.2 24.5 60.7 2.0 2.0 4.1% 5.7
G31_All Vessels 137 44.6 6.6 30.0 60.0 2.1 2.5 5.5% 6.8
G32_All Vessels 137 50.0 8.6 28.7 67.5 2.1 2.1 4.2% 5.8
G33_All Vessels 137 46.6 6.8 30.3 57.1 2.0 2.1 4.4% 5.7
Disc_H_Size (mm) 137 1.534 0.194 1.272 1.993 0.043 0.044 2.9% 0.123
Disc_V_Size (mm) 137 1.610 0.203 1.312 2.164 0.041 0.041 2.6% 0.114
DiscArea (mm2) 137 1.967 0.503 1.413 3.266 0.034 0.035 1.8% 0.098
CupArea (mm2) 137 0.721 0.443 0.000 1.674 0.017 0.017 2.4% 0.048
RimArea (mm2) 137 1.246 0.308 0.636 1.823 0.029 0.029 2.3% 0.082
3
Optic Disc CupVolume (mm ) 137 0.148 0.170 0.000 0.644 0.013 0.013 8.7% 0.035
RimVolume (mm3) 137 0.249 0.098 0.098 0.418 0.008 0.008 3.1% 0.021
C_D_Area_Ratio 137 0.348 0.171 0.000 0.602 0.007 0.007 2.0% 0.019
C_D_H_Ratio 137 0.494 0.197 0.000 0.816 0.009 0.009 1.8% 0.024
C_D_V_Ratio 137 0.639 0.211 0.000 0.916 0.012 0.012 1.9% 0.034
DiscElevation (µm) 137 64.5 109.8 -184.3 253.8 5.8 5.8 8.8% 15.9
CupDepth (µm) 137 156.0 95.2 0.0 402.1 6.0 6.0 3.9% 16.7

Retinal Thickness and Volume Parameters of 3 mm AngioRetina and 6 mm


HD AngioRetina Scans

Tables 14 through 16 summarize the results of R&R analysis of retinal thickness and
volume parameters of 3 mm AngioRetina and 6 mm HD AngioRetina scans for Normal,
Glaucoma and Retina groups.

RTVue XR Avanti User Manual Page 358 of 451 P/N 580-52576-005 Rev. A
Table 14. Retinal Thickness and Volume of Retinal Layer of AngioRetina Scans, Normal Group

Normal
6 mm HD Angio Retina 3 mm Angio Retina
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
C (1) 128 43.3 11.5 24.1 71.1 0.8 0.9 2.1% 2.4 129 43.3 11.3 24.7 71.5 1.1 1.2 2.7% 3.3
T (1-3) 128 102.4 10.3 79.1 123.1 0.7 0.7 0.7% 2.1 129 102.4 10.7 78.5 123.9 0.7 0.8 0.8% 2.2
S (1-3) 128 113.7 11.9 89.3 135.1 0.9 1.0 0.9% 2.8 129 113.7 12.2 88.6 136.2 1.0 1.0 0.9% 2.8
N (1-3) 128 109.8 12.5 78.8 132.1 0.7 0.8 0.8% 2.3 129 109.6 12.8 79.2 133.6 1.1 1.1 1.0% 2.9
I (1-3) 128 114.4 12.3 82.9 133.7 1.0 1.1 0.9% 2.9 128 114.0 12.8 83.0 135.4 1.2 1.2 1.1% 3.4
S_Hemi (1-3) 128 109.6 11.5 84.4 131.0 0.7 0.8 0.8% 2.3 129 109.5 11.8 83.2 132.0 0.8 0.9 0.8% 2.4
I_Hemi (1-3) 128 110.6 11.8 81.1 130.9 0.7 0.7 0.7% 2.1 129 110.2 12.2 81.0 132.6 1.0 1.0 0.9% 2.8
All (1-3) 128 110.1 11.6 82.8 130.5 0.6 0.7 0.6% 1.8 129 109.8 12.0 83.3 132.3 0.7 0.7 0.6% 1.9
T (3-6) 128 85.7 8.0 69.4 99.1 0.9 0.9 1.1% 2.6 - - - - - - - - -
ILM ~ IPL S (3-6) 128 99.8 10.8 77.6 117.3 1.0 1.1 1.1% 3.0 - - - - - - - - -
Thickness N (3-6) 128 116.5 12.9 87.8 141.9 0.9 1.0 0.8% 2.7 - - - - - - - - -
(µm) I (3-6) 128 98.5 11.4 69.6 124.1 1.0 1.0 1.1% 2.9 - - - - - - - - -
S_Hemi (3-6) 128 99.7 9.9 78.4 114.3 0.8 0.8 0.8% 2.3 - - - - - - - - -
I_Hemi (3-6) 128 100.5 11.1 74.0 124.0 0.7 0.8 0.8% 2.2 - - - - - - - - -
All (3-6) 128 100.1 10.2 76.4 118.7 0.6 0.7 0.7% 2.0 - - - - - - - - -
S_Hemi (0-6)/(0-3) 128 100.4 10.0 78.3 116.2 0.7 0.7 0.7% 2.1 129 102.1 11.4 76.7 123.1 0.8 0.8 0.8% 2.3
I_Hemi (0-6)/(0-3) 128 101.2 10.9 74.4 122.5 0.6 0.7 0.7% 1.9 129 102.5 11.8 74.7 123.5 1.0 1.0 0.9% 2.7
All (0-6)/(0-3) 128 100.8 10.3 76.6 118.4 0.5 0.6 0.6% 1.7 129 102.3 11.5 76.8 123.3 0.7 0.7 0.7% 1.9
WI_S_Hemi 128 99.8 10.2 75.3 117.7 1.6 1.6 1.6% 4.4 129 103.8 11.1 78.9 123.8 1.0 1.1 1.0% 3.0
WI_I_Hemi 128 101.7 10.5 76.6 121.5 1.1 1.1 1.1% 3.0 129 104.1 11.6 77.0 124.9 1.1 1.1 1.1% 3.2
WI 128 100.7 10.2 76.8 119.5 1.2 1.2 1.2% 3.2 129 104.1 11.3 78.9 124.5 0.9 0.9 0.8% 2.4
ILM ~ IPL C (1) 128 0.034 0.009 0.019 0.056 0.001 0.001 2.3% 0.002 129 0.034 0.009 0.019 0.056 0.001 0.001 2.7% 0.003
Volume All (0-6)/(0-3) 128 2.831 0.286 2.114 3.307 0.017 0.018 0.6% 0.049 129 0.709 0.079 0.532 0.866 0.011 0.011 1.5% 0.030
(mm3) WI 128 3.634 0.367 2.770 4.312 0.042 0.042 1.2% 0.117 129 0.939 0.102 0.712 1.123 0.008 0.008 0.8% 0.021
C (1) 128 253.6 21.6 212.9 291.0 1.5 1.8 0.7% 5.0 129 253.3 22.0 212.0 292.4 1.7 1.9 0.8% 5.4
T (1-3) 128 315.3 16.9 288.9 347.6 1.3 1.4 0.5% 4.0 129 314.9 17.3 288.6 347.5 1.3 1.5 0.5% 4.2
S (1-3) 128 329.0 18.1 293.2 360.0 1.3 1.7 0.5% 4.7 129 328.8 18.5 292.7 360.5 1.4 1.5 0.5% 4.3
N (1-3) 128 329.2 17.3 299.0 361.5 1.1 1.5 0.4% 4.0 129 329.0 17.5 298.5 360.5 1.0 1.4 0.4% 3.8
I (1-3) 128 325.2 16.9 296.0 356.1 1.5 1.6 0.5% 4.4 128 325.2 17.4 296.3 356.8 1.6 1.6 0.5% 4.5
S_Hemi (1-3) 128 325.7 17.5 293.5 357.0 1.1 1.5 0.5% 4.2 129 325.4 17.9 293.1 356.4 1.1 1.4 0.4% 3.9
I_Hemi (1-3) 128 323.7 16.7 295.6 354.2 1.2 1.4 0.4% 3.8 129 323.4 17.2 295.6 354.4 1.3 1.4 0.4% 3.9
All (1-3) 128 324.7 17.0 294.6 355.2 1.1 1.3 0.4% 3.7 129 324.4 17.4 294.6 355.4 1.1 1.3 0.4% 3.6
T (3-6) 128 271.6 13.8 252.3 303.9 1.6 1.8 0.7% 5.1 - - - - - - - - -
ILM ~ RPE S (3-6) 128 288.5 15.3 260.6 314.5 1.4 1.8 0.6% 5.0 - - - - - - - - -
Thickness N (3-6) 128 303.5 16.3 271.3 333.5 1.2 1.5 0.5% 4.1 - - - - - - - - -
(µm) I (3-6) 128 275.4 14.1 254.3 311.5 1.5 1.8 0.6% 4.9 - - - - - - - - -
S_Hemi (3-6) 128 288.3 14.6 261.3 312.7 1.2 1.6 0.6% 4.5 - - - - - - - - -
I_Hemi (3-6) 128 281.2 14.0 258.6 313.0 1.3 1.5 0.6% 4.3 - - - - - - - - -
All (3-6) 128 284.8 14.0 261.6 312.9 1.1 1.5 0.5% 4.1 - - - - - - - - -
S_Hemi (0-6)/(0-3) 128 295.7 14.9 267.2 321.4 1.1 1.5 0.5% 4.1 129 317.3 17.7 284.2 347.5 1.1 1.4 0.4% 3.8
I_Hemi (0-6)/(0-3) 128 290.0 14.4 267.2 321.3 1.2 1.4 0.5% 3.9 129 315.4 17.2 285.9 345.3 1.3 1.4 0.4% 3.9
All (0-6)/(0-3) 128 292.8 14.4 267.7 321.3 1.0 1.4 0.5% 3.8 129 316.3 17.3 285.3 346.4 1.1 1.3 0.4% 3.5
WI_S_Hemi 128 289.5 14.6 263.9 317.5 2.4 2.4 0.8% 6.6 129 315.9 17.2 282.2 344.6 1.2 1.4 0.4% 3.8
WI_I_Hemi 128 284.8 13.8 261.3 314.6 1.6 1.9 0.7% 5.2 129 314.0 16.7 284.3 343.2 1.4 1.5 0.5% 4.1
WI 128 287.2 14.0 263.8 316.2 1.7 1.8 0.6% 4.9 129 315.1 16.8 283.6 344.1 1.1 1.3 0.4% 3.5
ILM ~ RPE C (1) 128 0.200 0.017 0.168 0.229 0.001 0.001 0.7% 0.004 129 0.199 0.017 0.167 0.230 0.001 0.002 0.8% 0.004
Volume All (0-6)/(0-3) 128 8.227 0.403 7.442 8.989 0.042 0.044 0.5% 0.122 129 2.194 0.122 1.893 2.427 0.029 0.029 1.3% 0.079
(mm3) WI 128 10.36 0.505 9.519 11.41 0.061 0.064 0.6% 0.177 129 2.844 0.152 2.560 3.106 0.010 0.011 0.4% 0.032
C (1) 128 210.2 12.4 181.4 229.9 1.2 1.4 0.6% 3.7 129 209.9 13.0 181.0 230.2 1.5 1.5 0.7% 4.2
T (1-3) 128 212.9 9.2 198.6 230.4 1.3 1.3 0.6% 3.7 129 212.4 9.3 196.0 230.5 1.3 1.4 0.6% 3.7
S (1-3) 128 215.3 8.7 198.1 231.5 0.9 1.1 0.5% 3.1 129 215.1 9.0 197.9 233.0 1.2 1.3 0.6% 3.7
N (1-3) 128 219.5 8.8 203.9 233.6 0.8 1.0 0.5% 2.8 129 219.4 8.9 202.4 234.1 1.0 1.3 0.6% 3.5
I (1-3) 128 210.8 8.2 198.4 225.0 1.3 1.4 0.6% 3.8 128 211.3 8.2 197.9 226.6 1.3 1.4 0.7% 3.9
S_Hemi (1-3) 128 216.1 8.7 199.9 231.6 0.8 1.0 0.5% 2.8 129 215.9 8.9 199.4 232.6 1.1 1.2 0.6% 3.3
I_Hemi (1-3) 128 213.1 8.3 200.5 227.7 1.1 1.2 0.6% 3.4 129 213.2 8.3 200.5 228.8 1.2 1.3 0.6% 3.6
All (1-3) 128 214.6 8.4 200.5 229.7 0.9 1.0 0.5% 2.9 129 214.6 8.5 200.0 230.0 1.0 1.2 0.5% 3.2
T (3-6) 128 185.9 8.1 173.0 206.5 1.4 1.6 0.9% 4.5 - - - - - - - - -
IPL ~ RPE S (3-6) 128 188.8 8.6 171.5 204.0 1.0 1.3 0.7% 3.5 - - - - - - - - -
Thickness N (3-6) 128 187.1 8.3 166.8 199.8 1.3 1.3 0.7% 3.7 - - - - - - - - -
(µm) I (3-6) 128 176.8 6.6 164.4 188.4 1.3 1.4 0.8% 3.8 - - - - - - - - -
S_Hemi (3-6) 128 188.6 8.3 172.3 203.7 1.0 1.2 0.6% 3.3 - - - - - - - - -
I_Hemi (3-6) 128 180.7 6.6 168.2 192.0 1.1 1.2 0.7% 3.4 - - - - - - - - -
All (3-6) 128 184.7 7.4 170.7 196.6 0.9 1.1 0.6% 3.1 - - - - - - - - -
S_Hemi (0-6)/(0-3) 128 195.3 8.2 178.8 210.2 0.9 1.1 0.6% 3.0 129 215.2 9.0 197.4 231.4 1.1 1.2 0.5% 3.3
I_Hemi (0-6)/(0-3) 128 188.8 6.8 176.5 199.1 1.0 1.2 0.6% 3.2 129 212.8 8.4 198.3 228.9 1.1 1.2 0.6% 3.4
All (0-6)/(0-3) 128 192.1 7.4 178.4 204.1 0.9 1.1 0.6% 2.9 129 214.0 8.6 197.9 230.0 1.0 1.1 0.5% 3.2
WI_S_Hemi 128 189.7 8.0 174.4 203.6 1.2 1.3 0.7% 3.5 129 212.1 8.9 193.8 229.2 1.2 1.3 0.6% 3.5
WI_I_Hemi 128 183.1 6.7 169.9 194.2 1.2 1.4 0.7% 3.7 129 209.9 8.0 195.8 225.5 1.3 1.5 0.7% 4.1
WI 128 186.4 7.2 173.4 198.2 1.2 1.1 0.6% 3.0 129 211.0 8.3 195.1 226.0 1.1 1.2 0.6% 3.3
IPL ~ RPE C (1) 128 0.166 0.010 0.143 0.181 1.2 0.001 0.7% 0.003 129 0.165 0.010 0.142 0.181 0.001 0.001 0.8% 0.004
Volume All (0-6)/(0-3) 128 5.396 0.209 5.024 5.751 1.2 0.034 0.6% 0.096 129 1.484 0.065 1.310 1.604 0.019 0.019 1.3% 0.053
(mm3) WI 128 6.730 0.262 6.260 7.153 1.2 0.039 0.6% 0.109 129 1.905 0.075 1.762 2.041 0.010 0.011 0.6% 0.030

RTVue XR Avanti User Manual Page 359 of 451 P/N 580-52576-005 Rev. A
Table 15. Retinal Thickness and Volume of Retinal Layer of AngioRetina Scan, Glaucoma Group

Glaucoma
6 mm HD Angio Retina 3 mm Angio Retina
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
C (1) 133 36.9 10.8 20.2 58.4 0.8 0.8 2.1% 2.2 134 38.0 10.4 21.0 59.2 1.3 1.3 3.6% 3.7
T (1-3) 133 81.5 16.4 50.1 113.6 0.8 0.8 1.0% 2.2 134 83.2 15.8 51.5 114.9 0.7 0.7 0.9% 2.0
S (1-3) 133 94.4 18.9 51.6 126.5 0.9 0.9 0.9% 2.4 134 95.7 19.6 52.6 127.7 0.9 0.9 0.9% 2.4
N (1-3) 133 95.9 17.1 46.3 126.6 1.4 1.4 1.4% 3.7 134 96.7 18.0 46.3 127.2 1.0 1.0 1.0% 2.7
I (1-3) 133 89.0 21.1 51.6 124.2 0.9 0.9 1.0% 2.5 133 90.2 21.0 54.1 124.6 1.0 1.0 1.1% 2.8
S_Hemi (1-3) 133 92.0 17.4 53.3 121.6 1.0 1.0 1.1% 2.7 134 93.3 17.7 53.4 122.9 0.8 0.8 0.8% 2.1
I_Hemi (1-3) 133 88.5 18.8 54.6 121.6 0.7 0.7 0.8% 2.0 134 89.5 18.8 54.3 122.3 0.8 0.8 0.9% 2.3
All (1-3) 133 90.2 16.8 54.2 121.4 0.7 0.7 0.8% 2.0 134 91.5 16.9 54.3 122.4 0.6 0.6 0.6% 1.6
T (3-6) 133 65.3 8.8 48.6 86.6 0.6 0.6 0.9% 1.7 - - - - - - - - -
ILM ~ IPL S (3-6) 133 79.5 14.3 55.5 107.2 0.8 0.8 1.0% 2.2 - - - - - - - - -
Thickness N (3-6) 133 95.4 14.8 53.0 128.2 2.3 2.3 2.5% 6.5 - - - - - - - - -
(µm) I (3-6) 133 72.6 14.0 49.6 104.7 1.4 1.4 1.9% 3.8 - - - - - - - - -
S_Hemi (3-6) 133 80.9 13.0 57.4 107.6 0.8 0.8 0.9% 2.1 - - - - - - - - -
I_Hemi (3-6) 133 75.6 12.8 52.7 105.0 1.0 1.1 1.4% 2.9 - - - - - - - - -
All (3-6) 133 78.3 12.0 56.4 106.3 0.7 0.7 0.9% 2.0 - - - - - - - - -
S_Hemi (0-6)/(0-3) 133 82.2 13.6 55.4 109.2 0.6 0.6 0.8% 1.8 134 87.1 16.5 50.2 115.1 0.7 0.7 0.8% 2.0
I_Hemi (0-6)/(0-3) 133 77.4 13.7 53.3 107.3 0.9 0.9 1.1% 2.4 134 83.7 17.3 50.6 114.4 0.8 0.8 1.0% 2.2
All (0-6)/(0-3) 133 79.8 12.8 54.9 108.1 0.6 0.6 0.8% 1.7 134 85.4 15.8 50.6 114.6 0.6 0.6 0.7% 1.5
WI_S_Hemi 133 80.7 13.0 56.2 109.5 1.0 1.0 1.2% 2.7 134 87.9 16.3 53.2 116.3 0.8 0.8 0.9% 2.2
WI_I_Hemi 133 76.7 12.9 53.4 107.5 1.1 1.1 1.4% 3.0 134 83.7 16.9 52.5 115.4 1.0 1.0 1.3% 2.9
WI 133 78.8 12.1 55.4 108.5 0.8 0.8 1.0% 2.2 134 86.1 15.3 53.1 115.8 0.8 0.8 0.9% 2.2
ILM ~ IPL C (1) 133 0.029 0.009 0.016 0.046 0.001 0.001 2.3% 0.002 134 0.030 0.008 0.017 0.047 0.001 0.001 3.5% 0.003
Volume All (0-6)/(0-3) 133 2.238 0.358 1.528 3.041 0.020 0.020 0.9% 0.056 134 0.592 0.109 0.344 0.805 0.009 0.010 1.6% 0.027
(mm3) WI 133 2.843 0.435 1.999 3.916 0.028 0.028 1.0% 0.079 134 0.774 0.146 0.170 1.045 0.028 0.028 3.7% 0.078
C (1) 133 244.4 22.2 208.3 291.3 1.1 1.2 0.5% 3.2 134 246.0 21.6 208.0 292.9 1.4 1.5 0.6% 4.2
T (1-3) 133 289.9 20.2 257.1 329.6 1.2 1.2 0.4% 3.2 134 290.9 20.4 257.8 331.4 0.8 0.9 0.3% 2.6
S (1-3) 133 303.0 22.1 262.7 341.9 1.0 1.2 0.4% 3.2 134 304.3 23.3 261.9 343.4 1.1 1.2 0.4% 3.4
N (1-3) 133 310.1 21.8 253.7 351.9 1.2 1.2 0.4% 3.3 134 311.2 22.9 253.9 354.6 1.0 1.1 0.4% 3.1
I (1-3) 133 296.5 23.3 250.7 333.3 1.1 1.1 0.4% 3.1 133 298.1 23.3 251.4 333.5 1.0 1.2 0.4% 3.2
S_Hemi (1-3) 133 301.9 21.2 259.5 339.0 1.0 1.1 0.4% 2.9 134 303.2 22.2 259.9 340.2 0.9 1.0 0.3% 2.9
I_Hemi (1-3) 133 297.8 21.9 252.9 334.1 1.0 1.0 0.3% 2.8 134 299.0 22.2 253.2 334.7 0.9 1.0 0.3% 2.8
All (1-3) 133 299.9 20.8 256.2 336.5 0.9 0.9 0.3% 2.6 134 301.1 21.5 256.6 337.2 0.8 0.9 0.3% 2.4
T (3-6) 133 240.5 12.9 212.9 264.8 1.1 1.1 0.5% 3.0 - - - - - - - - -
ILM ~ RPE S (3-6) 133 256.8 16.9 231.0 282.0 1.1 1.2 0.5% 3.2 - - - - - - - - -
Thickness N (3-6) 133 273.0 19.0 228.1 302.7 1.0 1.1 0.4% 2.9 - - - - - - - - -
(µm) I (3-6) 133 242.5 16.3 211.0 274.2 1.2 1.2 0.5% 3.3 - - - - - - - - -
S_Hemi (3-6) 133 258.6 16.2 229.9 283.7 0.9 1.0 0.4% 2.8 - - - - - - - - -
I_Hemi (3-6) 133 247.9 16.2 214.7 277.0 1.0 1.0 0.4% 2.7 - - - - - - - - -
All (3-6) 133 253.3 15.5 224.6 280.4 0.7 0.7 0.3% 1.9 - - - - - - - - -
S_Hemi (0-6)/(0-3) 133 267.9 16.9 236.5 295.5 0.8 0.9 0.3% 2.5 134 296.7 21.3 256.6 333.2 0.9 1.0 0.3% 2.9
I_Hemi (0-6)/(0-3) 133 259.0 16.8 226.3 289.3 0.9 0.9 0.3% 2.5 134 293.0 21.3 250.3 328.7 0.9 1.0 0.3% 2.8
All (0-6)/(0-3) 133 263.5 16.2 231.8 292.4 0.7 0.7 0.3% 1.9 134 294.9 20.7 253.6 331.0 0.8 0.9 0.3% 2.5
WI_S_Hemi 133 260.7 16.2 230.6 288.7 1.2 1.4 0.5% 3.8 134 293.0 21.1 253.7 330.4 1.3 1.4 0.5% 3.9
WI_I_Hemi 133 252.6 16.0 221.8 284.5 1.1 1.1 0.4% 3.1 134 289.1 20.4 247.8 324.2 1.5 1.5 0.5% 4.1
WI 133 256.7 15.4 226.5 286.2 0.9 0.9 0.3% 2.4 134 291.2 20.2 250.9 327.3 1.0 1.1 0.4% 3.0
ILM ~ RPE C (1) 133 0.193 0.018 0.164 0.230 0.001 0.001 0.5% 0.003 134 0.193 0.017 0.163 0.230 0.001 0.001 0.6% 0.003
Volume All (0-6)/(0-3) 133 7.390 0.459 6.447 8.250 0.039 0.041 0.6% 0.113 134 2.045 0.144 1.725 2.324 0.028 0.029 1.4% 0.082
(mm3) WI 133 9.267 0.554 8.175 10.329 0.031 0.031 0.3% 0.085 134 2.616 0.241 0.791 2.955 0.128 0.128 4.9% 0.355
C (1) 133 207.4 14.0 182.9 234.2 1.1 1.1 0.5% 3.0 134 207.9 14.1 180.5 234.1 1.6 1.7 0.8% 4.6
T (1-3) 133 208.4 7.7 194.9 223.0 0.9 0.9 0.4% 2.5 134 207.7 8.3 192.7 223.8 1.0 1.0 0.5% 2.8
S (1-3) 133 208.6 7.1 194.9 218.6 0.8 1.0 0.5% 2.7 134 208.6 7.4 194.4 220.4 1.0 1.1 0.5% 3.1
N (1-3) 133 214.3 7.8 202.1 232.8 0.9 0.9 0.4% 2.6 134 214.5 8.4 201.5 233.2 1.2 1.3 0.6% 3.6
I (1-3) 133 207.5 8.1 195.8 227.5 1.0 1.0 0.5% 2.7 133 207.9 8.6 193.8 229.3 1.1 1.2 0.6% 3.2
S_Hemi (1-3) 133 210.0 6.8 197.1 221.1 0.8 0.9 0.4% 2.4 134 209.9 7.3 196.7 222.2 1.0 1.1 0.5% 3.0
I_Hemi (1-3) 133 209.4 7.9 197.5 229.4 0.9 0.9 0.4% 2.4 134 209.5 8.5 195.5 230.6 1.0 1.0 0.5% 2.9
All (1-3) 133 209.7 7.1 198.1 224.3 0.7 0.7 0.3% 2.0 134 209.7 7.7 197.8 225.0 0.8 0.9 0.4% 2.4
T (3-6) 133 175.2 7.7 159.6 189.0 0.8 0.9 0.5% 2.5 - - - - - - - - -
IPL ~ RPE S (3-6) 133 177.3 6.5 165.6 187.9 0.8 0.8 0.5% 2.3 - - - - - - - - -
Thickness N (3-6) 133 177.6 7.8 150.0 192.9 2.3 2.4 1.3% 6.6 - - - - - - - - -
(µm) I (3-6) 133 169.8 6.4 152.3 182.6 1.4 1.4 0.8% 3.8 - - - - - - - - -
S_Hemi (3-6) 133 177.7 6.7 165.4 187.7 0.9 1.0 0.6% 2.8 - - - - - - - - -
I_Hemi (3-6) 133 172.3 6.7 158.6 184.6 1.1 1.1 0.6% 2.9 - - - - - - - - -
All (3-6) 133 175.0 6.5 162.5 185.8 0.8 0.9 0.5% 2.4 - - - - - - - - -
S_Hemi (0-6)/(0-3) 133 185.7 6.3 174.7 195.5 0.8 0.9 0.5% 2.6 134 209.7 7.7 196.8 223.5 1.0 1.1 0.5% 2.9
I_Hemi (0-6)/(0-3) 133 181.6 6.4 169.2 194.2 0.9 0.9 0.5% 2.5 134 209.3 8.7 196.2 229.9 1.0 1.0 0.5% 2.9
All (0-6)/(0-3) 133 183.7 6.2 172.7 194.7 0.7 0.8 0.4% 2.1 134 209.5 8.0 197.9 225.0 0.8 0.9 0.4% 2.5
WI_S_Hemi 133 180.1 6.0 169.1 190.4 0.9 1.0 0.6% 2.9 134 205.1 7.5 191.5 219.6 1.3 1.4 0.7% 4.0
WI_I_Hemi 133 175.9 6.2 164.1 188.3 1.1 1.1 0.6% 3.1 134 205.4 8.6 191.8 226.7 1.3 1.3 0.6% 3.6
WI 133 178.0 5.9 167.6 189.0 0.7 0.7 0.4% 2.0 134 205.1 7.6 193.6 218.9 0.9 1.0 0.5% 2.7
IPL ~ RPE C (1) 133 0.164 0.011 0.144 0.185 0.001 0.001 0.5% 0.002 134 0.163 0.011 0.142 0.184 0.001 0.001 0.8% 0.004
Volume All (0-6)/(0-3) 133 5.152 0.176 4.755 5.474 0.031 0.033 0.6% 0.091 134 1.453 0.056 1.324 1.552 0.020 0.021 1.4% 0.058
(mm3) WI 133 6.424 0.212 6.048 6.822 0.026 0.026 0.4% 0.073 134 1.842 0.127 0.621 1.977 0.101 0.101 5.5% 0.280

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Table16. Retinal Thickness and Volume of Retinal Layers of AngioRetina Scan, Retina Group

Retina
6 mm HD Angio Retina 3 mm Angio Retina
repeat reprodu Reprodu 95%_limits_ repeat reprodu Reprodu 95%_limits_
Parameter Scan # Mean SD min max ability cibility cibility of_reprodu Scan # Mean SD min max ability cibility cibility of_reprodu
SD SD CV cibility SD SD CV cibility
C (1) 251 51.5 13.3 24.8 87.8 2.1 2.1 4.1% 5.9 255 51.8 13.2 26.3 86.8 1.4 1.4 2.7% 3.9
T (1-3) 251 103.4 13.6 74.5 141.4 1.2 1.2 1.2% 3.3 255 104.2 14.2 74.9 142.5 1.1 1.1 1.1% 3.0
S (1-3) 251 116.3 17.3 51.5 170.9 1.7 1.7 1.5% 4.7 255 116.6 17.9 62.5 168.3 1.5 1.5 1.3% 4.1
N (1-3) 251 114.0 15.3 75.7 156.6 1.9 1.9 1.7% 5.2 255 113.8 15.5 75.6 157.0 1.6 1.6 1.4% 4.3
I (1-3) 251 116.0 17.6 82.5 173.7 1.7 1.7 1.5% 4.8 249 115.6 16.9 82.8 178.2 1.4 1.4 1.2% 3.9
S_Hemi (1-3) 251 112.5 14.8 67.7 159.5 1.3 1.3 1.1% 3.5 255 112.9 15.5 73.8 157.7 1.1 1.1 1.0% 3.1
I_Hemi (1-3) 251 112.3 15.4 83.2 161.8 1.4 1.4 1.2% 3.8 255 112.3 14.9 83.2 165.0 1.2 1.2 1.1% 3.3
All (1-3) 251 112.4 14.4 86.7 160.1 0.9 0.9 0.8% 2.6 255 112.6 14.5 88.2 161.4 0.8 0.8 0.7% 2.3
T (3-6) 251 86.1 13.1 56.9 130.5 1.4 1.4 1.7% 4.0 - - - - - - - - -
ILM ~ IPL S (3-6) 251 100.6 14.7 66.2 144.3 1.6 1.6 1.6% 4.4 - - - - - - - - -
Thickness N (3-6) 251 120.1 17.0 92.5 157.1 1.4 1.4 1.2% 3.8 - - - - - - - - -
(µm) I (3-6) 249 99.5 15.7 65.8 150.4 2.1 2.1 2.1% 5.8 - - - - - - - - -
S_Hemi (3-6) 251 101.2 13.8 73.3 135.5 1.2 1.3 1.2% 3.5 - - - - - - - - -
I_Hemi (3-6) 251 102.0 15.6 69.4 152.4 1.4 1.4 1.4% 3.8 - - - - - - - - -
All (3-6) 251 101.6 13.9 71.5 136.6 0.9 0.9 0.9% 2.6 - - - - - - - - -
S_Hemi (0-6)/(0-3) 251 102.3 13.2 71.5 137.7 1.0 1.0 1.0% 2.8 255 106.0 14.6 70.3 147.0 1.1 1.1 1.0% 3.0
I_Hemi (0-6)/(0-3) 251 102.9 14.5 72.0 150.3 1.1 1.1 1.1% 3.1 255 105.3 14.0 79.2 153.6 1.1 1.1 1.1% 3.1
All (0-6)/(0-3) 251 102.6 13.1 74.9 135.6 0.8 0.8 0.8% 2.1 255 105.7 13.7 81.4 150.3 0.8 0.8 0.8% 2.2
WI_S_Hemi 251 101.4 12.8 72.2 137.0 1.3 1.4 1.4% 3.8 255 107.0 14.6 71.8 147.9 1.7 1.7 1.6% 4.8
WI_I_Hemi 251 103.0 13.7 72.3 141.4 1.5 1.6 1.5% 4.3 254 106.5 14.1 78.4 150.3 1.5 1.5 1.4% 4.1
WI 251 102.2 12.6 73.8 133.2 1.1 1.1 1.1% 3.1 255 106.9 13.8 83.0 149.3 1.1 1.1 1.1% 3.1
ILM ~ IPL C (1) 251 0.041 0.010 0.020 0.069 0.002 0.002 4.1% 0.005 255 0.041 0.010 0.021 0.068 0.001 0.001 2.8% 0.003
Volume All (0-6)/(0-3) 251 2.878 0.367 2.103 3.768 0.028 0.028 1.0% 0.076 255 0.729 0.094 0.538 1.048 0.016 0.016 2.2% 0.044
(mm3) WI 251 3.657 0.470 2.194 4.804 0.114 0.116 3.2% 0.323 254 0.950 0.140 0.272 1.347 0.063 0.063 6.7% 0.176
C (1) 251 285.9 87.4 112.6 609.0 5.1 5.1 1.8% 14.2 255 285.5 88.3 116.6 610.3 9.5 9.5 3.3% 26.3
T (1-3) 251 315.7 49.6 223.6 495.2 3.1 3.2 1.0% 9.0 255 314.5 50.5 222.3 495.3 1.9 2.0 0.6% 5.5
S (1-3) 251 325.3 55.0 231.6 562.1 1.8 1.9 0.6% 5.1 255 324.9 54.9 233.0 566.4 2.9 2.9 0.9% 8.0
N (1-3) 251 324.8 46.6 216.6 493.7 3.2 3.3 1.0% 9.0 255 322.9 45.6 218.0 491.1 8.7 8.7 2.7% 24.0
I (1-3) 251 320.9 48.8 229.4 535.3 4.8 4.8 1.5% 13.4 249 318.8 48.5 220.8 530.7 4.8 4.8 1.5% 13.4
S_Hemi (1-3) 251 323.2 50.6 232.8 530.6 1.8 1.8 0.6% 5.0 255 322.3 50.6 234.0 531.0 4.4 4.4 1.4% 12.1
I_Hemi (1-3) 251 320.2 46.1 218.0 503.7 3.4 3.4 1.1% 9.3 255 318.3 45.6 212.6 506.4 3.6 3.6 1.1% 9.9
All (1-3) 251 321.7 47.5 225.7 516.2 2.1 2.1 0.7% 5.8 255 320.3 47.1 224.0 518.6 3.1 3.1 1.0% 8.7
T (3-6) 251 273.0 27.9 225.8 374.3 1.8 1.8 0.7% 5.0 - - - - - - - - -
ILM ~ RPE S (3-6) 251 287.0 34.1 219.9 411.0 2.0 2.0 0.7% 5.6 - - - - - - - - -
Thickness N (3-6) 251 300.3 31.3 227.4 394.7 1.6 1.6 0.5% 4.4 - - - - - - - - -
(µm) I (3-6) 249 277.8 26.2 230.7 355.9 1.6 1.6 0.6% 4.4 - - - - - - - - -
S_Hemi (3-6) 251 286.6 31.2 222.9 396.2 1.4 1.4 0.5% 4.0 - - - - - - - - -
I_Hemi (3-6) 251 282.4 26.2 232.0 349.1 1.4 1.4 0.5% 3.9 - - - - - - - - -
All (3-6) 251 284.5 27.4 227.6 365.0 1.0 1.0 0.4% 2.8 - - - - - - - - -
S_Hemi (0-6)/(0-3) 251 294.8 35.2 222.3 432.4 1.4 1.4 0.5% 3.8 255 318.1 54.1 220.9 540.1 4.2 4.2 1.3% 11.6
I_Hemi (0-6)/(0-3) 251 291.0 29.6 225.4 380.6 1.4 1.5 0.5% 4.0 255 314.5 49.5 201.4 518.2 4.0 4.0 1.3% 11.1
All (0-6)/(0-3) 251 292.9 31.5 224.0 405.4 1.1 1.1 0.4% 3.1 255 316.3 51.0 211.8 529.1 3.4 3.4 1.1% 9.5
WI_S_Hemi 251 288.9 32.1 223.2 414.2 1.5 1.5 0.5% 4.2 255 316.0 50.7 223.7 525.7 4.3 4.3 1.4% 11.9
WI_I_Hemi 251 285.7 26.5 226.0 362.5 1.6 1.8 0.6% 4.9 254 312.0 44.7 204.0 492.1 3.8 3.8 1.2% 10.4
WI 251 287.3 28.4 224.5 384.1 1.1 1.1 0.4% 3.1 255 314.0 46.5 216.1 506.9 3.1 3.1 1.0% 8.7
ILM ~ RPE C (1) 251 0.225 0.069 0.089 0.480 0.004 0.004 1.8% 0.011 255 0.224 0.069 0.092 0.480 0.007 0.007 3.3% 0.021
Volume All (0-6)/(0-3) 251 8.214 0.885 6.173 11.362 0.059 0.059 0.7% 0.165 255 2.183 0.356 1.426 3.681 0.045 0.045 2.1% 0.126
(mm3) WI 251 ##### 1.089 6.409 13.865 0.320 0.322 3.1% 0.892 254 2.797 0.473 0.709 4.578 0.169 0.169 6.0% 0.469
C (1) 251 234.4 81.8 87.7 551.3 5.3 5.4 2.3% 14.9 255 233.7 83.6 89.4 549.6 9.3 9.3 4.0% 25.8
T (1-3) 251 212.3 41.9 126.8 353.8 3.1 3.1 1.5% 8.7 255 210.3 42.8 125.5 354.1 2.0 2.0 1.0% 5.6
S (1-3) 251 208.9 44.0 134.3 395.4 2.0 2.0 1.0% 5.6 255 208.3 44.1 134.0 400.8 2.7 2.8 1.3% 7.6
N (1-3) 251 210.8 37.4 116.2 338.5 2.9 2.9 1.4% 8.1 255 209.2 37.2 117.0 338.1 8.8 8.8 4.2% 24.3
I (1-3) 251 205.0 37.6 121.1 362.7 4.8 4.8 2.4% 13.4 249 203.2 38.0 116.4 356.3 4.7 4.7 2.3% 13.2
S_Hemi (1-3) 251 210.6 41.0 136.7 375.8 1.9 1.9 0.9% 5.4 255 209.4 41.3 136.3 375.7 4.3 4.3 2.0% 11.9
I_Hemi (1-3) 251 207.9 36.7 113.0 348.1 3.5 3.5 1.7% 9.6 255 206.0 36.9 110.0 343.6 3.6 3.6 1.7% 10.0
All (1-3) 251 209.3 38.4 124.9 361.9 2.1 2.1 1.0% 5.8 255 207.7 38.4 123.9 359.5 3.1 3.1 1.5% 8.7
T (3-6) 251 186.9 18.4 152.0 267.7 1.9 2.0 1.1% 5.5 - - - - - - - - -
IPL ~ RPE S (3-6) 251 186.4 24.0 133.7 273.9 2.0 2.0 1.1% 5.6 - - - - - - - - -
Thickness N (3-6) 251 180.2 22.4 113.1 244.1 1.8 1.8 1.0% 5.1 - - - - - - - - -
(µm) I (3-6) 249 178.2 16.7 139.4 249.9 2.3 2.3 1.3% 6.3 - - - - - - - - -
S_Hemi (3-6) 251 185.4 21.8 134.8 263.8 1.5 1.5 0.8% 4.3 - - - - - - - - -
I_Hemi (3-6) 251 180.4 15.6 139.9 230.7 1.7 1.7 1.0% 4.8 - - - - - - - - -
All (3-6) 251 182.9 18.0 137.9 237.4 1.2 1.2 0.7% 3.3 - - - - - - - - -
S_Hemi (0-6)/(0-3) 251 192.4 26.2 134.2 296.1 1.4 1.4 0.7% 3.9 255 212.1 45.5 131.0 395.7 4.1 4.1 1.9% 11.3
I_Hemi (0-6)/(0-3) 251 188.1 19.9 132.9 251.9 1.6 1.6 0.9% 4.5 255 209.2 41.4 107.6 367.0 3.9 3.9 1.9% 10.9
All (0-6)/(0-3) 251 190.3 22.6 133.9 273.3 1.2 1.2 0.6% 3.3 255 210.7 43.0 119.9 381.2 3.4 3.4 1.6% 9.4
WI_S_Hemi 251 187.5 23.3 135.7 280.5 1.5 1.7 0.9% 4.6 255 209.0 42.0 133.6 383.1 4.0 4.0 1.9% 11.0
WI_I_Hemi 251 182.7 17.4 133.9 233.8 1.9 1.9 1.1% 5.3 254 205.4 36.5 107.7 344.2 3.7 3.7 1.8% 10.3
WI 251 185.1 19.8 135.6 255.3 1.2 1.2 0.7% 3.4 255 207.1 38.3 122.9 361.4 3.0 3.0 1.5% 8.4
IPL ~ RPE C (1) 251 0.185 0.064 0.069 0.435 0.004 0.004 2.3% 0.012 255 0.184 0.066 0.070 0.432 0.007 0.007 4.0% 0.020
Volume All (0-6)/(0-3) 251 5.337 0.637 3.694 7.660 0.046 0.047 0.9% 0.130 255 1.454 0.300 0.808 2.644 0.034 0.034 2.3% 0.093
(mm3) WI 251 6.626 0.754 4.215 9.221 0.214 0.214 3.2% 0.594 254 1.846 0.377 0.437 3.266 0.108 0.108 5.8% 0.299

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16.2.2 FAZ Parameter Validation (for non-vascular FAZ Parameters)
To validate OCTA-based FAZ measurements with the device software, the OCTA
derived FAZ area and FAZ perimeter parameters were compared to manually graded
FAZ measurements from fluorescein angiography images.

Study Data

The case series consisted of 30 eyes of 26 subjects (14 males and 12 females) from 3
clinical sites. One early phase FA image with sufficient quality to visualize the FAZ per
case was included in the FA grading set, and one 3 mm AngioRetina scan per case with
sufficient scan quality was included in the OCTA measurement set. The case series
consisted of 4 normal eyes, 3 eyes of wet AMD with CNV, 7 eyes with NPDR, 5 eyes
with PDR, 4 eyes with BRVO, and remaining 7 eyes with other retinal pathologies
(including dryAMD, CSC, MacTel, and ERM).

Methods

Three readers experienced in FA image grading performed FAZ measurements. Each


grader followed a grader-specific randomized grading order, masked to each other’s
results through the entire grading process, and masked to the OCTA images and
measurements. Measurement of Foveal Avascular Zone (FAZ) parameters was done
using ImageJ software.

Results

Table 17a. Distribution of FAZ measurements based on FA and OCTA for the case series

FA (Manual Grading) OCTA (Device Software)


2
Area (mm ) Perimeter (mm) Area (mm2) Perimeter (mm)
Mean 0.399 2.752 0.328 2.547
SD 0.328 1.368 0.306 1.572
Median 0.333 2.497 0.281 2.201
Min 0.120 1.584 0.037 0.860
Max 1.957 9.039 1.801 9.896

Table 17b. Limits of Agreement Analysis for FAZ measurements between OCTA and FA

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lower upper lower upper
LOA LOA
Difference mean 95%CI 95%CI 95%CI 95%CI
mean SD min max lower upper
(FA - OCTA) (%) for LOA for LOA for LOA for LOA
bound* bound**
lower lower upper upper
2
Area (mm ) 0.070 17.7% 0.132 -0.129 0.356 -0.189 0.330 -0.349 -0.029 0.170 0.489
Perimeter (mm) 0.205 7.5% 0.761 -1.480 1.121 -1.287 1.697 -1.697 -0.876 1.287 2.108
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

Table 17c. Deming Regression Analysis for FAZ measurements between OCTA and FA
intercept intercept slope slope
n intercept slope
CI lower CI upper CI lower CI upper
Area (mm2) 30 -0.043 -0.123 0.038 0.929 0.721 1.136
Perimeter (mm) 30 -0.655 -1.017 -0.292 1.163 1.031 1.296

16.2.3 FAZ Parameters Agreement between 3 mm AngioRetina and 6


mm HD AngioRetina Scans
The agreement between the 3 mm and 6 mm AngioRetina scan patterns for FAZ
parameters (FAZ area, FAZ perimeter, and FD-300 vessel density) was evaluated on
the R&R study data set.
Of the 67 subjects enrolled in the R&R study, 5 subjects were excluded for following
reasons: no FAZ, indeterminant FAZ, or missing one of the scan type for comparison.
The evaluation was then performed for the combined group of 15 Normal, 15 Glaucoma
and 32 Retina study eyes (62 subjects/eyes). Agreement (Bland-Altman analysis,
Deming regression analysis) between 3 mm AngioRetina and 6 mm HD AngioRetina
FAZ measurements are provided based on the first replicate per study eye per scan
pattern.

Results

Table 18a. Limits of Agreement Analysis for FAZ measurements between 3 mm AngioRetina and
6 mm HD AngioRetina Scans

lower upper lower upper


Difference LOA LOA
mean 95%CI 95%CI 95%CI 95%CI
(6-mm Scan - mean SD min max lower upper
(%) for LOA for LOA for LOA for LOA
3-mm Scan) bound* bound**
lower lower upper upper
Area (mm2) -0.007 -0.3% 0.024 -0.055 0.089 -0.055 0.04 -0.0671 -0.0457 0.0311 0.0524
Perimeter (mm) -0.107 -5.0% 0.107 -0.304 0.182 -0.317 0.103 -0.3697 -0.2758 0.0619 0.1558
FD-300 (%) 3.195 6.9% 3.695 -5.8 13.89 -4.047 10.436 -5.8568 -2.6223 9.0116 12.2462
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

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Table 18b. Deming Regression Analysis for FAZ measurements between 3 mm AngioRetina and 6 mm HD AngioRetina
Scans

intercept intercept slope slope


n intercept slope
CI lower CI upper CI lower CI upper
Area (mm2) 62 -0.007 -0.022 0.007 1.002 0.952 1.052
Perimeter (mm) 62 0.004 -0.121 0.129 0.948 0.891 1.006
FD-300 (%) 62 -0.464 -13.145 12.218 1.079 0.818 1.340

16.2.4 Retinal Thickness, RNFL Thickness and Disc Measurements


Agreement between OCT and OCTA scans
A subset of the R&R study data was used to perform the agreement assessment of
structural measurements (Full Retina, Inner Retina or GCC, and RNFL thickness) with
the predicate. The agreement was assessed based on the combined group of 67 study
eyes of 67 subjects (15 Normal, 16 Glaucoma, and 36 Retina) for evaluation of Full
Retina and Inner Retina thickness, and 31 subjects (15 Normal and 16 Glaucoma) for
evaluation of RNFL thickness and optic disc measurement. 64 subjects had matched
scan pairs for comparison between 3 mm AngioRetina scan and Retina Map scan, 63
subjects had matched scan pairs for comparison between the 6 mm HD AngioRetina
scan and Retina Map scan, 62 subjects had matched scan pair for comparison between
6 mm HD AngioRetina scan and GCC scan, and 30 subjects (normal subjects and
glaucoma subjects only) with matched scan pair for the comparison between the
4.5 mm HD AngioDisc scan and the ONH scan. Overall scan attrition was low for any
given scan type (< 5.0%). A summary of key parameters is shown in the table below for
Mean of Differences and standard deviation (STDEV) of differences.

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Table 19. Limits of Agreement Analysis for Full Retina, Inner Retina (i.e. GCC), RNFL and Optic
Disc Measurements (All Groups Combined)

Difference (6-mm HD AngioRetina Scan vs. Retina Map Scan)


lower upper lower upper
LOA LOA
95%CI 95%CI 95%CI 95%CI
Parameter mean SD lower upper
for LOA for LOA for LOA for LOA
bound* bound**
lower lower upper upper
C (1) -1.7 6.9 -15.3 11.9 -18.2 -12.4 8.9 14.8
All (1-3) 3.8 5.1 -6.2 13.8 -8.4 -4.0 11.7 16.0
S_Hemi (1-3) 3.5 5.3 -6.9 13.9 -9.1 -4.6 11.6 16.1
I_Hemi (1-3) 4.1 6.0 -7.6 15.8 -10.1 -5.1 13.2 18.3
T (1-3) 4.2 6.8 -9.2 17.6 -12.1 -6.3 14.7 20.5
S (1-3) 3.3 5.9 -8.2 14.8 -10.6 -5.7 12.3 17.3
Retina N (1-3) 2.5 6.8 -10.8 15.7 -13.6 -7.9 12.9 18.6
Thickness I (1-3) 5.0 6.3 -7.4 17.5 -10.1 -4.7 14.8 20.2
(µm) All (3-6) -4.7 4.9 -14.4 4.9 -16.5 -12.3 2.8 7.0
S_Hemi (3-6) -5.0 5.3 -15.4 5.5 -17.6 -13.1 3.2 7.7
I_Hemi (3-6) -4.7 5.9 -16.3 6.9 -18.8 -13.8 4.4 9.4
T (3-6) -7.4 6.4 -20.0 5.1 -22.7 -17.2 2.4 7.8
S (3-6) -4.6 6.6 -17.5 8.3 -20.2 -14.7 5.5 11.1
N (3-6) -2.9 6.3 -15.2 9.4 -17.8 -12.5 6.8 12.1
I (3-6) -4.5 7.7 -19.5 10.5 -22.7 -16.2 7.3 13.8
Difference (6-mm HD AngioRetina Scan vs. GCC Scan)
lower upper lower upper
LOA LOA
95%CI 95%CI 95%CI 95%CI
Parameter mean SD lower upper
for LOA for LOA for LOA for LOA
bound* bound**
lower lower upper upper
GCC All (0-6) 4.4 3.9 -3.2 12.1 -4.9 -1.5 10.4 13.7
Thickness S_Hemi (0-6) 4.6 4.3 -3.9 13.0 -5.7 -2.0 11.1 14.8
(µm) I_Hemi (0-6) 4.3 4.3 -4.1 12.7 -5.9 -2.3 10.8 14.5
Difference (4.5-mm HD AngioDisc Scan vs. ONH Scan)
lower upper lower upper
LOA LOA
95%CI 95%CI 95%CI 95%CI
Parameter mean SD lower upper
for LOA for LOA for LOA for LOA
bound* bound**
lower lower upper upper
TS (µm) -2.9 7.4 -17.4 11.7 -22.0 -12.8 7.1 16.2
ST (µm) -11.1 7.3 -25.4 3.3 -29.9 -20.9 -1.2 7.8
SN (µm) -3.6 10.3 -23.8 16.6 -30.2 -17.4 10.2 22.9
NS (µm) -3.0 8.2 -19.2 13.2 -24.3 -14.1 8.1 18.3
NI (µm) -1.7 7.5 -16.3 13.0 -20.9 -11.7 8.4 17.6
IN (µm) -3.5 10.3 -23.7 16.7 -30.1 -17.3 10.3 23.0
RNFL IT (µm) -9.2 7.7 -24.3 6.0 -29.1 -19.5 1.2 10.8
Thickness TI (µm) -3.4 8.2 -19.4 12.6 -24.5 -14.4 7.5 17.6
(ø3.45) T (µm) -3.2 7.1 -17.0 10.7 -21.4 -12.6 6.3 15.1
S (µm) -7.4 7.1 -21.3 6.5 -25.7 -16.9 2.2 10.9
N (µm) -2.3 7.0 -16.1 11.5 -20.5 -11.8 7.1 15.9
I (µm) -6.3 7.6 -21.3 8.6 -26.0 -16.6 3.9 13.4
S_Hemi (µm) -5.2 4.9 -14.8 4.5 -17.9 -11.8 1.5 7.6
I_Hemi (µm) -4.4 4.6 -13.5 4.6 -16.3 -10.6 1.8 7.5
All (µm) -4.8 4.2 -13.0 3.5 -15.7 -10.4 0.9 6.1
DiscArea (mm2) -0.130 0.147 -0.418 0.157 -0.508 -0.327 0.066 0.247
2
CupArea (mm ) -0.450 0.186 -0.816 -0.085 -0.931 -0.700 -0.200 0.031
RimArea (mm2) 0.319 0.190 -0.052 0.691 -0.169 0.065 0.574 0.808
Optic CupVolume (mm3) -0.162 0.168 -0.491 0.166 -0.595 -0.387 0.063 0.270
Disc RimVolume (mm3) 0.263 0.095 0.076 0.450 0.017 0.135 0.391 0.509
C_D_Area_Ratio -0.194 0.075 -0.340 -0.047 -0.386 -0.294 -0.094 -0.001
C_D_H_Ratio -0.256 0.090 -0.433 -0.078 -0.489 -0.377 -0.134 -0.022
C_D_V_Ratio -0.157 0.124 -0.400 0.085 -0.476 -0.323 0.009 0.162

* LOA lower bound = mean-1.96xSD


** LOA upper bound = mean+1.96xSD

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Table 20. Deming Regression Analysis for Full Retina, Inner Retina (i.e. GCC), RNFL and Optic
Disc Measurements (All Groups Combined)

6-mm HD AngioRetina Scan vs. Retina Map Scan


intercept intercept slope slope
Parameter n intercept slope
CI lower CI upper CI lower CI upper
C (1) 63 -3.3 -9.5 2.9 1.01 0.98 1.03
All (1-3) 63 2.0 -17.6 21.6 1.01 0.94 1.07
S_Hemi (1-3) 63 6.0 -4.3 16.3 0.99 0.96 1.02
I_Hemi (1-3) 63 -1.3 -30.3 27.6 1.02 0.92 1.11
T (1-3) 63 9.8 -2.9 22.5 0.98 0.94 1.02
S (1-3) 63 3.5 -8.9 15.9 1.00 0.96 1.04
Retina N (1-3) 63 9.4 -9.3 28.1 0.98 0.92 1.04
Thickness I (1-3) 63 -2.1 -51.5 47.3 1.02 0.86 1.18
(µm) All (3-6) 63 4.5 -16.4 25.4 0.97 0.89 1.04
S_Hemi (3-6) 63 10.8 -2.1 23.7 0.94 0.90 0.99
I_Hemi (3-6) 63 -3.0 -29.5 23.4 0.99 0.90 1.09
T (3-6) 63 14.0 2.1 25.9 0.92 0.88 0.97
S (3-6) 63 15.2 -1.2 31.5 0.93 0.87 0.99
N (3-6) 63 -5.0 -23.8 13.8 1.01 0.94 1.07
I (3-6) 63 -1.0 -40.5 38.6 0.99 0.84 1.14
6-mm HD AngioRetina Scan vs. GCC Scan
intercept intercept slope slope
Parameter n intercept slope
CI lower CI upper CI lower CI upper
GCC All (0-6) 62 -1.2 -7.1 4.8 1.06 1.00 1.12
Thickness S_Hemi (0-6) 62 0.2 -7.0 7.4 1.05 0.97 1.12
(µm) I_Hemi (0-6) 62 -3.3 -9.5 2.9 1.08 1.02 1.15
4.5-mm HD AngioDisc Scan vs. ONH Scan
intercept intercept slope slope
Parameter n intercept slope
CI lower CI upper CI lower CI upper
TS (µm) 30 -4.1 -13.0 4.7 1.02 0.88 1.16
ST (µm) 30 -29.1 -38.4 -19.8 1.15 1.07 1.24
SN (µm) 30 -24.7 -35.3 -14.2 1.21 1.10 1.32
NS (µm) 30 -3.6 -15.6 8.3 1.01 0.84 1.17
NI (µm) 30 -14.1 -25.3 -2.9 1.18 1.03 1.33
IN (µm) 30 -19.8 -32.0 -7.7 1.16 1.03 1.29
RNFL IT (µm) 30 -22.3 -31.1 -13.4 1.12 1.04 1.20
Thickness TI (µm) 30 7.5 -9.3 24.3 0.82 0.54 1.09
(ø3.45) T (µm) 30 1.5 -10.5 13.5 0.93 0.74 1.11
S (µm) 30 -26.1 -34.2 -18.0 1.17 1.09 1.26
N (µm) 30 -8.4 -18.7 1.8 1.08 0.95 1.22
I (µm) 30 -20.2 -29.6 -10.7 1.13 1.04 1.23
S_Hemi (µm) 30 -12.2 -20.0 -4.3 1.08 0.98 1.17
I_Hemi (µm) 30 -9.9 -16.7 -3.1 1.06 0.98 1.15
All (µm) 30 -10.3 -16.4 -4.1 1.06 0.99 1.14
DiscArea (mm2) 30 -0.148 -0.470 0.173 1.01 0.86 1.15
2
CupArea (mm ) 30 -0.219 -0.325 -0.113 0.75 0.63 0.88
RimArea (mm2) 30 0.511 0.243 0.780 0.84 0.63 1.05
Disc CupVolume (mm3) 30 -0.024 -0.038 -0.009 0.46 0.40 0.53
RimVolume (mm3) 30 0.120 0.063 0.177 2.22 1.62 2.83
C_D_Area_Ratio 30 -0.122 -0.185 -0.058 0.83 0.69 0.98
C_D_H_Ratio 30 -0.315 -0.524 -0.105 1.09 0.79 1.40
C_D_V_Ratio 30 -0.340 -0.580 -0.100 1.28 0.96 1.60

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16.2.5 Thickness Measurements Agreement between 3 mm
AngioRetina Scan and 6 mm HD AngioRetina Scan

There are several redundant parameters for Full Retina thickness, Inner Retina
thickness, and Outer Retina thickness for the central 3 mm macula between 3 mm
AngioRetina and 6 mm HD AngioRetina scans. The redundancy is provided to reduce
scan acquisition burden and maintain flexibility for user to select preferred scan pattern
in clinical use.

The agreement evaluation is based on the study dataset described in the OCTA R&R
study for the combined group (67 subjects/study eyes, including 15 Normal, 16
Glaucoma, and 36 Retina subjects).

All qualified scans (up to 9 scans per study eye from 3 repeats per study device and 3
study devices) were included in the limits of agreement analysis and the Deming
regression analysis.

Results

Eight thickness measurement parameters were evaluated for Full Retina thickness and
Inner Retina thickness. Results provided in Tables 21 through 24.

Full Retina Thickness (ILM to RPE)

Table 21. Limits of agreement for the full retina thickness (ILM to RPE) parameters, 3 mm OCTA scan versus 6 mm HD
OCTA scan, based on the combined group (15 Normal, 16 Glaucoma, and 36 Retina subjects).
All (Groups combined)
LOA_lower_ LOA_upper_ lower_95%CI_ upper_95%CI_ lower_95%CI_ upper_95%CI_
Parameter mean SD
bound* bound** for_LOA_lower for_LOA_lower for_LOA_upper for_LOA_upper
C (1) 0.0 8.4 -16.4 16.5 -18.6 -14.3 14.3 18.7
All (1-3) -0.4 3.1 -6.4 5.7 -7.3 -5.6 4.9 6.5
S_Hemi (1-3) -0.4 3.5 -7.2 6.3 -8.1 -6.4 5.5 7.2
Retina
I_Hemi (1-3) -0.3 4.3 -8.7 8.1 -9.8 -7.5 6.9 9.3
Thickness
T (1-3) -0.1 3.3 -6.7 6.4 -7.6 -5.8 5.5 7.3
(µm)
S (1-3) -0.9 2.9 -6.7 4.8 -7.4 -5.9 4.1 5.6
N (1-3) 0.0 7.0 -13.6 13.7 -15.4 -11.9 11.9 15.5
I (1-3) -0.5 5.6 -11.5 10.5 -13.0 -10.0 9.0 12.0

* LOA lower bound = mean-1.96xSD


** LOA upper bound = mean+1.96xSD

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Table 22. Deming regression analysis for the full retina thickness (ILM to RPE) parameters, 3 mm OCTA scan versus 6
mm HD OCTA scan, based on the combined group (15 Normal, 16 Glaucoma, and 36 Retina subjects).
All (Groups combined)
intercept_ intercept_ slope_ slope_
Parameter n intercept slope
CI_lower CI_upper CI_lower CI_upper
C (1) 67 0.8 -1.9 3.6 1.00 0.99 1.01
All (1-3) 67 0.9 -2.9 4.7 1.00 0.98 1.01
S_Hemi (1-3) 67 1.7 -1.2 4.5 0.99 0.98 1.00
Retina
I_Hemi (1-3) 67 0.8 -6.1 7.7 1.00 0.97 1.02
Thickness
T (1-3) 67 2.3 -2.3 6.8 0.99 0.98 1.01
(µm)
S (1-3) 67 1.8 -0.7 4.2 0.99 0.98 1.00
N (1-3) 67 -7.5 -26.3 11.2 1.02 0.96 1.08
I (1-3) 66 2.1 -4.1 8.3 0.99 0.97 1.01

Inner Retina Thickness (ILM to IPL)

Table 23. Limits of agreement for the inner retina thickness parameters, 3 mm OCTA scan versus 6 mm HD OCTA scan,
based on the combined group (15 Normal, 16 Glaucoma, and 36 Retina subjects).
All (Groups combined)
LOA_lower_ LOA_upper_ lower_95%CI_ upper_95%CI_ lower_95%CI_ upper_95%CI_
Parameter mean SD
bound* bound** for_LOA_lower for_LOA_lower for_LOA_upper for_LOA_upper
C (1) -0.2 2.3 -4.7 4.3 -5.3 -4.1 3.7 4.9
All (1-3) -0.6 1.2 -3.1 1.8 -3.4 -2.7 1.4 2.1
Inner Retina S_Hemi (1-3) -0.9 1.6 -4.1 2.3 -4.5 -3.6 1.9 2.8
Thickness I_Hemi (1-3) -0.4 1.9 -4.1 3.3 -4.6 -3.5 2.7 3.8
(ILM~IPL) T (1-3) -0.8 1.5 -3.8 2.1 -4.2 -3.4 1.7 2.5
(µm) S (1-3) -0.9 2.0 -4.9 3.1 -5.5 -4.4 2.6 3.7
N (1-3) -0.4 2.1 -4.5 3.7 -5.1 -4.0 3.1 4.2
I (1-3) -0.3 2.5 -5.1 4.5 -5.9 -4.4 3.8 5.2

* LOA lower bound = mean-1.96xSD


** LOA upper bound = mean+1.96xSD

Table 24. Deming regression analysis for the inner retina thickness parameters, 3mm OCTA scan versus 6 mm HD
OCTA scan, based on the combined group (15 Normal, 16 Glaucoma, and 36 Retina subjects).
All (Groups combined)
intercept_ intercept_ slope_ slope_
Parameter n intercept slope
CI_lower CI_upper CI_lower CI_upper
C (1) 67 -1.8 -2.9 -0.7 1.03 1.01 1.06
All (1-3) 67 -1.9 -3.3 -0.4 1.01 1 1.02
Inner
S_Hemi (1-3) 67 -1.9 -4.1 0.2 1.01 0.99 1.03
Retina
I_Hemi (1-3) 67 -2 -5.1 1.1 1.02 0.98 1.05
Thickness
T (1-3) 67 -0.5 -2.1 1.2 1 0.98 1.01
(ILM~IPL)
S (1-3) 67 -2.6 -5.6 0.4 1.02 0.99 1.04
(µm)
N (1-3) 67 -1.3 -3.9 1.3 1.01 0.98 1.03
I (1-3) 66 -1.8 -4.9 1.3 1.01 0.98 1.04

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17 Appendix F: Signal Strength Index (SSI)
The system provides a Signal Strength Index (SSI) to help you determine if the scan
quality is acceptable or not. The Signal Strength Index (SSI) is based on the intensity, or
brightness, of reflected light during scanning. Greater intensity corresponds with a
higher SSI. SSI is based on a global average over the entire scan pattern. The SSI
appears after each scan.

The SSI is a quantitative measure of signal strength, a major component of image


quality, but is not intended to be used alone to determine image quality. However, when
SSI is lower than the minimum recommended values given in Table below, Optovue
recommends that you re-take the scan to achieve an SSI value above the minimum
recommended, if possible.

Table Minimum Recommended SSI for Each Scan Type

Scan Type Minimum Recommended SSI

Retina Map SSI > 39

ONH SSI > 28

GCC SSI > 32

Minimum recommended values for SSI are different for Retina Map, ONH and GCC
scan types, because these scans address anatomical features that vary in their general
reflectivity. For example, GCC and Retina Map scans address the inner-plexiform layer
(IPL), which is generally less reflective, and thus darker when scanned, than other
layers. The system therefore requires greater intensity of reflected light to enable
recognition of the IPL. The minimum recommended SSI is lower for the ONH, because
the RNFL layer is highly reflective, allowing recognition of its layers even if the intensity
of reflected light is lower.

Characteristics of certain patients’ eyes can prevent the system from achieving an SSI
value above the recommended minimum, even after you retake the scan. One example
is ocular opacity from a cataract. In such cases, the clinician can choose to use the
scan, but should interpret it with more caution, compared to a scan with a high SSI.

Optovue established the SSI cutoff values for RTVue based on review of a large data
set of RTVue scans. The data set comprises approximately 100 scans with a wide
range of SSI values. It includes EMM5, ONH, and GCC scan types. These three scan

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types are the same in RTVue XR. (The EMM5 in RTVue is equivalent to Retina Map in
XR.) The criteria to establish the minimum recommended SSI was whether or not
visualization of the relevant retinal layers was possible. The relevant layers include the
ILM for all scan types; the RNFL for glaucoma scans; the IPL for GCC and retina scans;
and the RPE for retina scans. The minimum recommended SSI value was the value
where the relevant retinal layers could no longer be reliably visualized in the B scans.
Such scans cannot be segmented accurately, because the retinal layers cannot be
reliably visualized with low variability. The SSI values associated with this point (where
retinal layers cannot be reliably visualized) were determined to be the minimum
recommended values given in the table above.

To validate the minimum recommended SSI, which differentiates scans of acceptable


and unacceptable quality, Optovue evaluated all three scan patterns scans at different
SSI levels. To do this, we gathered SSI data from repeat scans performed on six normal
subjects with clear ocular media, which we used to establish a normal baseline. We
repeated each scan three times to calculate repeatability, defined as the standard
deviation of the thickness values for each measurement. We manipulated image quality
by defocusing the OCT image during scan acquisition. The defocusing and resulting
lower image quality mimics the clinical situation that occurs with media opacity and
small pupils. Analysis of all measurements results in the values presented in the
following tables. (Numerical values represent the standard deviation of the three scans
averaged across all six subjects.) The average standard deviation of thickness values
indicates the amount of measurement variability present when the SSI is above and
below the recommended minimum value; the higher the standard deviation, the greater
the measurement variability.

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Table EMM5 Scan: Thickness Standard Deviation when SSI Is Above and Below
Recommended Cutoff

Measurements Above Cutoff Below Cutoff

Fovea 9.58 54.57

Tempo 7.27 62.04

Superior 10.77 43.42

Nasal 6.91 52.72

Full
Inferior 10.90 60.97
Retina

Tempo2 5.33 38.96

Superior2 2.90 33.91

Nasal2 5.59 42.38

Inferior2 9.91 52.25

Average 7.68 49.02

Table shows the standard deviation of thickness for the three scans averaged over all
subjects for each EMM5 thickness parameter. The first column of data is the result
when the image quality is above the recommended cutoff (equal to or above the ROC
cutoff 39) and the scans are deemed acceptable and usable. The second column of
data is the result when the image quality is below the recommended cutoff (below the
ROC cutoff 39) and the scans are deemed unacceptable and not usable. Observe that
the standard deviations are very good (small) when the image quality is usable, and
then get much worse (large) when the image quality is unusable. Due to the high
variability and poor image quality of such unusable scans, Optovue recommends that
these scans not be used for clinical decision making.

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Table below shows ONH scan variability when SSI values are above and below the
recommended cutoff.

ONH scan Thickness Standard Deviation


when SSI Is Above and Below Recommended
Cutoff

ONH

Measurements Above Cutoff Below Cutoff

Avg RNFL 2.01 5.88

Sup RNFL 2.56 4.31

Inf RNFL 2.76 8.82

Tempo 6.21 11.52

Superior 3.96 10.46

Nasal 4.55 12.68

Inferior 3.68 8.36

TU 5.68 14.16

ST 5.29 13.37

SN 5.92 15.63

NU 5.82 15.79

NL 4.52 10.99

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ONH scan Thickness Standard Deviation
when SSI Is Above and Below Recommended
Cutoff

ONH

Measurements Above Cutoff Below Cutoff

IN 5.40 14.56

IT 4.29 13.93

TL 7.76 19.08

Average 4.69 11.97

+ Note: The EMM5 scan in the RTVue has been renamed to Retina Map in the
RTVue 100 XR.

Table shows the standard deviation values of three scans averaged over all subjects for
each ONH thickness parameter. The first column of data is the result when the image
quality is above the recommended cutoff (equal to or above the ROC cutoff 28). The
second column of data is the result when the image quality is below the recommended
cutoff (below the ROC cutoff 28). Observe that the standard deviations are very good
(small) when the image quality is usable, and then get much worse (large) when the
image quality is unusable. Due to the high variability and poor image quality of such
unusable scans, Optovue recommends that these scans not be used for clinical
decision making.

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Table GCC Scan: Thickness Standard Deviation when SSI Is Above and Below
Recommended Cutoff

GCC

Measurements Above Cutoff Below Cutoff

Inner Retina Average 1.88 12.25

Superior Average 2.13 14.06

Inferior Average 3.25 14.02

S-I Average 4.13 12.43

GCC-FLV 0.98 3.59

GCC-GLV 1.47 4.85

Average 2.31 10.20

Table shows the standard deviation values of three scans averaged over all subjects for
each GCC thickness parameter. The first column of data is the result when the image
quality is listed as above the cutoff (equal to or above the ROC cutoff 32) and the scans
are deemed acceptable and usable. The second column of data is the result when the
image quality is below the cutoff (below the ROC cutoff 32). Observe that the standard
deviations are very good (small) when the image quality is usable, and then get much
worse (large) when the image quality is unusable. Due to the high variability and poor
image quality of such unusable scans, Optovue recommends that these scans not be
used for clinical decision making.

When scanning, the Signal Strength Index (SSI) should be green. However, due to
individual patient variability and the light absorption properties of pathologies, it is not
always possible to achieve a green signal. If signal strength is not in the green over a
range of patients including normals, contact Optovue Technical Support for assistance.

_______________End of section_______________

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18 Appendix G Cornea Anterior Module (CAM)

Safety Notes
General
This XR system accessory has been developed and tested in accordance with the
Optovue safety standards as well as national and international regulatory guidelines. A
high degree of instrument safety has been ensured. Observe all safety notes and
information in this manual and on the device labels.

Proper Instrument Use


1. Always clean all patient contact surfaces (forehead and chin rest according to the
cleaning method in the XR user manual.
2. Ensure the CAM lens is attached when capturing scans in the Cornea category.
3. Note the working distance to the cornea surface for CAM lens (13mm for the CAM-L)
4. Align the eye to the proper eye position (canthus) indicator mark on the chin rest.
5. Illuminate the external eye structures using the Red LED illumination lights
6. Use the Live IR video image on the LCD monitor and the OCT scan window to
monitor distance and focus relative to the patient’s eye.

Intended Use
The CAM, an auxiliary lens adapter, when used in conjunction with XR, is indicated
for in vivo imaging and measurement of the cornea and other ocular structures of the
anterior segment of the eye, including pachymetry and corneal power.

+ Note: Neither XR nor XR/CAM OCT are intended to be used as the sole
diagnostic aid in disease identification of classification.

Warning: Corneal Power Feature


The Net Corneal Power value determined by the TCP function is NOT
INTERCHANGEABLE with the corneal power value determined by any
other device. The Net Corneal Power determined by the TCP function
of the CAM option for XR is not intended to be used in lieu of, or
replace a value from another device into your standard IOL
calculation formula.

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Warning: User Changes to Software or Hardware
The XR and XR with CAM Option are medical devices. The software and
hardware is designed in accordance with U.S., European and other
international medical device design and manufacturing standards.
Unauthorized modification of RTVue XR100 or RTVue XR with CAM
Option software or hardware in any way can jeopardize the safety of
operators and patients, the performance of the instrument, and the integrity
of patient data. Modification of either of these in any way also voids the
instrument warranty in its entirety.

Warning: Phototoxicity
The CAM Option is an accessory only for the Avanti system and has no
function whatsoever as an independent product. As such, the CAM option
may not be used independently of the Avanti system, and should be kept
in the storage (wooden) box when not in use.

There is no increase in the risk of phototoxicity from the Avanti system


when used in conjunction with the CAM option. Refer to the Avanti user
manual for all Safety Notes pertaining to the use of the system.

Product Compliance
European Conformity

0197 2007/47/EC Medical Device Directive

European Notified Body:


TÜV Rheinland LGA Products GmbH
Tillystrasse 2, 90431 Nuremberg Germany

European Representative

Medical Device Safety Services (MDSS) GMbH


Schiffgraben 41
30175 Hannover, Germany

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Lens Identification and Serial Number Location:

CAM-L Lens (also referred to as CAM Lens)

_______________End of section_______________

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Instrument Description
The Avanti/CAM system is comprised of the XR system and the CAM option (cornea
lens adapter) for use in imaging the cornea and anterior chamber of the eye.

The lens adapter is attached and removed by a trained operator. The cornea scan
patterns and analysis functions are enabled only after the XR/CAM license is
purchased.

XR/CAM System Configuration:


The lens adapter with low magnifications (CAM-L) is not included in the standard XR
systems:
1. XR Scanner
2. Computer
3. System Table
4. Monitor (Computer Display)
5. Keyboard and Mouse
6. Printer
7. Cornea lens adapter (CAM)

Refer to the XR user manual for detailed descriptions of all sub-systems.

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External Fixation
(yellow LED)

Cornea
Illuminators
(red LED)

Figure 241 Scanner head with fixation and cornea illumination lights

_______________End of section_______________

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Getting Started
Refer to the XR Installation Manual for system unpacking and installation instructions.

18.4.1 Mounting the Lens Adapters


The lens has a bayonet mount system.

+ Note: The working distance between the lens adapter and cornea is
13 mm on the CAM-L model.

Pull the scanner head all the way back, align using the live IR video image
of the patient’s eye, then gradually move the scanner head forward until
OCT scan is in the target area. This will coincide approximately with the
patient’s iris coming into focus in the live IR video image.

Do not move the instrument head quickly and monitor proximity to patient
in order to avoid incidentally hitting the patient’s eye with the CAM lens
surface.

_______________End of section_______________

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Patient Menu
Refer to the XR User Manual for this section.

_______________End of section_______________

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Examine Menu

18.6.1 Scan Patterns


Click the Cornea button and then select a scan pattern from the list that appears, which
activates scan acquisition. (See section 9 for a list of scan patterns and specifications.)

Figure 242 Scan pattern selection

18.6.2 Scan Acquisition:


The following is a general procedure to acquire cornea OCT images:
1. Turn off the exam room light (recommended)
2. Attach the CAM lens
3. Use the two red external illumination LEDs on headrest to illuminate the cornea (one
for each eye).
4. Instruct patient to fixate on the center of light blue internal fixation target.
5. Use the yellow external fixation LED on headrest to guide patient fixation if required.
For corneal power scan, use an internal fixation target
6. Operator should center the scan on the pupil. If the misalignment exceeds 1 mm
(pupil center exceeds the boundary of the smallest alignment circle), the scan should
be excluded.

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7. Operator should make sure that the eyelid or eyelashes are not blocking or
shadowing a significant portion of the image in vertical meridians concentric circle on
the screen. If there is blocking or shadowing, the scan should be excluded.
8. Operator should observe the measurement reliability index status on the report
screen (for cornea power). A measurement with poor measurement reliability
indicates increased risk of measurement variability. Measurements with poor
reliability should be replaced if possible.

Note: Corneal power measurements are not displayed for poor quality
scans in which an algorithm failed. In this case, the scan should be
repeated.
9. Align on the desired area to scan.
10. Move forward until the iris is in focus in the live IR image (the image of the desired
external scanned region should be within the target zone (two dashed red horizontal
lines).
11. Adjust scan beam to target zone and orientation with joystick.
12. Adjust image quality/scan strength (P-Motor adjustment).
13. Capture scan using joystick button or capture button on screen.
14. Review and process (averaging) the OCT images.
15. Save the scan.

Remember the following key operation points:


1. Use the XR with CAM like a Photo slit lamp in that when the live IR video image is in
focus, stop forward motion of the scanning head as the scan should be in the target
area (or very close).
2. Auto All and Auto-Z are disabled.
3. Minimal Focus motor adjustment may be used (only available in manual scan control
options).
4. Use the P-Motor to optimize scan signal strength.

The following items are preset and not adjustable.


1. Internal Illumination: Set to 0
2. Focus: default set to cornea (can be adjusted to optimize the image intensity for
Line, Cross Line and Angle scans)
3. Z position: Set at constant value depends on the system

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18.6.3 Scan Alignment
OCT scan window: Place the cornea B-scan image in between the two red guide lines
to optimize the cornea scan images. Pachymetry, PachymetryWide and cross line
scans will have two OCT windows, one for vertical b- scan, and one for horizontal b-
scan.

Figure 243 B scan between red lines

Scan pattern live video window-alignment will depend on scan type chosen.
1. Pachymetry and Pachymetry Wide scan: Align the aiming circle (inner circle is
4mm diameter and outer circle is 6mm diameter) to the center of the pupil.

Figure 244 Iris image

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2. Angle scan: Use the external fixation (yellow light on gooseneck cable) to guide the
patients fixation until the cornea/sclera edge is parallel and located in the red
guided lines region. Place center of scan line pattern on the limbus and
cornea/scleral OCT image parallel to the red horizontal guidelines.

Figure 245 Iris and B scan image for Angle

+ Note: Only when the posterior cornea/sclera tissue is parallel or


contained inside the red lines (from left to right edge of scan) are the
AOD/TISA measurements accurate.

3. Line, cross line, 3-D cornea: these scans are centered on the pupil or particular
area of interest.

Figure 246 Cross line centering

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18.6.4 Technical Note Regarding Dewarp
Dewarp is a mathematic calculation (Snell’s Law) used to transfer the OCT image in
“optical distance space” to “physical distance space.” A good example of the image in
“optical distance space” is when you see a straw in a glass with half water full. The
straw in the water seems bent at the interface between water and air, and the portion of
the straw in the water looks thicker than the portion of the straw in the air.

There are two aspects to the dewarp calculation:


1. Shape change (like the bending of the straw): This is caused by the cornea surface
that is not perpendicular to the scan beam. This cannot be avoided when scanning a
length greater than 3mm of the cornea. If you scan on a relative flat surface of
cornea or sclera, the incident beam is relatively perpendicular to the surface. In this
instance the beam will not be bent or warped. For example, if you make the straw
perpendicular to the water surface, the straw does not look bent or warped at the
water and air interface.
2. Distance Change: The straw looks thicker because the index of refraction (n) of
water is 1.33 times of the air (n=1.33). The cornea (n= 1.38) and aqueous (n=1.34)
are very similar but are at a higher index than that of air. To make the physical
distance measurement, the tissue thickness needs to be divided by the index of
refraction of the media.

A dewarp calculation is used on the cornea Line, Cross line and Pachymetry scans to
transfer the OCT image into a physical image of the cornea for both shape and
distance. For all other scans, the live scan image is placed within the red dashed lines,
so the incident beam is relatively perpendicular to the tissue surface. A distance scale
factor is only applied in the measurement tool to get accurate distance and area
measurements.

_______________End of section_______________

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Review Menu

18.7.1 Review Layout


Refer to the XR user manual.

18.7.2 Measurement
Refer to the XR user manual.

18.7.3 Review Result Layout

18.7.4 Line

Figure 247 Line scan report

If the image saved is an average processed image on both Line and Cross line scans,
both the averaged and single frame image will be saved.

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18.7.5 Cross Line Scan
The illustration below shows both vertical and horizontal cornea scan images.

Figure 248 Cross line report

18.7.6 Scan with Thickness Measurement Tool

Figure 249 B scan with Measurement tool

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Figure 250 B scan with artifact

+ Note: The artifact in the image is from an interference signal caused by the
strong signal on both anterior and posterior cornea surface. The artifact is
fixed at the same location. To avoid or remove the artifact from your scan,
use the joystick to move the scan on the eye slightly up/down, left or right.
(Use the chinrest elevation control up/down switch for chin adjustment down
to avoid the artifact).

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18.7.7 Angle
This surface should be parallel or fall
between the red dashed lines.

Figure 251 B scan of angle

18.7.8 TISA/AOD Measurement Tool


TISA (Trabecular Iris Surface Area) Measurement tool is used to measure the angle
area and AOD (angle open distance) in the anterior chamber angle. The number 500 or
750 is the distance (in microns) measured between the two upper points along the
posterior cornea surface. One of these two upper points shall be located on the sclera
spur and the other one on the posterior cornea surface 500 or 750µm away from sclera
spur. The AOD is the distance from cornea to iris. The area is measured as the
trapezoidal area encompassed by these four points.

Figure 252 Four scan display page

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18.7.9 3D Cornea
The Cornea 3D scan has scan density of 513 A-scans and 101 B-scans.

Figure 253 3D Cornea report

See the Avanti user manual for more information on the 3D scan presentations. The 3D
Cornea presentation is similar to that for the retinal 3D presentations (without retinal
features). Below is a sample presentation created by clicking on 3D Display.

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Figure 254 3D Cornea Volume presentation

18.7.10 Pachymetry
The pachymetry scan is a set of 8 radial meridians 6mm in length and centered on the
pupil.

Figure 255 Illustration of Pachymetry scan pattern, 8 meridians, 6mm long

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.

The pachymetry report is a comprehensive collection of maps, tables, and images that
provide qualitative and quantitative assessment of the cornea.

Cornea thickness results are presented as a color-coded map (6mm) and a color scale
provides reference values for colors. Thicker values are hot colors like red and orange,
while thinner values are cool colors like blue and black.

Individual B-scans are displayed in the presentation window above the map. Different B-
scans can be displayed by clicking on the thickness map (making it interactive) and
moving the cursor around slowly to the white lines (scan location indicators).

Figure 256 Pachymetry report

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18.7.11 Pachymetry Assessment
The Pachymetry analysis provides some key thickness parameters in the table to the
left of the Pachymetry report. The Epithelial map also has a normalized mode to
highlight thickness variation.

Image Below: Selecting the “Stroma map” will cause the stroma map to replace the
epithelial thickness map.

Figure 257 Pachymetry report with epithelial thickness/Stroma map

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18.7.12 Symmetry and Change Analysis

Figure 258 Symmetry Analysis for Pachymetry Results (Normalized)

Figure 259 Change Analysis Results for Pachymetry, Cornea Power and
Epithelial/Stroma Map

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18.7.13 Wide Field Pachymetry (9mm)

Figure 260 9mm Widefield Pachymetry with Epithelial/Stroma thickness

Note: Shaded areas indicate suspect data, the scan should be reviewed to determine
accuracy. (Data is often compromised by lid related issues)

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The Epithelial scale can be displayed with the locked scale 35-65 microns or for more
enhanced visualization with a normalized scale.

Figure 261 Widefiled Pachymetry with normalized Epithelial scale

Figure 262 Widefield Pachymetry Change Analysis

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Figure 263 Widefield Pachymetry OU report with Epithelial/Stroma maps

All Stroma maps are the result of pachymetry (total thickness) minus epithelial thickness.

18.7.14 Corneal Power


The Corneal Power feature is available to customers who have purchased the Corneal
Power upgrade. For information on how to install and validate the cornea power tool,
refer to the installation manual.

The Net Corneal Power value determined by the TCP function is NOT
INTERCHANGEABLE with the corneal power value determined by any other
device. The Net Corneal Power determined by the TCP function of the CAM option
for Avanti is not intended to be used in lieu of, or replace a value from another
device into your standard IOL calculation formula.

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18.7.15 Summary Description
Corneal power is one of the key input parameters for IOL power calculation in cataract
surgery. In clinical practice, corneal power is commonly measured by manual or
automated keratometry or by simulated keratometry (Sim-K) from Placido-ring corneal
topographers. Corneal power provided by keratometry or topography is based on
measuring the anterior surface curvature of the cornea and assuming a fixed ratio of
0.883 between posterior and anterior curvature to compute the total corneal power.3
Corneal power measurement with keratometer or topographer works well enough in
normal eyes, but the assumption of fixed ratio between anterior and posterior curvature
could lead to erroneous corneal power assessment in eyes with corneal pathology or
eyes with prior refractive surgery for obvious reasons.1,2,3 Therefore, direct
measurement of both anterior and posterior corneal curvatures to assess corneal
refractive power as implemented in XR CAM could be advantageous.

The XR CAM net corneal power is not clinically interchangeable with keratometric
corneal power measurements or Pentacam net corneal power measurement for IOL
Power calculation. In other words, the XR CAM corneal power measurements cannot be
directly applied in existing IOL power formulas developed based on measurements
provided by other devices, such as keratometer or Pentacam

XR corneal power scan is performed with CAM adaptor and with the “Pachymetry” scan
protocol which consists of 5 sets of pachymetry scan. Each set of pachymetry scan
consists of 8 evenly spaced meridian scans (6 mm in length each) centered on the
pupil.

The corneal curvature radii are derived based on best fit sphere to the central 3 mm for
anterior and posterior surfaces. The anterior and posterior corneal power is calculated
based on refractive indices of 1.376 for the cornea and 1.336 for the aqueous. The net
corneal power is calculated using a thick lens formula based on anterior corneal power,
posterior corneal power, taking into account the central thickness of the cornea.

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18.7.16 Summary Report
The results of the Corneal Power scan provides Net, Anterior, and Posterior power
measurements, representing the net corneal power, anterior corneal power, and
posterior corneal power respectively, in measurement unit of diopter (D). The radius of
curvature measurements are also provided, in measurement unit of mm. A
measurement reliability index for the corneal power measurement is also provided on
the analysis report. Selecting the “Stroma map” will cause the stroma map to replace
the epithelial thickness map

Figure 264 Pachymetry report with Corneal power values

When acquiring Corneal Power scan, the following steps should be observed.
1. Patient must be instructed to fixate on the center of light-blue internal fixation target
with the test eye.
2. Operator should center the scan on the pupil. If the misalignment exceeds 1 mm
(pupil center exceeds the boundary of the smallest concentric circle on the screen),
the scan should be excluded.
3. Operator should set the working distance properly by placing the corneal cross-
sectional images within the range defined by the two horizontal red lines to avoid
image cropping.

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4. Operator should make sure that the lids of the eye are not blocking or shadowing a
significant portion of the image in vertical meridians.
5. Operator should observe the measurement reliability index status on the report
screen. A measurement with poor measurement reliability indicates increased risk of
measurement variability. Measurements with poor reliability should be replaced if
possible.
6. Corneal power measurements are not displayed for poor quality scans in which an
algorithm failed. In this case, the scan should be repeated.

Correct patient fixation and alignment centered on pupil are both critical to
produce consistent corneal power measurement.

Examples of corneal power scan quality problems to watch for are provided in Appendix A

Figure 265 Pachymetry & Epithelial change analysis with Corneal Power values

18.7.17 Repeatability
The repeatability (standard deviation) of the corneal power scan with XR CAM is
summarized in the table below. The repeatability of corneal power parameters is better

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than 0.25D for a single scan in the normal eye and the post-laser refractive surgery
eyes. For clinical use, it is recommended that a user takes at least three corneal power
scans and calculate mean corneal power to further reduce measurement variability.

Pathological or
Post-Laser Refractive
Normal Post-Incisional
Surgery
Surgery
Net Corneal Power (D) 0.21 0.17 0.35
Anterior Corneal Power (n=1.3375) (D) 0.20 0.16 0.39
Posterior Corneal Power (D) 0.05 0.05 0.16
Anterior Radius of Curvature (mm) 0.034 0.030 0.064
Posterior Radius of Curvature (mm) 0.050 0.048 0.172
Central Corneal Thickness (µm) 2.1 1.9 3.8
Thinnest Corneal Thickness (µm) 3.8 1.3 18.0
Figure 266 repeatability (standard deviation) of the corneal power scan

18.7.18 Validation
To ensure system stability overtime, the corneal power software automatically prompts
for a weekly validation test. The validation test is performed with the corneal power
validation tool stored with the instrument. The result of the validation test is compared
with the stored value obtained during the initial corneal power calibration to verify
system stability. The limit of acceptable difference is ±0.25D; if exceeded, the software
will not allow acquisition of corneal power scan. A warning message is displayed on
screen with instructions for further actions. See section 18.12 A for instructions to
perform the Validation Test.

If the weekly validation test is not performed on schedule, the corneal power feature will
be automatically disabled and only pachymetry measurement will be produced. To
reactivate corneal power measurement, select the validation test and perform the test
according to instruction.

18.7.19 References:
1. Seitz B, Langenbucher A, Nguyen NX, Kus MM, Ku¨chle M. Underestimation of
intraocular lens power for cataract surgery after myopic photorefractive keratectomy.
Ophthalmology 1999; 106:6936–702.
2. Wang L, Hill WE, Koch DD. Evaluation of intraocular lens power prediction methods
using the American Society of Cataract and Refractive Surgeons Post-
Keratorefractive Intraocular Lens Power Calculator. J Cataract Refract Surg 2010;
36:1466–1473.

RTVue XR Avanti User Manual Page 402 of 451 P/N 580-52576-005 Rev. A
3. Tang M, Li Y, Avila M, Huang D. Measuring total corneal power before and after
laser in situ keratomileusis with high-speed optical coherence tomography. J
Cataract Refract Surg. 2006; 32:1843-50.

18.7.20 Epithelium Thickness Mapping


The Epithelium Thickness Mapping feature is available to customers who have
purchased the Epithelium Thickness Mapping upgrade, USA 9mm ETM and
international 6mm & 9mm ETM are available..

There is a clinical need to measure epithelial cell layer separately from the pachymetry
of the cornea. The thickness distribution of the layer is useful in the evaluation and
follow up of patients for irregularities and/or changes due to pathologies, contact lens,
or refractive surgeries. Epithelium Thickness measures the thickness from the epithelial
cell surface to Bowman’s membrane. The Epithelium Thickness Mapping feature is an
upgrade to the pachymetry scan – a sample pachymetry report with epithelium
thickness mapping is shown below. Selecting the “Stroma map” will cause the stroma
map to replace the epithelial thickness map

Figure 267 Pachymetry report displaying Epithelial thickness map

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The scan report of epithelium thickness displays an Epithelium/Stroma Map to the right
of the pachymetry scan.

+ Note: The Epithelium Map uses a different color legend than that for the
Pachymetry Map. An Epithelium/Stroma Thickness analysis is displayed
under the Pachymetry analysis as well.

Symmetry Analysis

Figure 268 Pachymetry Change Analysis with Epithelial Thickness/Stroma and Corneal
Power

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OU Report

Figure 269 Pachymetry OU Report With Epithelial Mapping/Stroma and Corneal Power

_______________End of section_______________

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File Management Menu
Refer to the XR manual for this section.

_______________End of section_______________

Maintenance and Troubleshooting


Refer to the XR user manual for this entire section plus additional CAM lens care.

Cleaning the Corneal Power Validation Tool


1. Keep the CAM lenses and the Corneal Power Validation Tool in the wooden case
provided when not in use.
2. Routinely check the lens for dust, fingerprints, or smudges.
3. Use the same cleaning method as is recommended in the XR User Manual to use to
clean the front ocular lens of the XR.

_______________End of section_______________

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Scan Pattern Specifications
See the table below for scan pattern specification information.
# A-Scan
Scan Pattern
Description (without Adjustability Default
Name
averaging)
8 radial lines with 6mm scan
length (1020 A-scans/line) 6mm radial
Pachymetry 1020 x 8 Fixed
and 22.5 degree interval. B scan
scan 4 frame avg.
8 radial scans with 6mm
scan length (1020 A-
1020 x 8 x 5
Pachymetry + scans/line) and 22.5 degree 6mm radial
(due to 5 Fixed
Corneal Power interval. scan
repeated sets)
5 repeated sets are taken.
8 radial scans with 9mm
scan length (1536 A-
9 mm radial
PachymetryWide scans/line) and 22.5 degree 1536 x 8 Fixed
scan
interval. B scan 4 frame
avg.
Transverse: 2 -8
mm (0.5 mm
1020 A-scans/line with 8mm, 0
Cornea Line 1020 x 1 increment) Angle: -
adjustable scan length degree
90° - 90° (1°
increment)
Transverse: 2 -8
Two scan lines orthogonal
mm (0.5 mm
Cornea Cross to each other with 8mm, 0
1020 x 2 increment) Angle: -
Line adjustable scan length degree
90° - 90° (1°
(1020 A-scans/line)
increment)
Transverse: 2 -6
1 scan line with adjustable mm (0.5 mm
3mm, 0
Angle scan length (1020 A- 1020 x 1 increment) Angle: -
degree
scans/line) 90°- 90° (1°
increment)
101 horizontal scan lines
Transverse: 4mm -
with 6mm scan length (513
6mm (1mm
3D Cornea A-scans/line) and 60 µm 513 x 101 6 mm
increment)
interval between each
Angle: fixed at 0°
horizontal scan.

_______________End of section_______________

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Technical Data

18.11.1 System Specifications

Performance Specifications Summary:


1. OCT Image Resolution: 5 µm (in tissue)
2. OCT Image Scan Rate: 70,000 A-Scan/Second
3. Scan Depth: Maximum of 2.3 mm
4. Scan Length (CAM-L): 2-8 mm
5. Cornea Image FOV: 12mm x 8mm

Cornea Imager:
• Monochrome CCD Camera: 811x 508 pixel 1/3” CCD Format
• NIR Illumination: 735nm LED

Patient Interface:
• Working distance:
• CAM-L: 13 mm
• Motorized Chin-Rest adjustable range: 65mm
• Joystick controlled X-Y-Z adjustment: X-100m, Y-85mm, Z-25mm
• Lock-mechanism: Manual

Measurement Features:
Cornea Analysis:
• CAM-L:
a. Pachymetry map
i. Cornea thickness map
ii. Flap/Stroma thickness Measurement
iii. Pachymetry Assessment
iv. Corneal Power Assessment
b. Line: Flap/Stroma, Distance/Area measurement
c. Cross line : Flap/Stroma, Distance, Area measurement

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d. Angle Scan (3mm scan length, 2.3mm depth)
i. AOD 500/750 measurement
ii. TISA 500/750 measurement
iii. Angle in degrees

_______________End of section_______________

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Corneal Power

+ Note: This feature is a license controlled revenue product and payment


for the license is only in advance.

Follow the activation instructions provided with the license key in the document titled
Corneal Power License Key – Activation Instructions.

18.12.1 Validating Corneal Power Calibration Tool


Corneal Power (Calibration) Validation
The Cornea Power scan must be re-calibrated every seven days. Clinical staff should
be trained to perform the below calibration validation steps every 7 days. Before using
the calibration tool, please make sure tool is clean. Refer to section 18.9 for steps to
clean the calibration tool.
• Attach the CAM lens onto the Avanti machine and slip the calibration tool on the
end of the lens until it stops. Tighten the white lock nut as shown in the figure
below.

Figure 270 Mounting of Corneal power validation tool

• Select Test Patient


• Click Examine and select the Pachymetry scan. A warning window will pop-up
as shown in the below image. Click the Yes button.

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Figure 271 Validation message

• Start the scan.


• Check that the two images are between the red parallel lines. The two images
are in the X and Y axis planes.

Figure 272 Validation screen

• Using the mouse, click and hold the target on the aiming screen and move the
aim LEFT or RIGHT to get a wide reflection on the image and to align the center
of the reflection to the center guideline on the X Axis plane.
• Using the mouse, click and hold the target on the aiming screen and move the
aim UP or DOWN to get a wide reflection on the image and to align the center of
the reflection to the center guideline on the Y Axis plane.

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Figure 273 OCT Reflection signal

• Press Auto P to optimize the signal.


• Once the OCT reflection and red dotted line are aligned, click the green check
mark, and save the scan. The machine will confirm calibration of cornea power.
• The device is now ready.

+ Note: The calibration procedure will need to be repeated every 7 days.

• If validation fails and error message similar to the one below appears, remove
and clean the Validation tool.

Figure 274 Validation failure message

• Re-install the Validation tool over the CAM lens until it stops, tighten the white
lock screw and retry validation.
• If error message continues to appear when attempting the Validation, the TCP
requires a re-installation. Contact your Optovue service department for
assistance.

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18.12.2 Corneal Power Scan and Calculations
The corneal power scan consists of 5 sets of pachymetry scans in rapid succession.
Each set of pachymetry scan consists of 8 meridian scans of 6mm in length centered on
the pupil.

As illustrated in the figure below, the anterior and posterior corneal curvature radii are
calculated from 8 meridian corneal cross-sectional images based on the central 3 mm
zone. The corneal anterior power ( K a ) and posterior power ( K p ) are calculated based
on the anterior radius ( Ra ) and the posterior radius ( R p ) as follow:

n1 − n0 n2 − n1
Ka = , Kp =
Ra Rp

where n0 = 1, n1 = 1.376 and n2 = 1.336.

Figure 275 Curvature illustration

The net corneal power is computed using thick lens formula:

D
K = Ka + K p − * Ka * K p
n1

where D is the central corneal thickness.

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18.12.3 Samples of Poor or Borderline Quality Corneal Power Scan

Figure 276 Invalid scan. No corneal power measurements are calculated

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Figure 277 Poor reliability index.

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Figure 278 Scan out of range

Scan out of range, placed too low in the window that part of the corneal cross-sectional
OCT image is cropped.

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Figure 279 Eyelid blocking more than 1 mm of the image.

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Figure 280 Eyelid blocking between 0.5 mm ~ 1 mm of the image.

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Figure 281 Eyelid / Eyelash artifact

Occasionally, eyelid or eyelash artifact in meridians other than the vertical one (due to
blinking) could cause obvious artifact in the pachymetry map but no obvious impact on
CCPNet measurement quality.

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Figure 282 Misalignment on pupil between 0.5 mm ~ 1 mm.

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Figure 283 Pupil blocked by eyelid in the video image and alignment cannot be assessed.

_______________End of section_______________

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Pachymetry & Epithelium Mapping

+ Note: This ETM is a license controlled revenue product and payment


for the license is only in advance.

Follow the activation instructions provided with the license key in the document titled
Epithelium Mapping License Key – Activation Instructions.

1.1 Detection of Epithelial Boundaries


The automatic algorithm measures epithelial thickness from corneal anterior surface to
the posterior boundary of the epithelia. The posterior boundary is defined as the
interface of epithelia and Bowman’s Layer. When the Bowman’s layer is absent as in
post-PRK eyes, the posterior boundary is defined as the interface of epithelia and the
corneal stroma. There is characteristic reflectivity change at the interfaces which is
utilized in the automatic algorithm for boundary detection. The automatic segmentation
of the corneal anterior and posterior boundaries and epithelial posterior boundary and
resulting corneal thickness map and epithelial thickness map are illustrated with a post-
LASIK eye and with a post-PRK eye as illustrated in the following two images
respectively. Because of the difference in the characteristics in the epithelial posterior
boundary in LASIK and PRK eyes, for this validation study, we separated the post-laser
refractive surgery eyes into LASIK group and PRK group in the data analysis.

Figure 284 Automatic segmentation boundaries Lasik

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Automatic segmentation of corneal and epithelial boundaries in the right eye of a 33 yrs.
old male study subject with LASIK previously. The Bowman’s layer is clearly visible and
in some region, the LASIK flap interface is also visible. The automatic segmentation
lines for the corneal and epithelial boundaries are shown in the middle. The resulting
thickness maps are shown on the right.

Figure 285 Automatic segmentation boundaries PRK

Automatic segmentation of corneal and epithelial boundaries in the left eye of a 42 yrs.
old female study subject with PRK previously. The Bowman’s Layer is absent as the
result of the PRK procedure. The automatic segmentation lines for the corneal and
epithelial boundaries are shown in the middle. The resulting thickness maps are shown
on the right.

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18.13.1 Identification of Segmentation Error and Manual Correction
Check epithelial map for obvious segmentation error along the eight meridian scan
lines. When segmentation error was noted, corresponding cross-sectional OCT image
with segmentation line overlay was reviewed for confirmation. Examples of scans from
the same eyes with successful segmentation and with obvious segmentation error are
shown in the figure below.

Figure 286 Segmentation error

Pachymetry maps (Left) and epithelial maps (Right) of a 44 yrs. old KCN patient. The
epithelial segmentation was acceptable for the 1st scan (Top row) but failed in meridian

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2 (M-2) in the 2nd scan (Bottom row). The segmentation error is easily recognized based
on sharp color change along the scan lines.

Manual correction is quite feasible when the error is limited to a small number of
meridians, and could be helpful when imaging difficult eyes. As illustrated in the figure
below, the segmentation error in meridian 6 causing a visible artifact in the epithelial
map (Top row), and with manual correction of the segmentation error in meridian 6, the
artifact in the epithelial map is much reduced. Note that manual correction of the
posterior boundary of the epithelial layer didn’t affect the pachymetry map. If a scan has
segmentation error in multiple meridians, it is probably more efficient to retake the scan
instead of manually correcting each affected meridian.

Figure 287 Reprocessed Map

Pachymetry map and epithelial map of the left eye of a 65 yrs. old male KCN patient.
Note the artifact in the epithelial map in meridian 6 (M-6) in the top row. After manually

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adjusting the epithelial segmentation line for Meridian 6, the epithelial map was
reprocessed with the correction. Note the defect in the epithelial map after is much
reduced (bottom row). The pachymetry map remains the same before and after.

Clinical Validation Study 6mm Pachymetry scan


Clinical validation of the software was performed based on the following study groups
1. Normal cornea with no contact lens wearing history (Normal)
2. Normal cornea with regular contact lens wearing history (CL)
3. Post-laser refractive surgery cornea (Post-LRS), which was further separated
into two sub groups in the analysis: post-LASIK group (LASIK) and post-PRK
group (PRK)
4. Keratoconus cornea (KCN)

While we do not expect the dry eye syndrome group to pose extra difficulty in the
epithelial thickness automatic measurement algorithm as compared to the KCN group
or the LASIK and PRK groups, the performance data for the dry eye syndrome
group has not been established and extra caution is recommended when using
the device for the measurement of the dry eye subject group.

18.14.1 Enrollment Criteria

18.14.2 Normal
Subjects were recruited from staff volunteers, patients seeking refractive surgery
consultation, and patients seeking cataract surgery consultation according to the
following criteria.
1. 18 years of age or older
2. No corneal pathology
3. Not a contact lens wearer
4. No prior ocular surgery and no prior laser refractive surgery
5. No history and no current diagnosis of dry eye

18.14.3 CL
Subjects were recruited from staff volunteers, patients seeking refractive surgery
consultation, and patients seeking cataract surgery consultation according to the
following criteria.
1. 18 years of age or older
2. A regular contact lens wearer

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3. No corneal pathology
4. No prior ocular surgery and no prior laser refractive surgery

18.14.4 LASIK
Subjects were recruited from the pool of post-LASIK patients according to the following
criteria.
1. 18 years of age or older
2. No corneal pathology
3. No prior ocular surgery except laser refractive surgery
4. At least 1 week post laser refractive surgery without complication

18.14.5 PRK
Subjects were recruited from the pool of post-PRK patients according to the following
criteria.
1. 18 years of age or older
2. No corneal pathology
3. No prior ocular surgery except laser refractive surgery
4. At least 1 week post laser refractive surgery without complication

18.14.6 KCN
Subjects were recruited from the pool of patients with keratoconus diagnosis according
to the following criteria.
1. 18 years of age or older
2. Clinical diagnosis of keratoconus
3. No prior laser refractive surgery

Epithelial measurement parameters evaluated:


1. Min: Minimum epithelial thickness of the map
2. Max: Maximum epithelial thickness of the map
3. Std Dev: Standard deviation of the epithelial thickness of the map
4. Superior: Average epithelial thickness of the superior region of the map between
2mm to 5mm in diameter
5. Inferior: Average epithelial thickness of the inferior region of the map between 2mm
to 5mm in diameter.

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6. Central: Average epithelial thickness of the central 2mm diameter region

18.14.7 Study Subject Demographics and Characteristics


17 normal subjects, 10 CL subjects, 12 LASIK subjects, 9 PRK subjects, and 13 KCN
patients were included in the validation study.

Age distribution by study group.

Analysis Variable : Age

Group N Obs N Mean Std Dev Range Minimum Maximum

CL 10 10 34.500 12.748 38.000 18.000 56.000

KCN 13 13 48.538 12.306 42.000 27.000 69.000

LASIK 12 12 50.583 12.937 39.000 26.000 65.000

Normal 17 17 46.294 15.280 46.000 19.000 65.000

PRK 9 9 41.778 12.969 41.000 23.000 64.000

Signal strength distribution by study group.

Analysis Variable : SSI

Group N Obs N Mean Std Dev Range Minimum Maximum

CL 10 10 40.913 3.548 12.590 36.097 48.686

KCN 13 13 42.135 8.810 29.304 33.072 62.376

LASIK 12 12 39.238 3.921 12.453 32.500 44.953

Normal 17 17 39.785 3.029 12.410 32.090 44.500

PRK 9 9 42.019 4.545 11.828 36.199 48.027

Central corneal thickness distribution by study group.

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Analysis Variable : CCT

Group N Obs N Mean Std Dev Range Minimum Maximum

CL 10 10 525.709 16.174 58.267 497.644 555.911

KCN 13 13 486.507 54.382 182.265 367.665 549.930

LASIK 12 12 530.350 34.791 122.611 467.318 589.930

Normal 17 17 541.930 46.227 159.123 468.417 627.540

PRK 9 9 464.734 57.486 173.957 361.434 535.391

Thinnest corneal thickness distribution by study group.

Analysis Variable : Thinnest_CT

Group N Obs N Mean Std Dev Range Minimum Maximum

CL 10 10 515.257 23.813 83.673 465.889 549.562

KCN 13 13 427.430 79.515 273.886 239.691 513.578

LASIK 12 12 522.215 35.396 126.346 457.260 583.606

Normal 17 17 534.254 46.444 164.254 457.860 622.114

PRK 9 9 455.636 57.296 170.372 353.674 524.047

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Evaluation of the Repeatability and Reproducibility
of PachymetryWide 9mm Corneal Epithelial Thickness
Mapping with SD-OCT

18.15.1 Clinical Performance Testing

Two anterior segment clinical studies were conducted to demonstrate substantial equivalence of
the subject device to the predicate RTVue XR with CAM for pachymetry, corneal epithelial
thickness, and corneal stromal thickness measurements with PachymetryWide scan. One study
evaluated the repeatability and reproducibility of the cornea measurements, and the second study
evaluated agreement with manual measurements based on the PachymetryWide scan software
results.

18.15.2 Evaluation of the Repeatability and Reproducibility of


Corneal Epithelial Thickness Mapping with SD-OCT

This was a prospective, observational study conducted at a single clinical U.S. site. Eligible
participants age 18 or older were enrolled and assigned to one of two study groups: 1)
individuals with no corneal pathology, eyelid margin disease, or conditions in qualifying for the
other sub-group; 2) those with four specified corneal conditions (soft and hard contact lens
wearers, post-refractive surgery, dry eye, keratoconus). Each study eye was imaged at least three
times using the PachymetryWide scan pattern with each of three Avanti instrument/operator
pairs. Post-acquisition image review of signal strength, pupil alignment, eyelid artifact, scan
range, and motion artifact was conducted on all scans. Repeatability and reproducibility of the
parameters (all zonal thicknesses [epithelial and stromal thickness], “summary statistics”
parameters) were calculated using a crossed, random-effects ANOVA model.

Results
A total of 62 participants were consented and enrolled, 12 “normals,” 12 contact lens wearers, 12
with dry eye, 12 post-laser refractive surgery (post-LRS), and 14 with keratoconus (KCN).
Analysis was conducted on scans from 60 participants. The age distribution and clinical
characteristics of the study cohort are shown in Tables 21 through 26.

64 of 581 total acquired scans (11%) were excluded from R&R analysis due to scan quality
issues. Out of 517 scans qualified for final R&R analysis, 60 (12%) required manual edits of the
segmentation lines.

Table 21. Age Distribution for All Subjects by Enrollment Group

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Age by Category (n=60) Min Median Mean Max SD
Normal (n=12) 21 45.5 46.3 72 15.68
Contact Lens (n=12) 31 40.5 46.7 67 14.43
Dry Eye (n=11) 39 66.0 63.0 75 9.79
Post Laser Refractive Surgery (n=12) 19 47.5 44.7 73 16.34
Keratoconus (n=13) 18 38.0 39.4 71 16.31

All subjects in the Contact Lens group wore soft contact lens regularly for eight or more hours
per day, and for at least three months at the time of enrollment.

Table 22. Contact Lens Wear Data for the Contact Lens Study Group
Contact Lens Wear Min Median Mean Max SD
Duration (yr.) 2 15.5 22.5 45 14.77
Hours/Day 10 14.5 13.7 16 1.84

The severity of dry eye condition was documented using Ocular Surface Disease Index (OSDI)
score with a scale from 0 to 100 (mild to severe) in the table below.

Table 23. OSDI Score Distribution of the Dry Eye Study Group
Dry Eye Assessment Min Median Mean Max SD
ODSI Score 14.58 33.33 42.8 75 21.42

Table 24. Post-LRS Group Clinical Data Summary


Procedure Total % Total
LASIK 9 75.0%
PRK 3 25.0%
Correction
Myopic 10 83.3%
Hyperopic 1 8.3%
Astigmatism 1 8.3%
Duration since procedure
> 1yr 10 83.3%
> 3mo 1 8.3%
> 1mo 1 8.3%

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The subjects in the KCN group all had a clinical diagnosis of keratoconus. None of the KCN
subjects had any prior surgical treatment.

Table 25. KCN Group Distribution by Clinical Signs and Severity


Clinical Signs Total % Total
Slit lamp exam 8 57.1%
Topographic patterns 2 14.3%
Slit lamp exam & Topographic patterns 4 28.6%
Retinoscope reflex 0 0.0%
Severity (clinically established by PI) Total % Total
Mild 6 42.9%
Moderate 5 35.7%
Severe 3 21.4%

Table 26. Distribution of Steep K and Delta K (difference between Steep K and Flat K) in KCN Group
Corneal Curvature Min Median Mean Max SD
Steep K 45.73 52.36 52.27 62.72 5.098
Delta K 1.02 3.23 4.75 21.95* 5.154

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18.15.3 Normal Group R&R

Table 27a. Zonal Parameters


Normal Group (n = 105 scans)
Pachymetry Epithelium Stroma
Repeat Repeat Repeat
Reproducibility Reproducibility Reproducibility
ability ability ability
Mean SD Min Max Mean SD Min Max Mean SD Min Max
95% 95% 95%
SD SD COV SD SD COV SD SD COV
Limits Limit Limits
C_2 551.3 23.2 518.4 608.1 1.4 1.5 0.3% 4.3 54.5 5.9 45.3 69.1 0.7 0.8 1.4% 2.1 496.7 23.2 467.2 546.6 1.2 1.2 0.3% 3.5
T_2_5 564.7 23.9 527.5 615.0 2.3 2.3 0.4% 6.3 53.8 5.1 44.5 66.1 0.8 0.8 1.5% 2.2 510.9 23.4 476.9 555.3 2.1 2.1 0.4% 5.9
ST_2_5 580.9 22.4 547.8 625.7 3.4 3.5 0.6% 9.6 53.9 4.5 46.0 63.9 0.9 0.9 1.7% 2.6 527.0 22.0 494.1 569.4 3.3 3.4 0.7% 9.6
S_2_5 593.9 20.7 561.7 639.1 4.0 4.0 0.7% 11.0 54.2 4.3 46.1 63.9 1.2 1.2 2.2% 3.3 539.7 20.8 507.5 581.8 3.9 4.0 0.7% 11.0
SN_2_5 590.5 19.8 554.1 639.9 4.1 4.1 0.7% 11.5 54.5 4.5 46.3 65.7 1.2 1.2 2.2% 3.3 536.0 20.1 500.9 580.6 4.0 4.1 0.8% 11.3
N_2_5 579.2 20.3 545.6 631.2 3.3 3.3 0.6% 9.1 54.9 4.9 46.2 67.3 0.9 1.0 1.8% 2.7 524.3 20.5 493.0 570.9 3.1 3.1 0.6% 8.7
IN_2_5 571.2 21.8 542.0 625.9 2.7 2.7 0.5% 7.5 56.0 5.6 48.3 69.1 0.7 0.7 1.3% 2.1 515.2 21.5 488.6 564.1 2.5 2.5 0.5% 6.9
I_2_5 565.4 23.2 530.1 623.9 2.1 2.2 0.4% 6.1 56.2 6.6 46.9 71.7 0.8 0.8 1.5% 2.3 509.2 22.4 482.3 559.7 2.1 2.1 0.4% 5.8
IT_2_5 560.3 23.9 523.2 617.7 1.8 1.8 0.3% 4.9 54.8 6.0 45.7 70.1 0.9 0.9 1.7% 2.6 505.5 23.3 474.2 555.5 1.9 1.9 0.4% 5.1
T_5_7 592.9 23.6 544.7 634.7 3.8 3.8 0.6% 10.4 53.2 4.1 42.0 61.0 0.9 0.9 1.6% 2.4 539.7 22.8 500.3 578.8 3.8 3.8 0.7% 10.7
ST_5_7 621.0 20.9 584.5 661.5 4.8 5.0 0.8% 13.8 52.0 3.5 45.2 61.1 1.1 1.1 2.2% 3.1 569.0 20.7 533.7 609.8 5.0 5.2 0.9% 14.4
S_5_7 641.9 19.2 609.0 683.7 5.1 5.2 0.8% 14.4 52.3 3.4 45.8 65.0 1.4 1.5 2.9% 4.1 589.6 20.1 555.1 630.4 5.2 5.4 0.9% 14.9
SN_5_7 634.5 18.9 600.1 675.2 5.9 6.0 1.0% 16.7 54.2 3.1 47.9 62.1 1.2 1.3 2.3% 3.5 580.3 19.2 544.8 618.5 5.7 5.9 1.0% 16.4
N_5_7 615.2 18.2 584.0 654.9 4.9 4.9 0.8% 13.6 55.2 4.1 48.5 65.0 0.9 1.0 1.8% 2.7 560.1 18.2 529.9 596.5 4.6 4.6 0.8% 12.8
IN_5_7 604.3 20.3 569.9 652.9 4.7 4.7 0.8% 13.1 56.3 5.2 47.9 68.7 0.8 0.8 1.3% 2.1 548.0 19.9 521.9 598.3 4.5 4.5 0.8% 12.5
I_5_7 597.6 22.7 553.3 646.6 4.1 4.2 0.7% 11.6 56.7 6.7 45.1 71.1 0.8 0.8 1.4% 2.1 540.9 21.6 508.2 592.1 4.1 4.2 0.8% 11.6
IT_5_7 588.1 23.2 540.4 636.7 3.9 3.9 0.7% 10.7 55.1 5.6 45.1 66.8 1.0 1.0 1.8% 2.7 533.0 22.5 493.2 575.1 4.0 4.0 0.7% 11.1
T_7_9 628.0 24.6 569.6 674.7 6.8 7.0 1.1% 19.5 52.2 3.6 42.9 58.4 0.9 0.9 1.7% 2.5 575.8 23.9 525.6 623.0 6.8 7.1 1.2% 19.7
ST_7_9 666.2 22.1 616.6 703.4 7.9 8.3 1.2% 22.9 49.3 3.3 41.5 57.1 1.1 1.2 2.3% 3.2 616.9 22.3 571.6 655.8 8.1 8.5 1.4% 23.7
S_7_9 688.2 19.6 641.0 724.0 8.1 8.2 1.2% 22.7 49.7 3.4 41.3 56.5 1.5 1.5 3.0% 4.1 638.4 21.1 588.6 676.4 8.1 8.3 1.3% 23.0
SN_7_9 681.9 19.7 635.0 724.9 8.2 8.2 1.2% 22.7 53.4 3.0 48.0 61.0 1.5 1.5 2.9% 4.3 628.5 20.6 578.2 672.3 8.1 8.1 1.3% 22.5
N_7_9 658.0 20.3 619.7 697.4 6.8 6.8 1.0% 18.8 56.4 4.1 49.7 66.8 1.4 1.4 2.5% 4.0 601.6 20.4 567.5 643.3 6.4 6.4 1.1% 17.9
IN_7_9 646.2 23.0 598.0 713.3 7.3 7.3 1.1% 20.2 56.5 5.3 49.2 69.9 0.9 0.9 1.6% 2.6 589.7 23.4 548.0 658.2 7.1 7.1 1.2% 19.8
I_7_9 635.7 25.4 578.6 701.0 6.7 6.8 1.1% 18.9 56.4 6.6 46.9 71.0 0.7 0.7 1.2% 1.9 579.3 25.2 531.4 646.3 6.8 6.9 1.2% 19.2
IT_7_9 623.8 24.0 563.5 663.1 6.5 6.5 1.0% 18.1 55.2 5.8 44.2 68.0 0.8 0.9 1.5% 2.4 568.6 23.8 518.0 610.9 6.5 6.6 1.2% 18.2

Table 27b. Summary Parameters


Normal Group (n = 105 scans)
Repeat
Reproducibility
ability
Mean SD Min Max
95%
SD SD COV
Limit
Pachymetry
SN-IT (2-5mm)__Pachy 30.2 10.7 8.4 52.0 5.3 5.4 18.1% 15.0
S-I (2-5mm)__Pachy 28.5 10.8 6.7 51.5 5.6 5.6 20.0% 15.6
Min_Pachy 544.8 24.0 512.8 603.7 1.2 1.2 0.2% 3.4
Location_Y_Pachy -0.4 0.2 -0.8 0.3 0.1 0.1 -31.7% 0.3
Min-Median_Pachy -25.7 3.3 -32.4 -16.5 1.4 1.4 -5.5% 3.9
Min-Max_Pachy -69.4 10.8 -91.2 -46.7 4.8 4.8 -7.0% 13.3
Epithelium
Min_Epi 48.3 3.2 38.6 54.3 1.2 1.2 2.6% 3.4
Max_Epi 59.5 5.9 50.4 72.9 1.0 1.0 1.7% 2.7
Min-Max_Epi -11.2 4.7 -24.8 -4.9 1.4 1.4 -12.5% 4.0
STD Dev_Epi 2.5 1.2 1.0 6.1 0.3 0.3 11.5% 0.8
S (2-7)__Epi 53.2 3.4 46.3 62.0 1.2 1.3 2.4% 3.5
I (2-7)__Epi 56.5 6.5 46.0 71.4 0.7 0.7 1.3% 2.1
Stroma
Min_Stroma 490.2 23.8 462.2 541.9 0.8 0.9 0.2% 2.4
Max_Stroma 607.1 20.5 571.1 649.5 6.1 6.2 1.0% 17.3
Min-Max_Stroma -116.8 12.8 -148.6 -87.2 5.8 5.8 -5.0% 16.1
STD Dev_Stroma 29.4 3.4 22.6 36.2 1.3 1.3 4.5% 3.6
S (2-7)__Stroma 566.3 20.3 532.9 607.7 4.6 4.7 0.8% 13.0
I (2-7)__Stroma 526.1 21.8 496.5 574.2 3.1 3.2 0.6% 8.8

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18.15.4 Contact Lens Group R&R

Table 28a. Zonal Parameters


Contact Lens Group (n = 101 scans)
Pachymetry Epithelium Stroma
Repeat Repeat Repeat
Reproducibility Reproducibility Reproducibility
ability ability ability
Mean SD Min Max Mean SD Min Max Mean SD Min Max
95% 95% 95%
SD SD COV SD SD COV SD SD COV
Limits Limits Limits
C_2 555.4 46.1 454.7 662.6 2.3 2.6 0.5% 7.1 51.1 4.2 40.3 63.0 2.0 2.1 4.0% 5.7 504.3 46.5 400.5 610.5 1.2 1.5 0.3% 4.2
T_2_5 569.2 47.2 465.1 679.2 3.3 3.4 0.6% 9.4 50.4 3.8 41.1 60.3 2.0 2.0 3.9% 5.5 518.9 47.9 412.3 630.4 2.6 2.6 0.5% 7.3
ST_2_5 587.6 45.8 474.0 699.0 4.6 4.7 0.8% 12.9 51.0 3.9 42.7 61.0 1.9 1.9 3.8% 5.3 536.5 47.0 420.6 651.6 4.3 4.4 0.8% 12.3
S_2_5 602.6 45.8 482.3 712.2 4.6 4.9 0.8% 13.5 51.4 3.7 41.8 60.7 1.7 1.7 3.4% 4.8 551.2 46.9 427.7 663.8 4.4 4.8 0.9% 13.4
SN_2_5 598.1 45.1 482.6 704.9 4.2 4.5 0.8% 12.4 51.8 3.9 40.3 61.2 1.7 1.8 3.4% 4.9 546.3 46.2 426.5 655.3 4.0 4.4 0.8% 12.1
N_2_5 584.1 46.1 477.3 690.4 3.3 3.6 0.6% 9.9 51.5 3.7 42.4 58.9 1.7 1.7 3.3% 4.7 532.6 46.7 420.2 637.9 3.3 3.5 0.7% 9.6
IN_2_5 574.3 48.2 476.9 686.0 3.0 3.1 0.5% 8.5 51.6 3.5 43.9 58.9 1.0 1.0 2.0% 2.8 522.7 47.9 418.9 631.1 2.9 2.9 0.6% 8.1
I_2_5 568.3 49.7 472.9 685.4 2.6 2.6 0.5% 7.1 51.8 3.6 44.9 59.4 1.3 1.3 2.5% 3.5 516.5 49.0 416.7 629.1 2.2 2.2 0.4% 6.0
IT_2_5 564.0 49.4 466.8 678.6 2.7 2.7 0.5% 7.5 50.8 3.7 42.8 61.0 1.8 1.8 3.6% 5.1 513.2 49.0 412.3 624.6 1.8 1.8 0.3% 4.9
T_5_7 598.2 49.7 487.5 712.9 4.8 4.8 0.8% 13.4 50.3 2.8 43.1 57.2 1.5 1.5 3.0% 4.2 547.9 49.8 434.7 665.2 4.5 4.5 0.8% 12.4
ST_5_7 630.5 47.7 508.4 745.1 6.4 6.4 1.0% 17.9 49.9 3.7 39.5 59.0 1.9 2.1 4.1% 5.7 580.7 48.2 453.6 698.9 6.5 6.6 1.1% 18.3
S_5_7 655.5 46.1 526.8 756.6 5.9 6.1 0.9% 16.8 50.1 3.3 43.8 59.2 1.9 2.0 4.0% 5.6 605.4 47.0 471.0 709.8 5.8 6.1 1.0% 16.9
SN_5_7 645.1 45.4 518.2 747.3 6.0 6.4 1.0% 17.7 51.8 3.3 41.4 61.4 1.8 1.8 3.5% 5.0 593.3 46.2 463.7 698.1 5.9 6.3 1.1% 17.4
N_5_7 620.0 45.4 504.8 721.4 5.0 5.2 0.8% 14.4 52.0 3.4 42.3 59.6 1.4 1.4 2.7% 3.9 568.0 45.8 450.6 669.4 5.0 5.1 0.9% 14.2
IN_5_7 608.1 47.9 502.9 714.1 5.1 5.1 0.8% 14.2 52.3 2.7 46.8 58.8 1.0 1.0 1.9% 2.8 555.9 47.8 447.8 661.5 4.9 4.9 0.9% 13.5
I_5_7 601.8 50.4 500.9 716.8 4.3 4.3 0.7% 11.8 52.6 3.0 47.0 60.6 1.3 1.3 2.5% 3.7 549.2 50.0 443.9 662.0 4.2 4.2 0.8% 11.7
IT_5_7 592.9 51.5 490.3 710.2 4.4 4.4 0.7% 12.1 51.6 2.6 45.5 60.0 1.4 1.4 2.7% 3.8 541.3 51.1 435.6 657.0 3.9 3.9 0.7% 10.9
T_7_9 633.6 51.4 521.0 755.4 9.4 9.4 1.5% 26.0 50.2 3.3 44.2 59.9 1.7 1.8 3.5% 4.9 583.4 51.0 469.8 709.2 8.8 8.8 1.5% 24.5
ST_7_9 677.7 48.4 549.7 790.1 12.0 12.1 1.8% 33.6 48.9 5.2 34.5 64.6 2.1 2.2 4.5% 6.1 628.8 48.9 499.5 747.7 12.1 12.2 2.0% 33.9
S_7_9 706.0 45.6 571.7 797.4 9.6 9.6 1.4% 26.6 47.7 5.1 38.2 64.9 2.6 2.6 5.5% 7.3 658.3 46.1 523.7 759.2 10.2 10.2 1.6% 28.3
SN_7_9 695.2 44.5 566.3 780.6 7.3 7.8 1.1% 21.7 50.8 4.7 39.7 62.6 1.9 1.9 3.7% 5.2 644.4 45.3 516.7 736.7 7.7 8.2 1.3% 22.7
N_7_9 662.3 43.9 550.3 759.2 6.0 6.2 0.9% 17.1 53.8 3.7 41.8 62.6 1.4 1.4 2.6% 3.8 608.5 44.7 497.4 708.2 5.5 5.6 0.9% 15.5
IN_7_9 649.5 47.0 544.1 750.7 7.7 7.7 1.2% 21.4 53.2 3.7 44.9 62.7 1.1 1.1 2.1% 3.1 596.3 47.5 489.4 702.1 7.3 7.3 1.2% 20.2
I_7_9 640.2 49.8 537.5 753.6 6.6 6.6 1.0% 18.3 53.0 3.2 45.7 60.9 1.2 1.3 2.4% 3.5 587.3 50.7 480.6 703.0 6.7 6.8 1.2% 18.8
IT_7_9 628.0 52.5 524.0 747.3 7.7 7.7 1.2% 21.2 52.7 2.7 45.2 62.1 1.3 1.3 2.5% 3.7 575.4 52.5 470.6 695.9 7.3 7.3 1.3% 20.3

Table 28b. Summary Parameters


Contact Lens Group (n = 101 scans)
Repeat
Reproducibility
ability
Mean SD Min Max
95%
SD SD COV
Limits
Pachymetry
SN-IT (2-5mm)__Pachy 34.1 15.2 11.8 77.9 6.0 6.1 18.3% 17.0
S-I (2-5mm)__Pachy 34.3 16.3 5.5 76.6 6.6 6.7 20.2% 18.6
Min_Pachy 548.0 47.1 451.0 657.2 1.9 2.0 0.4% 5.5
Location_Y_Pachy -0.4 0.3 -1.7 0.1 0.2 0.2 -35.9% 0.4
Min-Median_Pachy -27.5 4.4 -41.4 -17.7 1.7 1.7 -6.2% 4.7
Min-Max_Pachy -76.6 16.1 -118.8 -46.5 5.6 5.7 -7.6% 15.9
Epithelium
Min_Epi 46.1 3.6 35.9 52.0 1.5 1.5 3.2% 4.1
Max_Epi 56.8 3.0 51.5 67.7 2.3 2.3 4.1% 6.4
Min-Max_Epi -10.7 3.8 -25.9 -4.0 2.1 2.1 -19.5% 5.8
STD Dev_Epi 2.2 0.9 1.0 5.6 0.5 0.5 21.8% 1.4
S (2-7)__Epi 50.7 3.2 43.9 59.0 1.6 1.7 3.4% 4.7
I (2-7)__Epi 52.2 3.1 46.1 59.9 1.2 1.2 2.3% 3.3
Stroma
Min_Stroma 497.3 47.1 396.9 603.3 0.9 1.2 0.2% 3.2
Max_Stroma 623.8 46.6 486.3 723.7 6.4 6.6 1.1% 18.4
Min-Max_Stroma -126.5 20.1 -172.9 -89.4 6.1 6.2 -4.9% 17.0
STD Dev_Stroma 31.4 5.2 22.3 44.8 1.5 1.6 5.0% 4.4
S (2-7)__Stroma 580.1 46.8 450.8 688.3 5.1 5.5 0.9% 15.1
I (2-7)__Stroma 533.9 49.5 431.2 646.6 3.2 3.2 0.6% 8.8

RTVue XR Avanti User Manual Page 434 of 451 P/N 580-52576-005 Rev. A
18.15.5 Dry Eye Group R&R

Table 29a. Zonal Parameters


Dry Eye Group (n = 89 scans)
Pachymetry Epithelium Stroma
Repeat Repeat Repeat
Reproducibility Reproducibility Reproducibility
ability ability ability
Mean SD Min Max Mean SD Min Max Mean SD Min Max
95% 95% 95%
SD SD COV SD SD COV SD SD COV
Limits Limits Limits
C_2 536.1 29.0 485.0 588.5 1.6 2.0 0.4% 5.5 54.0 2.8 48.8 59.8 1.1 1.3 2.3% 3.5 482.1 28.9 428.6 529.2 1.4 1.5 0.3% 4.2
T_2_5 549.7 29.1 493.0 598.5 2.9 2.9 0.5% 8.1 53.4 2.6 47.9 59.4 0.9 1.0 1.9% 2.8 496.3 29.3 436.5 541.3 2.7 2.7 0.5% 7.5
ST_2_5 565.9 27.7 507.4 609.7 4.0 4.0 0.7% 11.1 52.1 2.6 45.6 59.5 1.3 1.3 2.5% 3.6 513.8 28.0 453.6 553.1 3.9 3.9 0.8% 10.8
S_2_5 578.7 26.8 527.1 619.4 4.3 4.4 0.8% 12.2 52.0 2.7 45.3 59.2 1.4 1.4 2.8% 4.0 526.7 27.2 473.7 566.3 4.5 4.5 0.9% 12.6
SN_2_5 574.8 26.4 525.1 621.4 4.1 4.3 0.7% 11.9 52.8 2.8 46.6 59.9 1.5 1.5 2.9% 4.2 522.0 26.8 470.8 561.8 4.2 4.4 0.8% 12.1
N_2_5 562.3 27.4 510.1 614.7 3.3 3.7 0.7% 10.2 53.8 2.8 48.6 62.3 1.3 1.4 2.6% 3.8 508.6 27.5 454.3 555.4 3.3 3.6 0.7% 10.0
IN_2_5 554.7 28.5 506.3 606.2 2.5 2.8 0.5% 7.7 54.6 2.8 48.6 63.5 1.2 1.2 2.3% 3.4 500.1 28.8 449.5 546.6 2.4 2.5 0.5% 7.0
I_2_5 550.4 29.2 502.6 598.1 2.3 2.6 0.5% 7.2 55.1 2.8 49.7 60.9 1.1 1.2 2.1% 3.2 495.3 29.4 444.2 543.1 2.0 2.2 0.4% 6.0
IT_2_5 545.2 30.1 491.2 596.1 2.0 2.3 0.4% 6.3 54.3 2.8 48.1 60.7 0.9 1.0 1.8% 2.7 490.9 30.0 433.6 537.0 1.7 1.9 0.4% 5.2
T_5_7 576.6 28.7 513.3 621.6 4.6 4.6 0.8% 12.9 52.3 2.6 46.1 59.2 1.0 1.1 2.0% 2.9 524.3 29.1 458.4 563.7 4.7 4.7 0.9% 12.9
ST_5_7 605.3 28.1 542.2 657.2 5.6 5.6 0.9% 15.6 49.2 3.1 41.4 57.2 1.3 1.3 2.7% 3.7 556.2 28.8 492.3 608.6 5.8 5.8 1.0% 16.1
S_5_7 627.1 27.4 581.3 682.8 5.9 6.0 1.0% 16.7 48.5 4.0 35.2 57.1 1.7 1.7 3.6% 4.8 578.6 28.2 528.1 634.0 6.3 6.3 1.1% 17.6
SN_5_7 616.9 26.1 566.3 654.1 5.6 6.0 1.0% 16.6 51.5 3.5 43.0 59.8 1.5 1.5 3.0% 4.2 565.4 27.2 511.7 603.0 5.9 6.2 1.1% 17.3
N_5_7 594.6 26.9 538.5 641.3 5.1 5.4 0.9% 14.9 53.3 2.6 49.4 63.8 1.3 1.4 2.6% 3.8 541.3 27.4 484.0 582.3 4.9 5.2 1.0% 14.4
IN_5_7 584.6 27.8 536.6 630.4 3.9 4.0 0.7% 11.2 54.1 3.1 49.0 63.7 1.3 1.4 2.6% 4.0 530.5 28.6 480.5 578.5 3.8 3.9 0.7% 10.7
I_5_7 580.1 28.7 533.6 634.5 3.8 4.1 0.7% 11.3 54.4 3.3 48.7 60.8 1.2 1.4 2.5% 3.8 525.7 29.9 476.1 584.4 3.5 3.7 0.7% 10.1
IT_5_7 571.6 29.9 516.6 622.1 4.0 4.1 0.7% 11.4 54.3 2.7 49.9 60.7 1.2 1.2 2.3% 3.4 517.3 29.9 459.6 568.1 3.7 3.8 0.7% 10.6
T_7_9 607.4 30.3 538.3 656.0 7.6 7.6 1.3% 21.1 50.0 3.2 41.1 56.1 1.2 1.2 2.4% 3.4 557.4 31.4 485.3 607.6 7.9 7.9 1.4% 21.8
ST_7_9 645.1 31.7 586.2 730.9 8.2 8.2 1.3% 22.8 46.2 4.0 37.6 53.7 1.2 1.3 2.9% 3.7 598.9 32.9 534.8 679.9 8.2 8.3 1.4% 23.0
S_7_9 675.3 34.3 614.5 790.9 13.5 14.2 2.1% 39.4 46.4 4.9 27.3 55.9 2.0 2.0 4.3% 5.5 628.9 34.6 566.9 742.3 14.0 14.7 2.3% 40.7
SN_7_9 658.8 33.0 604.2 733.1 8.6 9.1 1.4% 25.1 49.5 4.4 37.8 56.6 1.6 1.7 3.4% 4.6 609.3 34.2 548.7 680.6 9.0 9.4 1.5% 26.1
N_7_9 626.4 30.8 562.0 670.3 7.0 7.3 1.2% 20.3 53.2 3.2 46.3 64.8 1.7 1.8 3.4% 5.0 573.2 31.4 506.0 619.9 6.5 7.0 1.2% 19.5
IN_7_9 615.4 29.2 563.4 663.8 6.9 6.9 1.1% 19.2 53.3 5.3 44.2 63.6 1.8 1.9 3.6% 5.4 562.1 31.6 506.7 618.6 6.8 6.8 1.2% 18.8
I_7_9 611.1 31.7 557.5 667.8 5.7 5.7 0.9% 15.8 53.2 5.2 40.3 62.0 1.2 1.3 2.5% 3.7 557.9 34.1 502.7 627.6 6.1 6.1 1.1% 16.9
IT_7_9 603.7 31.7 540.9 659.5 6.0 6.2 1.0% 17.2 53.5 3.1 48.2 59.6 1.0 1.0 1.9% 2.8 550.2 32.6 483.6 608.6 6.1 6.2 1.1% 17.2

Table 29b. Summary Parameters


Dry Eye Group (n = 89 scans)
Repeat
Reproducibility
ability
Mean SD Min Max
95%
SD SD COV
Limits
Pachymetry
SN-IT (2-5mm)__Pachy 29.6 10.8 3.3 55.7 5.4 5.6 19.0% 15.6
S-I (2-5mm)__Pachy 28.3 12.9 -5.2 60.3 6.1 6.2 21.8% 17.1
Min_Pachy 529.4 30.1 478.3 583.3 1.4 1.8 0.3% 5.0
Location_Y_Pachy -0.3 0.2 -0.7 0.3 0.1 0.1 -41.7% 0.4
Min-Median_Pachy -25.4 4.8 -35.3 -16.0 1.1 1.1 -4.4% 3.1
Min-Max_Pachy -69.6 15.4 -110.9 -43.2 4.5 4.7 -6.7% 13.0
Epithelium
Min_Epi 45.1 5.5 24.8 53.6 1.7 1.7 3.7% 4.7
Max_Epi 57.8 3.1 52.3 65.8 1.3 1.4 2.4% 3.8
Min-Max_Epi -12.7 5.5 -30.9 -5.8 2.0 2.1 -16.1% 5.7
STD Dev_Epi 2.6 1.1 1.1 5.7 0.5 0.5 19.0% 1.3
S (2-7)__Epi 50.1 3.0 42.9 58.1 1.4 1.4 2.8% 4.0
I (2-7)__Epi 54.7 3.0 49.8 60.4 1.1 1.2 2.2% 3.3
Stroma
Min_Stroma 475.0 30.2 421.4 524.1 1.0 1.2 0.2% 3.2
Max_Stroma 596.0 28.9 546.6 656.2 7.4 7.6 1.3% 21.0
Min-Max_Stroma -121.1 20.4 -177.4 -87.1 7.0 7.3 -6.0% 20.1
STD Dev_Stroma 29.6 5.4 20.4 43.9 1.6 1.7 5.7% 4.7
S (2-7)__Stroma 554.4 27.4 502.7 598.7 5.3 5.4 1.0% 14.9
I (2-7)__Stroma 511.5 29.4 461.2 565.1 2.8 2.9 0.6% 8.0

RTVue XR Avanti User Manual Page 435 of 451 P/N 580-52576-005 Rev. A
18.15.6 Post-LRS Group R&R

Table 30a. Zonal Parameters


Post-LRS Group (n = 112 scans)
Pachymetry Epithelium Stroma
Repeat Repeat Repeat
Reproducibility Reproducibility Reproducibility
ability ability ability
Mean SD Min Max Mean SD Min Max Mean SD Min Max
95% 95% 95%
SD SD COV SD SD COV SD SD COV
Limits Limits Limits
C_2 504.6 44.6 418.3 573.5 1.3 1.6 0.3% 4.4 57.4 4.3 46.9 64.1 0.7 0.8 1.4% 2.3 447.2 46.4 359.2 519.2 1.2 1.4 0.3% 3.8
T_2_5 531.2 35.5 459.4 594.2 4.2 4.2 0.8% 11.7 58.2 3.4 50.7 66.5 1.0 1.1 1.8% 3.0 473.1 37.5 396.3 539.3 4.3 4.3 0.9% 12.0
ST_2_5 548.2 39.1 461.7 611.9 5.9 6.0 1.1% 16.5 57.4 4.3 48.5 65.4 1.0 1.1 1.8% 2.9 490.7 41.1 399.5 555.9 6.0 6.0 1.2% 16.6
S_2_5 562.3 40.4 474.6 630.0 7.0 7.1 1.3% 19.7 56.9 4.7 44.3 65.7 1.1 1.2 2.1% 3.3 505.4 42.7 412.2 575.7 7.0 7.1 1.4% 19.8
SN_2_5 556.6 40.4 466.2 633.8 6.8 7.0 1.3% 19.4 58.0 4.0 49.1 66.4 1.1 1.2 2.1% 3.3 498.6 42.4 403.1 577.1 7.0 7.2 1.4% 20.0
N_2_5 544.1 38.1 460.5 617.8 5.1 5.4 1.0% 14.9 58.5 3.1 52.1 64.6 0.9 1.0 1.8% 2.9 485.7 39.7 398.4 560.9 5.3 5.7 1.2% 15.7
IN_2_5 539.1 35.3 465.5 599.8 4.5 4.5 0.8% 12.6 58.0 3.2 50.9 63.3 0.8 0.9 1.6% 2.6 481.1 37.0 405.1 546.1 4.9 4.9 1.0% 13.5
I_2_5 535.7 34.7 463.2 595.8 4.7 4.7 0.9% 13.1 58.3 3.5 50.7 63.7 0.8 0.8 1.3% 2.1 477.3 36.9 400.4 542.9 4.9 4.9 1.0% 13.5
IT_2_5 528.9 34.1 454.6 586.9 4.7 4.7 0.9% 13.0 58.3 3.0 50.4 63.7 0.9 0.9 1.5% 2.4 470.6 36.0 390.8 530.4 4.9 4.9 1.0% 13.6
T_5_7 575.3 27.9 515.1 634.2 5.1 5.2 0.9% 14.4 54.7 3.5 47.6 65.1 1.2 1.2 2.3% 3.4 520.5 29.6 457.3 582.1 5.6 5.6 1.1% 15.5
ST_5_7 606.6 30.1 541.1 669.7 7.7 7.7 1.3% 21.4 53.6 4.2 40.3 61.7 1.6 1.7 3.2% 4.7 553.1 31.2 481.8 616.9 8.5 8.5 1.5% 23.6
S_5_7 631.8 30.0 562.8 700.7 8.1 8.1 1.3% 22.5 52.0 4.0 39.5 58.6 1.8 1.9 3.6% 5.2 579.8 30.4 506.4 647.1 8.7 8.8 1.5% 24.4
SN_5_7 620.1 31.5 547.4 699.1 8.3 8.4 1.4% 23.3 54.3 3.8 41.3 60.7 1.4 1.6 3.0% 4.5 565.8 31.7 492.0 645.7 8.8 9.0 1.6% 25.0
N_5_7 598.0 31.0 537.3 680.8 6.2 6.4 1.1% 17.7 55.5 4.0 46.1 65.1 1.1 1.2 2.2% 3.4 542.6 31.6 484.5 625.4 6.6 6.8 1.3% 18.9
IN_5_7 591.5 28.9 534.6 662.4 5.4 5.4 0.9% 14.9 54.8 3.3 47.7 61.4 0.8 0.8 1.4% 2.2 536.7 29.6 474.4 606.7 5.7 5.7 1.1% 15.8
I_5_7 588.3 27.2 538.0 658.3 6.1 6.2 1.0% 17.1 55.4 2.6 49.4 59.9 0.9 0.9 1.7% 2.6 532.9 27.8 479.7 604.1 6.3 6.4 1.2% 17.7
IT_5_7 574.1 26.0 520.3 639.6 6.4 6.4 1.1% 17.8 55.8 3.4 49.5 64.5 1.1 1.2 2.1% 3.3 518.3 27.1 463.4 585.6 6.8 6.8 1.3% 18.9
T_7_9 616.6 23.3 564.0 679.7 6.2 6.4 1.0% 17.7 51.4 2.6 44.4 55.7 1.1 1.2 2.3% 3.3 565.2 23.7 510.5 627.8 6.5 6.7 1.2% 18.7
ST_7_9 653.7 23.8 608.0 712.3 8.5 8.5 1.3% 23.6 50.3 3.8 41.0 59.6 1.5 1.5 3.1% 4.2 603.4 22.6 558.2 659.7 8.9 8.9 1.5% 24.6
S_7_9 682.2 26.6 622.0 739.1 12.6 13.6 2.0% 37.8 48.7 4.2 36.5 57.5 2.5 2.5 5.2% 7.0 633.5 25.2 576.2 690.0 12.8 13.9 2.2% 38.4
SN_7_9 673.9 24.9 613.8 730.7 7.9 7.9 1.2% 21.9 52.1 5.3 41.5 66.6 1.4 1.4 2.7% 3.9 621.7 22.5 566.5 676.7 7.8 7.8 1.2% 21.5
N_7_9 647.5 25.4 604.7 717.3 5.9 6.2 1.0% 17.2 54.6 3.6 47.8 65.1 1.3 1.3 2.3% 3.5 592.9 24.7 552.8 661.4 5.7 6.1 1.0% 16.9
IN_7_9 638.1 26.6 575.3 704.7 7.6 7.6 1.2% 21.1 53.8 2.6 47.0 60.3 0.9 0.9 1.6% 2.5 584.3 25.8 524.6 648.7 7.6 7.6 1.3% 21.2
I_7_9 633.1 24.8 595.2 699.4 6.1 6.1 1.0% 16.9 53.8 2.6 47.3 58.0 1.0 1.1 2.0% 2.9 579.4 25.1 541.7 646.1 6.3 6.3 1.1% 17.5
IT_7_9 618.1 23.7 575.7 683.9 7.5 7.5 1.2% 20.9 53.7 2.5 47.4 59.2 1.2 1.3 2.3% 3.5 564.4 24.3 524.3 631.0 7.6 7.6 1.3% 21.0

Table 30b. Summary Parameters


Post-LRS Group (n = 112 scans)
Repeat
Reproducibility
ability
Mean SD Min Max
95%
SD SD COV
Limits
Pachymetry
SN-IT (2-5mm)__Pachy 27.7 14.5 -20.3 71.3 11.3 11.5 41.7% 31.8
S-I (2-5mm)__Pachy 26.7 14.2 -17.3 52.7 11.5 11.6 43.4% 32.1
Min_Pachy 496.7 44.8 409.1 567.8 1.0 1.2 0.2% 3.3
Location_Y_Pachy -0.2 0.2 -0.8 0.3 0.1 0.1 -50.7% 0.3
Min-Median_Pachy -38.8 10.0 -59.4 -22.6 1.5 1.5 -4.0% 4.3
Min-Max_Pachy -95.5 15.6 -135.1 -60.6 7.5 7.9 -8.2% 21.8
Epithelium
Min_Epi 47.8 3.6 36.1 55.7 1.4 1.5 3.1% 4.1
Max_Epi 64.3 3.5 57.4 69.8 1.0 1.1 1.7% 3.0
Min-Max_Epi -16.4 5.7 -27.1 -6.7 1.5 1.5 -9.2% 4.2
STD Dev_Epi 3.9 1.6 1.5 6.5 0.3 0.3 7.4% 0.8
S (2-7)__Epi 54.3 3.8 43.5 60.5 1.3 1.4 2.7% 4.0
I (2-7)__Epi 56.8 2.5 51.7 60.6 0.7 0.7 1.3% 2.1
Stroma
Min_Stroma 439.1 45.9 353.0 513.8 0.7 0.8 0.2% 2.3
Max_Stroma 602.7 26.6 540.9 666.8 8.1 8.4 1.4% 23.2
Min-Max_Stroma -163.6 27.3 -225.5 -113.9 7.9 8.2 -5.0% 22.6
STD Dev_Stroma 42.6 9.3 28.6 61.8 1.7 1.8 4.2% 4.9
S (2-7)__Stroma 545.1 35.6 462.4 613.8 7.8 7.9 1.5% 22.0
I (2-7)__Stroma 506.9 31.1 442.7 575.5 5.6 5.6 1.1% 15.5

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18.15.7 KCN Group R&R

Table 31a. Zonal Parameters


Keratoconus Group (n = 110 scans)
Pachymetry Epithelium Stroma
Repeat Repeat Repeat
Reproducibility Reproducibility Reproducibility
ability ability ability
Mean SD Min Max Mean SD Min Max Mean SD Min Max
95% 95% 95%
SD SD COV SD SD COV SD SD COV
Limits Limits Limits
C_2 487.0 28.1 403.4 523.7 7.0 7.0 1.4% 19.4 50.9 4.8 40.6 65.5 1.9 1.9 3.7% 5.2 436.0 26.9 358.3 473.1 6.4 6.4 1.5% 17.8
T_2_5 503.5 29.4 411.4 553.5 8.0 8.0 1.6% 22.2 47.3 5.3 36.6 59.0 2.1 2.1 4.4% 5.7 456.1 28.4 366.3 502.7 6.9 7.0 1.5% 19.3
ST_2_5 540.3 29.4 458.6 595.9 7.3 7.5 1.4% 20.8 52.4 4.7 39.8 66.0 2.1 2.1 3.9% 5.7 488.0 29.7 406.5 537.4 6.2 6.5 1.3% 18.0
S_2_5 559.4 32.6 473.2 617.9 7.9 8.1 1.4% 22.4 54.4 3.4 45.4 62.6 2.1 2.2 3.9% 6.0 505.0 32.5 413.9 561.0 6.9 7.2 1.4% 19.9
SN_2_5 555.8 32.1 466.2 615.7 7.5 7.5 1.4% 20.9 54.8 4.6 41.9 63.9 1.8 1.9 3.4% 5.2 501.0 32.2 405.4 556.7 6.9 7.0 1.4% 19.5
N_2_5 537.5 31.9 454.7 596.2 8.7 8.7 1.6% 24.0 54.6 5.1 43.2 67.5 1.6 1.6 3.0% 4.5 482.9 31.0 395.9 536.1 7.9 7.9 1.6% 22.0
IN_2_5 509.9 34.0 431.0 557.9 9.5 9.5 1.9% 26.2 53.9 4.7 44.5 71.6 2.1 2.1 3.9% 5.8 456.1 32.4 380.2 502.7 9.3 9.3 2.0% 25.8
I_2_5 480.0 36.3 397.4 533.1 7.2 7.3 1.5% 20.2 50.9 4.8 40.9 63.9 2.3 2.3 4.6% 6.4 429.1 36.2 341.1 478.5 7.6 7.7 1.8% 21.3
IT_2_5 477.7 29.2 392.0 529.9 8.0 8.1 1.7% 22.4 47.0 4.7 37.4 56.9 1.9 1.9 4.0% 5.3 430.8 27.6 346.1 476.4 7.6 7.7 1.8% 21.3
T_5_7 539.0 42.4 402.1 600.5 9.2 9.2 1.7% 25.5 50.5 5.4 37.0 60.4 1.6 1.6 3.2% 4.5 488.5 42.2 347.7 546.7 8.7 8.8 1.8% 24.5
ST_5_7 586.4 45.8 460.1 675.8 7.5 7.8 1.3% 21.6 52.4 4.3 43.0 63.0 1.8 1.9 3.6% 5.2 534.0 43.9 413.9 619.4 7.4 7.8 1.5% 21.5
S_5_7 610.1 49.3 474.5 689.3 6.9 7.1 1.2% 19.5 51.7 3.7 45.0 60.6 1.8 1.8 3.5% 5.0 558.4 46.9 426.7 633.8 7.0 7.2 1.3% 20.1
SN_5_7 604.0 42.7 486.2 684.7 8.5 8.6 1.4% 24.0 52.7 3.7 43.0 63.0 1.9 2.0 3.8% 5.6 551.3 41.3 431.4 628.2 8.7 9.0 1.6% 25.0
N_5_7 580.5 39.3 479.2 667.1 8.4 8.4 1.4% 23.3 53.6 4.3 44.4 63.1 1.4 1.4 2.6% 3.8 527.0 37.3 424.2 605.9 8.5 8.5 1.6% 23.6
IN_5_7 553.8 34.9 463.6 608.2 9.1 9.1 1.6% 25.3 54.1 5.5 44.4 68.5 1.6 1.6 3.0% 4.4 499.7 31.0 414.6 550.5 9.0 9.0 1.8% 25.0
I_5_7 520.5 40.3 413.6 571.2 8.0 8.3 1.6% 23.0 52.0 8.3 36.8 69.5 2.0 2.0 3.8% 5.5 468.5 36.7 374.1 516.6 7.8 8.0 1.7% 22.3
IT_5_7 514.4 39.4 380.4 583.0 9.9 9.9 1.9% 27.5 50.3 5.6 36.8 59.6 2.3 2.3 4.6% 6.4 464.1 38.5 331.9 526.0 9.0 9.0 1.9% 24.8
T_7_9 587.0 42.0 463.1 663.5 12.4 12.6 2.1% 35.0 51.0 3.7 42.8 58.2 1.1 1.1 2.2% 3.1 536.0 40.8 414.5 615.5 12.1 12.4 2.3% 34.5
ST_7_9 613.2 51.0 474.3 730.7 15.4 15.4 2.5% 42.8 49.6 3.0 43.1 58.3 1.6 1.7 3.4% 4.6 563.6 50.7 427.2 683.5 15.6 15.6 2.8% 43.2
S_7_9 638.6 53.8 479.1 745.7 18.3 18.3 2.9% 50.6 47.5 4.1 35.8 56.1 2.2 2.2 4.5% 6.0 591.1 52.9 437.3 693.9 18.3 18.3 3.1% 50.7
SN_7_9 635.8 42.6 505.4 704.1 13.6 13.7 2.1% 37.8 50.8 4.3 39.0 61.4 1.7 1.7 3.4% 4.8 585.0 40.3 459.4 655.7 13.6 13.6 2.3% 37.8
N_7_9 617.0 36.9 522.4 688.1 9.9 9.9 1.6% 27.5 52.8 4.6 43.4 66.7 1.2 1.2 2.3% 3.4 564.2 33.5 474.5 629.6 9.7 9.7 1.7% 26.8
IN_7_9 602.9 41.3 491.8 698.0 13.6 13.6 2.2% 37.7 53.2 5.5 41.3 63.0 1.3 1.3 2.5% 3.6 549.7 36.8 447.8 638.0 13.6 13.6 2.5% 37.7
I_7_9 579.7 50.9 438.8 692.4 16.3 17.0 2.9% 47.2 52.6 7.9 31.1 67.0 2.1 2.1 4.0% 5.9 527.0 45.3 400.0 628.1 15.9 16.7 3.2% 46.2
IT_7_9 572.5 47.8 413.0 663.5 14.8 14.9 2.6% 41.2 52.2 5.3 37.8 61.2 1.7 1.7 3.3% 4.8 520.3 44.3 367.5 604.6 14.4 14.5 2.8% 40.1

Table 31b. Summary Parameters


Keratoconus Group (n = 110 scans)
Repeat
Reproducibility
ability
Mean SD Min Max
95%
SD SD COV
Limits
Pachymetry
SN-IT (2-5mm)__Pachy 78.1 31.7 10.4 166.1 13.3 13.3 16.8% 36.9
S-I (2-5mm)__Pachy 79.4 44.3 7.2 202.3 13.4 13.8 16.9% 38.2
Min_Pachy 447.0 41.7 350.3 513.7 5.2 5.2 1.2% 14.5
Location_Y_Pachy -1.0 0.4 -2.2 -0.2 0.2 0.2 -20.6% 0.6
Min-Median_Pachy -66.6 31.4 -145.3 -17.2 4.3 4.4 -6.4% 12.1
Min-Max_Pachy -136.5 60.1 -283.4 -42.4 7.4 7.6 -5.5% 21.1
Epithelium
Min_Epi 40.4 5.1 31.4 50.5 1.6 1.6 3.8% 4.3
Max_Epi 63.3 5.4 52.3 75.6 1.7 1.7 2.6% 4.6
Min-Max_Epi -22.9 7.7 -35.3 -8.4 1.6 1.6 -7.2% 4.5
STD Dev_Epi 5.1 1.8 1.8 8.1 0.3 0.3 6.3% 0.9
S (2-7)__Epi 53.0 2.8 47.7 59.5 1.6 1.7 3.2% 4.7
I (2-7)__Epi 51.5 5.9 40.2 65.1 1.9 1.9 3.7% 5.3
Stroma
Min_Stroma 396.2 46.3 289.9 462.1 5.4 5.4 1.4% 14.9
Max_Stroma 579.4 46.2 451.1 653.5 8.9 9.1 1.6% 25.2
Min-Max_Stroma -183.3 67.3 -348.9 -81.6 10.0 10.1 -5.5% 28.0
STD Dev_Stroma 45.3 16.2 19.8 85.9 2.2 2.2 4.9% 6.2
S (2-7)__Stroma 533.4 39.9 420.7 599.0 6.5 6.8 1.3% 19.0
I (2-7)__Stroma 450.1 34.8 373.4 493.5 7.2 7.3 1.6% 20.3

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Evaluation of the Agreement of the Corneal
Epithelial Thickness Mapping with SD-OCT
This was a prospective, observational study conducted at three study sites to evaluate the
agreement of the Avanti 9mm ETM software with manual measurements performed by three
qualified graders. Eligible participants age 18 or older were enrolled and assigned to one of two
groups as described under #5 above. The manual measurements were performed at 15 locations
along each of the eight meridians in the PachymetryWide scan pattern in a randomized order
with a 2-section caliper tool that was available in the previously cleared RTVue XR with CAM
device. One eye per study subject was included in the study. One scan of sufficient image
quality was required per study eye. Agreement was evaluated with calculation of 95% limits of
agreement (LOAs) and Deming regression analyses.

A total of 89 subjects were enrolled. Scans from a total of 85 (17 “normal,” 15 contact lens
wearers, 18 with dry eye, 19 post-laser refractive surgery, and 16 with keratoconus) were
included in analyses. The age distribution and clinical characteristics of the study cohort are
shown in Tables 32 through 38.

Table 32. Age Distribution by Entire Study Group and by Sub-Groups

Age Distribution Min Median Mean Max SD


Entire Group 23 34 38.6 73 12.6
Normal 25 32 33.5 66 10.4
Contact Lens 25 30 35.2 58 11.1
Dry Eye 24 51 46.5 73 15.3
Post Laser Refractive Surgery 23 38 38.8 56 8.9
Keratoconus 25 34 38.0 62 11.7

Of the 16 subjects enrolled in the Contact Lens group, 15 wore soft contact lens and one wore
hard contact lens. Subjects wore contact lenses for eight or more hours each day for at least one
year prior to testing.

Table 33. Contact Lens Wear Data for the Contact Lens Sub-Group
Contact Lens Wear Min Median Mean Max SD

Duration (yr) 1 10 11 20 6.07


Hours/Day 8 12 12.6 16 2.06

For the subjects in the Dry Eye group, the severity of the dry eye condition for each study subject
was documented using Ocular Surface Disease Index (OSDI) score with a scale from 0 to 100
(mild to severe) and Tear Break Up Time (TBUT).

Table 34. OSDI Score and Tear Break Up Time (TBUT) Distribution of the Dry Eye Sub-Group
Dry Eye Min Median Mean Max SD
OSDI score 6.3 20.8 22.2 40.9 5.28
TBUT 1 4.8 4.6 7 1.83

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For the subjects in the Post-LRS group, the majority (75%) had had a LASIK procedure versus
the PRK procedure (25%), mainly for myopic vision correction (83.3%) and most had the
procedure done at least one year or more prior to testing (83.3%).

Table 35. Summary of the Post LRS Sub-Group


Procedure Total % Total (n=20)
LASIK 15 75.0%
PRK 5 25.0%
Correction
Myopic 13 65.0%
Hyperopic 4 20.0%
Astigmatism 0 0.0%
Mixed* 3 15.0%
Duration since procedure
> 1yr 16 80.0%
> 3mo 4 20.0%
> 1mo 0 0.0%
*Mixed represented procedures either combining myopic correction with astigmatism correction or hyperopic
correction with astigmatism correction.

The 16 subjects in the KCN sub-group all had a clinical diagnosis of keratoconus. None of the
subjects in the KCN sub-group underwent any surgical treatment for KCN. The clinical signs of
KCN diagnosis for the study subjects, severity of keratoconus for the KCN subjects, and details
on corneal curvature are summarized in the table below.

Table 36. KCN Subjects Diagnosis by Clinical Signs


slit lamp slit lamp slit lamp slit lamp slit lamp slit lamp topo bow- topo topo
Subject ID Severity
thinning protrusion munson vogt fleisher rizutti tie steep claw
DS-10 moderate 1 1
DS-12 mild 1 1
DS-21 moderate 1 1 1
DS-29 moderate 1 1 1 1
DS-31 severe 1 1 1
DS-32 moderate 1 1 1
DS-34 severe 1 1 1
DS-36 moderate 1 1 1
DS-37 mild 1 1
MP-08 severe 1
MP-14 moderate 1 1
MP-19 moderate 1 1
MP-25 mild 1
MP-28 severe 1
MP-31 moderate 1
K1, SH moderate 1

Table 37. KCN Group Distribution by Severity


Severity Total % Total (n=16)
Mild 3 18.8%
Moderate 9 56.3%
Severe 4 25.0%

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Table 38. Distribution of Steep K and Delta K (difference between Steep K and Flat K) of the KCN Sub-
Group
Corneal
Min Median Mean Max SD
Curvature
Steep K 41.80 47.76 49.65 70.80 6.47
Delta K 0.36 2.67 3.30 8.33 2.17

12 of the 85 total study scans required manual segmentation editing (five from the keratoconus
sub-group, three from the post-laser refractive surgery group, three from the contact lens groups,
and one from the normal group).

Manual image grading was performed by three qualified graders. Each grader was assigned one
randomized grading order to follow. The graders were masked to each other’s results.

18.16.1 Results

Normal Group Agreement

Table 39a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Normal Group (n= 17)


Epithelial Thickness Stromal Thickness Corneal Thickness
LOA LOA LOA LOA LOA LOA
Parameter
mean SD lower upper mean SD lower upper mean SD lower upper
bound* bound** bound* bound** bound* bound**
C_2 -0.4 1.3 -3.1 2.2 -2.5 1.6 -5.6 0.6 -2.9 0.8 -4.4 -1.4
T_2_5 -0.2 2.0 -4.1 3.7 1.0 1.9 -2.8 4.8 0.8 0.9 -1.0 2.6
ST_2_5 -0.3 2.0 -4.1 3.6 2.1 2.0 -1.8 6.1 1.9 1.0 -0.1 3.8
S_2_5 0.4 1.8 -3.2 4.0 2.9 1.8 -0.5 6.4 3.3 0.9 1.6 5.0
SN_2_5 0.3 1.7 -3.0 3.6 2.6 1.6 -0.6 5.8 2.9 1.1 0.7 5.0
N_2_5 0.5 1.4 -2.3 3.3 1.6 1.7 -1.7 4.8 2.1 0.9 0.3 3.9
IN_2_5 0.7 1.7 -2.7 4.1 1.1 2.0 -2.8 4.9 1.8 1.0 -0.1 3.7
I_2_5 0.3 1.8 -3.3 3.9 1.1 2.1 -3.1 5.2 1.4 1.0 -0.5 3.3
IT_2_5 -0.1 1.8 -3.6 3.4 1.0 2.0 -2.9 5.0 1.0 1.0 -1.1 3.0
T_5_7 0.5 2.3 -4.1 5.0 -1.1 2.2 -5.4 3.2 -0.7 0.9 -2.5 1.2
ST_5_7 -0.2 2.4 -4.8 4.4 1.0 2.7 -4.3 6.3 0.8 1.9 -2.9 4.5
S_5_7 0.0 1.9 -3.8 3.7 2.1 3.2 -4.1 8.3 2.0 2.5 -2.9 6.9
SN_5_7 1.2 1.9 -2.6 5.0 -0.2 2.1 -4.3 3.9 1.0 1.2 -1.3 3.3
N_5_7 1.6 2.0 -2.3 5.6 -1.7 2.2 -6.0 2.7 0.0 1.2 -2.4 2.4
IN_5_7 1.5 2.1 -2.6 5.6 -1.2 2.3 -5.7 3.3 0.3 0.9 -1.5 2.2
I_5_7 0.9 2.1 -3.1 4.9 0.1 2.8 -5.5 5.7 1.0 1.8 -2.5 4.5
IT_5_7 0.6 2.3 -3.9 5.1 0.3 4.3 -8.1 8.7 0.9 3.9 -6.7 8.5
T_7_9 -0.5 2.9 -6.3 5.3 0.6 4.7 -8.5 9.8 0.1 3.1 -5.9 6.1
ST_7_9 -1.8 3.5 -8.7 5.0 6.6 8.5 -10.1 23.3 4.8 7.7 -10.2 19.8
S_7_9 -1.9 2.9 -7.5 3.7 11.3 11.4 -11.2 33.7 9.4 10.6 -11.4 30.2
SN_7_9 -0.8 2.9 -6.5 4.9 7.1 8.3 -9.2 23.4 6.3 6.9 -7.2 19.9
N_7_9 1.3 3.0 -4.6 7.1 -0.4 5.4 -11.0 10.2 0.9 4.4 -7.8 9.5
IN_7_9 0.8 2.6 -4.3 6.0 0.7 4.8 -8.7 10.0 1.5 3.9 -6.2 9.2
I_7_9 -0.3 3.1 -6.4 5.9 2.4 5.7 -8.9 13.7 2.1 4.5 -6.6 10.9
IT_7_9 0.1 3.1 -5.9 6.2 2.5 7.4 -12.0 16.9 2.6 7.0 -11.1 16.3
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

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Table 39b. Deming Regression Analysis between Software and Manual Measurements

Normal Group (n= 17)


Epithelial Thickness Stromal Thickness Corneal Thickness
Parameter intercept intercept slope slope intercept intercept slope slope intercept intercept slope slope
intercept slope intercept slope intercept slope
CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper
C_2 -10.1 -22.4 2.3 1.18 0.95 1.41 3.0 -5.5 11.6 0.99 0.97 1.01 -1.8 -5.1 1.4 1.00 0.99 1.00
T_2_5 -20.6 -42.1 0.9 1.38 0.97 1.78 3.1 -11.7 18.0 1.00 0.97 1.03 -1.2 -8.3 5.9 1.00 0.99 1.02
ST_2_5 -8.7 -19.6 2.1 1.16 0.95 1.36 3.8 -5.2 12.8 1.00 0.98 1.01 -0.2 -7.6 7.2 1.00 0.99 1.02
S_2_5 -8.2 -19.9 3.5 1.16 0.94 1.38 4.6 -4.8 14.0 1.00 0.98 1.01 -1.8 -4.0 0.3 1.01 1.01 1.01
SN_2_5 -11.0 -22.7 0.8 1.21 1.00 1.42 3.6 -6.5 13.6 1.00 0.98 1.02 -3.1 -11.8 5.5 1.01 1.00 1.03
N_2_5 -7.4 -19.7 5.0 1.15 0.92 1.38 1.6 -3.8 7.1 1.00 0.99 1.01 1.7 -3.1 6.5 1.00 0.99 1.01
IN_2_5 -10.3 -21.8 1.2 1.20 0.99 1.42 5.3 -2.8 13.4 0.99 0.98 1.01 2.4 -5.0 9.9 1.00 0.99 1.01
I_2_5 -11.4 -23.4 0.7 1.21 0.99 1.43 5.7 -6.1 17.5 0.99 0.97 1.01 1.6 -3.9 7.1 1.00 0.99 1.01
IT_2_5 -18.8 -32.9 -4.7 1.34 1.08 1.60 0.9 -10.5 12.2 1.00 0.98 1.02 -2.6 -8.1 3.0 1.01 1.00 1.02
T_5_7 -14.9 -45.6 15.8 1.29 0.71 1.87 4.9 -8.7 18.6 0.99 0.96 1.01 0.9 -11.3 13.1 1.00 0.98 1.02
ST_5_7 -10.9 -20.1 -1.7 1.20 1.03 1.37 9.5 -0.8 19.8 0.98 0.97 1.00 8.4 0.6 16.2 0.99 0.98 1.00
S_5_7 -8.3 -15.9 -0.6 1.16 1.02 1.29 18.0 9.5 26.5 0.97 0.96 0.99 15.8 5.8 25.9 0.98 0.96 0.99
SN_5_7 -8.4 -21.5 4.6 1.18 0.93 1.42 4.9 -6.3 16.1 0.99 0.97 1.01 -0.6 -7.4 6.1 1.00 0.99 1.01
N_5_7 -2.3 -17.8 13.3 1.07 0.79 1.36 7.0 -11.5 25.5 0.98 0.95 1.02 3.4 -11.3 18.1 0.99 0.97 1.02
IN_5_7 -4.3 -13.6 5.0 1.11 0.94 1.28 -3.1 -10.5 4.3 1.00 0.99 1.02 -3.8 -9.8 2.3 1.01 1.00 1.02
I_5_7 -8.2 -16.7 0.3 1.17 1.01 1.32 3.1 -12.1 18.3 0.99 0.96 1.02 -0.8 -11.7 10.0 1.00 0.98 1.02
IT_5_7 -12.0 -29.4 5.5 1.23 0.90 1.56 -5.4 -26.8 16.1 1.01 0.97 1.05 -13.1 -35.2 9.0 1.02 0.98 1.07
T_7_9 -8.0 -54.7 38.7 1.14 0.26 2.02 20.3 -5.7 46.4 0.96 0.92 1.01 13.7 -13.9 41.4 0.98 0.93 1.02
ST_7_9 -8.1 -49.6 33.4 1.12 0.33 1.92 16.8 -28.3 62.0 0.98 0.91 1.06 12.0 -50.1 74.2 0.99 0.89 1.08
S_7_9 -1.8 -18.0 14.4 1.00 0.68 1.31 5.6 -109.4 120.6 1.01 0.83 1.19 11.0 -98.8 120.9 1.00 0.84 1.16
SN_7_9 -0.6 -11.3 10.1 1.00 0.80 1.19 -16.8 -89.0 55.4 1.04 0.92 1.16 -21.4 -91.7 48.9 1.04 0.93 1.15
N_7_9 7.4 -6.2 21.0 0.89 0.64 1.13 10.9 -33.3 55.1 0.98 0.90 1.06 3.5 -41.0 47.9 1.00 0.93 1.07
IN_7_9 -0.6 -9.7 8.5 1.03 0.85 1.20 7.5 -12.7 27.8 0.99 0.95 1.02 5.6 -13.4 24.7 0.99 0.96 1.02
I_7_9 -14.3 -27.4 -1.2 1.26 1.02 1.50 8.4 -39.7 56.4 0.99 0.90 1.08 1.4 -45.3 48.2 1.00 0.92 1.08
IT_7_9 -8.8 -26.6 9.0 1.16 0.83 1.49 -13.9 -60.8 33.0 1.03 0.94 1.12 -23.8 -78.7 31.0 1.04 0.95 1.14

Contact Lens Group Agreement

Table 40a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Contact Lens Group (n= 15)


Epithelial Thickness Stromal Thickness Corneal Thickness
LOA LOA LOA LOA LOA LOA
Parameter
mean SD lower upper mean SD lower upper mean SD lower upper
bound* bound** bound* bound** bound* bound**
C_2 -0.4 1.3 -2.9 2.1 -1.7 2.0 -5.6 2.3 -2.1 1.6 -5.2 1.0
T_2_5 -0.2 1.7 -3.6 3.1 1.5 1.5 -1.4 4.5 1.3 1.0 -0.6 3.2
ST_2_5 -0.1 1.8 -3.6 3.4 2.4 1.4 -0.4 5.3 2.3 1.1 0.3 4.4
S_2_5 0.3 1.3 -2.2 2.8 3.0 1.5 0.1 5.8 3.3 1.4 0.6 5.9
SN_2_5 0.2 1.4 -2.6 2.9 2.8 1.4 0.1 5.6 3.0 0.9 1.1 4.8
N_2_5 0.4 1.5 -2.7 3.4 1.7 1.3 -0.9 4.3 2.1 0.8 0.6 3.6
IN_2_5 0.4 1.6 -2.7 3.5 1.2 1.6 -2.0 4.3 1.6 0.9 -0.1 3.3
I_2_5 0.0 1.3 -2.4 2.5 1.2 1.2 -1.2 3.6 1.2 0.7 -0.2 2.6
IT_2_5 0.0 1.8 -3.6 3.6 1.1 1.6 -2.1 4.2 1.1 1.0 -0.9 3.1
T_5_7 0.1 2.2 -4.1 4.4 -0.1 2.5 -5.1 4.9 0.0 1.4 -2.7 2.8
ST_5_7 -0.1 2.3 -4.6 4.4 0.6 2.3 -3.9 5.1 0.5 1.0 -1.4 2.4
S_5_7 0.1 1.9 -3.6 3.7 1.4 2.0 -2.4 5.3 1.5 1.0 -0.5 3.4
SN_5_7 0.2 1.8 -3.4 3.8 0.8 2.0 -3.2 4.8 1.0 0.9 -0.9 2.8
N_5_7 1.0 1.7 -2.3 4.3 -0.8 1.9 -4.5 2.9 0.1 1.0 -1.8 2.1
IN_5_7 1.2 1.8 -2.2 4.7 -0.8 1.9 -4.5 2.9 0.5 0.9 -1.4 2.3
I_5_7 0.3 1.7 -2.9 3.6 -0.3 1.7 -3.6 3.1 0.1 0.9 -1.8 1.9
IT_5_7 0.7 2.6 -4.3 5.8 -0.5 4.4 -9.2 8.2 0.2 3.3 -6.4 6.8
T_7_9 0.1 3.0 -5.7 5.8 1.5 4.3 -6.9 10.0 1.6 3.5 -5.3 8.5
ST_7_9 -1.7 3.4 -8.4 5.0 4.1 7.2 -10.0 18.2 2.4 5.8 -9.0 13.8
S_7_9 -1.7 3.1 -7.8 4.3 6.8 7.8 -8.5 22.2 5.1 6.3 -7.2 17.4
SN_7_9 -1.3 2.7 -6.5 4.0 3.3 7.5 -11.5 18.0 2.0 6.0 -9.8 13.9
N_7_9 0.4 2.2 -4.0 4.7 0.0 4.2 -8.3 8.3 0.4 3.0 -5.5 6.3
IN_7_9 1.2 2.3 -3.2 5.6 -0.6 3.6 -7.7 6.6 0.6 2.7 -4.6 5.9
I_7_9 0.0 2.7 -5.3 5.3 0.9 4.4 -7.7 9.4 0.9 2.7 -4.4 6.2
IT_7_9 0.5 3.4 -6.0 7.1 -1.0 11.9 -24.3 22.4 -0.4 11.2 -22.3 21.5
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

RTVue XR Avanti User Manual Page 441 of 451 P/N 580-52576-005 Rev. A
Table 40b. Deming Regression Analysis between Software and Manual Measurements

Contact Lens Group (n= 15)


Epithelial Thickness Stromal Thickness Corneal Thickness
Parameter intercept intercept slope slope intercept intercept slope slope intercept intercept slope slope
intercept slope intercept slope intercept slope
CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper
C_2 -2.3 -12.7 8.2 1.04 0.83 1.25 0.4 -20.4 21.3 1.00 0.95 1.04 6.5 -10.1 23.1 0.98 0.95 1.01
T_2_5 5.4 -3.7 14.6 0.89 0.71 1.06 6.2 -18.4 30.7 0.99 0.94 1.04 -1.4 -21.3 18.6 1.01 0.97 1.04
ST_2_5 5.3 -2.3 12.9 0.89 0.75 1.04 -1.4 -28.9 26.1 1.01 0.95 1.06 -11.5 -25.5 2.6 1.03 1.00 1.05
S_2_5 2.8 -0.5 6.0 0.95 0.89 1.01 -10.7 -27.1 5.6 1.03 0.99 1.06 -14.3 -32.6 4.0 1.03 1.00 1.06
SN_2_5 3.3 -0.8 7.4 0.94 0.86 1.02 -6.7 -21.6 8.3 1.02 0.99 1.05 -6.3 -15.2 2.5 1.02 1.00 1.03
N_2_5 5.2 2.9 7.6 0.91 0.86 0.95 -0.4 -7.9 7.1 1.00 0.99 1.02 -5.7 -16.6 5.2 1.01 0.99 1.03
IN_2_5 2.7 -5.4 10.9 0.96 0.79 1.12 -10.1 -23.4 3.1 1.02 1.00 1.05 -8.7 -16.5 -0.9 1.02 1.00 1.03
I_2_5 1.7 -6.1 9.5 0.97 0.81 1.12 -4.3 -15.0 6.4 1.01 0.99 1.03 -4.3 -13.0 4.3 1.01 0.99 1.03
IT_2_5 3.8 -6.3 13.9 0.93 0.74 1.12 3.6 -5.7 12.8 0.99 0.98 1.01 -4.1 -18.0 9.7 1.01 0.98 1.04
T_5_7 6.4 -10.9 23.8 0.88 0.54 1.21 9.0 -9.7 27.7 0.98 0.95 1.02 -5.9 -16.2 4.5 1.01 0.99 1.03
ST_5_7 1.6 -12.9 16.0 0.97 0.68 1.25 4.2 -28.1 36.4 0.99 0.93 1.05 -10.4 -33.5 12.6 1.02 0.98 1.06
S_5_7 2.7 -5.7 11.1 0.95 0.78 1.11 10.6 -23.5 44.7 0.98 0.92 1.05 6.2 -23.9 36.4 0.99 0.94 1.04
SN_5_7 0.3 -6.2 6.9 1.00 0.87 1.13 1.4 -8.3 11.1 1.00 0.98 1.02 -6.7 -30.7 17.3 1.01 0.97 1.05
N_5_7 7.5 3.1 12.0 0.87 0.78 0.96 -5.1 -11.2 1.1 1.01 1.00 1.02 -10.3 -20.5 -0.2 1.02 1.00 1.04
IN_5_7 5.6 -0.8 11.9 0.92 0.80 1.04 -9.3 -18.3 -0.3 1.02 1.00 1.03 -7.0 -23.7 9.7 1.01 0.98 1.04
I_5_7 -5.7 -11.5 0.1 1.11 1.01 1.22 4.0 -9.1 17.2 0.99 0.97 1.02 4.1 -8.4 16.6 0.99 0.97 1.02
IT_5_7 6.1 -27.0 39.2 0.90 0.26 1.53 32.5 -42.0 106.9 0.94 0.79 1.08 21.4 -43.9 86.7 0.96 0.84 1.08
T_7_9 2.3 -13.1 17.7 0.96 0.65 1.26 -5.6 -22.0 10.8 1.01 0.98 1.04 -26.6 -38.2 -14.9 1.05 1.03 1.07
ST_7_9 1.6 -22.1 25.4 0.93 0.46 1.40 13.0 -42.6 68.6 0.98 0.89 1.08 -12.8 -51.0 25.4 1.02 0.96 1.09
S_7_9 -6.3 -22.9 10.2 1.10 0.77 1.43 -31.8 -51.7 -11.9 1.06 1.03 1.09 -36.3 -80.2 7.5 1.06 1.00 1.13
SN_7_9 -2.5 -12.1 7.1 1.02 0.84 1.21 -12.1 -117.9 93.7 1.03 0.85 1.20 -4.7 -121.1 111.6 1.01 0.83 1.19
N_7_9 6.3 0.2 12.5 0.88 0.77 1.00 20.6 -1.9 43.0 0.96 0.93 1.00 20.5 -11.4 52.4 0.97 0.92 1.02
IN_7_9 -0.8 -8.9 7.3 1.04 0.88 1.19 11.2 -31.5 53.9 0.98 0.90 1.06 16.5 -26.4 59.3 0.97 0.90 1.05
I_7_9 -9.6 -24.8 5.5 1.18 0.90 1.47 -3.4 -17.2 10.4 1.01 0.98 1.03 15.7 5.4 26.0 0.98 0.96 0.99
IT_7_9 10.5 -16.9 37.8 0.81 0.28 1.34 69.9 -86.7 226.5 0.87 0.58 1.16 59.2 -128.8 247.2 0.90 0.58 1.22

Dry Eye Group Agreement

Table 41a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Dry Eye Group (n= 18)


Epithelial Thickness Stromal Thickness Corneal Thickness
LOA LOA LOA LOA LOA LOA
Parameter
mean SD lower upper mean SD lower upper mean SD lower upper
bound* bound** bound* bound** bound* bound**
C_2 -0.3 1.0 -2.3 1.7 -2.4 1.1 -4.5 -0.3 -2.7 0.7 -4.1 -1.3
T_2_5 -0.2 1.6 -3.3 2.8 1.1 1.8 -2.4 4.5 0.8 0.8 -0.6 2.3
ST_2_5 -0.3 1.8 -3.9 3.2 2.2 1.7 -1.1 5.5 1.9 1.0 -0.1 3.8
S_2_5 0.3 1.5 -2.5 3.2 2.8 1.6 -0.4 6.0 3.1 1.3 0.6 5.6
SN_2_5 -0.1 1.8 -3.7 3.4 2.8 2.1 -1.4 7.0 2.7 1.1 0.6 4.7
N_2_5 -0.1 1.5 -3.1 2.8 1.9 1.5 -1.1 4.9 1.7 0.7 0.3 3.2
IN_2_5 0.1 1.6 -3.1 3.2 1.6 1.8 -1.9 5.0 1.6 0.9 -0.1 3.3
I_2_5 0.2 1.8 -3.3 3.7 1.2 1.9 -2.6 5.0 1.4 1.0 -0.6 3.5
IT_2_5 0.1 1.5 -2.8 3.0 0.5 1.4 -2.3 3.3 0.6 0.8 -1.0 2.2
T_5_7 0.7 2.9 -5.1 6.5 -1.4 4.8 -10.9 8.0 -0.7 4.3 -9.1 7.6
ST_5_7 0.4 2.7 -4.8 5.6 0.9 4.6 -8.2 10.0 1.3 3.6 -5.8 8.4
S_5_7 0.5 2.3 -4.0 5.0 1.8 4.6 -7.2 10.7 2.3 4.2 -6.0 10.6
SN_5_7 0.8 2.2 -3.6 5.1 0.0 2.3 -4.4 4.5 0.8 1.5 -2.2 3.8
N_5_7 0.6 1.8 -3.0 4.1 -0.3 2.0 -4.2 3.7 0.3 1.1 -1.8 2.4
IN_5_7 1.1 1.8 -2.4 4.5 -0.7 1.8 -4.3 2.8 0.3 0.9 -1.4 2.0
I_5_7 0.6 1.9 -3.0 4.3 0.2 1.8 -3.3 3.7 0.8 0.9 -1.0 2.5
IT_5_7 0.9 2.6 -4.2 6.0 -0.5 2.4 -5.3 4.2 0.3 2.1 -3.7 4.4
T_7_9 -0.2 4.0 -8.0 7.6 1.6 8.2 -14.5 17.8 1.4 7.4 -13.1 16.0
ST_7_9 -1.5 3.4 -8.2 5.2 4.9 5.6 -6.2 15.9 3.4 5.5 -7.4 14.2
S_7_9 -2.1 3.0 -7.9 3.7 7.4 9.2 -10.7 25.5 5.3 8.3 -11.0 21.6
SN_7_9 -0.6 2.8 -6.0 4.9 5.3 11.1 -16.5 27.1 4.7 10.0 -15.0 24.4
N_7_9 0.5 3.2 -5.7 6.7 0.1 4.9 -9.6 9.8 0.6 4.2 -7.6 8.8
IN_7_9 0.4 3.0 -5.4 6.3 0.3 4.1 -7.7 8.4 0.8 3.1 -5.3 6.8
I_7_9 -0.4 3.1 -6.6 5.7 1.6 3.4 -5.1 8.2 1.1 1.8 -2.5 4.7
IT_7_9 0.4 3.2 -5.9 6.7 1.3 5.6 -9.6 12.2 1.7 4.2 -6.6 10.0
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

RTVue XR Avanti User Manual Page 442 of 451 P/N 580-52576-005 Rev. A
Table 41b. Deming Regression Analysis between Software and Manual Measurements

Dry Eye Group (n= 18)


Epithelial Thickness Stromal Thickness Corneal Thickness
Parameter intercept intercept slope slope intercept intercept slope slope intercept intercept slope slope
intercept slope intercept slope intercept slope
CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper
C_2 -1.6 -6.6 3.3 1.02 0.93 1.12 0.6 -3.3 4.4 0.99 0.99 1.00 -0.8 -13.4 11.8 1.00 0.97 1.02
T_2_5 5.3 0.3 10.3 0.89 0.80 0.99 -5.2 -22.0 11.5 1.01 0.98 1.05 -4.0 -8.1 0.2 1.01 1.00 1.02
ST_2_5 -0.2 -9.7 9.4 1.00 0.81 1.18 -0.2 -7.8 7.4 1.00 0.99 1.02 0.0 -4.9 5.0 1.00 0.99 1.01
S_2_5 -4.1 -11.0 2.8 1.08 0.95 1.22 2.4 -7.4 12.3 1.00 0.98 1.02 1.2 -9.1 11.5 1.00 0.99 1.02
SN_2_5 -8.6 -23.8 6.6 1.16 0.88 1.44 8.0 -3.3 19.3 0.99 0.97 1.01 2.6 -5.2 10.3 1.00 0.99 1.01
N_2_5 -10.6 -17.7 -3.5 1.20 1.06 1.33 5.8 -7.0 18.6 0.99 0.97 1.02 0.4 -4.0 4.8 1.00 0.99 1.01
IN_2_5 -2.6 -11.7 6.5 1.05 0.88 1.22 2.0 -14.0 17.9 1.00 0.97 1.03 -4.6 -11.6 2.5 1.01 1.00 1.02
I_2_5 -3.4 -8.9 2.0 1.07 0.96 1.17 -5.7 -17.9 6.4 1.01 0.99 1.04 -4.5 -10.5 1.4 1.01 1.00 1.02
IT_2_5 -2.1 -7.3 3.0 1.04 0.95 1.14 -7.1 -11.3 -2.8 1.02 1.01 1.02 -6.1 -14.3 2.1 1.01 1.00 1.03
T_5_7 4.0 -14.3 22.2 0.94 0.58 1.29 5.5 -83.5 94.5 0.99 0.81 1.16 30.1 -35.8 95.9 0.95 0.83 1.06
ST_5_7 -8.4 -38.2 21.5 1.17 0.60 1.73 -34.9 -112.6 42.8 1.07 0.92 1.21 -21.3 -86.9 44.3 1.04 0.92 1.15
S_5_7 -6.0 -22.0 9.9 1.13 0.82 1.43 -25.7 -95.0 43.6 1.05 0.92 1.17 -30.0 -99.5 39.4 1.05 0.94 1.17
SN_5_7 0.6 -14.6 15.8 1.00 0.72 1.29 5.0 -6.0 16.1 0.99 0.97 1.01 -1.7 -15.8 12.4 1.00 0.98 1.03
N_5_7 -1.9 -13.1 9.3 1.05 0.84 1.25 -2.4 -20.7 16.0 1.00 0.97 1.04 -7.3 -21.3 6.8 1.01 0.99 1.04
IN_5_7 -0.4 -11.0 10.1 1.03 0.83 1.22 6.2 -2.3 14.6 0.99 0.97 1.00 -3.5 -11.4 4.3 1.01 0.99 1.02
I_5_7 0.0 -11.7 11.7 1.01 0.79 1.23 -6.7 -13.6 0.3 1.01 1.00 1.03 -0.2 -6.6 6.2 1.00 0.99 1.01
IT_5_7 -1.0 -22.2 20.2 1.03 0.64 1.43 -10.8 -25.8 4.2 1.02 0.99 1.05 1.3 -9.3 11.9 1.00 0.98 1.02
T_7_9 -1.5 -22.6 19.5 1.03 0.62 1.43 -8.8 -99.3 81.6 1.02 0.85 1.19 26.7 -25.6 79.0 0.96 0.87 1.05
ST_7_9 4.8 -8.2 17.8 0.88 0.64 1.12 13.4 -16.9 43.8 0.99 0.93 1.04 33.6 -9.3 76.4 0.95 0.89 1.02
S_7_9 -4.4 -21.3 12.5 1.05 0.73 1.37 24.4 -30.3 79.2 0.97 0.89 1.06 10.2 -29.7 50.1 0.99 0.94 1.05
SN_7_9 2.4 -6.4 11.2 0.94 0.78 1.11 -37.8 -131.4 55.9 1.07 0.92 1.23 -56.7 -157.6 44.2 1.09 0.94 1.25
N_7_9 -8.3 -23.3 6.7 1.16 0.89 1.44 -14.3 -46.9 18.4 1.02 0.97 1.08 -34.9 -61.5 -8.2 1.06 1.01 1.10
IN_7_9 -7.6 -27.1 11.9 1.15 0.78 1.52 3.2 -13.1 19.5 0.99 0.97 1.02 -13.2 -28.7 2.3 1.02 1.00 1.05
I_7_9 -7.6 -25.3 10.1 1.13 0.81 1.45 2.4 -10.4 15.1 1.00 0.98 1.02 -1.3 -8.6 6.0 1.00 0.99 1.02
IT_7_9 3.1 -30.3 36.5 0.95 0.33 1.57 -15.1 -42.4 12.2 1.03 0.98 1.08 -1.3 -17.1 14.4 1.01 0.98 1.03

Post-LRS Group Agreement

Table 42a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Post-Laser Refractive Surgery Group (n= 19)
Epithelial Thickness Stromal Thickness Corneal Thickness
LOA LOA LOA LOA LOA LOA
Parameter
mean SD lower upper mean SD lower upper mean SD lower upper
bound* bound** bound* bound** bound* bound**
C_2 0.4 1.2 -2.1 2.8 -3.9 1.8 -7.4 -0.5 -3.5 1.0 -5.5 -1.5
T_2_5 1.4 2.1 -2.7 5.6 0.3 2.3 -4.2 4.8 1.7 1.4 -1.1 4.6
ST_2_5 1.1 2.2 -3.3 5.5 1.8 2.4 -2.9 6.5 2.9 1.6 -0.1 6.0
S_2_5 1.1 2.0 -2.8 5.0 3.1 2.1 -0.9 7.2 4.2 1.9 0.5 7.9
SN_2_5 0.8 2.1 -3.3 4.9 3.1 2.0 -0.8 6.9 3.9 1.4 1.1 6.7
N_2_5 0.7 1.9 -3.1 4.5 2.2 1.9 -1.4 5.9 2.9 1.6 -0.3 6.2
IN_2_5 1.0 1.8 -2.6 4.6 1.6 2.0 -2.4 5.6 2.6 1.6 -0.6 5.8
I_2_5 1.3 1.7 -2.1 4.7 1.2 1.8 -2.4 4.7 2.5 1.4 -0.3 5.3
IT_2_5 1.6 1.8 -1.9 5.0 0.2 2.0 -3.8 4.1 1.7 1.5 -1.1 4.6
T_5_7 1.1 4.0 -6.6 8.9 -1.2 4.5 -10.1 7.8 0.0 1.5 -3.0 2.9
ST_5_7 0.4 3.1 -5.7 6.5 1.1 4.1 -7.1 9.2 1.5 2.1 -2.7 5.7
S_5_7 1.3 3.6 -5.8 8.4 1.2 4.2 -7.0 9.4 2.5 2.0 -1.3 6.4
SN_5_7 1.4 2.9 -4.3 7.1 -0.6 3.2 -6.9 5.8 0.8 2.7 -4.5 6.1
N_5_7 1.4 2.7 -3.8 6.6 -0.4 2.7 -5.7 5.0 1.1 1.4 -1.6 3.7
IN_5_7 1.5 2.5 -3.3 6.3 -0.3 2.9 -6.0 5.4 1.2 1.5 -1.8 4.2
I_5_7 1.0 2.9 -4.7 6.7 1.1 3.8 -6.4 8.7 2.1 1.7 -1.2 5.5
IT_5_7 0.9 2.7 -4.3 6.2 -0.4 3.4 -7.0 6.3 0.6 1.4 -2.3 3.4
T_7_9 -1.3 4.2 -9.4 6.9 1.8 7.5 -12.9 16.5 0.5 5.2 -9.7 10.7
ST_7_9 -1.0 4.5 -9.9 7.9 3.6 9.5 -15.1 22.3 2.6 7.4 -11.9 17.1
S_7_9 -0.5 5.1 -10.4 9.4 4.2 13.7 -22.7 31.1 3.7 12.6 -20.9 28.3
SN_7_9 -0.3 4.2 -8.5 7.9 2.5 7.5 -12.2 17.2 2.2 6.7 -10.9 15.3
N_7_9 1.1 3.3 -5.5 7.6 0.7 5.4 -9.9 11.2 1.8 4.3 -6.7 10.2
IN_7_9 0.3 3.7 -7.0 7.6 1.0 5.9 -10.6 12.6 1.3 4.6 -7.6 10.3
I_7_9 -0.2 3.4 -6.7 6.4 2.0 5.4 -8.5 12.6 1.9 3.8 -5.6 9.3
IT_7_9 -0.3 4.0 -8.2 7.5 1.9 5.6 -9.1 12.8 1.6 3.7 -5.8 8.9
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

RTVue XR Avanti User Manual Page 443 of 451 P/N 580-52576-005 Rev. A
Table 42b. Deming Regression Analysis between Software and Manual Measurements

Post-Laser Refractive Surgery Group (n= 19)


Epithelial Thickness Stromal Thickness Corneal Thickness
Parameter intercept intercept slope slope intercept intercept slope slope intercept intercept slope slope
intercept slope intercept slope intercept slope
CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper
C_2 -4.5 -8.1 -0.9 1.09 1.02 1.15 -10.1 -17.0 -3.2 1.02 1.00 1.03 -6.8 -11.1 -2.5 1.01 1.00 1.02
T_2_5 -5.6 -14.8 3.6 1.12 0.96 1.29 -2.9 -17.1 11.3 1.01 0.98 1.04 1.1 -7.7 9.9 1.00 0.98 1.02
ST_2_5 -5.1 -12.1 1.8 1.11 0.98 1.24 -1.6 -9.2 5.9 1.01 0.99 1.03 5.1 -2.0 12.1 1.00 0.98 1.01
S_2_5 -4.3 -12.1 3.4 1.10 0.95 1.25 -2.7 -22.6 17.2 1.02 0.97 1.06 10.3 0.3 20.3 0.99 0.97 1.01
SN_2_5 -5.2 -12.6 2.1 1.11 0.97 1.25 4.9 -22.8 32.7 1.00 0.94 1.05 13.3 6.3 20.4 0.98 0.97 1.00
N_2_5 -4.6 -14.2 5.0 1.10 0.92 1.27 4.8 -16.5 26.1 1.00 0.95 1.04 11.6 3.5 19.8 0.98 0.97 1.00
IN_2_5 -2.1 -11.3 7.2 1.05 0.89 1.21 24.6 -4.3 53.6 0.96 0.89 1.02 2.5 -4.4 9.4 1.00 0.99 1.01
I_2_5 -4.5 -9.5 0.6 1.10 1.01 1.19 11.0 -36.2 58.2 0.98 0.88 1.08 5.6 -2.0 13.2 0.99 0.98 1.01
IT_2_5 -2.6 -8.6 3.4 1.07 0.96 1.18 -21.1 -75.8 33.6 1.05 0.93 1.16 1.8 -6.4 9.9 1.00 0.98 1.02
T_5_7 -24.2 -54.4 6.0 1.47 0.91 2.03 -14.8 -62.2 32.6 1.03 0.93 1.12 2.0 -9.2 13.2 1.00 0.98 1.02
ST_5_7 -11.6 -25.9 2.6 1.22 0.97 1.48 -0.4 -22.7 22.0 1.00 0.96 1.04 0.7 -8.5 10.0 1.00 0.99 1.02
S_5_7 -9.3 -17.1 -1.4 1.20 1.07 1.34 -30.0 -67.0 7.0 1.06 0.99 1.13 2.9 -8.1 13.8 1.00 0.98 1.02
SN_5_7 4.0 -8.8 16.8 0.95 0.71 1.19 -26.9 -53.1 -0.7 1.05 1.00 1.10 2.1 -26.1 30.3 1.00 0.95 1.04
N_5_7 -6.3 -22.9 10.3 1.14 0.83 1.46 -15.7 -49.8 18.5 1.03 0.97 1.09 -0.3 -10.3 9.7 1.00 0.99 1.02
IN_5_7 -1.7 -12.3 8.9 1.06 0.86 1.25 -8.4 -68.0 51.2 1.01 0.91 1.12 0.8 -8.5 10.0 1.00 0.98 1.02
I_5_7 -14.7 -32.4 3.0 1.28 0.96 1.60 -17.8 -43.7 8.0 1.03 0.98 1.08 5.8 -4.3 16.0 0.99 0.98 1.01
IT_5_7 -17.2 -40.8 6.3 1.33 0.90 1.76 -57.4 -155.1 40.3 1.11 0.91 1.30 1.4 -11.6 14.4 1.00 0.98 1.02
T_7_9 -1.5 -59.9 57.0 1.00 -0.13 2.14 -10.5 -55.9 34.9 1.03 0.95 1.11 -13.7 -44.0 16.6 1.02 0.97 1.07
ST_7_9 -5.1 -49.0 38.8 1.08 0.21 1.95 -9.6 -55.7 36.5 1.02 0.94 1.10 -7.5 -44.7 29.7 1.02 0.96 1.08
S_7_9 -32.2 -86.2 21.8 1.64 0.52 2.75 16.0 -60.6 92.6 0.97 0.83 1.11 -9.2 -95.1 76.8 1.02 0.89 1.15
SN_7_9 1.5 -14.3 17.4 0.96 0.65 1.28 3.4 -58.2 65.1 1.00 0.89 1.11 -31.4 -70.0 7.2 1.05 0.99 1.11
N_7_9 -10.6 -26.6 5.4 1.22 0.92 1.51 26.6 -15.3 68.4 0.95 0.88 1.03 -32.8 -71.1 5.6 1.05 0.99 1.11
IN_7_9 1.4 -15.4 18.3 0.98 0.67 1.29 45.4 -29.8 120.6 0.92 0.78 1.05 -14.5 -32.0 3.0 1.03 1.00 1.05
I_7_9 10.6 -4.7 25.8 0.80 0.52 1.08 -31.0 -74.8 12.9 1.07 0.98 1.15 14.5 -2.7 31.7 0.98 0.95 1.01
IT_7_9 13.6 -17.3 44.5 0.73 0.14 1.32 -49.6 -116.0 16.9 1.10 0.97 1.22 -6.8 -23.9 10.2 1.01 0.99 1.04

Keratoconus Group Agreement

Table 43a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Keratoconus Group (n= 16)


Epithelial Thickness Stromal Thickness Corneal Thickness
LOA LOA LOA LOA LOA LOA
Parameter
mean SD lower upper mean SD lower upper mean SD lower upper
bound* bound** bound* bound** bound* bound**
C_2 -0.4 1.9 -4.2 3.4 -3.4 1.9 -7.2 0.5 -3.8 2.2 -8.1 0.6
T_2_5 -0.2 3.9 -7.9 7.5 1.3 3.3 -5.2 7.8 1.1 2.6 -4.0 6.2
ST_2_5 1.0 3.0 -4.9 6.8 3.4 2.9 -2.3 9.2 4.4 3.3 -2.1 10.9
S_2_5 1.0 2.4 -3.7 5.8 4.8 3.1 -1.4 10.9 5.8 4.2 -2.4 14.1
SN_2_5 0.7 2.6 -4.4 5.7 4.5 3.1 -1.6 10.6 5.2 4.1 -2.8 13.1
N_2_5 0.8 2.4 -3.9 5.6 3.7 2.9 -2.0 9.3 4.5 3.9 -3.2 12.2
IN_2_5 0.3 3.8 -7.3 7.8 4.0 4.8 -5.4 13.5 4.3 3.4 -2.4 11.0
I_2_5 -0.5 4.6 -9.5 8.6 1.5 7.6 -13.3 16.3 1.0 5.7 -10.2 12.3
IT_2_5 -0.6 4.3 -8.9 7.8 -1.5 9.7 -20.4 17.4 -2.1 10.5 -22.6 18.4
T_5_7 0.5 4.4 -8.1 9.1 -2.1 5.8 -13.5 9.2 -1.6 5.8 -13.0 9.7
ST_5_7 1.2 3.5 -5.7 8.2 1.5 4.1 -6.5 9.5 2.8 3.7 -4.6 10.1
S_5_7 1.1 3.1 -5.0 7.2 3.6 7.2 -10.4 17.7 4.8 6.8 -8.5 18.0
SN_5_7 1.3 3.2 -4.9 7.6 1.8 6.5 -10.9 14.5 3.2 5.4 -7.4 13.8
N_5_7 1.3 2.8 -4.1 6.7 -0.8 5.2 -11.0 9.4 0.5 5.3 -9.8 10.8
IN_5_7 1.5 2.7 -3.7 6.7 -0.9 9.3 -19.2 17.4 0.6 10.0 -19.1 20.2
I_5_7 1.0 3.8 -6.4 8.4 -2.1 5.8 -13.4 9.3 -1.1 6.2 -13.3 11.1
IT_5_7 0.7 4.9 -9.0 10.4 -6.5 12.2 -30.5 17.5 -5.8 11.6 -28.5 16.8
T_7_9 0.6 3.6 -6.5 7.7 4.9 14.2 -22.9 32.6 5.5 13.7 -21.4 32.3
ST_7_9 0.2 4.0 -7.7 8.0 1.9 11.4 -20.4 24.2 2.1 11.3 -20.0 24.2
S_7_9 0.0 4.0 -7.8 7.8 -1.0 16.0 -32.3 30.3 -1.0 14.5 -29.5 27.5
SN_7_9 0.9 4.7 -8.2 10.0 2.3 11.0 -19.3 23.9 3.2 9.8 -16.0 22.3
N_7_9 0.8 4.3 -7.7 9.2 -0.1 6.1 -12.0 11.8 0.7 4.5 -8.1 9.5
IN_7_9 0.3 3.8 -7.1 7.7 0.0 12.1 -23.8 23.7 0.3 10.9 -21.2 21.7
I_7_9 0.5 4.2 -7.6 8.7 5.5 13.2 -20.4 31.4 6.0 12.3 -18.1 30.2
IT_7_9 0.8 4.5 -8.0 9.6 2.3 18.8 -34.6 39.1 3.1 16.8 -29.9 36.1
* LOA lower bound = mean-1.96xSD
** LOA upper bound = mean+1.96xSD

RTVue XR Avanti User Manual Page 444 of 451 P/N 580-52576-005 Rev. A
Table 43b. Deming Regression Analysis between Software and Manual Measurements

Keratoconus Group (n= 16)


Epithelial Thickness Stromal Thickness Corneal Thickness
Parameter intercept intercept slope slope intercept intercept slope slope intercept intercept slope slope
intercept slope intercept slope intercept slope
CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper CI lower CI upper
C_2 -5.2 -8.8 -1.7 1.09 1.02 1.16 -12.4 -16.6 -8.1 1.02 1.01 1.03 -16.2 -27.8 -4.7 1.03 1.00 1.05
T_2_5 -8.7 -26.2 8.7 1.17 0.85 1.48 -5.1 -13.5 3.3 1.01 0.99 1.03 -12.3 -29.2 4.5 1.03 0.99 1.06
ST_2_5 -5.0 -15.2 5.1 1.11 0.94 1.28 -3.2 -10.7 4.4 1.01 0.99 1.03 -8.5 -25.1 8.2 1.02 0.99 1.06
S_2_5 -0.5 -12.9 11.9 1.03 0.79 1.26 1.5 -5.8 8.9 1.00 0.99 1.02 -6.4 -33.6 20.9 1.02 0.97 1.07
SN_2_5 -5.8 -27.3 15.6 1.12 0.74 1.49 2.0 -4.1 8.1 1.00 0.99 1.01 -0.4 -36.8 35.9 1.01 0.95 1.07
N_2_5 -4.2 -19.2 10.8 1.09 0.83 1.35 4.1 -3.7 12.0 1.00 0.98 1.01 -2.4 -43.7 39.0 1.01 0.94 1.09
IN_2_5 -3.3 -10.1 3.5 1.06 0.93 1.20 -0.9 -8.9 7.2 1.01 0.99 1.02 15.1 -14.4 44.6 0.98 0.92 1.03
I_2_5 1.1 -36.1 38.2 0.97 0.26 1.69 -0.9 -8.1 6.3 1.00 0.99 1.02 8.1 -27.1 43.3 0.99 0.92 1.05
IT_2_5 -0.3 -27.6 27.0 1.00 0.45 1.54 -2.9 -10.5 4.7 1.01 0.99 1.02 -32.2 -96.4 32.0 1.06 0.94 1.18
T_5_7 -7.1 -35.6 21.3 1.14 0.61 1.68 -0.7 -22.1 20.8 1.00 0.96 1.04 -21.0 -62.7 20.6 1.04 0.96 1.11
ST_5_7 -17.8 -43.0 7.4 1.36 0.88 1.83 -4.7 -19.0 9.6 1.01 0.98 1.04 -3.1 -27.7 21.6 1.01 0.97 1.05
S_5_7 -8.1 -50.2 34.0 1.17 0.39 1.96 -20.8 -45.5 3.8 1.04 1.00 1.08 -28.5 -74.4 17.4 1.05 0.98 1.13
SN_5_7 0.8 -92.9 94.5 1.01 -0.69 2.71 -11.2 -28.9 6.4 1.02 0.99 1.05 -26.3 -62.8 10.3 1.05 0.99 1.11
N_5_7 0.4 -20.5 21.2 1.02 0.65 1.39 -5.3 -23.7 13.0 1.01 0.98 1.04 -15.9 -58.7 27.0 1.03 0.96 1.10
IN_5_7 4.5 -8.0 17.1 0.95 0.73 1.16 -0.4 -16.2 15.4 1.00 0.97 1.03 -8.9 -80.4 62.5 1.02 0.90 1.13
I_5_7 -7.4 -28.1 13.3 1.15 0.79 1.51 11.4 -15.1 37.8 0.98 0.93 1.03 -14.0 -36.7 8.7 1.02 0.99 1.06
IT_5_7 3.7 -37.0 44.3 0.94 0.19 1.70 6.5 -14.4 27.4 0.99 0.94 1.03 -57.1 -152.3 38.0 1.10 0.93 1.26
T_7_9 5.0 -14.0 23.9 0.92 0.57 1.27 -19.8 -69.7 30.1 1.04 0.95 1.13 4.7 -61.8 71.3 1.00 0.89 1.11
ST_7_9 5.0 -34.2 44.2 0.91 0.13 1.68 -22.5 -63.7 18.8 1.04 0.97 1.12 4.7 -54.5 63.8 1.00 0.90 1.09
S_7_9 -56.6 -115.7 2.5 2.13 0.94 3.32 -47.3 -113.1 18.6 1.08 0.97 1.19 35.2 -42.6 113.0 0.94 0.82 1.07
SN_7_9 13.0 -72.3 98.3 0.77 -0.80 2.35 -5.1 -61.4 51.1 1.01 0.92 1.10 15.9 -48.4 80.2 0.98 0.88 1.08
N_7_9 20.8 2.5 39.2 0.64 0.32 0.96 -31.6 -78.2 15.0 1.06 0.98 1.13 25.8 -4.6 56.2 0.96 0.91 1.01
IN_7_9 8.3 -30.3 46.9 0.86 0.18 1.53 -21.6 -38.3 -4.9 1.04 1.01 1.07 52.4 -21.7 126.6 0.92 0.79 1.04
I_7_9 -1.8 -18.4 14.8 1.04 0.76 1.32 10.8 -13.1 34.8 0.98 0.94 1.03 -35.6 -88.6 17.3 1.07 0.98 1.16
IT_7_9 -3.9 -32.6 24.7 1.09 0.58 1.59 -11.8 -44.0 20.3 1.02 0.97 1.08 -50.2 -102.9 2.6 1.09 1.00 1.18

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19 Glossary
A Amperes (amps)

AMD Age-Related Macular Degeneration

AngioFlow The brand name given to OCT angiography en face images

AngioVue OCT angiography software for the Avanti System

Avanti (RTVue XR Avanti System) The brand name of this OCT system

En face Face-on visualization of OCT data between defined boundaries

ETDRS Early Treatment Diabetic Retinopathy Study

FLV Focal loss volume

Fundus The bottom or base of the eye (the retina)

GCC Ganglion Cell Complex (RNFL, ganglion cell and inner plexiform layer)

GCL Ganglion cell layer

GLV Global loss volume

GUI Graphical User Interface, the means by which the user and a computer system
interact, in particular the visual interface of the system software

ILM Inner Limiting Membrane

IPL Inner-plexiform layer

MCT Motion Correction Technology

NDB Normative Database

OCT Optical Coherence Tomography, an optical signal acquisition and processing


method that captures micrometer-resolution, three-dimensional images from within
optical scattering media.

OCTA OCT Angiography

OD Oculus dexter, right eye

ONH Optic nerve head

RTVue XR Avanti User Manual Page 446 of 451 P/N 580-52576-005 Rev. A
OS Oculus sinister left eye

RNFL Retinal nerve fiber layer

RPE Retinal pigmented epithelium

RPE tips Ends of the RPE at the optic disc, which are used to define the optic disc
margin

RNFL scan Retinal Nerve Fiber Layer scan

RT Real-time

Scanner Main component used to scan the patient’s eye, collect the OCT signal and
send it to the computer for processing

SLO Scanning laser ophthalmoscope

SSI Signal strength index

TSNIT Temporal-superior nasal-inferior-temporal

UI User interface, the means by which the user and a computer system interact, in
particular the use of input devices and software

μm Micrometers

V Volts

VAC Volts - Alternating Current

VF Visual fields.

_______________End of section_______________

RTVue XR Avanti User Manual Page 447 of 451 P/N 580-52576-005 Rev. A
Index

2D Map Off in Map/Chart overlay, Auto All function, 69, 218


117 Auto All Setting, 183
3D Clinical Scan, 143 Auto All=Auto Z, F, and P, 82
3D Disc Report, 144 Auto F slider, 85
3D Disc Scan for ONH Auto P option, STEP 2, cornea
registration, 100 scans only, 69
3D Disc Scan showing eye motion Auto P slider, 85
artifact, 146 Auto Play/Scan Video Quality
3D Display Controls, 134 Settings, 183
3D OCT Sum, 183 Auto saving PNG, 184
3D Preferences Dialog, 139 Auto Z slide, 84
3D Volume Checkbox, 136 Automatic Usage, 187
3D Volume Low Cut Off, 138 Average # Tab, 184
3D Widefield Scan for Retina Map Basic Search, 52
Registration, 99 Batch Process, 176
Add Patient button, 52 Batch Process Options, 176
Add Visit shortcut, 58 Black Level, 186
Advanced Search link, 52 Cabling, 40
Allow save eye blink data, 182 calibration verification, 195
AngioVue 3D Retina OverVue, 246 CAM option measuring tools, 95
AngioVue Disc 3D Main Report, Chart Off in Map/Chart overlay,
269 117
AngioVue Disc Change Analysis, checkmark button, 74
275 Chorioretinal radio button, 85
AngioVue Disc OverVue, 265 Chorioretinal scan mode, 85
AngioVue Retina 3D Main Report, Circuit Breaker and Fuse
252 specifications, 202, 203
AngioVue Retina Change Clean Diagnosis Data, 177
Analysis, 258 Clean Diagnosis Data Options,
AngioVue Review, 244 178
AngioVue Scan Acquisition, 211 Clear Log File—Advanced GUI
AngioVue Scan Acquisition and only, 181
Review, 211 Clinical Tab Setting, 183
AngioVue Scan Patterns, 210 Comment field, 90
Angle Caliper tool, 96 Comparison for 3D Disc, 147
Angle measurement tools—for Compliance specifications, 203
CAM option only, 95 Computer Maintenance, 195
Angle slider, 84 Computer specifications, 201
Archive Selection Dialog, 174 Contrast slider, 84

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cornea scan alignment procedure, Global Loss Volume, 160
66 Glossary, 446
Cornea Tab, 184 green bar, signal strength, 70, 218
CPU And GPU sample distances, Grey Scale or Color Scale, 81
140 Grey/Color tool, 94
Cross Line scan, 104 Help Menu, 194
Dark Eye/Light Eye Settings, 186 Hemisphere and Quadrant Maps,
Dark/Light Eye Method, 186 152
Darken/Brighten tools, 94 Home Menu, 194
Data Backup, 175 Illumination, 186
Database Management menu, 187 Image Quality Signal Strength
Date Format, 182 Index, 187
Default 3D Disc View, 183 joystick button to capture scans,
Default 3D Retina View, 183 74, 223
Default 3D View, 183 Left Angle/Right Angle tools, 95
Delete Current Patient Warning, 57 Left/Right TISA 500 and 750
Delete Visit shortcut, 58 measuring tools, 95
Diagnosis OCT Image, 187 Length slider, 84
Display Unit (monitor) Line Scan, 103
specifications, 202 Line Scan, Number of frames used
Distance measuring tool, 92 in averaging, 103
Draw Contours Manually, 120 Line tool, 93
Editing tab, 96 Main Menu, 167
EMR (Electronic Medical Manual Tab, 84
Records), 54 Marginally Significant Change on
EMR ID search option, 54 p-value chart, 163
Enable Joystick to Save Scan, 183 Measure Area tool, 93
ETDRS Chart, 122 Modify Baseline, 185
Examine OCT Image, 187 Modify Boundary, 185
Export as PNG tool, 95 Modify RPE Anchor Points, 156
eye selection, 63, 213 Motion Correction Technology,
File Menu, 167 328
Fixation LED Current (0-1000), 183 Move a visit to another patient, 60
Focal Loss Volume, 160 NDB Reference Map, 160
Followup / Tracking, 184 NDB references for full retinal
Fundus Imager specifications, 201 thickness only, 116
fundus scan alignment, set Normative Database, 313
working distance, 66, 215 Normative Database, limitations
GCC Change Analysis Report, 160 for patient comparison, 116
GCC Report, 158 OCT Image Menu, 185
GCC Report Components, 158 OCT Image Menu, 185
GCC thickness map examples, OD and OS Retina OverVue
159 buttons, 52

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OD=oculus dexter=right eye, 63, Reset System, Advanced GUI
213 only, 184
ONH Change Analysis Report, Retina Line Scan Reports, 102
153, 161 Retina Map Change Analysis
ONH image alignment, 69 Report, 125
ONH OU Report, 154 Retina Map Components, 113
ONH Report, 148 Retina Map Report, 113
ONH Report Layout, 148 retina map scan baseline image,
ONH scans—manually drawing 125
disc margin, 100 Retinal Thickness Map and Chart
Operating Environment Overlay, 117
specifications, 204 Review button, 52
Operator Editor, 191 RNFL Thickness Map, 151
Optic Disc Baseline, 155 RPE tips, 156
OS=oculus sinister=left eye, 63, RT Scan Pattern Tab, 184
213 Save Report as JPG tool, 94
OU Report Button, 89 Scaling and Zoom Options, 91
Pan tool, 97 Scan Alignment, 215
Patient and Visit Shortcuts, 57 Scan button, 52
Patient Detail area, 52 Scan list, 52
Patient Interface specifications, Scan Parameter Setting dialog,
201 186
Patient list, 52 Scan Pattern Management, 180
Patient Window, 52 Scan Types and Protocols, 78
Physician Editor, 190 Scanner specifications, 201
PNG directory, 184 Secondary Archive Drive, 183
Power On and Launch, 27 Secondary Backup Drive, 175, 183
Power Table specifications, 202 Select Eye(s) and Scan(s), 213
Primary Archive Drive, 183 Select tool, 96
Primary Backup Drive, 183 Service Policy, 3
Printer Installation, 313 Shading Checkbox, 138
Product Labels, 50 Show Boundary Curves
protective packing symbols, 49 Checkbox, 123
Protocol Editor Dialog, 188 Show Lines Checkbox, 118
Radial Lines, 110 Show/Hide Boundaries tool, 95, 97
Radial Lines Report, 110 Signal Strength (SSI), 89
Raster Scan, 106 Signal Strength Index (SSI), 369
Recycling Label, 51 Significant Change on p-value
Reference Image, 116 chart, 163
Reload Baseline, 185 Standard Accessories, 39
Repeatability and Reproducibility Steps to Acquire OCT Images, 62
Studies, 331 System Hardware, 26
Text Annotation tool, 93

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Thickness And Volume Parameter Video Brightness slider, 84
Table, 121 Video Contrast, 186
Thickness Map, 118 Video Enhancement, 183
Threshold and Volume Fields, 119 Video Reset tool, 94
Tint, 131 View B-scans tool, 95
Tool Page Editing Tools, 96 Visit list, 52
Tools Menu, 179 Vitreoretinal radio button, 85
Tracking for select scans, 83 Vitreoretinal scan mode, 85
Undo/Redo tools, 98 Warranty Information, 2
User Interface Setting, 183 Width slider, 84
User Preference Dialog, 182 Zoom In/Out tool, 98
Video Auto tool, 94 Zoom to Fit tool, 98
Video Brightness, 186

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