Insert to January 2020

WHEN YOU THINK

MONOFOCAL,
THINK ISOFOCAL

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 AN INNOVATIVE EDOF ISOFOCAL
IOL TECHNOLOGY
A detailed description of the IsoPure 1.2.3 and a report on early clinical results.
BY RAFAEL BILBAO-CALABUIG, MD, PHD, FEBOS-CR; AND PAVEL STODULKA, MD, PHD

Just recently, PhysIOL manufactured with the

announced the company’s hydrophobic
availability of an glistening-free material
IOL that represents (G-free) and has four closed
a new segment of haptics to enhance the
lenses—one between predictive effective lens posi-
monofocal and tion, achieve a very comfort-
premium multifocal able insertion, and provide
IOLs, meaning it can provide excel- excellent centration and sta-
lent distance vision and improve bility in the capsualar bag.
intermediate vision without inducing
photic phenomena. This new IOL is HOW IT WORKS
the fully refractive, aspheric, isofocal In myopic patients, with
IsoPure 1.2.3 (PhysIOL). a 6.5-mm pupil, the average
Figure 1. The IsoPure 1.2.3 accentuates the extended depth of focus. level of spherical aberration
is about +0.24 µm; it is likely
ISOPURE 1.2.3:
EDOF @ 3.0mm aperture, 50 Lp/mm**
higher in hyperopic patients, at about
+0.34 µm. A standard monofocal IOL with
DESIGN DETAILS
0.8
0.80 its nominal power focuses the light rays
By Rafael Bilbao-Calabuig, MD, PhD, on a single focus, which provides a sharp
0.60
image at only one distance. Alternatively,
EDOF (P MAX-P 0.17)

0.54
FEBOS-CR
0.40
the IsoPure 1.2.3, with a 100% monofo-
Extended depth of focus cal refractive optic, combines a unique
(EDOF) IOLs have been 0.20 anterior/posterior surface profile of
available for several years increased negative spherical aberration
now. They intented to pro- 0.00 (SA) that is fine-tuned for each diopter
vide a better and broader intermediate MONOFOCAL ISOPURE on the whole optic. This design ensures
range of vision compared to monofocal Figure 2. The IsoPure 1.2.3 IOL achieves about 1.00 D of that central and peripheral rays entering
IOLs, theoretically without the unwanted EDOF in a 3-mm pupil. the pupil do not converge identically, thus
photic phenomena and loss of contrast causing an extension of the foci on the
sensitivity related to multifocal IOLs. with the best of both worlds, combining retina. Succession of convergence points
However, some previous EDOF models the advantages of a monofocal IOL with extends the focal points and provides
have failed to achieve some of these goals the elongated focus of a real EDOF lens. depth of focus (Figure 1). In this system,
and have induced similar dysphotopic The IsoPure 1.2.3 is based on PhysIOL’s the plane of the best image shifts between
phenomena and showed nonsuperior Micropure monofocal lens platform, the different foci and over the retina.
intermediate vision and worse near vision with which we have extensive experi- Then, as the pupil constricts, the focus of
than trifocal lenses. ence in Clínica Baviera showing excellent the peripheral rays is no longer visible—
Now, with the introduction of the visual, refractive, anatomic, and posterior because the pupil interferes with the path.
IsoPure 1.2.3, we have access to an IOL capsular opacification rates. The lens is The eye becomes slightly myopic, and, as

2 INSERT TO CATARACT & REFRACTIVE SURGERY TODAY EUROPE | JANUARY 2020

G-free®
EDOF @ 3-4.5mm aperture, 50 Lp/mm** We concluded that the IsoPure 1.2.3
1.20 ISOPURE makes the optical system less sensitive
1.00
MICROPURE
to defocusing and offers a continuous
0.80
0.80
visual field between distance and inter-
EDOF (D)

0.73
0.69

0.60 0.54
0.58 mediate vision.
0.44 0.45
0.41
0.40

0.20
3.00 3.50 4.00 4.50 FIRST CLINICAL
OUTCOMES WITH
Pupil (mm)

Figure 3. The IsoPure 1.2.3 maintains the extended depth Figure 5. Defocus curve at 1-month postoperative.
of focus independent of pupil size.
a result, intermediate vision improves and
THE ISOPURE 1.2.3 better and 83% achieved 20/40 or better
uncorrected intermediate visual acuity
By Pavel Stodulka, MD, PhD
an elongated depth of field is achieved. at 80 cm. For distance-corrected
However, as the rate of SA increases I am happy to present the intermediate visual acuity at 80 cm,
and the focal area extends, resolution first clinical outcomes with 56% of eyes had achieved 20/32 or bet-
power and contrast sensitivity of the eye the IsoPure 1.2.3, a lens with ter and 81% achieved 20/40 or better
decrease. The value of SA introduced a unique design for each (Figure 4A). For distance-corrected
is crucial in order to maximize its ben- diopter. The multicenter, prospective intermediate visual acuity at 66 cm,
eficial effect without introducing the study, performed by Dr. Bilbao-Calabuig 35% of eyes had achieved at least 20/32
deleterious effects of blur and loss of in Clínica Baviera Spain and our clinics in and 68% at least 20/40 (Figure 4B). Our
contrast sensitivity. the Czech Republic, included 38 eyes of results confirm that this new implant
19 patients. The 12 female and seven male provides both high-quality distance and
ACHIEVING EDOF patients had a mean age of 69.9 years. intermediate uncorrected visual acuities.
Optical bench testing showed that the Also at 1-month postoperative, the
IsoPure 1.2.3 IOL achieves about 1.00 D of STUDY RESULTS defocus curve (Figure 5) and contrast
EDOF in a 3-mm pupil, representing an At the time of publication, 1-month sensitivity were as expected. The defocus
increase of approximately 50% extended follow-up was available for all eyes. We range for a visual acuity of at least 20/32
depth of focus compared to the stan- aimed for slight myopia in all cases. When was -1.10 to 0.70 D, and contrast sensitivity
dard aspheric monofocal MicroPure IOL we looked at postoperative refractive cyl- for both photopic and mesopic was within
(Figure 2). Further, the IsoPure 1.2.3 main- inder, we found no statistically significant the normal range for this age group.
tained the extended depth of focus inde- difference in the results at 1 week and
pendent of pupil size (Figure 3). Regarding 1 month. In fact, the cylinder decreased CONCLUSION
the quality of vision, when we compared slightly because the incision was created The 1-week and 1-month outcomes
the IsoPure 1.2.3 to the MicroPure, the on the steep corneal meridian. As would shared here serve as a proof of concept for
quality of the image was only minimally be expected, uncorrected distance mon- the IsoPure 1.2.3 IOL. Results indicate that
reduced with the IsoPure and was less ocular vision improved significantly, with patients can see well from 77 cm to infin-
reduced under myopic conditions. There 45% of eyes achieving 20/20 or better at ity. As with any new technology, longer
was no significant difference between the 1-month visit. When we looked at follow-up in a larger quantity of eyes is
the lenses for distance vision, whereas the corrected distance visual acuity, 89% of warranted. For now, I am looking forward
IsoPure maintained a much clearer inter- eyes achieved at least 20/20. to using the IsoPure 1.2.3 in many more of
mediate vision image as compared with Monocularly, by 1-month postopera- our patients. n
the MicroPure monofocal IOL. tive, 56% of eyes had achieved 20/32 or
A B Rafael Bilbao-Calabuig, MD
nC  línica Baviera, Instituto Oftalmológico Europeo,

Madrid, Spain
n r [email protected]
nF  inancial disclosure: None acknowledged

Pavel Stodulka, MD, PhD

n C hief Eye Surgeon, CEO, Gemini Eye Clinics, Czech

Republic
ns  [email protected]
n F inancial disclosure: None acknowledged
Figure 4. Distance-corrected intermediate visual acuity at 80 cm (A) and 66 cm (B) with the IsoPure 1.2.3.

JANUARY 2020 | INSERT TO CATARACT & REFRACTIVE SURGERY TODAY EUROPE 3

New solution
for your
cataract patient

ISO
I SO
SOFO
SOF
S FOCA
F CA L OP T I C

ISOFOCALTECHNOLOGY
by PhysIOL
PhysIOL introduces the new IsoPure IOL to answer the
specific needs and modern lifestyles of cataract patients.
• Far visual quality equal to a monofocal lens
• Improved intermediate vision for daily activities
• No induced photic phenomena.

More info on www.isopure123.com

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