LABORATORY SCIENCE

Biomechanical and optical properties of 2 new

hydrophobic platforms for intraocular lenses
Dimitriya Bozukova, PhD, Christophe Pagnoulle, PhD, Christine J
er^
ome, PhD

PURPOSE: To compare the biomechanical and optical properties of 2 new hydrophobic platforms
and a series of commercially available foldable intraocular lenses (IOLs).
SETTING: Center for Education and Research on Macromolecules, University of Liege, Liege, Belgium.
DESIGN: Experimental study.
METHODS: Eleven benchmark foldable IOLs (iPure, Podeye, Acrysof SN60WF, Envista MX60,
Sensar AR40e, Tecnis ZCB00, Isert 251, AF-1 YA-60BB, Finevision, Acri.Tec 366D, and Ioflex)
were tested by standard analytical methods for biomechanical, rheological, and optical
investigations under identical conditions.
RESULTS: With 1 exception, IOLs equilibrated in aqueous medium had a lower glass-transition
temperature, higher deformability, lower injection forces, and complete recovery of their initial
optical properties after injection. Typical hydrophobic acrylic dry-packaged IOLs required higher
injection forces with high residual deformation and lost part of their initial optical quality after
injection. Hydrophobic acrylic C-loop, double C-loop, and closed quadripod haptics applied
optimum compression forces to the capsular bag with negligible optic axial displacement and tilt
compared with plate haptics and poly(methyl methacrylate) haptics.
CONCLUSIONS: The combination of the C-loop haptic and the bioadhesive glistening-free material,
which absorbs a predetermined amount of water, allowed for a biomechanically stable IOL. The
same material used in association with a double C-loop haptic design facilitated the perioperative
manipulation and placement of the IOL in a smaller capsular bag without impairing the other
biomechanical properties of a single C-loop design.
Financial Disclosure: Dr. Pagnoulle has a proprietary interest in the GF material. Drs. Pagnoulle and
Bozukova are employees of Physiol S.A. Dr. J
er^ome has no financial or proprietary interest in any
material or method mentioned.
J Cataract Refract Surg 2013; 39:1404–1414 Q 2013 ASCRS and ESCRS

Recently, the trends in cataract and refractive surgery
are toward diminishing corneoscleral incisions to
lower the risk for postsurgical complications.1 There-
fore, foldable intraocular lenses (IOLs) of acrylic or
silicone polymers are preferred for replacement of
the opacified cataractous natural lens.
An IOL is considered to be compatible with mini-
mally invasive cataract surgery when it (1) is injectable
via a sub-3.0 mm incision, (2) does not permanently
change its optical and mechanical properties as a result
of IOL folding and compression during injection, (3)
preserves its biocompatibility, (4) does not induce
higher posterior capsule opacification (PCO) rates,
and (5) provides sufficient refractive stability.1
Sharp-edged IOL platforms have proved their effi-
ciency in PCO prevention,2,3 although some authors
state that sharp-edge is not able to prevent PCO alone.4
In that aspect, the materials' properties,5–7 the IOL
design,5,7 and the haptic shape, material, and
strength6–8 remain important factors. Previous studies
report higher biocompatibility with a reduced risk for
PCO formation,9,10 better biomechanical stability,7
and better refractive and rotational stability8 of hydro-
phobic acrylic IOLs compared with their silicone plate-
haptic counterparts.
For 1-piece IOLs, the material should be able to pro-
vide the IOL with excellent optical properties as well
as sufficient rotational and mechanical stability, which
is usually obtained by selecting the proper haptic de-
sign. It has been thought that haptics that apply stron-
ger compression force to the capsular bag provide the
IOL with better biomechanical stability.11 However, in

1404 Q 2013 ASCRS and ESCRS 0886-3350/$ - see front matter

Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jcrs.2013.01.050
 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS
experimental studies, Lane et al.7 and Pandey et al.6
found that the risk for posterior capsule striae, capsule
stretch, and capsulorhexis ovaling was higher when
silicone or hydrophilic acrylic IOLs with poly(methyl
methacrylate) (PMMA), polypropylene, or plate
haptics were implanted than when hydrophobic
acrylic 1-piece IOLs were used. Such deformations of
ocular tissue may result in an increased risk for PCO,
fibrosis, IOL decentration, and IOL tilt and may cause
zonular stress in a direction parallel to the IOL
haptics.6
Meanwhile, the mechanical resistance of the mate-
rial of a typical hydrophobic acrylic IOL is an
important advantage but may also be a major limita-
tion. Such material is usually slow to fold and unfold,
which may cause it to become damaged during
injection and lead to loss of optical quality after
implantation as a result of IOL deformation.1 The pres-
ence of a low, but controlled, quantity (!5 wt%) of
small molecules with a plasticizing effect, such as
water, may significantly improve this aspect.12 It
imparts the hydrophobic acrylic IOL with shape
memory properties, improved foldability, and
controlled unfolding while preserving its mechanical
stability and biocompatibily.13
The purpose of this study was to experimentally
evaluate the biomechanical and rheological properties
of 11 benchmark IOLs of hydrophobic and hydrophilic
acrylic materials with different optic designs (refrac-
tive, diffractive) and haptic designs (C-loop, double-
C-loop, plate, PMMA, closed quadripod). The results
in this study should be considered in relation to results
in clinical trials.
MATERIALS AND METHODS
Tested Intraocular Lenses
The iPure (C-loop) and Podeye (double C-loop) IOLs
(Physiol S.A.) are of a proprietary, patented hydrophobic
acrylic glistening-free material (GF)14 and have obtained
Conformit
e Europ
eenne certification. The other tested
benchmark IOLs were as follows: Finevision (Physiol S.A.),
Submitted: September 6, 2012.
Final revision submitted: January 9, 2013.
Accepted: January 27, 2013.
From the Research and Development Department (Bozukova,
Pagnoulle), Physiol S.A., and the Center for Education and
Research on Macromolecules (J
er^ome), University of Liege,
Liege, Belgium.
Supported by the R
egion Wallone (public Belgian support).
Corresponding author: Dimitriya Bozukova, PhD, Liege Science
Park, All
ee des Noisetiers, 4, B-4031 Liege, Belgium. E-mail:
d.bozukova@physiol.be.
J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013
1405
Acri.Tec 366D (Carl Zeiss Meditec AG), Ioflex (Mediphacos
Ltda.), Acrysof SN60WF (Alcon Laboratories, Inc.), Envista
MX60 (Bausch&Lomb, Inc.), Tecnis ZCB00 and Sensar
AR40e (Abbott Medical Optics, Inc.), and Isert 251 and
AF-1 YA-60BB (Hoya Surgical Optics GmbH) (Table 1).
Systematically, new IOLs were used for each test. When
appropriate, method validation was performed with a series
of 5 samples of the Podeye IOL and the corresponding and
similar variation in the measured value was used for all tested
IOL models.
Water Uptake
The quantity of water present in a material influences its
rigidity, opacity, sterilization ability, and biocompatibility.
For determining the water uptake, IOLs (1 per IOL model)
were incubated in water for 24 hours at 65
C to reach their
equilibrium water content. Their surface was then dried by
a short air flush to eliminate water droplets, and the IOLs
were weighed with a laboratory microbalance to obtain their
weight in the hydrated state (Wh). They were then dried at
65
C for 24 hours and their weight in the dry state (Wd)
was measured. The water uptake was determined according
to the following equation:
WU wt% Z ½ðWh  WdÞ  100=Wd
The measurements were performed with a balance with
precision of 0.0001 g, which can induce 0.45% variation in
the measured value.
Glass-Transition Temperature
Glass-transition temperature (Tg) is the temperature at
which an amorphous material passes from its rigid glassy
state to its soft rubbery state.15 It is particularly important
in the case of IOLs because it determines their ability to
fold upon implantation in the eye. Hence, the lower the
glass-transition temperature (Tg) of the material, the more
foldable the IOL. This parameter was determined for all
test IOLs in their original packaging state with a differential
scanning calorimeter (Perkin-Elmer series 7, operating with
Pyris version 8 software). Specimens were hermetically
sealed in aluminum capsules, placed in the equipment,
cooled to 60
C and then heated from 60
C to 100
C
with a heating speed of 15
C/min. One measurement was
performed per IOL model. The method was validated with
a series of 5 samples of the Podeye IOL, and a value variation
coefficient of 10.7% was established.
Haptic Compression Force
The force applied by the haptics to the capsular bag is im-
portant for IOL rotational and refractive stability and may
have some effect on its resistance to PCO. The force was
determined with a compression force tester (MFC-1385-
IOL, Applied Micro Circuits Corp.); the possible value
variation was less than 0.2%. Before the measurement, the
equipment was calibrated according to the standard manu-
facturer's procedure. Intraocular lenses in their original
packaging state (1 per IOL model) were placed between
the 2 jaws, and the compression force, in milligrams force,
was measured for well diameters of 11.0 mm, 10.5 mm,
10.0 mm, and 9.5 mm, corresponding to various sizes of
the capsular bag. In all cases, measurements were taken
1406 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS

Table 1. Experimental and manufacturers' data for the test and reference IOL models.

Hazardous-Light Packaging
Model Design* Material* Protection* Sterilization* State* WU, %† Tg,
C† RI @ 23
C*

iPure Monofocal, 1-piece, C- Hydrophobic acrylic UV/blue Steam Hydrated 4.9 9 1.52
loop GF materialA
Podeye Monofocal, 1-piece, Hydrophobic acrylic UV/blue Steam Hydrated 4.9 9 1.52
double C-loop GF materialA
Envista Monofocal, 1-piece, Hydrophobic acrylic UV Gamma Hydrated 4.9 21 1.54
MX60 double C-loop
Acri.Tec Bifocal, double-plate Hydrophilic acrylic UV Steam Hydrated 28.0 1 1.46
366D haptics with hydrophobic
surface
Finevision Trifocal, 1-piece, Hydrophilic acrylic UV/blue Steam hydrated 25.0 1 1.46
closed-haptics
quadripod
Ioflex Monofocal, 1-piece, Hydrophilic acrylic UV Steam Hydrated 25.4 1 1.46
C-loop
Acrysof Monofocal, 1-piece, Hydrophobic acrylic UV/blue EO Dry 1.1 15 1.55
SN60WF C-loop
Tecnis Monofocal, 1-piece, Hydrophobic acrylic UV EO Dry 2.4 14 1.47
ZCB00 C-loop
Sensar Monofocal, 3-piece, Hydrophobic acrylic UV EO Dry 1.4 16 1.47
AR40e C-loop with PMMA haptics
AF-1 Monofocal, 3-piece, Hydrophobic acrylic UV/blue EO Dry 0.0 18 1.52
YA-60BB C-loop with PMMA haptics
Isert 251 Monofocal, pseudo Hydrophobic acrylic UV/blue EO Dry 0.6 18 1.52
1-piece, C-loop with PMMA haptics

EO Z ethylene oxide; GF Z glistening free; RI Z refractive index; PMMA Z poly(methyl methacrylate); UV Z ultraviolet; WU Z water uptake
*Data from the intraocular lens specification
†
Experimental data

30 seconds after haptic compression to give the haptic
material time to relax.
Axial Displacement in Compression
On compression, the haptics of the IOLs may deform
differently and, therefore, the IOL optic may remain at the
initial position or not, moving forward or backward along
the optical axis. This is referred to as the effective lens posi-
tion (ELP).
This displacement was measured in air at 20
C G 2
(SD)
for all tested IOL models (1 per IOL model) in their original
packaging state (hydrated or dried). The IOLs were placed in
wells of 11.0 mm, 10.5 mm, 10.0 mm, and 9.5 mm. The axial
displacement was determined using an optical comparator
with a precision of G0.01 mm according to the procedure
described by International Organization for Standardization
(ISO) 11979-9.16
Theoretical Maximum Optic Tilt
As a consequence of haptic compression and eventual
optic axial displacement, optic tilt can occur. This degree of
theoretical maximum optic tilt was calculated based on
the measured axial displacement according to the adapted
protocol described in ISO 11979-916 (1 per IOL model).
The following equation was applied:
Tilt maximum
Z ½asinðAD=RÞ
where AD is the measured axial displacement for a certain
well diameter and R is the radius of the respective IOL optic.
Rheological Properties
The IOLs were tested for their rheological properties on
compression and relaxation with the aim of predicting their
behavior during and after implantation, respectively. The
results from the creep step of the rheological analyses give
an idea of the IOL's mechanical resistance during folding
and injection and are compared with the forces required
for IOL injection in an in vitro model (see Intraocular Lens
Injection Force below).
The data obtained for the recovery refer to the shape
memory of the IOL and its ability to recover its initial optical
properties, which is monitored on an optical bench (see
Optical Bench Measurements below).
The rheological behavior of the optic portion of the IOLs
was tested by dynamic mechanical analyses with the IOLs
in their original packaging state (1 per IOL model; method
validation with 5 Podeye IOLs) with a dynamic mechanical
analyzer (Perkin-Elmer series 7) in the creep/recovery
mode. The IOLs were placed between the two 15.0 mm circu-
lar parallel plates, and the system was closed. Initially, they
were conditioned by applying 20 mN force for 3 minutes to
reach the test temperature of 20
C, corresponding to the

J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013

 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS
temperature at which they are usually implanted in the
surgical room. In the first step, the creep step, a static force
of 1000 mN was applied for 60 seconds. This step evaluates
the behavior of the IOL on compression, as in the case of
IOL folding during implantation. For the second step, the
recovery step, the force was dropped to 20 mN and the
material relaxation was observed for 300 seconds, which cor-
responds to the IOL unfolding in the eye. Longer relaxation
times were not tested because the water-absorbing materials
dehydrated and false results were obtained. The method
was validated with 5 Podeye IOLs, and a value variation
coefficient of 10.5% was established.
Hence, a purely elastic material, such as rubber, deforms
immediately on force application, achieving its deformation
equilibrium level instantly (Figure 1). Such material also rap-
idly recovers its initial shape once the force is removed, with
no residual deformation and with preserved molecular
organization.
In contrast, plastic or viscous materials, such as modeling
clay, deform continuously on applied stress. Their molecules
irreversibly reorganize so that once the stress is removed,
these materials are no longer able to recover their shape
and high residual deformation is observed.17
Intraocular Lens Injection Force
The force necessary to inject an IOL is an important factor
because high injection forces may be related to an enhanced
risk for IOL damage (scratches, haptic or optic cracks) or
injection system damage (cartridge breaking).
Although the manufacturers of the IOLs in this study usu-
ally recommend the use of particular injection systems, the
force required for IOL injection was tested each time with
the Accuject 2.2 -1P (Medicel AG) to allow comparison of
the mechanical properties of the IOL materials (1 per IOL
model). The injection system uses a standard cartridge that
is connected to the injector device. Sodium hyaluronate
1.55% (Physiovisc Integral) was used as the ophthalmic
viscosurgical device (OVD), and the measurements were
performed at 21
C with a compression/traction mechanical
bench (FL Plus Lloyd Instruments, Ametek) with a possible
value variation of less than 0.05%, simulating surgical
manipulation. The test equipment is supplied with a load
cell of 100 N and operates with Nexygen FM software
(Chatillon, Ametek, Inc.). The typical injection procedure
includes the following traditional operational steps: (1) fill-
ing the empty cartridge with OVD, (2) loading the IOL,
Figure 1. Relationship between the deformation level over time for
viscous and elastic materials during and after compression.
J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013
1407
(3) closing the cartridge and placing it on the mechanical
bench, (4) pushing the piston 20.0 mm at a speed of
200.0 mm/min, (5) pushing the piston 18.0 mm more at
a speed of 150.0 mm/min, (6) pulling the piston back
5.0 mm with a speed of 200.0 mm/min, and (7) pushing
the piston 10.5 mm at a speed of 150.0 mm/min. The IOL
was typically expulsed during step 7, and the value of the
force maximum was taken into consideration.
A control assay was performed, where an injection simu-
lation was performed with an empty cartridge (no IOL
inside). The purpose of this test was to determine the force
generated by the friction of the silicone cushion within the
cartridge.
Optical Bench Measurements for Monofocal
Intraocular Lenses
A manufacturer of an IOL predicts the quality of the
retinal image of an IOL by measuring a parameter called
the modulation transfer function (MTF).1 For the monofocal
IOLs in this study, the MTF was measured by an eye model
with an optical bench (NIMO TR0815, Lambda X) according
to ISO 11979-2.18 The IOLs (1 per IOL model) were posi-
tioned in a quartz cuvette filled with buffered salt solution
(0.9% sodium chloride, Baxter). The measurement was
performed at a 3.0 mm aperture and spatial frequency of
100 cycles/mm. The relative contrast sensitivity recovery
was calculated according to the formula:


Relative contrast sensitivity % Z MTF  =MTF0  100
where MTF0 and MTF* are the MTF values measured before
injection and at each timepoint after injection, respectively.
The relative contrast sensitivity is presented as the percent-
age of contrast sensitivity recovered after injection at
different timepoints.
In a practical way, after IOL implantation, when 70% of
MTF recovery is achieved, the IOL is properly unfolded,
the surgeon can manipulate it if necessary, and the surgery
can be achieved within a reasonable time.
Optical Bench Measurements for Diffractive
Multifocal Intraocular Lenses
The MTF of multifocal IOLs was measured by real-time
MTF and optical-power measuring using an eye model
optical bench (PMTF, Lambda X) according to ISO
11979-9.16 The IOLs (1 per IOL model) were positioned in
a quartz cuvette filled with buffered salt solution (0.9%
sodium chloride). The MTF value was determined for far
vision, corresponding to the main optical lens power,
3.0 mm aperture, and spatial frequency of 100 cycles/mm.
The relative contrast sensitivity was calculated as described
above. This equipment takes longer to measure than
the NIMO TR0815; therefore, only the result 1 hour after
injection was taken into consideration.
The optical properties of the IOLs after injection were
determined by measuring their MTF before folding and up
to 1 hour after injection with the model injecting system
and the OVD. The IOLs were divided into 4 MTF groups
according to the criterion of having recovered 70% of their
initial MTF over a fixed time interval. These groups were
as follows: Group 1, recovered 70% in fewer than 30 seconds;
Group 2, recovered 70% in fewer than 1 minute; Group 3,
recovered 70% in fewer than 4 minutes; Group 4, recovered
70% in 5 minutes or more.
1408 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS

RESULTS contrast, dry-packaged hydrophobic acrylic IOLs left

General Intraocular Lens Characteristics, Water their glassy state at temperatures higher than 14
C,
Uptake, and Glass-Transition Temperature which was the case for the Acrysof SN60WF, Tecnis
ZCB00, Sensar AR40e, AF-1 YA-60BB, and Isert
Table 1 and Figure 2 show the main IOL character-
251 models. Envista MX60 IOLs, although conditioned
istics and platforms as they were experimentally
in water, showed a relatively high Tg.
obtained or derived from the manufacturers' data-
According to the refractive index values provided
sheets. Except for the AF-1 YA-60BB, all IOLs absorb
by the manufacturers, hydrophobic acrylic IOLs that
water on heating. The hydrophobic acrylic IOLs
are said to comprise aromatic polymers in their for-
iPure, Podeye, and Envista MX60 and the hydrophilic
mulations (Acrysof SN60WF, iPure, Podeye, Envista
acrylic IOLs Finevision, Acri.Tec 366D, and Ioflex are
MX60, AF-1 YA-60BB, Isert 251) were distinguished
packaged and sterilized in saline buffer solution and
by their high refractive index (O1.5). Meanwhile, the
achieve their equilibrium water content before
other hydrophilic and nonaromatic hydrophobic
implantation.
IOLs presented a limited refractive index (range 1.46
The water present in the IOLs packaged in their
to 1.47). Therefore, at a constant dioptric power,
hydrated state imparted them with flexibility, and
thinner IOLs can be obtained from higher refractive
lower Tg values were measured for these models,
index materials.
which decreased with increasing water content. In

Figure 2. Designs of the test and

reference IOLs derived from the
manufacturers' datasheets.

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 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS 1409

Haptic Compression Force
For a test well diameter of 10.0 mm, corresponding
to a mean anatomic capsular bag size, higher compres-
sion forces were measured for the IOLs with PMMA
C-loop haptics (Sensar AR40E andAF-1 YA-60BB)
and plate hydrophilic acrylic haptics, followed by
those with closed quadripod hydrophilic haptics
(Table 2). Significantly lower compression forces in
nearly the same range were measured for all 1-piece
hydrophobic C-loop and double C-loop IOLs and
were 1 order of magnitude lower than those in the first
3 categories.
The general tendency, whatever the haptic design
and IOL material, was toward increasing compression
force with a decreasing test well diameter. However,
the slope of this increase was stronger for the PMMA
C-loop and the plate-haptic IOLs. It was intermediate
for the closed quadripod models and lowest for the
C-loop and double C-loop IOLs.
The Envista MX60 IOL behaved as a 1-piece hydro-
phobic model for the higher well diameters (11.0 mm
and 10.5 mm) but showed elevated radial compression
for the lower diameters (10.00 mm and 9.5 mm),
comparable to 3-piece PMMA C-loop IOLs.
Axial Displacement in Compression and Theoretical
Maximum Optic Tilt
For a well diameter of 10.0 mm, the optical part of
the plate-haptic (Acri.Tec 366D) and PMMA C-loop
(Sensar AR40e, AF-1 YA-60BB) IOLs was prone to
displace along the optic axis on haptic compression,
which may result in severe tilt (up to 20 degrees)
(Table 2). As expected, diminishing the test-well
diameter resulted in more severe shift and tilt.
The 1-piece C-loop (iPure, Acrysof SN60WF, Tecnis
ZCB00, Isert 251), double C-loop (Podeye), and closed
quadripod (Finevision) platforms showed lower axial
displacement. Thus, the calculated theoretical tilt
was also low even with smaller well diameters.
This axial stability was also observed for the hydro-
phobic acrylic Envista MX60 IOL with a well diameter
up to 10.0. However, a 2.79-degree tilt was calculated
for the 9.5 mm well diameter (Table 2).
Rheological Properties
Three groups of IOL materials may be distinguished
with respect to their compressibility (Table 3 and
Figure 3) and shape memory: (1) (hydrophilic) elastic
like, (2) (hydrophobic) viscoelastic, and (3) hydropho-
bic plastic-like materials. The first group comprises the
hydrophilic models Acri.Tec 366D, Finevision, and
Ioflex, which had higher equilibrium deformation
levels (15% to 16%) after 60 seconds of applied con-
stant stress, which is in accordance with their high
water uptake and low Tg (1
C). These IOLs completely
recovered their initial shape with less than 0.2% of
residual deformation 300 seconds after the stress was
removed as a result of the hydrogel elastic memory.
Among the hydrophobic acrylic models, soft visco-
elastic and less deformable plastic-like materials may

Table 2. Compression forces applied by the IOL haptics to the capsular bag.

Acrysof Tecnis AF-1 Envista Acri.Tec Sensar

Ioflex SN60WF ZCB00 Podeye iPure Isert 251 YA-60BB Finevision MX60 366D AR40E
Parameter 21.0 D 19.5 D 22.0 D 20.0 D 20.0 D 19.5 D 20.0 D 20.0 D 20.5 D 20.0D 20.0 D

Haptic compression
force (mg)
11.0 mm test well 15 15 24 5 17 11 77 3 19 100 178
10.5 mm test well 28 22 29 22 35 12 132 26 31 371 265
10.0 mm test well 34 34 39 38 50 28 222 195 126 318 365
9.5 mm test well 46 45 54 63 69 94 346 367 380 388 456
Axial displacement
(mm)*
11.0 mm test well 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000
10.5 mm test well 0.027 0.000 0.024 0.011 0.011 0.007 0.106 0.021 0.053 0.297 0.200
10.0 mm test well 0.046 0.000 0.034 0.047 0.027 0.018 0.291 0.032 0.057 1.032 0.200
9.5 mm test well 0.032 0.054 0.084 0.091 0.065 0.063 0.436 0.045 0.146 1.025 1.135
Maximum tilt (mm)*
11.0 mm test well 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
10.5 mm test well 0.54 0.00 0.46 0.21 0.21 0.13 2.02 0.39 1.01 5.68 3.82
10.0 mm test well 0.92 0.00 0.65 0.90 0.52 0.34 5.57 0.60 1.09 20.12 3.82
9.5 mm test well 0.64 1.03 1.60 1.74 1.24 1.20 8.36 0.84 2.79 19.98 22.23

*Absolute value

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1410 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS

Table 3. Residual optic deformation after 60 sec of compression and 300 seconds relaxation after compression.

Optic Deformation on Compression (%)

Acrysof Tecnis AF-1 Envista Acri.Tec

Ioflex SN60WF ZCB00 Podeye iPure Isert 251 YA-60BB Finevision MX60 366D Sensar AR40E
Parameter 21.0D 19.5 D 22.0 D 20.0 D 20.0 D 19.5 D 20.0 D 20.0 D 20.5 D 20.0 D 20.0 D

After 60 s compression 14.7 9.87 11.07 9.7 9.7 5.36 8.01 16.11 6.14 16.1 7.84
After 300 s relaxation 0.18 1.57 2.4 0.7 0.7 1.71 2.46 0.11 2.3 0.20 2.33

be distinguished. The Acrysof SN60WF, iPure, Intraocular Lens Injection Force

Podeye, and Tecnis ZCB00 IOLs, belonging to the
intermediate group of hydrophobic soft IOLs,
deformed spontaneously on compression, reaching
up to 11.07% deformation within 30 seconds. They
recovered their initial shape almost completely after
1 hour of relaxation with 0.7% to 1.57% residual
deformation. Mechanically, the IOLs of the
glistening-free hydrophobic acrylic material (Podeye
and iPure) were closer to the hydrophilic acrylic
IOLs, with a low Tg (9
C) and lower residual defor-
mation levels (0.7%) than the other soft hydrophobic
IOLs.
The less deformable hydrophobic IOLs (Sensar
AR40e, AF-1 YA-60BB, Isert 251, and Envista MX60)
after 60 seconds of compression achieved equilibrium
deformation levels of 5% to 8%, 2 to 3 times lower
than the levels of their hydrophilic counterparts. On
relaxation, they had a residual deformation of
1.71% to 2.46%. These IOLs had a higher Tg (between
16
C and 21
C).
The Tecnis ZCB00 IOL had a particular behavior,
presenting relatively high residual deformation
(2.4%) after 300 seconds, although it compressed
similarly to the soft hydrophobic models and its Tg
was moderate (14
C).
With the tested in vitro model simulating the surgi-
cal intervention, lower injection forces (14 to 16 N)
were measured for the hydrophilic acrylic models
(Finevision and Ioflex) and were comparable to the
force of the control assay without IOL in the cartridge
(Figure 4). A force of 19 N was required for injection of
the Acri.Tec 366D IOL.
The hydrophobic IOLs from the less deformable,
plastic-like category of the compression test (Sensar
AR40e, Isert 251, Envista MX60, and AF-1 YA-60BB)
required higher injection forces (23 to 29 N; up to
71 N for AF-1 YA-60BB with cartridge damage)
compared with the 18 to 19 N required for the soft
hydrophobic viscoelastic IOLs (Podeye, iPure, Acrysof
SN60WF, and Tecnis ZCB00).
These results are indicative only and should be
considered with caution because the injection
forces may change when using injecting systems rec-
ommended or provided by the suppliers for each
IOL model.
Optical Properties After Intraocular Lens Injection
Table 4 shows the loss of contrast sensitivity 1 hour
after IOL injection. Figure 5 shows the contrast

Figure 3. Rheological properties of the test and reference IOL models Figure 4. Force required for the injection of the IOLs.
tested at 20
C in their original state of packaging (dry or hydrated).

J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013

 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS
Table 4. Loss of contrast sensitivity 1 hour after injection.
Acri.Tec
Parameter Finevision 366D Ioflex iPure/ Podeye SN60WF Envista ZCB00 Isert 251 AR40e YA-60BB
Contrast sensitivity loss (%) 0.0 0.0 0.0
sensitivity of the IOLs before and after folding during
injection.
The hydrophilic acrylic trifocal Finevision and bifo-
cal Acri.Tec 366D IOLs were in MTF Group 1, recover-
ing 70% of their initial MTF in less than 30 seconds.
Within 1 minute, these IOLs had recovered 100% of
their initial contrast sensitivity, unfolding more rap-
idly than their hydrophilic acrylic counterparts Ioflex,
iPure, and Podeye. These IOLs were in MTF Group 2,
recovering 70% of their initial MTF in less than 1 min-
ute. They recovered 100% of their MTF0 in 1 hour and
had 0.7% residual deformation after 5 minutes.
The hydrophobic acrylic Acrysof SN60WF, Tecnis
ZCB00, and Sensar AR40e IOLs were in MTF Group
3, unfolding quite slowly (up to 4 minutes for 70%
MTF recovery). None of these models completely
recovered their initial MTF value, losing 1.7%, 4.1%,
and 9.6% of MTF0, respectively, even 1 hour after the
injection. These values are in good agreement with
the corresponding residual deformation levels of
1.57%, 2.4%, and 2.33%, respectively, measured after
5 minutes of relaxation.
The Envista MX60, Isert 251, and AF-1 YA-60BB
IOLs were in MTF Group 4. They were the least
deformable hydrophobic models according to the
rheological classification of the previous test, and
they required more than 5 minutes to unfold.
One hour after injection, the IOLs showed a loss of
3.5% and 14.5% of their MTF0, respectively.
DISCUSSION
The water absorbed by some polymers for biomedical
application at a predetermined level means the
Figure 5. Contrast sensitivity of the IOLs before and after folding
during injection (MTF Z modulation transfer function).
J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013
1411
Acrysof Tecnis Sensar AF-1
0.0 1.7 3.5 4.1 7.1 9.6 14.5
medical device can be preconditioned in aqueous
medium, allowing it to achieve its equilibrium water
content before implantation. This is especially impor-
tant for IOLs, which can develop glistenings after
implantation, particularly if packaged in their dry
state.19 In such cases, the devices are sterilized by
steam or gamma sterilization. According to Davis,20
steam sterilization is advantageous because of its
efficacy, speed, process simplicity, and lack of toxic
residues. In contrast, gamma sterilization may lead
to partial oxidative degradation of the implant 20 or
of its packaging.21 It may induce generation of
radicals, crosslinking, and chemical decomposition of
the material or of some of its additives, such as
chromophores.22–24
The iPure and Podeye IOLs are made of a proprie-
tary, patented hydrophobic acrylic glistening-free
material incorporated with both ultraviolet and blue-
light protection filters covalently copolymerized with
the main polymer network. The IOLs are steam steril-
ized. Despite the small amount of absorbed water, the
glistening-free material shows bioadhesiveness com-
parable to that of typical hydrophobic acrylic IOL
materials, and it is plasticized by this water content.13
This bioadhesiveness and the 360-degree squared
edge of the 2 IOLs minimize PCO rates.7
Any water molecules present in the material would
have a plasticizing effect, facilitating the chain mobil-
ity within the polymer network. This would contribute
to a decrease in the Tg of the IOL material, making the
IOL softer, even at lower temperatures; more elastic;
and easily injectable. It would also give the IOL good
shape memory. However, for a 1-piece IOL made of
such material, the IOL design should be precisely
selected to compensate for the material deformability
and ensure appropriate haptic compression.
According to Krag and Andreassen25 and Fisher,26
the ultimate load resistance of the posterior capsule
for persons between 40 years old and 60 years old is
in the range of 400 to 800 mg force. This means that
for an average capsular bag size of 10.0 mm, the hap-
tics of the Sensar AR40e IOL and Acri.Tec 366D IOL
apply forces that are close to the mechanical resistance
of the posterior capsular bag.
On the other hand, excessive force applied to
the capsular bag by the IOL can result in decentration
and tilt, which would affect visual quality.7
Indeed, this was the case for the Acri.Tec 366D, AF-1
1412 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS
YA-60BB, Sensar AR40e, and Envista MX60 IOLs,
which shifted significantly along the optical axis. In
such cases, the ELP would not be easily predictable
and refractive errors due to inappropriate IOL power
calculation would be significant.
In contrast, the haptics of iPure, Podeye, Acrysof
SN60WF, Tecnis ZCB00, Isert 251, and Ioflex IOLs
have a C-loop or double C-loop 1-piece design. These
IOLs applied a relatively constant force, always lower
than 94 mg, whatever the capsular bag size. C-loop
haptics have high bending deformation capacity to
allow the IOL to adapt to all capsule sizes with low
stress to the capsule. This finding implies that the
C-loop haptic design in a 1-piece IOL prevents capsu-
lar bag damage, which is in accordance with previous
clinical11 and experimental6,7 results. Such biomechan-
ical behavior helps prevent capsular bag striae.
Although reversible in some cases, these striae can
initiate lens epithelial cell migration and eventually
PCO formation and fibrosis. Moreover, the axial
displacement and tilt tests showed that whatever the
test-well diameter, the optical part of the C-loop and
double C-loop IOLs remained in a stable position.
Clinically, the C-loop haptic design combined with a
1-piece hydrophobic acrylic platform and the applica-
tion of compression forces in the measured magnitude
provides rotational stability, which is necessary, espe-
cially for the astigmatism-correcting toric IOLs.7,8
In the case of the Finevision IOL, the deformation of
the 4 closed haptics with the reduction in the capsule
size yielded higher compression force to the capsular
bag than C-loop IOLs, but without impairing the
IOL's position stability. The 4 closed haptics act as anti-
vaulting deformable loops and can deform in such
a way that the optic remains in nearly the same plane
as the haptics. This is especially important when the
diffractive trifocal optic of the Finevision is used
because its optical properties can be altered by any
optic shift or tilt.
In this study, the Acri.Tec 366D IOL showed a con-
siderable shift with reduction of the test-well diameter,
and that shift might significantly affect the IOL's clin-
ical optical performance. Indeed, plate haptics intrinsi-
cally have limited deformation capacity in the IOL
plane.
The haptic compression forces measured in this
study for the 1-piece C-loop and the PMMA haptics
are in agreement with the results reported by Lane
et al.7 for similar models. The authors suggested that
1-piece hydrophobic acrylic C-loop IOLs provide sta-
ble postoperative refraction, maintain their initial posi-
tion in the capsular bag, and ensure long-term
refractive stability.4 Assia et al.27 reached a similar
conclusion. The combination of a C-loop or a dou-
ble C-loop haptic design that applies moderate
J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013
compression forces and a bioadhesive hydrophobic
acrylic material is a prerequisite for IOL rotational
and refractive stability.5,8,10 The haptic compression
test simulates capsular bag compression on symmetric
fibrosis and contraction of the capsular bag. The
results should be considered in relation to actual
clinical cases.
The optic of a hydrophilic acrylic IOL, such as the
Finevision, Acri.Tec 366D, and Ioflex, has a relatively
high water content; relatively high compressibility,
elasticity, deformability; and good shape memory.
These characteristics provide easy IOL folding, moder-
ate injection force, entire recovery of the initial IOL
shape, and recovery of optical quality within a reason-
able time after injection of the IOL. Here, the Acri.Tec
366D IOL was an exception, with a slightly higher
injection force than that measured for the other 2 hy-
drophilic IOLs (Finevision and Ioflex). This may be
because the IOL's hydrophobic surface affects its
friction and increases the injection force.
The diffractive IOLs (trifocal Finevision and bifocal
Acri.Tec 366D) unfolded more rapidly than their
monofocal counterpart, Ioflex, probably because of
the reinforcing effect of the diffractive optic pattern
in accordance with the rheological behavior of these
IOLs during the recovery step.
The low predetermined water uptake of the
glistening-free hydrophobic acrylic material resulted
in relatively low injection forces for the Podeye and
iPure IOLs. They unfolded within approximately 1
minute, as shown by the relaxation and contrast sensi-
tivity recovery results. Thus, they unfolded more
slowly than their hydrophilic acrylic counterparts,
which may help prevent ocular tissue damage.25,26
There was no residual deformation 1 hour after injec-
tion, which indicates these IOLs have predictable
visual quality.
The Envista MX60 IOL, although containing the
same amount of water at the equilibrium as the Podeye
and iPure IOLs, showed less deformable behavior.
This IOL had a Tg of 21
C, which is higher than that
of the glistening-free material of the iPure and Podeye
IOLs (Tg 9
C). Thus, the Envista MX60 IOL was in-
jected with higher force and required longer relaxation
times. The plasticizing effect of water was limited in
this case, and high residual deformation was mea-
sured, resulting in significant loss of contrast sensitiv-
ity at least 1 hour after injection. This IOL would
restore its initial shape slowly in a real clinical case,
and the surgeon would require a longer time to locate
it properly in the capsular bag. A possible explanation
for this is the excessively high Tg of the initial polymer
matrix before water uptake or crosslinking reactions
within the polymer material during gamma
sterilization, which would increase the IOL's rigidity.
 LABORATORY SCIENCE: TWO NEW HYDROPHOBIC PLATFORMS FOR IOLS
Rheologically, typical hydrophobic acrylic IOLs
(Acrysof SN60WF, Sensar AR40e, Isert 251, and AF-1
YA-60BB) were more plastic due to the lack of water
in their composition. The slow and low deformation
measured during the creep step explains the relatively
high injection forces. High residual deformation was
established in these cases and could account for the
short-term decrease in optical quality after IOL
injection.
This corroborates that the injection is driven mainly
by the optic deformation rather than by surface
friction. Thinner IOLs are expected when the material
refractive index increases. However, this was not
found to significantly influence the injection forces
(compare Acrysof SN60WF, which has a refractive
index of 1.55, and the Tecnis ZCB00, which has a refrac-
tive index of 1.48).
Over the long-term, the relaxation processes are
expected to continue, and the IOLs may recover their
optical properties, which would benefit the patient's
vision. However, testing this process for longer
periods would be difficult with conventional optical
benches because the IOL position in the experimental
setup may be affected, leading to biased measure-
ments. However, the purpose of the present test was
to evaluate the rheological behavior of the IOL during
implantation, which takes a few minutes. Moreover,
testing period of 1 hour is long enough to give a clear
idea about the material shape recovery capacity.
In conclusion, this experimental study assessed the
biomechanical properties of 11 commercially available
IOLs to compare their compressibility, deformability,
injectability, and optical quality before and after injec-
tion. It was found that the double C-loop and the
closed quadripod 1-piece IOLs provided moderate
haptic compression force, which contributes to an
IOL's positional and refractive stability. In contrast,
plate haptics and PMMA haptics had a lower deforma-
tion capacity and therefore applied higher radial
compression forces to the capsular bag. In extremely
small capsules, the IOLs can shift along the optical
axis or tilt, affecting the refractive stability.
The lower deformability and longer material relaxa-
tion time of the optic of typical hydrophobic acrylic
dry-packaged IOLs (Acrysof SN60WF, Tecnis
ZCB00, Isert 251, Sensar AR40e, and AF-1 YA-60BB)
resulted in short-term loss of visual quality and
contrast sensitivity with relatively high residual defor-
mation levels. The same phenomena were observed
for the recently developed hydrophobic acrylic
Envista MX60 IOL, which is packaged in aqueous
solution. These parameters are also responsible for
the high injection forces required for Envista MX60,
Sensar AR40e, and AF-1 YA-60BB IOLs with the
model injection devices under the test conditions.
J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013
1413
Hence, cartridge damage was observed with the
AF-1 YA-60BB IOL.
Meanwhile, a predetermined amount of water
absorbed by the glistening-free material plasticized
it, allowing iPure and Podeye IOLs to completely re-
cover their initial shape and optical properties within
a reasonable time after injection while preserving an
advantageous bioadhesivity13 that is comparable to
that of typical hydrophobic acrylic materials. These
IOLs are equilibrated and steam sterilized in physio-
logical solution before implantation, thus avoiding
the risk for glistening formation.
This experimental study may help surgeons make
proper IOL selections but should be considered in
relation to clinical results. Several clinical studies are
being performed with the iPure and Podeye IOLs,
and the results will be reported in following publica-
tions to reinforce the knowledge and comprehension
of these IOLs and of the glistening-free material.
WHAT WAS KNOWN
 Hydrophobic IOLs can lose their optical properties due to
residual deformation after implantation. This is in contrast
to hydrophilic IOLs, which are more elastic and have
better shape memory.
WHAT THIS PAPER ADDS
 The new hydrophobic glistening-free material with low
and controlled amount of absorbed water completely
recovered its initial shape and optical properties after
injection.
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First author:
Dimitriya Bozukova, PhD
Research and Development
Department, Physiol S.A.,
Liege, Belgium