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New Hydrophobic IOL Materials and Understanding the Science of Glistenings

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 Current Eye Research

ISSN: 0271-3683 (Print) 1460-2202 (Online) Journal homepage: http://www.tandfonline.com/loi/icey20

New Hydrophobic IOL Materials and

Understanding the Science of Glistenings

Manfred Tetz & Matthew R. Jorgensen

To cite this article: Manfred Tetz & Matthew R. Jorgensen (2015) New Hydrophobic IOL
Materials and Understanding the Science of Glistenings, Current Eye Research, 40:10, 969-981

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 Current Eye Research, 2015; 40(10): 969–981
Copyright ! Taylor & Francis Group, LLC
ISSN: 0271-3683 print / 1460-2202 online
DOI: 10.3109/02713683.2014.978476

REVIEW ARTICLE

New Hydrophobic IOL Materials and Understanding

the Science of Glistenings
Manfred Tetz1 and Matthew R. Jorgensen2

1
Berlin Eye Research Institute, Berlin, Germany and 2Institute for Integrative Nanosciences, Dresden, Germany

ABSTRACT
An introduction to the history of intraocular lenses (IOLs) is given, leading up to modern hydrophobic
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examples. The roles of hydrophobicity, hygroscopy, materials chemistry, and edge design are discussed in the
context of IOLs. The four major types of IOL materials are compared in terms of their chemistry and
biocompatibility. An example of a modern ‘‘hydrophobic’’ acrylic polymer with higher water content is
discussed in detail.
Keywords: Glistenings, hydrophilic, hydrophobic, intraocular lens, IOL material

INTRODUCTION innovative step came with the introduction of silicone

The materials and designs of intraocular lenses (IOLs)
have been evolving since the first modern demon-
stration in 1949 by Harold Ridley.1 From the time
since the invention of the original polymethylmetha-
crylate (PMMA) IOL, the variety of materials and
designs available to ophthalmologists has multiplied
to myriad choices. PMMA was originally chosen by
Ridley because he had observed that pieces of the
material embedded in pilots’ eyes during World War
II fighting remained benign. The earlier years of IOLs
stayed close to the original PMMA material, with
Ridley, Benedetto Strampelli, Peter Choyce, Cornelius
Binkhorst, Edward Epstein, and others making sig-
nificant modifications related to IOL design to try and
keep it in place within the eye.2–7 Placement was a
challenge due to the weight of PMMA IOLs.8 The first
years of trial and error in lens design were difficult,
leading many ophthalmologists to reject the idea of
implantation altogether. Though not widely cited in
the literature, in 1968 Edward Epstein first implanted
IOLs made from soft contact lens material to counter
some of the early problems PMMA had with pigment
dispersion and iris atrophy. Figure 1 shows an image
of an autopsy eye that had been clinically implanted
with one of the first flexible implanted IOLs.9 A major
IOLs, which were implanted by the mid-1970s by
Mehta and Epstein without being folded.10,11 Later, in
the early 1980s, Epstein began to make silicone lenses
with the intention of folding them so that they could
be inserted through the narrow incisions allowed by
phacoemulsification.4,12 The practice of IOL implant-
ation was revolutionized in 1984 when Thomas
Mazzocco began folding and implanting the plate
haptic silicone IOL that had been previously acquired
by Staar Surgical.11 With the rising popularity of
phacoemulsification and foldable silicone IOLs in the
1980s, competing companies began to develop alter-
native materials. One early example that illustrates
the way in which the IOL market can be influenced is
the IOgel lens.
The hydrophilic IOgel lens, trademarked in 1984,
was a response to the rising popularity of silicone
and other foldable lenses. IOgel was implanted in a
significant number of eyes, but there was a serious
problem – when implanted in the bag, a secondary
cataract was observed.13 When the cataracts were
treated with a YAG capsulotomy, the lens could get
displaced into the vitreous.14,15 Due to the seriousness
of this complication, many surgeons were unwilling
to implant the IOgel lens. The IOgel experience, along
with reports of calcification,16–19 caused many doctors

Received 11 February 2014; revised 30 September 2014; accepted 12 October 2014; published online 16 January 2015
Correspondence: Prof. Dr. Manfred Tetz, Berlin Eye Research Institute, Augentagesklinik, Spreebogen, Alt-Moabit 101B, 10559 Berlin,
Germany. Tel: +49 30-39 80 98-0. Fax: +49 30-39 80 98-44. E-mail: info@atk-spreebogen.de

969
 970 M. Tetz & M. R. Jorgensen
to have a lingering negative attitude towards hydro-
philic lenses despite the significant improvement
in their performance over time. In the early 1990s,
Alcon began to emphasize foldable hydrophobic
acrylic lenses. A departure from the three main
classes of IOL materials at the time, the company’s
AcrySof IOL performed well and was implanted in
many eyes. Square edges on the AcrySof resulted in
low posterior capsule opacification (PCO) rates, and
the haptics on the 1-piece design were less likely to get
caught on injection. Additionally, there was not fear of
discoloration as sometimes found in silicone lenses,
and calcification was generally not a problem.20–31
The rise of foldable lenses, the complications with
the IOgel lens, and success of early flexible hydro-
phobic acrylics are some of the major factors that
have led to the creation of several versions of flexible
IOLs on the market, making hydrophobic acrylic
the preferred optic material.32
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FIGURE 1 One of the first flexible IOLs implanted by Edward
Epstein in 1968 (human cadaver eye).
FIGURE 2 Schematic diagram of a hydrophobicity measurement. A water droplet is placed on the surface for testing, is carefully
photographed, and the angle between the surface and the droplet is measured. Hydrophilic surfaces have shallow angles (left) while
hydrophobic surfaces have larger angles (right).
The wide variety of modern IOLs has allowed
surgeons the luxury of selecting a lens best suited to
a patient’s particular situation. Unfortunately, this
availability also has led to some confusion regarding
the classification of IOLs and conflicting accounts
of their performance. Part of this confusion arises
naturally from the evolution of IOLs, as new gener-
ations of products were distinguished in the market
using terminology that is not necessarily appropriate
anymore. This article will explain some of the
terminology surrounding modern IOLs. The strengths
and weaknesses of the four main types of lenses will
be summarized. Finally, focusing on the most modern
hydrophobic IOLs, improvements in material chem-
istry and design will be explained in detail.
HYDROPHOBICITY AND
HYGROSCOPY IN THE CONTEXT OF
IOLS
Hydrophobicity is a measure of a particular material’s
tendency to repel or separate itself from water. In
general, every material has a measurable hydropho-
bicity that is typically graded using contact-angle
measurements. In one form of these measurements,
a droplet of water is placed on a material’s surface,
the droplet is carefully photographed, and the angle
between the water droplet’s surface and the surface of
the material is measured. Figure 2 shows a schematic
of the measurement that highlights the difference
between hydrophilic and hydrophobic surfaces. It
should be noted that, strictly speaking, hydrophobi-
city is a surface property, not necessarily representative
of the bulk material.33–36 Contact angle measurements
range from only a few degrees for almost perfectly
hydrophilic surfaces, such as bare silica glass pre-
pared with dangling hydroxyl groups,37 to almost 180
Current Eye Research

degrees for super-hydrophobic surfaces, such as the
Lotus leaf.35,37 A material’s chemistry plays a large
role on its hydrophobicity because the oxygen–
hydrogen bonds in water are highly polar, meaning
that there are partial electric charges on the atoms.
These partial charges tend to be attracted to opposite
charges, so water can dissolve salts (which consist of
charged atoms) and is attracted to materials that also
have partially charged bonds. Polymers, unless spe-
cifically designed otherwise, consist primarily of non-
polar carbon–carbon and carbon–hydrogen bonds,
which is why they are not generally hydrophilic.
Although not often mentioned in ophthalmology
literature, hygroscopy better explains a material’s
tendency to absorb and hold water. A highly hygro-
scopic material draws water into itself usually
accompanied by some physical changes such as
swelling. Certainly, it is possible for a material to be
hydrophilic but not hygroscopic. For example, bare
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silica glass is hydrophilic but because there is no
internal room for the penetration of water, it is
not hygroscopic. In the context of ophthalmology,
hydrophobicity has been used to describe both the
surface and interior of IOLs. In the following discus-
sion, we differentiate between the interaction of an
IOL’s surface with water (hydrophobicity) and the
ability of IOLs to draw water into their interior
(hygroscopy).
BIOCOMPATIBILITY
Biocompatibility is a term used in many contexts,
including IOLs. The biological response to a foreign
material depends on both the chemistry of the
material and the design or morphology. Scales noted
in the 1950s that for a material to be biocompatible,
it should be chemically inert, physically stable, non-
carcinogenic, non-allergenic, capable of fabrication in
the required form, and have no foreign body reac-
tion.38 Within the context of ophthalmology, a material
should also be optically transparent for long periods
of time, have a high resolving power or refractive
index, and should block ultraviolet rays. Although all
of Scales’s recommendations remain true, we have
developed a deeper and more detailed view of what
makes an IOL biocompatible today. Particular to IOLs,
there are certain features that enhance the biocom-
patibility of the lens in the eye. As discussed in detail
below, features of IOL design, such as edge square-
ness and surface roughness, can affect PCO and cell
adhesion, which in turn influence biocompatibility.
The material also plays an important role in IOL
biocompatibility and overall lens quality, as discussed
below in a comparison of the four major classes of IOL
materials.
In addition to the issues of biocompatibility-related
stability and safety, it must be remembered that
Copyright ! 2015 Taylor & Francis Group, LLC
New Hydrophobic IOL Materials 971
to be biocompatible, a material must be able to
actually perform the task for which it was designed.
A perfectly safe, stable, and square-edged IOL
is not biocompatible if it cannot perform on target
optically.
PROS AND CONS OF IOL MATERIALS
Properties of Polymers: ‘‘All Non-Crystalline
Polymers are Fluids’’
To understand the difference between various acrylic
polymers used for IOLs, a brief diversion into poly-
mer chemistry and nomenclature is needed. As acrylic
polymers form, the carbon–carbon double bonds of
the monomers open and join to each other to form the
polymer backbone. Any substituent groups attached
directly to the backbone are added as a prefix to the
‘‘acrylate’’ base, while substituents attached further
away from the backbone to the oxygen are separately
designated. Note, for example, the differences
between poly(methyl acrylate; PMA), poly(methyl
methacrylate), and poly(ethyl methacrylate) are
shown in Figure 3. When more than one type of
monomer is polymerized together, the resulting plas-
tic can be called a copolymer.
The long chains of polymers and copolymers twist
and fold and link with each other in a messy fashion,
trying to find configurations that minimize the poly-
mer’s internal energy. It should be noted that this
process continues, slowly, even when a polymer is in
its solid-like glassy state. Technically, all non-crystal-
line polymers are fluids. This fluidity changes with
temperature, which is a measure of a material’s
internal kinetic energy. At low temperatures, the
polymer chains move slowly, and the bulk material
flows so gradually that it appears solid and brittle.
Above a certain temperature, the long chains of glassy
polymers have enough energy to overcome local
attractive and steric forces, and the polymer transi-
tions to a rubber-like or molten state. The temperature
at which this change from a solid-like fluid to a
rubber-like fluid takes place is called the glass
transition temperature (Tg).
The stiffness of an acrylic polymer, which correlates
with its Tg, results from a compromise between the
bulkiness and flexibility of additions on the polymer
backbone. Adding bulk increases the stiffness,
while adding flexibility decreases it.39 For example,
PMMA is stiffer than PMA because addition of the
methyl group increases bulk but does nothing for
flexibility. On the other hand, poly(phenylethyl meth-
acrylate) or poly-PEMA (Tg = 26  C) is much softer
than PMMA (Tg = 105  C), even though it is bulky
because a great amount of flexibility is given by the
rotating bonds in the long chain of atoms in the
phenylethyl group.
 972 M. Tetz & M. R. Jorgensen

FIGURE 3 Examples of acrylic polymers. PMA, poly(methacrylate); PMMA, poly(methyl methacrylate); PEMA, poly(ethyl
methacrylate); poly-HEMA, poly(2-hydroxyethyl methacrylate). The hydroxyl group in poly-HEMA significantly increases this
polymer’s hygroscopy.
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FIGURE 4 Model of two cross-linked chains of PHS copolymer. Due to the bulky side chains and uneven folding, the polymer
contains regions which are slightly more packed than others.

Polymer Hygroscopy and the Etiology of
Glistenings
Although most polymer materials are not engineered
to contain water, all have a certain propensity to
absorb it, or to be hygroscopic. In the case of the
AcrySof copolymer, discussed below, an equilibrium
water content of about 0.1–0.5% has been observed,
depending on the temperature.40 The equilibrium
water content of various copolymers can also vary
strongly depending on the concentration of salts (ionic
strength) in the surrounding solution, for example, the
aqueous humor or storage media.41 The hygroscopic
nature of polymers, and how this varies depending on
temperature and ionic strength of the surrounding
solution, is well explained and understood from the
perspective of chemical potential equilibrium using
concepts familiar to physical chemistry.42 Due to the
dynamics of the process of polymerization, it is clear
that an entire piece of bulk material will not be
completely connected, with polymer chains perfectly
folded. Therefore, it is natural that there should be
regions with the polymer more densely folded and
others that are loose. Figure 4 is a schematic of just
two folded polymer chains cross-linked to each other.
It can be readily seen that there arise areas that are
much denser than others. Of course, polymers have
many more cross-linked chains than what is shown in
Figure 4, but the principle remains the same. Water
diffuses into the polymer, due to normal equilibrium
driving mechanisms, and then can collect in lower
density ‘‘pockets’’, especially when the equilibrium
Current Eye Research
 New Hydrophobic IOL Materials 973
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FIGURE 5 Examples of different grades of glistenings. (a) Relatively minor glistenings observed in an Alcon lens, unknown model,
9 years after implantation. (b) Moderate glistenings observed in an AcrySof lens 4 years after implantation. Note the visible surface
scratches. (c) Severe glistenings in an Acrysof lens 2 years after implantation.

TABLE 1 Physical properties of IOL material classes.

Material Eq. Hygroscopy (%) Cont. angle Tensile str. (Mpa) n Tg ( C)

PMMA 0.4–0.8 65–71 47–70 1.49 105–113

Silicone 0.38 97–120 5.9–8.2 1.43 ( 120)–( 90)
Hydrophilic acrylics 18–38 20–70 0.4–0.6 1.40–1.43 10–20
Hydrophobic acrylics 0.1–0.5 72–88 no data 1.47–1.56 5–16
Standard new hydrophobic acrylics 4–5 69–79 4–6 1.54 27–29
(approx. values)

hygroscopy of the polymer is quickly changed due to
changes in temperature.42–44 These pockets can
enlarge over time until they become discreet vacuoles
of water visible as glistenings,45,46 or subsurface
nanoglistenings (SSNG), examples of which are
shown in Figure 5.
Much has been said on the subject of glistenings,
especially with respect to the popular AcrySof
lens.14,44,46–51 Two studies, each including 115 eyes,
showed the incidence of glistenings in the AcrySof
MA60BM increasing over time since implantation. In
one, the incidence increased from 20% at 3 months to
55% at 12 months.52 In the other 56% of IOLs showed
glistenings at 14 months which increased to 87% at 28
months.53 A third study including 42 eyes implanted
with the MA60BM or MA30BA found 100% occur-
rence of glistenings after 4–46 months, postopera-
tively.54 While glistening studies have focused on the
AcrySof lenses, they have been observed in all the
early lens materials and were reported in PMMA at
least as early as 1984.50 Glistenings have been
associated with less severe visual effects such as
reduced contrast sensitivity but represent an
Copyright ! 2015 Taylor & Francis Group, LLC
undesired defect nevertheless.48 Because glistenings
develop over time, they indicate a dynamic process
within the lens/eye system with causes and long-term
outcomes that are not entirely clear. There are some
cases where lenses with glistenings have been
explanted,55 though this is rare.
Table 1 lists several important physical properties
of common IOL materials for comparison, where Eq.
Hygroscopy is the mass percent of water within the
lens at equilibrium, Cont. Angle is the angle between
the leading edge of a water droplet and the IOL
surface, Tensile Str. is the greatest amount of stress the
material class can withstand while being pulled
without breaking, n is the refractive index, and Tg is
the glass transition temperature.
PMMA
The first IOL, implanted in 1949, was made of PMMA.
Thanks to its excellent tissue tolerance, its relatively
high refractive index (1.49), and optical clarity better
than glass, PMMA has been used in a wide variety of
 974 M. Tetz & M. R. Jorgensen
implants for more than 70 years.56 Though PMMA has
been almost completely replaced by modern foldable
lenses, they still are available from a variety of
companies. Primitive by today’s standards, the ori-
ginal PMMA lenses still performed remarkably well.
There have been reports of original lenses implanted
by Ridley remaining perfectly clear and centered for
more than 28 years.4 On the other hand, it also was
reported that some spontaneously dislocated into the
vitreous.11 Because PMMA is a rigid material and
original manufacturing was somewhat crude com-
pared to today’s techniques, it has been shown to
irritate the sensitive uveal tissues, resulting in chronic
inflammation.10 However, inflammation is not the
most serious drawback of PMMA’s rigidity. Because
it is too rigid to fold, the lens cannot pass through
the small incisions allowed by phacoemulsification.
Widening of the incision is frustrating after removal
of the natural lens through a 2-mm opening and
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increases patient recovery time as well as surgically-
induced astigmatism.
Silicone
Silicone also has a long history in medicine and
in cataract surgery. It was used even before folding
was common practice and was the first lens to be
widely used in procedures requiring folding, which
started to become popular in 1984.13 In addition to the
immediate benefit of flexibility, properly formulated
silicone can be manufactured by molding, is auto-
clavable, and has superior biocompatibility.57
Polydimethoxysiloxane, a typical form of silicone,
has a water content of less than 0.4%, though this
can be significantly higher for silicone hydrogels.58
In studies comparing IOL edges, silicone had the
squarest edges, which is a factor in their low PCO
rate.59–61 The chemistry of silicone’s surface also is a
factor, as lens epithelial cells (LECs) are half as likely
to adhere to the surface than PMMA.62 Silicone also
has the most demanding fabrication, contributing to
production costs of these IOLs. Perhaps, the most
significant problem with early silicone IOLs was their
potential to develop a brown discoloration, first
reported by Milauskas in 1991.63 In response to the
initial report, the vice president of quality assurance
of one of the companies involved assured doctors that
the company had not found the discoloration in vitro,
and that it had examined one of the patients in
question only to find ‘‘an almost imperceptible,
unidentifiable imperfection on the periphery of the
lens’’.64 Milauskas was quick to reply that the lens in
question had been examined by no less than five
people who all agreed that it was indeed brown.63
Ultimately, the exchanges between Milauskas, silicone
lens manufacturers, and other doctors recorded in the
literature were enough to create a lasting association
between silicone IOLs and discoloration.65
Unfortunately, there also were problems with surface
calcification associated with certain eye conditions
that led to explantation.66 More modern silicone
IOLs appear to have largely addressed these issues,
some of which arose due to complications with
the way silicone IOLs were sterilized in permeable
packages.51,63
Hydrophilic (Hygroscopic) Acrylic
Hydrophilic acrylic lenses, or, more accurately, hydro-
gel lenses, are highly hygroscopic, with an equilib-
rium water content ranging from 18 to 34% (or in
certain cases even higher).67,68 Their contact angle
measurements do not necessarily correspond to their
hygroscopy, as the surface of the lenses could be
modified to alter their hydrophobicity. Hygroscopic
acrylic polymers are made by modifying the side-
chains connected to the methacrylate backbone of
regular PMMA to contain hydroxyl components that
attract water, most commonly poly(2-hydroxyethyl
methacrylate), poly-HEMA, or just HEMA as shown
in Figure 3. The folding of poly-HEMA chains
depends significantly on the level of hydration, and
so the physical and optical properties of the polymer
change as a function of water content. In the dry state,
hygroscopic lenses are hard and opaque.67 It is in this
state that they are manufactured. As the lenses
hydrate, they absorb water like a sponge, becoming
soft and transparent.
Due to their high water content, they have a lower
refractive index that increases the IOL thickness but
also can reduce glare and other aberrations.
Hydrogel lenses are, in a sense, more like biological
tissue because they have such high water content.
Cell adhesion tests have shown that, like with
silicone, LECs are half as likely to adhere to the
polymer surface in vitro compared to PMMA.62 In a
prospective study comparing 11 IOL lens surfaces in
653 eyes, hydrogel lenses had fewer foreign body
giant cells than both plain PMMA and silicone
lenses.69 Unfortunately, the early experiences with
hydrophilic lenses were mostly negative. Early
examples were too soft, potentially resulting in
secondary cataracts and other complications as
described previously.15–17 Probably, the most signifi-
cant force limiting wider spread use of hydrophilic
IOLs is the risk of surface and internal calcification,
which has been reported and discussed exten-
sively.18–20,22,66 Aversion to hygroscopic materials
persists in spite of more recent reports that calcifi-
cation was more of a manufacturing and handling
problem rather than a material problem that may
have been addressed in second-generation hygro-
scopic IOLs.20 Recent studies surveying the edge
designs of IOLs across platforms have shown that
Current Eye Research

FIGURE 6 Example components of hydrophobic acrylic IOL
polymers. The AcrySof lens is a copolymer, a mix of the
components shown polymerized together. PEA, phenylethyl
acrylate; PEMA, phenylethyl methacrylate; BDDA, 1,4-butane-
diol diacrylate.
Downloaded by [183.89.85.100] at 21:24 21 October 2015
hygroscopic lenses tend to be the least reliable for
having a square edge, resulting in higher rates of
PCO.70,71 This difficulty in obtaining a square edge
likely results from the swelling that takes place in the
lens after it is lathe cut in the dry state.
Hydrophobic Acrylic
Hydrophobic acrylics are modern foldable IOLs, the
most widely used of which is the AcrySofÕ lens.
Foldable acrylic IOLs achieve polymer flexibility in a
manner different than the hydrogels. In the case of
AcrySof, a blend of the monomers phenylethyl acryl-
ate (PEA) and PEMA are polymerized together (PEA/
PEMA copolymer), along with a cross-linker butane-
diol diacrylate (BDDA), to create the desired stiffness.
Poly-PEA has a Tg of 3  C, poly-PEMA has a Tg of
26  C, while the final PEA/PEMA copolymer (which
includes some BDDA cross-linking) is a compromise
with a Tg of 14.0–15.5  C.72 The chemical structures of
the monomers involved in the AcrySof lens are shown
in Figure 6. By varying the flexibility of side chain
substituents, the relative proportion of different
monomers, and controlling the amount of cross-
linking between polymer chains, hydrophobic acrylic
polymers with a wide range of physical properties are
possible.
Hydrophobic lenses have a remarkably good track
record. These are the most widely used IOLs and
stand as tribute to the benefit of innovation in the field
of cataract surgery and materials chemistry. Single-
and multi-piece hydrophobic IOLs can be folded and
inserted through very small incisions while resisting
damage. PCO is significantly lower than PMMA but
generally a bit higher for hydrophobic acrylic lenses
compared with silicone, though this is usually clinic-
ally insignificant and may depend more on edge
design than anything else.26,73
Copyright ! 2015 Taylor & Francis Group, LLC
New Hydrophobic IOL Materials 975
EVOLUTION OF UNDERSTANDING IN
EDGE DESIGN
Before cataract surgery evolved to allow a nearly
100% successful in-the-bag implantation, IOL edges
would come into contact with and irritate sensitive
uveal tissue or rub against the iris. To minimize these
problems, the ultimate in early lens edge design was
to have it be as perfectly smooth as possible, which
was accomplished with tumble polishing, as shown in
Figure 7(A). At about the same time, improvements
were made that allowed for in-the-bag implantation,
foldable acrylic lenses were gaining popularity.
However, because of the softness of the material, it
was not possible to tumble polish those lenses,
resulting in sharp edges as shown in Figure 7(B).
Unexpectedly, the new hydrophobic acrylic lenses
with unpolished edges implanted in the bag had low
PCO rates, leading to numerous investigations into
the cause. At first, research into the relationship
between IOL design and PCO included different lens
types and materials, without clear attention to the
effect of the optic edges. Early in vitro experiments
showed that plano-convex lenses were less likely to
develop PCO than optics with ridges, but in these
studies, lenses with both different materials and
different designs were used, making it difficult to
determine the cause of the effects.74 Several similar
studies surfaced that focused on IOL design, and it
became clear that the optic edge specifically played a
role in inhibiting PCO.75–77 In 1999, Nishi compared a
square-edged AcrySof lens with a normal rounded
edge-PMMA lens and a PMMA lens that had been
specially made to have the same square edge as the
AcrySof. They found that the rounded-edge PMMA
failed to inhibit migrating LECs and the AcrySof did,
while the otherwise identical PMMA lens with the
square edges inhibited LEC migration to the same
degree as the AcrySof.78 These results clearly showed
that the primary player in the fight against PCO in
these lenses was the optic edge over the material.
More recently, there has been a series of papers
published, several with the author’s involvement, that
define and evaluate the squareness or sharpness of
IOL edges across the spectrum.61,71,75,79 If an image of
an IOL edge, such as the one shown in Figure 8(A), is
overlapped with a section of a true square corner, the
difference in their areas is a measure of squareness, as
shown in Figure 8(B). Alternatively, the sharpness can
be measured from the radius of the corner (Figure 8C).
Of course, all macroscopic edges are round if one
looks at high-enough magnification, so it is critical to
choose magnifications that can distinguish between
different degrees of sharpness and which are of
physiological importance. In the first published
work in a series of papers that define and evaluate
IOL edges, a set of otherwise equivalent PMMA
lenses were made with a varying amount of
 976 M. Tetz & M. R. Jorgensen
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FIGURE 7 A comparison between the previous ‘‘gold standard’’ rounded edges of tumble polished PMMA lenses (a), with the square
edge of the Acrysof lens that resulted in lower PCO and a shift towards square-edged lenses (b).

FIGURE 8 Edge profile of a hydrophilic (hygroscopic) acrylic lens, and the method for measuring squareness and sharpness. (a) Raw
environmental scanning electronic microscopy image of the IOL edge. (b) The squareness of an edge can be measured by the area
enclosed between the IOL edge and a true square. (c) The edge sharpness can be measured from the radius of curvature on the corner
itself.

squareness to their edge by tumble polishing them for
different amounts of time.76 The squareness was
evaluated from images at magnifications of 500
and 2000 taken using scanning electron microscopy
(SEM) by measuring the area contained between the
edges of a true square angle and the sloping edges of
the IOL. It was found that, as expected, the roundness
of the edge increased as the amount of time in the
polishing machine increased. The lenses were tested
for LEC migration in vitro, and it was shown that
lenses with a squareness above a certain threshold
were effective in blocking cells from crossing the
boundary of the optic.79 Following this report, two
subsequent studies tested the edges of 40 lenses for
squareness, including those made from PMMA, sili-
cone, hydrophilic acrylic, and hydrophobic
acrylic.61,71 Another group reported the sharpness of
17 IOLs.75 Interestingly, sharpness and squareness are
not necessarily the same thing as some lenses have
very sharp but obtuse corners. In this case, a lens may
look poor from the perspective of squareness but
favorable in terms of sharpness, so care must be used
in comparing the relative sharpness (or squareness)
across studies. Nevertheless, the major conclusions of
studies using both methods remain the same: silicone
has uniformly the squarest and sharpest corners,
hydrophobic lenses are slightly worse (with a bit more
variation), and hydrophilic lenses have the greatest
deviation from the ideal with a wide range of results.
Although some questions remain about the nature of
PCO prevention and IOL edges, a few things are clear:
PCO correlates with optic edge design, square and
Current Eye Research

sharp is better than rounded, and the degree of
sharpness varies significantly among IOLs, making
the issue of optic edge squareness an important factor
in overall IOL quality on a case-by-case basis.
PROPERTIES OF NEW HYDROPHOBIC
IOLS
As discussed above, IOL materials, chemistry, and
design have evolved with each generation of lens.
Flexible hydrophobic acrylic IOLs dominate the
market because they perform very well, are cost-
effective, and do not have a negative history. The
more modern hydrophilic and silicone lenses gener-
ally also have great performance. However, there still
is room for improvement as the gold-standard lens
should have, as it ought to, a material and design that
minimizes potential complications in the patient
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during and after surgery. The lens also should be
defect-free; a defect might be any undesirable irregu-
larity that is big enough to be visible at the slitlamp.
The most modern hydrophobic IOLs approach this
gold standard starting with the intelligent design of
their materials. An advance in IOL materials was
made in going from silicone to hydrophilic, because a
cost-effective way to make a flexible biomimetic
acrylic through the addition of water was used. An
advance was made moving to flexible hydrophobic
acrylic, because lenses could be flexible while avoid-
ing some of the issues specific to high water content
lenses. Still, a problem has remained that all polymers
are hygroscopic to one degree or another, and the
water which diffuses into the previous generation of
hydrophobic acrylic IOLs is not managed. Here, we
will focus on one modern IOL polymer that is made of
materials combining the best aspects of earlier hydro-
phobic and hydrophilic polymers, used in the Bausch
& Lomb enVista (previously the AVS EXACT) and the
Eternity IOL in Japan. This particular material, found
FIGURE 9 The components of a glistening-free hydrophobic acrylic. PEG-PEA: poly(ethylene glycol) phenyl ether acrylate; HEMA:
2-hydroxyethyl methacrylate; EG-DMA: ethylene glycol dimethacrylate. In the PEG-PEA component, the ethylene glycol subunit
(shown in red in online color version) is a repeating unit of variable length, making the link between the polymer backbone and the
phenyl group very long.
Copyright ! 2015 Taylor & Francis Group, LLC
New Hydrophobic IOL Materials 977
to be glistening-free when packaged in 0.9% saline
solution,80,81 is currently the only hydrophobic IOL
material with a published composition that contains a
substantial hydrophilic component. Figure 9 shows
the components of this hydrophobic/hydrophilic
hybrid material, which is actually a copolymer of
three different monomers PEG-PEA/HEMA/styrene
(collectively called the PHS copolymer) and a cross-
linker. The material is flexible primarily due to the
long flexible chains of poly(ethylene glycol),
which connect the phenyl ring to the polymer back-
bone. The styrene adds bulk and increases refractive
index, HEMA adds the ability to disperse water
through the material, and EG-DMA increases struc-
tural integrity.
Equilibrium Water Content and Glistenings
One of the primary advantages of having a hydro-
phobic polymer with a careful balance of HEMA is
that glistenings can be eliminated. As discussed
previously, water will enter all polymers to one
degree or another due to the principles of equilibrium.
Yet what happens to the water once inside? Is it more
favorable for the water to collect in vacancies, or for it
to be dispersed throughout the material? It is known
that the equilibrium water content of IOLs depends
on temperature and the ionic strength of the environ-
ment.42,43 In the PEA/PEMA copolymer, when the
equilibrium point for water is quickly reduced, the
‘‘excess’’ water must go somewhere, and it might not
have enough time to diffuse out of the lens. On the
other hand, the PHS copolymer contains a built-in
mechanism to keep water dispersed and locked
evenly throughout the material, so that when this
equilibrium point fluctuates, ‘‘excess’’ water would
rather connect to a water-friendly hydroxyl group
than collect in a dislocation surrounded by purely
hydrophobic polymer.
 978 M. Tetz & M. R. Jorgensen
When the PHS copolymer material is at equilib-
rium, it has 4% water by weight. Based on the relative
weights of the components of the polymer, that means
that 96% of the hydroxyl groups are hydrogen bonded
to a water molecule at equilibrium. During changes
in conditions that result in excess hydration, there still
are free hydroxyl groups available to connect to water,
after which water can slowly diffuse out, as the lens
again approaches equilibrium hydration.
It should be noted that lenses made from PHS
copolymer are not the only examples reported to be
glistening-free. The Hanita hydrophobic lenses, made
from a copolymer of ethoxyethyl methacrylate and
methyl methacrylate, also have an equilibrium water
content around 4% and have not been reported to
contain glistenings. In this case, the material supplier
carefully checks for glistenings as part of their quality
control. The Aurolab, Acrylmex, and Artis lenses
also have clinical studies that report an absence of
glistenings.72 Although it is difficult to discuss these
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lenses in detail because information is limited, an
important factor may be that all of them are lathe cut.
It has been shown previously that lathe-cut lenses are
less likely to develop glistenings, presumably because
a more homogeneous polymerization is possible
when done under bulk conditions.42,44,55
Physical Properties of PHS Copolymer IOLs
The nature of the IOL surface, including its hydro-
phobicity, resistance to damage, and smoothness are
important lens parameters because it is the surface
that is the first point of interaction with the eye.
Hydrophobicity is a factor influencing cell adhesion to
the surface. One recent study tracked how the contact
angle of the PHS copolymer material changed over
time as it was hydrated in balanced salt solution at
37  C. It was found that the contact angle, which was
initially 75 , stayed within a narrow window of 69–79
over a period of 4 weeks, suggesting that the hydro-
phobicity of the lens surface remains stable over time
as the lens is hydrated. A similar stability was found
for the Hoya AF-1 and Sensar AR40 materials, in
contrast to the PEA/PEMA copolymer material,
which had a contact angle that dropped from about
75 to 50 on hydration.82
Although it is not often discussed in the literature,
scratching or tearing of IOLs can occur during
insertion (as shown dramatically in an explanted
IOL in Figure 10 and more subtly in Figure 5b), only
to be discovered after the lens unfolds in the eye.
Unless the crack or tear is very minor, so that it is
unlikely to result in negative visual outcomes,83
the IOL must be explanted, often requiring an
enlargement of the incision.51 Nanoindentation meas-
urements have been used to test the surface hardness
of the AcrySof, Hoya AF-1, Sensar AR40, and PHS
FIGURE 10 IOL that had to be explanted because it was
scratched on injection. The inset shows a section of the scratch
in detail. A greater surface hardness could prevent such
problems on injection.
copolymer materials.84 In this study, a very sharp tip
was brought onto the surface of the IOL, and the
displacement of the tip into the surface was recorded
as a function of force applied.81 It was found that
the AcrySof, Hoya, and Sensar materials indented
by 800–1000 nm with an applied force of 60 mN, while
the PHS copolymer only indented by 150 nm. From
these measurements, and the dimensions of the tip,
the surface hardness can be calculated. It was found
that the PHS copolymer has a hardness of 1.8 MPa,
while the others had a hardness of 0.1–0.4 MPa.84
Although the study cited is limited by the number of
samples examined, it does highlight that the surface
hardness of IOLs and that this capability to resist
weakness, stress, and scratches can vary widely
between materials.
Early Experiences with PHS Copolymer
Lenses
The patent application for the PHS copolymer,
invented by Advanced Vision Sciences, was published
in 2007.85 The material has been marketed and used
in Japan since 2008 as the Eternity IOL. The rights to
develop and market the material were acquired by
Bausch & Lomb in 2009, after which a patent for an
updated design of the lens was filed in 2010.86 Finally,
the U.S. Food and Drug Administration approved the
material and new design marketed as enVista in 2012.
Although this material is still relatively new, there
have been a few clinical studies involving the lens.
The enVista directions for use include the results of
two clinical studies, one for the 3-piece design of the
lens packaged in 10% saline and the other for the 1-
piece design packaged in 0.9% saline. In both cases,
there were no adverse events attributable to the IOL.87
Interestingly, glistenings were observed in the IOLs
Current Eye Research

stored in 10% saline solution. In a separate study
conducted in Japan, glistenings were observed in 40
eyes of 40 patients.44 Following the change to 0.9%
saline solution, no glistenings in this material have
been reported.72,81,88 It is hypothesized that in the case
of the lenses stored in 10% saline, the higher salt
content within the lens caused an osmotic pressure
difference after implantation, which leads to an influx
of water and the formation of glistenings. Naturally,
the capability of any material formulation to disperse
water has limits.
With regards to PCO, one study including 221 eyes
showed the YAG capsulotomy rate was 3.6% after
21 months.89 Another study reported an average
EPCO score of 0.032 ± 0.101 for 122 eyes 4 to
6 months after implantation with the enVista lens.88
Our own reported experience includes over 400 eyes,
with no significant IOL-related complications or
glistenings.83 The biocompatibility of the enVista
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lens was tested in the rabbit model, using the
AcrySof lens as the control. The lenses were examined
1 through 4 weeks postoperatively. It was observed
that PCO was significantly less in the enVista lenses,
which had a PCO score of 1.5 ± 1.0 compared to the
AcrySof with a score of 2.2 ± 1.09 and that the lenses
were otherwise equally biocompatible.90 These results
and the promising accounts of early experiences from
ophthalmologists make the latest generation of hydro-
phobic lenses with a water dispersing component an
attractive option. This may be the beginning of a new
group of hydrophobic IOLs with water contents
around 4–5% offering measurable material
advantages.
CONCLUSION
IOLs have evolved over time, responding to changes
in surgical procedures and the demands of ophthal-
mologists for their patients. Each period of IOL
history had a gold standard – subject to change – of
what the ideal lens should be. In this article, we define
the gold standard IOL as being biocompatible, com-
patible with modern surgical techniques, and free
from any visible optical defects. We have discussed
the fluid nature of polymers, equilibrium hygroscopy,
and how the terms hydrophilic and hydrophobic are
categorically outdated in the context of IOLs making
classification that use these labels inaccurate. Rather,
IOL materials should be discussed, characterized, and
judged on the basis of their chemistry, which is too
nuanced for all IOLs to fit into one of two groups:
‘‘hydrophobic’’ or ‘‘hydrophilic’’. We have compared
the four main classes of IOL materials in terms of their
material and design properties. Overall, modern IOLs
across the spectrum have made improvements with
each generation and reach an acceptable level of
quality. However, improvement is still possible
Copyright ! 2015 Taylor & Francis Group, LLC
New Hydrophobic IOL Materials 979
towards a standard of quality that maximizes safety,
minimizes PCO and calcification, and is defect-free.
Flexible hydrophobic acrylic lenses offer controlled
injection and unfolding, their manufacture allows the
creation of a square optic edge, and they are not
associated with calcification. The most modern flex-
ible IOL materials contain a minimal amount of
equilibrium water content by design, a feature that
appears to have the benefit of preventing glistenings.
Modern IOLs have carefully fabricated edges to
minimize PCO. All of these factors make modern
acrylic lenses a welcome addition to the surgical
armamentarium.
DECLARATION OF INTEREST
The authors report no conflicts of interest. The authors
alone are responsible for the content and writing of
this article.
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