Werner 2010

REVIEW/UPDATE
Glistenings and surface light scattering

in intraocular lenses
Liliana Werner, MD, PhD
Glistenings are fluid-filled microvacuoles that form within the intraocular lens (IOL) optic when the
IOL is in an aqueous environment. They are observed in all types of IOLs but have been mainly
associated with hydrophobic acrylic IOLs. Experimental and clinical studies suggest the various
hydrophobic acrylic IOLs on the market exhibit different tendencies toward glistenings. Factors
influencing glistening formation include IOL material composition, manufacturing technique,
packaging, associated conditions such as glaucoma or those leading to breakdown of the
blood–aqueous barrier, as well as concurrent use of ocular medications. Although the impact
of glistenings on postoperative visual function and the evolution of glistenings in the late postop-
erative period remain controversial, IOL explantation has rarely been reported. The phenomenon
of surface light scattering has also been described in association with hydrophobic acrylic IOLs.
Its mechanism of formation is controversial but may be related to long-term phase separation
water near the IOL surface, although not seen as microvacuoles.
Financial Disclosure: The author has no financial or proprietary interest in any material or method
mentioned.
J Cataract Refract Surg 2010; 36:1398–1420 Q 2010 ASCRS and ESCRS
DEFINITION, ONSET, AND INCIDENCE OF GLISTENINGS available literature on glistenings describes them in as-
Glistenings are fluid-filled microvacuoles that form sociation with hydrophobic acrylic IOLs. However,
within the intraocular lens (IOL) optic when the IOL they have been observed with different IOL materials,
is in an aqueous environment (Figure 1).1 Most including silicone, hydrogel, and poly(methyl methac-
rylate) (PMMA).2–5 Although in some studies, glisten-
ings were not observed during the first postoperative
Submitted: December 3, 2009.
Final revision submitted: April 27, 2010. month,6,7 in others the time of onset was as early as
Accepted: April 29, 2010. 1 week after implantation.2,8 In some studies, such as
a prospective clinical trial by Miyata et al.,7 glistenings
From the John A. Moran Eye Center, University of Utah, Salt Lake were not observed up to 6 months postoperatively in
City, Utah, USA, and the Berlin Eye Research Institute, Berlin, at least 13 of 28 eyes.
Germany.
Whether the density/severity of glistenings in the
Supported in part by Research to Prevent Blindness Olga Keith same IOL increases over time or stabilizes after an ini-
Weiss Scholar Award and by a research grant from the European tial increase is a matter of controversy (see ‘‘Progres-
Society of Cataract and Refractive Surgeons (Dr. Werner). sion Over Time’’). The incidence of glistenings
reported in the literature appears to vary as a function
English translations of Japanese articles were provided by com-
mercial translation companies and supported by Santen Pharma- of the postoperative time considered. In 115 eyes im-
ceutical Co., Ltd (Japan). Scientists/biomedical engineers from planted with the 3-piece AcrySof MA60BM (Alcon,
the following intraocular lens manufacturers and regulatory Inc.), no glistenings were found 1 month after surgery;
agencies provided critical review of the manuscript (alphabetical or- the incidence was 20% at 3 months, 51% at 6 months,
der): Abbott Medical Optics, Inc., Advanced Vision Science, Inc., Al- and 55% at 1 year.6 In another 115 eyes implanted
con, Inc., Bausch & Lomb, U.S. Food and Drug Administration with the same IOL model, Peetermans and Hennekes9
(Division of Ophthalmic Devices), Hoya Surgical Optics GmbH, report an incidence of 55.7% at 14 months and 87.3% at
Key Medical Technologies, Inc., Ophthalmic Innovations Interna- 28 months. In a study in which 42 eyes implanted with
tional, Inc., and Santen Pharmaceutical Co., Ltd. the AcrySof MA30BA or MA60BM were examined
Corresponding author: Liliana Werner, MD, PhD, John A. Moran 2.4 years G 0.3 (SD) (range 6 to 46 months) after im-
Eye Center, University of Utah, 65 Mario Capecchi Drive, Salt plantation, all IOLs had glistenings.10 Regarding the
Lake City, Utah 84132, USA. E-mail: liliana.werner@hsc.utah.edu. 1-piece AcrySof IOLs, Davison11 observed trace to
1398 Q 2010 ASCRS and ESCRS 0886-3350/$dsee front matter

Published by Elsevier Inc. doi:10.1016/j.jcrs.2010.06.003
REVIEW/UPDATE: GLISTENINGS AND SURFACE LIGHT SCATTERING IN IOLS 1399
semiquantitative slitlamp grading of glistening den-

sity is shown in Figure 2. With the slitlamp beam set
at 10.0 mm by 2.0 mm, the glistenings were graded
as trace Z fewer than 10; 1C Z 10 to 20; 2C Z 20
to 30; 3C Z 30 to 40; and 4C Z more than 40.10 In
studies by Miyata et al.,1,6,7,15–17 the grades were 0 Z
no glistenings; 1 Z up to 50/mm3; 2 Z up to 100/mm3;
and 3 Z up to 200/mm3 (Figure 3).
Klos et al.18 suggest that Scheimpflug photography
could be used to quantify glistenings, as different
types of irregularities, damage, or disturbances in the
transparency of the IOL material could be identified
by more or less intensive light scattering. Ayaki
et al.19 describe that when the analysis area of the
Scheimpflug camera is adjusted to a cross-sectional
square area of 0.25 mm (thickness) by 3.0 mm (slit
length) inside the IOL optic or on the surface, the
mean value of scattering, representing the degree of
glistening (inside the IOL optic) or the surface scatter-
ing (see ‘‘Surface Light Scattering in Hydrophobic
Acrylic Intraocular Lenses’’), respectively, can be cal-
culated. The measurements in both locations are indi-
cated as computer compatible tape (CCT). This is
a measure of brightness or intensity of reflected (scat-
tered) light on a scale from 0 (black) to 255 (white) as
captured by the monochrome detector (charge-cou-
pled device [CCD]) in the camera (Figures 4 and 5).
In a recent study, Behndig and Mönestam20 describe
the use of this photography technique associated with
IOL light scattering quantification using an image
analysis program. The study showed the presence of
glistenings (indicated by light scattering) in all eyes
Figure 1. Slitlamp photographs of an eye implanted with a 3-piece implanted with AcrySof MA60AT or SA60AT IOLs
hydrophobic acrylic IOL (AcrySof) showing intraoptical glistenings. after a mean follow-up of 105 G 33 months; more glis-
(Photographs provided by Jane Durcan, MD, Spokane, Washington, tenings were observed in eyes with longer postopera-
USA). tive periods. According to the authors, glistenings
were more prominent near the IOL surfaces, especially
2C glistenings in 11 of 100 consecutive patients with the anterior surface. However, in the study by Klos
the SA30AL IOL examined 1 to 16 months postopera- et al.18 using Scheimpflug photography, the glisten-
tively (mean 8 months). Waite et al.12 examined con- ings found in all 41 AcrySof IOLs at 1 year were
secutive patients with the SA60 IOL at 12, 24, and described as ‘‘occurring in every part of the IOL.’’
36 months and patients with the SN60 at 12 months. Mackool and Colin21 believe there was some confu-
All 53 IOLs included in the study showed some degree sion between light scattering from glistenings and sur-
of glistenings. face light scattering in the study by Behndig and
Mönestam.20 They highlight the possible limitations
of the use of Scheimpflug photography in quantifying
GRADING, LOCATION, AND SIZE glistenings in a recently published letter to the editor.21
It is important to highlight that in the above- According to them, there is no demonstration of the
mentioned studies, the eyes did not have the same ability of this technique to distinguish between light
degree of glistenings. Common approaches to grading scattering due to glistenings and light scattering due
glistenings include subjective/semiquantitative grades to other variables, such as aqueous–IOL interface, pos-
of density assessed at the slitlamp2,8,13,14 and slitlamp terior capsule opacification (PCO), or biological mate-
photography of the IOL at high magnification with rials deposited on the IOL surface. Indeed, in the study
quantification of the size and number of glistenings by Behndig and Mönestam,20 the reported correlation
manually5–7 or by digital image analysis.12 A coefficients for the given light scattering amounts
J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

1400 REVIEW/UPDATE: GLISTENINGS AND SURFACE LIGHT SCATTERING IN IOLS
Figure 2. Slitlamp photographs of eyes implanted with hy-

drophobic acrylic IOLs (AcrySof 3-piece models) showing
clinical grading of glistenings based on the number of mi-
crovacuoles per field (slit beam set at 10.0 mm 2.0 mm).
A Z trace (fewer than 10); B Z 1C (10 to 20); C Z 2C (20 to
30); D Z 3C (30 to 40); E Z 4C (more than 40). Reprinted
with permission from JCRS (2001; 27:728–733). Copyright
2001 American Society of Cataract and Refractive Surgery
and European Society of Cataract and Refractive Surgeons.
(interpreted as glistenings) and postoperative time Glistenings are usually distributed throughout the
were higher for Scheimpflug photography than for entire IOL optic.8 The size of individual glistenings
subjective grading of glistenings done under a slitlamp range from 1 to 20 mm whether observed clinically or
in the same patients. Also, in their methodology, they induced in a laboratory setting by immersing the
say that glistenings were evaluated at the anterior and IOLs in water and submitting them to fluctuations in
posterior IOL surfaces20; there is no mention of mea- temperature. Clinically observed glistenings are usu-
suring light scattering in an analysis area adjusted to ally up to 10 mm in diameter, while larger glistenings
an area inside the IOL optic, as indicated by Ayaki may be observed during in vitro studies using signifi-
et al.19 cant temperature fluctuations.7,22

Figure 3. Slitlamp photographs of

eyes implanted with hydrophobic
acrylic IOLs (AcrySof MA60BM
and SA60AT models) taken after pu-
pil dilation at high magnification,
showing the Miyata grading system
for glistenings. (Photographs pro-
vided by Akira Miyata, MD, Japan).
MECHANISM OF FORMATION have different components, including different mono-

The mechanism of glistening formation within IOLs mers, chromophores, and crosslinking agents. Micro-
has been evaluated and described in various stud- voids can be found within the network of polymers
ies.1,23–25 Polymers used for the manufacture of IOLs depending on their architectural structure. When glis-
tening formation is repeatedly induced in the same
IOL in experimental conditions, the microvacuoles re-
appear in the same locations, which represent the sites
of the voids within the polymer.26 Polymers generally
absorb water when immersed in an aqueous environ-
ment for extended time. The water absorption rate
(amount of water absorbed/IOL weight) varies ac-
cording to the IOL material; for currently available hy-
drophobic acrylic IOLs, it is generally less than 1%.
The absorbed water is usually not visible because it
is present in the form of water vapor within the poly-
mer network. However, if water vapor detaches from
its surrounding matter, gathering into a void within
the polymer network (phase separation), the result is
the formation of a visible water drop. Since there is
a significant difference in the refractive index of water
droplets (1.33) and the bulk IOL polymer (eg, 1.555 for
AcrySof IOLs), the light is refracted and scattered at
the water–polymer interfaces, leading to a sparkling
appearance of the fluid-filled vacuoles (thus, the
term glistenings).
The water absorption rate of polymers changes ac-
cording to the temperature.1 For hydrophobic acrylics,
for example, when the temperature is below the glass
transition temperature (Tg) (above this temperature,
Figure 4. Schematic drawing showing the cross-sectional slit image the polymer exhibits flexible properties and below, it
(3.0 mm 0.25 mm) adjusted for analysis within the IOL optic (A) remains rigid), water absorption is minimal. However,
and near the optic surface (B) to measure light scattering intensity re-
sulting from glistenings and surface light scattering, respectively, when the Tg is exceeded and the material begins to
with the Scheimpflug camera. Modified with permission from soften, water absorption increases. The Tgs of poly-
JCRS (2006; 16:451–457). mers currently used in hydrophobic acrylic IOLs are

Figure 5. Scheimpflug photographs

of 2 eyes implanted with a hydro-
phobic acrylic IOL (AcrySof model
MA30BA) taken 3 years postopera-
tively. The IOL glistenings can be
seen as fine bright particles inside
the IOL optic. The anterior and pos-
terior contours of the IOLs appear
highlighted with surface scattering.
Although the degree of glistenings
in both IOLs is similar, the degree
of surface light scattering is differ-
ent. A and C: 13 CCT of glistenings
and 55 CCT of anterior surface scat-
tering. B and D: 12 CCT of glisten-
ings and 26 CCT of anterior
surface scattering. (Photographs
provided by Masahiko Ayaki,
MD, Japan).
usually close to room temperature. If the IOL is placed some fraction of hydrophilic monomers, are generated
in warm water and the temperature is then lowered, during polymerization. They would preferentially
the water inside the polymer becomes oversaturated. segregate out of the matrix material into polymer
The water surplus gathers inside the voids within voids (cavities), giving rise to an osmotic pressure dif-
the polymer network, forming glistenings. An experi- ference between the cavity and the external media in
mental study showed that glistening-like vacuole for- which the IOL is immersed. The authors used IOLs
mation in Wagon Wheel–packaged AcrySof MA60BM manufactured from a nonspecified hydrophobic
IOLs could be initiated by a 3 C temperature decrease acrylic material with a refractive index of approxi-
from body temperature (37 C).25 In the same study, mately 1.5 that were immersed in solutions exhibiting
the authors determined the temperature at the human osmolarities corresponding to 300, 150, and 0 mM. The
ocular surface after a 1-minute application of a polyeth- temperature was kept constant, and the IOLs were
ylene bag containing hot water at 45 C or iced water at continuously observed under an inverted optical mi-
0 C. They show that the temperature of the ocular sur- croscope. Progressive cavitation/glistening formation
face decreased approximately 7 C when the outer tem- was observed under isothermal conditions, and there
perature decreased from 45 C to 0 C. It is, therefore, was a significant increase in the mean size of the cavi-
likely that glistenings may form in vivo when the ties when the osmolarity of the external solution de-
IOL experiences small fluctuations in temperature in creased. According to the authors, the influx of water
aqueous humor.25 If the IOL is placed in water below into the cavity deforms the surrounding polymer until
the Tg of the IOL material, glistening formation is not the stress reaches a critical value when permanent de-
observed. This was confirmed in a series of experi- formation occurs (ie, cracking or tearing) and the cav-
ments by Shiba et al.,27,28 who immersed Wagon ity grows. This process would continue until
Wheel–packaged AcrySof IOLs for 6 months in a phys- equilibrium is achieved. The experiments were per-
iological saline at 15 C in one experiment. formed under a temperature of 323 K (49.85 C). The
Recently, the U.S. Food and Drug Administration authors postulate that at physiological temperatures
(FDA) described experiments that suggest a different (310 K or 36.85 C), the diffusivity of the impurities
mechanism for glistening formation.29 The authors would be lower. Therefore, it would take several
propose that glistenings (referred to as cavitation) months before equilibrium would be achieved, which
are the result of relatively slow-moving hydrophilic is consistent with clinical studies showing stabilization
impurities within the IOL material. These impurities, of the frequency and density of glistenings after an ini-
likely represented by oligomeric species that contain tial period of increase.7 In the FDA study,29 the authors

propose an analytical method to predict the propen-

sity for cavitation/glistening formation based on the
IOL material and impurity concentration.
FACTORS INFLUENCING GLISTENING FORMATION

Besides IOL material composition, factors such as IOL
manufacturing technique, IOL packaging, associated
conditions such as glaucoma or those leading to break-
down of the blood–aqueous barrier (BAB), as well as
concurrent ocular medications have been described
as having a possible impact on the development of
glistenings. In an experimental study, Nishihara
et al.30 compared glistening formation in hydrophobic
acrylic IOLs manufactured with 2 different processes:
Figure 6. Gross photograph showing WagonWheel packaging of the
cast molding and lathe cutting. In the cast-molding
AcrySof IOL on the left and AcryPak packaging on the right (poste-
process, a monomeric mixture is poured and polymer- rior view) with the folding device holding the IOL in a rectangular
ized in a polished casting mold, followed by detach- plastic case.
ment of the polymer from the mold. This method is
generally suitable for large-scale production. Disad- which were the IOLs implanted during the core stud-
vantages may include molecular weight dispersion ies of this IOL.10,12 In the experimental study by
and heterogeneous parts containing unreacted mono- Omar et al.,31 AcrySof IOLs in both types of packag-
mers if the polymerization is not complete. The lathe- ing showed glistening formation, with the AcryPak-
cutting process involves production of acrylic sheets packaged IOLs exhibiting significantly more
by bulk polymerization of a monomeric mixture, microvacuoles.
with subsequent lathing of each IOL for trimming/ Association between glistening formation and break-
polishing to remove heterogeneous parts. Disadvan- down of the BAB barrier (with higher levels of serum
tages include more processing steps, which may lead components in the aqueous humor) has been
to more costs. In Nishihara et al.’s study,30 IOLs man- investigated. Dick et al.32 evaluated the influence of
ufactured by both methods were immersed in solution aqueous humor components on the occurrence of glis-
and submitted to changes in temperature. Observation tenings in AcrySof IOLs. The IOLs were incubated at
under a stereoscopic microscope showed significantly body temperature for 3 or 6 months in anterior chamber
fewer glistenings in the lathe-cut IOLs. aqueous humor with or without fresh human serum.
The AcrySof IOL packaging was also implicated in The mean density score of glistenings was higher in
the process of glistening formation. The AcrySof was the group with serum; it was also higher at 6 months
the first commercially available foldable hydrophobic than at 3 months. A marked increase in the mean den-
acrylic IOL, approved for marketing in the United sity score was not observed in the IOLs incubated in
States in December 1994. The first peer-reviewed re- aqueous humor without serum. Mitooka and Tsuneo-
ports of glistening formation were related to AcrySof ka23 observed an association between glistenings and
IOLs packaged in the AcryPak system, which was diabetes. In their study, the total occurrence of glisten-
not used in the clinical trials conducted before FDA ap- ings was 46.5% among nondiabetic patients but 75.5%
proval. The AcryPak consisted of a plastic folding de- among diabetic patients. When they considered cases
vice in which the IOL was packaged and a large with grade 3C of the Miyata scoring system, 5.5% of
rectangular plastic container that held both IOL and the patients were not diabetic and 20.5% were diabetic.
folder (Figure 6). With this device, the IOL could be All the differences were statistically significant.
folded immediately after the package was opened so Moreno-Montañés et al.33 evaluated clinical factors
it could be easily grasped by the surgeon with possibly associated with the frequency and intensity
a forceps. The IOL and folder underwent terminal ster- of glistenings in AcrySof MA30BA IOLs. In a consecu-
ilization within this plastic case. Some authors hypoth- tive series of 129 eyes of 94 patients implanted with
esized that this changed the microenvironment of the this IOL by the same surgeon, 29.5% exhibited glisten-
IOL, facilitating glistening formation, which led to ings 20.6 G 11.5 months postoperatively (range 1 to
a voluntary withdrawal of the AcryPak packaging 50 months). There was a significant relationship be-
by Alcon.8,31 Studies demonstrate that glistenings tween the frequency of glistenings and the following
also occur with Wagon Wheel–packaged AcrySof factors: longer time after surgery, higher dioptric
IOLs (the type of packaging currently used) (Figure 6), power, and performance of phacotrabeculectomy.

The intensity of glistenings was significantly associ- components. There were intralenticular changes rang-
ated with the time after surgery (with higher intensi- ing from small vacuoles to crack-like structures in all
ties observed in cases with longer follow up) and IOLs incubated with the ophthalmic solution compo-
with the degree of postoperative inflammation. nents. The observed changes were generally less exten-
Ayaki et al.19 investigated the influence of topically sive in the AcrySof IOLs.
applied antiinflammatory agents on glistening forma- In a recently published retrospective clinical study,
tion. Thirty-two eyes receiving a commercial prepara- Colin et al.35 assessed potential correlations between
tion of diclofenac sodium containing a surfactant were glistenings and clinical and demographic factors in
compared with 31 eyes receiving a commercial prepa- 260 eyes of patients who received different models of
ration of betamethasone phosphate without surfac- AcrySof IOLs between September 2000 and December
tant. The drops were administered 3 times daily for 2007. There was a statistically significant association
1 month after phacoemulsification with implantation between the incidence and severity of glistenings
of an AcrySof MA30BA IOL. All surgeries and clinical and glaucoma. The authors hypothesize that this was
courses were uneventful. The mean glistening forma- because of the pathology of the glaucoma or the
tion intensity over 3 years was significantly higher in chronic topical medications used to lower intraocular
the diclofenac sodium–surfactant group. The authors pressure. Indeed, 97% of patients with glaucoma in
postulate that the surfactant enhanced water accumu- the study used antiglaucoma medications. Active in-
lation in the IOLs by reducing the surface energy. gredients or preservatives in antiglaucoma medica-
Later, the same group performed an in vitro study to tions may lead to rupture of the BAB36 or may have
investigate the effect of ophthalmic solutions and oph- a direct effect on the IOL material, as indicated in the
thalmic solution components on 3 hydrophobic acrylic study of antiinflammatory agents by Ayaki et al.19,34
IOLs: AcrySof MA30BA, Sensar AR40 (Abbott Medi- Colin et al.35 did not find that the presence of the
cal Optics, Inc.), and Acryfold (Hoya Surgical Optics blue light–filtering chromophore in yellow AcrySof
GmbH).34 The active components investigated were IOLs affected the incidence or severity of glistenings.
diclofenac sodium, bromfenac sodium, betametha-
sone phosphate, and dibekacin sulphate. Polysorbate
80 (surfactant), benzalkonium chloride (preservative/ GLISTENINGS IN HYDROPHOBIC ACRYLIC INTRAOCULAR
surfactant), methyl parahydroxybenzoate (preserva- LENSES
tive), and propyl parahydroxybenzoate (preservative) The hydrophobic acrylic IOLs on the market are not
were also evaluated. The IOLs were incubated at manufactured from the same material and by the
35 C for 2 weeks in the various solutions or same manufacturing process. Table 1 summarizes
Table 1. Characteristics of currently available hydrophobic acrylic IOLs.
IOL/Manufacturer Material Composition (All With UV filters) Refractive Index
3-piece and 1-piece Copolymer of phenylethyl acrylate and phenylethyl 1.555

AcrySof/Alcon Laboratories (USA) methacrylate, crosslinked with butanediol diacrylate
Sensar AR40 and AR40e/Abbott Medical Copolymer of ethyl acrylate, ethyl methacrylate, 1.47
Optics (USA) 2,2,2-trifluoroethyl methacrylate, crosslinked with
ethylene glycol dimethacrylate
AF-1 series/Hoya Surgical Optics (Japan) Crosslinked copolymer of phenylethyl methacrylate 1.52
and n-butyl acrylate, fluoroalkyl methacrylate
XACT/Advanced Vision Science (USA) Copolymer of hydroxyethyl methacrylate, polyethylene 1.54
glycol phenyl ether acrylate and styrene, crosslinked
with ethylene glycol dimethacrylate
HP 757SQ/Aurolab (India) Copolymer of ethylacrylate, ethylmethacrylate, crosslinked 1.47
with a difunctional acrylate/methacrylate
Acrylmex/Ophthalmic Innovations Terpolymer of butyl acrylate, ethyl methacrylate, and 1.49
International (USA) N-benzyl-N-isopropylpropenamide, crosslinked with ethylene
glycol dimethacrylate
Matrix Acrylic/Medennium (USA) Poly(2-phenyloxyethyl acrylate), crosslinked with 1.56
phenyl-containing dimethacrylate
Hydromax/Zeiss (Germany) Homopolymer of 2-phenoxy ethyl acrylate, crosslinked 1.56
with ethoxylated (2) bisphenol A dimethacrylate
L450/Wavelight–Oculentis (Germany) Not provided 1.5

general material characteristics of the hydrophobic 74 eyes implanted with the SA30AL AcrySof IOL
acrylic IOLs currently being manufactured. This infor- (n Z 17), the Acryfold IOL (n Z 37), or the Sensar
mation was obtained through the corresponding man- AR40e IOL (n Z 20) IOLs. The follow-up period
ufacturers and peer-reviewed literature37; the list is not ranged from 6 to 18 months. Slitlamp examination
exhaustive. For didactic purposes, the IOL manufactur- showed the presence of glistenings grade 1C (Miyata
ing methods listed in Table 1 can be divided into 2 gen- classification) in 35.3% of the AcrySof IOLs, 62.1% of
eral methods. (1) In direct cast molding, the polymer the Acryfold IOLs, and none of the Sensar IOLs. Ac-
can be cast into disposable plastic molds or into reus- cording to Hoya Surgical Optics GmbH, the manufac-
able metal molds. The polymer is cured in the mold, turer investigated the reports of glistening occurrences
and the individual IOL is removed from the mold after (a total of 29) in early IOL models VA60CA and
curing (AcrySof, Matrix Acrylic, Hydromax, L450). (2) VA60CB, which were never commercially released
In sheet casting and lathing, the polymer is cast into outside of Japan and were subsequently discontinued.
thick flat sheets and then cured. Buttons are cut out A team was organized to review materials and pro-
and then individually lathed into IOLs (Sensar, AF-1 cesses used to manufacture these IOLs. As a result, im-
series, XACT, HP 757SQ, Acrylmex). For polymers provements were implemented in the polymerization
that must be machined below the Tg, lathing is done and cleaning processes. Continued monitoring of the
at low temperatures (cryolathing). manufacturing processes and customer complaints
Although it is likely that the various hydrophobic shows that these changes have been effective.A
acrylic IOLs on the market exhibit different tendencies Two European clinical studies presented at a 2009
toward glistening formation, no peer-reviewed articles meeting described no glistenings in Acrylmex IOLs
on this subject for all the IOLs in Table 1 are currently (3-piece and 1-piece models EC-3 and EC-1Y, respec-
available. Most of the peer-reviewed literature de- tively) after postoperative periods up to 1 year.B,C
scribes glistening formation, incidence, and severity The first study included at least 10 cases with a mini-
in the AcrySof material; a relatively small number of mum follow-up of 18 months with no signs of
articles/presentations also evaluate glistening forma- glistening.
tion in the Acryfold VA60CA/CB, Acrylmex (Oph- Information contained in the FDA Summary of
thalmic Innovations International, Inc.), Sensar Safety and Effectiveness Data and the labeling of the
AR40(e), and XACT (Advanced Vision Science, Inc.) XACT IOL was obtained through the manufacturer.
IOLs. This IOL was approved for use in the U.S. in February
There is one Japanese clinical study of glistenings in 2009 (subsequently licensed to Bausch & Lomb) and in
the VA60CB (Acryfold) IOL.38 The authors evaluated Japan in 2008 (trade name Santen Eternity). The XACT
Table 1. (Continued)
Water Content (%) Contact Angle in Water ( ) Packaging Manufacturing Method Approved in U.S.
!0.5% 72 Dry Direct lens molding technology Yes
!0.5 88 Dry Precision cryolathing technology Yes
!0.3 85 Dry Lathe cut Yes
˜4.0 76 Prehydrated in Lathe cut at room temperature Yes

0.9% saline
!0.5 Not provided Dry Lathe cut No
!0.3 Not provided Dry Cryolathing No (currently completing

FDA clinical study)
!0.5 75o Dry Cast molding No
!0.5 81.7 Dry Molding No
!0.5 72 Dry Cast molding No

IOL is the only hydrophobic acrylic IOL packaged in cycle, glistenings appeared in the outer rim of the
solution. The current version packaged in 0.9% saline IOL optic only. However, upon repeated temperature
and gamma-sterilized has not been associated with load administration, they appeared not only in the
glistenings. In the initial clinical trials, the IOLs were same locations, but also in other locations and in the
packaged in 10.0% saline. The presence of glistenings center of the IOL. The mean number of glistenings
was first reported in a clinical trial conducted in Japan that appeared in the same amount of space also
in 40 eyes of 40 patients between 1 week and 1 month increased with each additional temperature load.
of surgery, with decreased density at each visit there- Although it is unclear whether this is a result of an in-
after. No differences in contrast sensitivity were ob- creasing number of microvoids or increased perme-
served between the study and control eyes except ability of the fluid with more microvoids that
a clinically insignificant difference in contrast sensitiv- become seen as glistenings, the study suggests that
ity detected in the highest spatial frequencies at 1 not only the temperature applied to the IOL but also
month. It was postulated that after implantation, the repeated temperature changes have an impact on the
osmotic differential between the IOL and aqueous amount of glistenings formed.26
humor could cause more water to be absorbed into Some experiments confirm glistening formation also
the IOL optic, resulting in the appearance of glisten- in Wagon Wheel–packaged AcrySof IOLs resulting
ings. Enrollment in the U.S. investigational device from temperature changes. Omar et al.31 compared
exemption clinical trial had been competed when the glistening formation between AcryPak-packaged and
change of hydration/storage media from 10.0% to Wagon Wheel–packaged AcrySof IOLs. In the first ex-
0.9% saline was implemented. Laboratory testing es- periment, the IOLs were immersed in purified water
tablished that glistenings were eliminated by the and maintained at a constant temperature of 37 C
change in storage media. This was confirmed in an ad- for 336 hours, including during examination under
ditional clinical trial conducted in the Dominican a microscope and a slitlamp. Examination performed
Republic and Germany,D the data from which were at 48-hour intervals showed glistening formation in
included in the FDA marketing application for the AcryPak-packaged IOLs beginning at 48 hours and
IOL. In this study, 172 eyes of 142 patients were exam- peaking at 288 hours; no glistenings were detected in
ined at least once between 1 month and 6 months and Wagon Wheel–packaged IOLs. In the second experi-
123 eyes of 101 patients were examined at least once ment, the IOLs were initially maintained at room tem-
between 6 months and 2 years. No glistenings were perature for 24 hours and then placed in a bath of
observed at any time. purified water under 37 C. However, the IOLs were
not maintained at a constant temperature during ex-
amination, which was performed at 48-hour intervals.
Laboratory Analyses Both IOL types showed glistening formation, with the
Although glistening formation induced in vitro may AcryPak-packaged IOLs exhibiting significantly more
produce morphological aspects that generally appear microvacuoles. In an experiment using the same con-
exaggerated in comparison to the clinical situation,7,39 ditions as the second Omar et al. experiment, Dhaliwal
in vitro studies are considered useful in the investiga- et al.8 found similar results with the Wagon Wheel–
tion of the phenomenon. They usually involve immer- packaged IOLs. In the experiment by Miyata et al.,6
sion of the IOLs in solution, which are then subjected Wagon Wheel–packaged IOLs were immersed in wa-
to temperature fluctuations. In the in vitro studies, 7,28,31 ter containing 0.1% methylene blue dye at 37 C for
the microvacuoles are generally observed throughout 2 days and then the water temperature was reduced
the thickness of the IOL optic and they completely to 25 C for an additional day. Examination of the
disappear after the IOLs are allowed to dry for at least IOLs under a microscope and slitlamp revealed the
30 minutes. presence of many roughly spherical microvacuoles
When repeatedly induced in the same IOL, glisten- that contained the dye.
ings reappear in the same location.26 Matsui et al.26 an- Gregori et al.40 compared glistening formation
alyzed glistening formation in the AcrySof MA60BM among 3 hydrophobic acrylic designs: Wagon Wheel–
IOLs by immersing them in distilled water and repeat- packaged 1-piece and 3-piece AcrySof IOLs and Sensar
edly lowering the temperature from 37 C to 25 C. The AR40 IOLs. The IOLs were immersed in a 37 C water
IOLs were continuously analyzed using a phase mi- bath and checked daily for 5 days under constant tem-
croscope, a CCD camera, and a video recorder without perature and after 2 hours of cooling under room tem-
removing the IOLs from the water bath. After the first, perature. Glistening quantities were minimal and did
second, and third temperature lowering, glistenings not differ among IOL types at 37 C (observed from
appeared within 4 minutes, 2 minutes, and 1 minute day 1). They were smallest in the 1-piece AcrySof;
and 30 seconds, respectively. In the first temperature 6.3 mm versus 11.5 mm in the Sensar and 13.4 mm in

the 3-piece AcrySof. Upon cooling, the glistening quan- content increased as the temperature increased with
tity increased dramatically in the 1-piece AcrySof IOLs all IOLs. The water content was higher in the AR40
and was the highest among the IOL types at room tem- IOLs at all temperatures, but the temperature-
perature. The 3-piece AcrySof showed a significant de- dependent increase in water content with increasing
crease in slitlamp-countable glistenings but acquired temperature was higher with the MA60BM IOLs. A
a dense haze seen as minute glistenings (4 mm) at 2 C decrease in temperature did not cause glistenings
80 magnification. The glistening quantity in the Sen- in any IOL; a 4 C decrease caused a small amount in
sar AR40 IOLs was fairly stable upon cooling, with only the MA60BM; a 6 C decrease caused a small
a statistical increase on the last day. Cooling nearly amount in the AR40 and a large amount in the
doubled the size of the Sensar glistenings, which MA60BM. Using a similar technique, Kato et al.25
were the largest at room temperature (21.7 mm). found that the relative water content of Wagon
More dramatic fluctuations in temperature were Wheel–packaged AcrySof IOLs was 3 times higher at
used in some studies. Miyata et al.7 immersed Wagon 70 C than at 37 C.
Wheel–packaged IOLs in physiological saline at 50 C Mentak et al.E evaluated the effect of hydration on
for 2 hours and then transferred them to a bath under the hydrophobicity of different hydrophobic acrylic
35 C for up to 60 days, with frequent examinations materials (1-piece AcrySof, Sensar AR40e, Hoya AF-1,
performed under a microscope and a slitlamp. The and XACT IOLs) by evaluating the contact angles
IOLs showed no change during immersion at 50 C (the higher the contact angle, the more hydrophobic
but became opacified immediately after they were the material). Contact angles for dry IOLs and for
transferred to the lower temperature bath. After sev- IOLs hydrated at 37 C in balanced salt solution (BSS)
eral hours, relatively large glistenings were formed, for 1, 2, 3, 7, 14, 21, and 28 days were measured. All
which were replaced by numerous relatively smaller dry IOLs were hydrophobic. However, a 4-week hy-
(approximately 10 mm) glistenings observed from 10 dration in BSS resulted in greater surface wettability
to 60 days, with no further changes. In another study for all IOLs; there was a 3-degree drop in contact angle
using similar conditions, Miyata16 compared glisten- for the XACT IOLs (to 73 degrees) and greater hydro-
ing formation in the VA60CA and the Sensar IOLs. philicity for the other IOLs. The contact angle de-
Both IOL types became opacified immediately upon creased 24 degrees (to 54 degrees) in the AcrySof
transfer to the 35 C solution, and then a small amount IOLs, 16 degrees (to 74 degrees) in the Sensar AR40e
of glistenings formed on both types. The diameter of IOLs, and 18 degrees (to 70 degrees) in the Hoya
the glistenings was 10 mm in the Sensar IOLs and AF-1 IOLs. In the same study, the authors correlated
5 mm in the VA60CA IOLs. Kato et al.25 found that the contact-angle findings with surface roughness/
the rate of temperature decrease had an effect on glis- morphology analyzed by atomic force microscopy
tening formation. In their study, when the temperature (AFM) in dry and hydrated states. The graph in
of the distilled water gradually decreased to 34 C, 1.0 Figure 7 and corresponding AFM images in Figure 8
to 20.0 mm glistenings were observed within the optic show that the magnitude of the surface roughness/
of Wagon Wheel–packaged AcrySof IOLs; glistening morphology changes observed on the surface of the
density was higher in IOLs cooled from 60 C than AcrySof IOLs was significantly higher than with the
IOLs cooled from 37 C. Transferring an IOL from other IOLs.E Dogru et al.41 demonstrated increased
a 60 C solution to a 23 C solution resulted in an opa- surface roughness under AFM in an explanted
que optic caused by formation of multiple small vacu- MA60BM AcrySof IOL, exhibiting glistening com-
oles (less than 1.0 mm) densely distributed compared pared with control IOLs of the same design.
with the results in a gradual cooling process. Although analyses may provide an assessment of
In vitro studies were performed to evaluate the the tendency to glistening formation of different IOL
change in water content of hydrophobic acrylic IOLs materials, the precise correlation between laboratory
as a function of temperature and the effect on glisten- observations and clinical outcomes has not been deter-
ing formation. Miyata and Yaguchi17 correlated the mined. Oshika et al.39 and Shiokawa and Oshika42 per-
degree of glistenings in 2 different hydrophobic acrylic formed optical bench studies to determine the possible
IOLs with their equilibrium water content. They im- influence of glistenings on the optic quality of the
mersed MA60BM (AcrySof) and AR40 (Sensar) IOLs IOLs. Wagon Wheel–packaged AcrySof IOLs were im-
in distilled water for 24 hours at temperatures of mersed in water at 37 C for 48 hours and then at 25 C
30 C, 40 C, or 50 C, removed the excess water from for 24 hours. Glistenings were scored as 1C to 4C. The
the IOLs, and measured the IOL weight. Another set 4C degree was extremely intense and thought to be
of the same IOLs were immersed in physiological sa- beyond the range of clinical settings. The authors
line under 37 C, 39 C, or 41 C for 2 hours and then found that the clinically compatible level of glisten-
transferred to physiological saline at 35 C. The water ings, up to 3C, did not adversely influence spectral

180 the bulk and the surface of the IOLs could be sepa-
160
rated. Measurements were performed before and after
the IOLs were immersed in purified water and placed
140
Dry in an oven with the temperature set at 35 C for 2 days.
120
24 hrs The authors found that IOLs with 10 mm and larger
100 28 days glistenings could cause light scattering comparable
nm
80 to that present in a 70-year-old crystalline lens.F,G

60
40
Effects on Visual Function
20
An influence of glistenings on the visual function of
0 patients has been reported in some clinical studies.
Hoya AF-1 Sensar Acrysof XACT
Dhaliwal et al.8 evaluated 17 patients implanted with
Figure 7. Graph showing the surface roughness of dry and hydrated AcrySof IOLs packaged in the AcryPak system (dis-
hydrophobic acrylic IOLs measured by AFM. (Data provided by continued in 2005) with glistenings ranging from trace
Khalid Mentak, PhD, Advanced Vision Science, Inc.)
to 2C. Ten patients had a silicone IOL in the contralat-
eral eye. The difference in contrast sensitivity between
the 2 IOLs was statistically significant. However, the
transmittance, scattering, modulation transfer func- authors noted that the glistenings improved over
tion, and resolving power at various contrasts. time, so they repeated visual function testing 4 months
Some researchers are attempting to correlate light- later. Only 4 of the 10 initial patients were available,
scattering characteristics of IOLs with light-scattering and 2 of them had improved results in contrast sensi-
levels found in healthy crystalline lenses of various tivity and glare testing as the number of glistenings de-
ages. The goal of such studies is to elaborate an in creased. Christiansen et al.10 reported the results in 42
vivo test to provide clinical estimates of the functional eyes implanted with Wagon Wheel–packaged Acry-
significance of scattering introduced by glistenings, as Sof IOLs at 2.4 G 0.3 years postoperatively. They
the researchers believe that the effect of glistenings on found a statistically significant difference in mean vi-
visual function is not demonstrated with current stan- sual acuity between eyes with less than 2C glistenings
dard clinical tests. In these studies, 2 types of hydro- and those with 2C or greater. However, the difference
phobic acrylic IOLs were placed in liquid cells. Using in glare testing and contrast sensitivity between the
slit projection at large angles, light scattering from same groups was not statistically significant.
Figure 8. Photomicrographs from the surface of dry and hydrated hydrophobic acrylic IOLs obtained by AFM analyses. (Provided by Khalid
Mentak, PhD, Advanced Vision Science, Inc.)

Gunenc et al.13 evaluated 91 eyes implanted with Regarding 1-piece IOLs specifically, Waite et al.12
AcrySof IOLs at 13.1 G 4.8 months. Fifteen eyes examined consecutive patients with the SA60 IOL at
were excluded because of coexisting pathology; there- 12, 24, and 36 months and those with the SN60
fore, 28 eyes with glistenings were compared with 48 (same design with an incorporated blue blocker) at
eyes without glistenings in terms of visual function. 12 months. All IOLs had glistenings, and neither
There was a statistically significant difference between size, density, nor severity index (size density) corre-
the groups in contrast sensitivity at the high spatial fre- lated with visual acuity, glare testing, or wavefront
quency (12 cycles per degree): 1.06 G 0.19 in the 28 analysis results. High spatial resolution contrast acuity
eyes with glistenings and 1.48 G 0.22 in the 48 eyes had a borderline correlation with the severity index, as
without. However, there appear to be some inconsis- did progress over time. In a clinical study by Fry and
tencies in the data in this study. The 48 eyes without Fry,H the incidence of glistenings at 1 year was 0% in
glistenings were further divided into a group of 17 25 eyes implanted with a silicone IOL (LI61AO,
eyes with folding optic marks and 31 eyes without Bausch & Lomb) and also 0% in 33 eyes implanted
folding optic marks. High-frequency spatial frequency with a hydrophobic acrylic IOL (ZA9003, Abbott Med-
results were noted as 1.04 G 0.11 and 1.09 G 16 in the ical Optics, Inc.). The 1-year glistening incidence was
eyes with the marks and without the marks, respec- 33% in 30 eyes implanted with a 1-piece AcrySof
tively. Therefore, the value of 1.48 G 0.22 initially re- IOL, increasing to 94% at 3 years. Although the pres-
ported for the 48 eyes without glistenings may be ence of grade 3C glistenings in 6 eyes in the same
inaccurate. study was associated with lower contrast sensitivity,
Other studies do not show an association between the series was considered too small to reach definitive
glistenings and decreased visual function. In a study conclusions.
of the MA60BM AcrySof IOL by Miyata et al.,6 com-
parison of 53 eyes without glistenings and 12 eyes ex- Progression Over Time
hibiting glistenings of grades 2C or 3C showed no In the study by Christiansen et al.,10 although 14 of
statistically significant difference in visual acuity, the 15 IOLs (AcrySof) that had greater than trace glis-
glare testing, and contrast sensitivity in the low- tenings had been in the eye for more than 1 year, a sta-
and high-frequency regions. Minami et al.43 investi- tistical association between the grade of glistenings
gated 136 eyes implanted with AcrySof IOLs; 87.5% and time could not be demonstrated. More recently,
had glistenings of various degrees according to the in a retrospective clinical study of 260 eyes with Acry-
Miyata grading system. Visual acuity was not worse Sof IOLs, Colin et al.35 did not find a significant differ-
in the group with 3C glistenings. Of 5 eyes with 2C ence in the incidence and severity of glistenings
or 3 glistenings that underwent further testing, de- between eyes with a follow-up shorter than 24 months
creased contrast sensitivity was observed in 1 eye and those with a longer follow-up.
when glare was applied. Yoshida et al.44 followed Other clinical studies show an increase in the fre-
12 eyes implanted with AcrySof IOLs for 5 years quency and density of glistenings within the postoper-
and compared them with 18 eyes implanted with ative time considered. In the study by Peetermans and
PMMA IOLs, also followed up to 5 years. Even Hennekes,9 115 eyes with the MA60BM AcrySof were
though the density inside the IOLs evaluated with examined at 14 G 4.4 months; 55 of the eyes were ex-
Scheimpflug photography and reported as CCT amined a second time at 28 G 4.5 months. At the first
(thought to correspond to glistenings) was signifi- examination, the mean glistening density was 1.1 G
cantly higher in the AcrySof group at various in- 1.24 in 55.7% of the eyes. At the second examination,
tervals, and actually increased over time, no it was 2.4 G 1.68 in 87.3% of the eyes. Moreno-Mon-
statistically significant difference in visual acuity, tañés et al.33 evaluated 129 eyes with the AcrySof
contrast sensitivity, and glare disability was observed MA30BA IOL and found an association between fre-
between the groups. In a prospective, randomized quency and intensity of glistenings with postoperative
study, Allers et al.45 followed 35 patients who had time. The mean postoperative time was 16.83 G
bilateral phacoemulsification with implantation of 9.8 months in eyes with no glistenings and 29.66 G
a silicone SI40NB IOL (Abbott Medical Optics, Inc.) 10.48 months in those with glistenings. In eyes with
in 1 eye and an AcrySof MA60BM IOL in the other no glistenings, surgery had been performed 16.83 G
eye. Postoperative examinations were done at 9.8 months before evaluation and in those with grade
7 days, 1 to 3 months, 6 months, and 1 year. The 2 or 3 glistenings, 33.94 G 8.89 months before evalua-
authors found no statistically significant difference tion. In the study by Tognetto et al.2 evaluating glisten-
in visual acuity between the groups, although sli- ings in 7 types of foldable IOLs, including 2 silicone, 3
tlamp and Scheimpflug images showed the presence hydrophilic acrylic, and 2 hydrophobic acrylic (Acry-
of glistenings in 40% of the AcrySof IOLs. Sof and Sensar), different degrees of glistenings were

found in all IOLs manufactured from all materials. The actually not clear whether explantation was per-
percentage of patients with glistenings generally in- formed in that case but it was certainly considered.
creased up to 90 days postoperatively and then be- The cataract surgery was uneventful, and at 6 months
came stable in all groups, with the exception of the the visual acuity was 20/20. At 2 years, the visual acu-
AcrySof IOL group, which had a continuous increase ity decreased to 20/30; the IOL was not decentered,
over time (up to 720 days). The mean glistenings grade glistenings grade 3C according to the Miyata scoring
generally increased up to 180 days postoperatively system were observed under slitlamp examination, as
and then became stable in all groups, with the excep- was PCO (referred to as mild). The authors said the
tion of the AcrySof and the 911A (silicone IOL) groups, neodymium:YAG (Nd:YAG) posterior capsulotomy
which exhibited a continuous increase over time. procedure was more difficult to perform than in stan-
However, the mean glistenings grade was signifi- dard cases because of the glistenings density. Visual
cantly higher in the AcrySof group. In the same study, acuity improved to 20/25 after the procedure, with
when all groups were considered, time had a signifi- persistent subjective complaints of decreased visual
cant influence on glistening formation. Mori46 fol- acuity by the patient. Evaluation of contrast sensitivity
lowed 129 eyes implanted with the AcrySof SA60AT at that point showed a decrease in this parameter in
for 3 years. The percentage of eyes with glistenings in- the high-frequency region under glare conditions.
creased from 53% in the first year to 64% and 69% in Dogru et al.41 describe the case of a 63-year-old Jap-
the second year and third year, respectively. The per- anese patient implanted with a Wagon Wheel–pack-
centage of eyes with the most severe degree of glisten- aged AcrySof MA60BM. One month postoperatively,
ings increased from 8% in the first year to 19% and 27% an Nd:YAG laser posterior capsulotomy was per-
in the second year and third year, respectively. formed because of PCO, which apparently changed
Other studies suggest a stabilization of the fre- the IOL’s position inside the capsular bag. A few
quency and density of glistenings after an initial pe- months later, the patient developed disabling night
riod of increase (which varied among the studies). In glare attributed to intralenticular glistenings as well
a prospective clinical study by Miyata et al.,7 49 eyes as a progressive hyperopic refractive error. The dis-
implanted with AcrySof IOLs were followed up to abling glare and hyperopic error resolved after explan-
20 months (mean 13.1 months). Glistening formation tation and exchange of the IOL with a PMMA IOL.
was observed from 2 to 16 months in 57% of eyes, The third article is related to a MA60AC AcrySof
with no further change in density 2 to 3 months after IOL that was explanted from the left eye of a
their presence was first noted. These results correlate 68-year-old patient 26 days after implantation because
with the experiments of the same authors in which of glistenings that were found to impair fundus visual-
no further changes in glistening formation within ization.48 The IOL was analyzed at the Berlin Eye Re-
AcrySof IOLs were noted between 10 days and 60 search Institute. The exact impact of the glistenings
days of immersion in solution, after an initial temper- on the visual function of the patient could not be deter-
ature decrease from 50 C to 35 C.1,6,7 Yoshida et al.44 mined because of retinal issues, and there was no sig-
followed 12 eyes implanted with AcrySof IOLs for 5 nificant improvement in the visual function after IOL
years. As controls, they used 18 eyes implanted with exchange. The fluid-filled vacuoles within the IOL op-
PMMA IOLs followed for the same period. Evaluation tic were initially observed 4 days after surgery and
of light scattering within the IOL optic using Scheimp- were very large (Figure 9, A and B). Glistening forma-
flug photography (thought to correspond to intraopti- tion was experimentally reproduced by immersion of
cal glistenings) showed stabilization of the CCT values the explant in BSS at 37 C; the IOL was then analyzed
in the AcrySof IOLs after 3 years. The CCT values in at room temperature for up to 2 weeks. An IOL of the
the AcrySof eyes were 9.09 G 9.92, 13.9 G 10.8, 22.9 same design was used as a control. Although both
G 3.0, and 23.0 G 11.4 at 1 month, 1 year, 3 years, IOLs were subjected to the same laboratory condi-
and 5 years after implantation, respectively. The corre- tions, gross and light microscopic analyses confirmed
sponding values for the PMMA IOLs were 1.64 G 5.69, that the glistenings in the explanted IOL were up to
0, 3.91 G 6.07, and 3.8 G 7.0 CCT. 100 mm in diameter, whereas those in the control IOL
were no more than 10 mm in diameter (Figure 9, C
and D). Analyses of the explant and control IOLs un-
Intraocular Lens Explantation Due to Glistenings der differential scanning calorimetry, as well as atten-
Three peer-reviewed articles report explantation of uated total reflection Fourier transform infrared
AcrySof IOLs relative to glistenings. Mitooka et al.47 spectroscopy performed in Germany, revealed slight
describe the case of a 70-year-old patient implanted differences in polymer composition between the
with a MA60BM AcrySof IOL with a decrease in visual IOLs; this was not confirmed by similar evaluations
acuity attributed to glistening formation. It was done at Alcon Laboratories. The reasons for this

Figure 9. Photographs of explanted

3-piece AcrySof IOL (case of Karl
Brasse, MD, Germany). A: Slitlamp
photograph of left eye taken 4 days
after implantation showing intra-
optical glistenings. B: Gross photo-
graph of the explant taken a few
hours after explantation. Large glis-
tening formations are visible, espe-
cially at the center of the optic. C
and D: Light photomicrographs of
the explanted (C) and control (D)
IOLs taken after removal from BSS
at 37 C (day 12). Both IOLs exhibit
isolated glistening formations
throughout the optic components.
Larger clusters of glistenings are
also observed within the optic of
the explanted IOL. (C and D: Origi-
nal magnification 200.)
unusual pattern in only 1 of the IOLs in the same lot, as no evidence of PCO. Glare/contrast sensitivity testing
well as those distributed globally, are unknown, and using the brightness acuity tester (BAT) with a modi-
to my knowledge, the case remains an exception. fied Pelli-Robinson chart was performed. The visual
In the laboratory at the John A. Moran Eye Center, acuity was 20/60 at 30% contrast through the BAT
University of Utah, an AcrySof IOL that was explanted on high setting. In the fellow eye, with 1C nuclear cat-
because of severe glistenings and negative dysphotop- aract, it was 20/50 at 60% contrast. The IOL was ex-
sia was examined. The IOL was a C21.0 diopter (D) planted on March 20, 2008, and exchanged with
SN60AT, explanted by Jack Singer, MD, in Randolph, a C24.0 D Staar AQ2003V (silicone IOL), implanted
Vermont, USA. The patient, a 60-year-old woman, pre- with the loops in the capsular bag and the optic cap-
sented to him on February 20, 2008, with a detailed tured anteriorly through the anterior capsulotomy.
written description of negative dysphotopsia and un- On March 31, 2008, the visual acuity was 20/25C2
wanted visual sensations in the left eye since cataract with 0.50, all symptoms had disappeared, the poste-
surgery that had been performed elsewhere in 2004. rior capsule remained clear and intact, and the result of
Her symptoms, which began immediately after sur- the glare/contrast sensitivity testing had changed to
gery, included blurred vision, a central blind spot 20/50 at 60% contrast. One month after Nd:YAG laser
with the inability to see the middle of individual posterior capsulotomy performed on May 06, 2009, for
words while reading, problems seeing at night, moderate PCO, visual acuity and glare/contrast sensi-
a dark temporal line, light flashes temporally, and tivity testing was 20/20 and 20/50 at 20% contrast,
‘‘bubble lights that pulsated.’’ The records indicated respectively.
uneventful surgery and cystoid macular edema diag- A search of adverse reports related to glistenings
nosed 3 weeks postoperatively, which was success- was performed on August 31, 2009, of the FDA web
fully treated with topical steroids and nonsteroidal siteI using the search term ‘‘intraocular lens glisten-
antiinflammatory drugs. On examination, the visual ings’’ and yielded 106 records between July 3, 1997,
acuity in the left eye was 20/30 1 with C1.50 C0.75 and June 4, 2009. The Manufacturer and User Facility
16 and J1 with C2.25. The IOL was in the appropri- Device Experience data represent reports of adverse
ate position; there were 4C glistenings (Figure 10), events involving medical devices. The data consist of
some in clusters, and an intact posterior capsule with all voluntary reports since June 1993, user facility

Figure 10. Photographs of explanted

1-piece AcrySof IOL (case of Jack
Singer, MD, Randolph, Vermont,
USA). A: Slitlamp photograph taken
4 years after implantation showing
intraoptical glistenings. B: Light
photomicrograph of the explanted
IOL taken after removal from BSS
at 37 C (day 10) showing glistenings
up to 10 mm in diameter (original
magnification 400).
reports since 1991, distributor reports since 1993, and authors did not observe this phenomenon with
manufacturer reports since August 1996. Twelve re- plasma-treated AcrySof IOLs. Cross-sectional image
ports were related to the SC60B-OUV (Medical Devel- by slit mode in Scheimpflug photography revealed
opmental Research) hydrophilic acrylic design. These that the surface scattering originated from the near
probably do not belong to the glistenings category, surface of the IOLs (anterior and posterior). The IOL
as research demonstrated that the optic opacity with surface scattering, quantified by area densitometry us-
these IOLs was generally related to the presence of ing Scheimpflug photography, estimated that the area
small calcified granules within the substance of the densitometry in those cases ranged from 46 to 79 CCT
IOL.49 All other reports were related to AcrySof versus a mean of 11.3 CCT for the plasma-treated
IOLs; 6 without specification of the model, 1 related IOLs.50,51 The phenomenon was clinically insignifi-
to the ReSTOR IOL (no model specification), 23 related cant, and the authors initially postulated that it was
to 3-piece models (12 MA60BM, 1 MA60BA, 2 originated by long-term phase separation water near
MA60AC, 1 MA30AC, and 7 MA30BA), and 64 related the IOL surface in a process similar to glistenings for-
to 1-piece models (18 SN60WF, 1 SN6AD3, 2 SA60D3, mation, although not seen as microvacuoles. Surface
8 SA60AT, 14 SN60D3, 20 SN60AT, and 1 SA30AL). In scattering was more significant with IOLs manufac-
most of the cases, the IOL was not explanted and the tured by cast molding than by lathe cutting,52 similar
reports described the presence of glistenings within to the observations regarding glistening formation
the IOL or noted glistenings in cases with decreased vi- with the 2 types of manufacturing processes.30
sual acuity or other symptoms leading to a decrease in In the 2004 study, Nishihara et al.52 reported that the
visual quality, but the relationship between the pres- source of light scattering was immediately below the
ence of glistenings and the symptoms was unclear. IOL optical surface. However, these authors later per-
Fourteen reports were related to IOL explantation; formed 2 in vitro studies using plasma-treated Acry-
one of them involved the IOL explanted by Singer Sof IOLs.53,54 In the first study, the IOLs were
and sent to the John A. Moran Eye Center (described explanted from cadaver eyes and analyzed for surface
above). Review of individual reports of the other 13 light scattering with the Nidek EAS-1000 anterior eye
cases showed that explantation was generally done be- segment analysis (Scheimpflug) system.53 Six of 10
cause of symptoms ultimately attributed to glistenings IOLs had surface light scattering clearly above base-
or ‘‘IOL opacity’’ by the surgeon, but details about line levels, which was reduced by 80% after surface
their influence on the visual function of the patients cleaning. In the second study, light scattering was
were not available. measured before and after immersion of unused
IOLs in distilled water in temperature conditions sim-
ulating up to 20 years of aging.54 There was no statis-
SURFACE LIGHT SCATTERING IN HYDROPHOBIC ACRYLIC tically significant difference between the baseline light
INTRAOCULAR LENSES scattering and light scattering at incubation times sim-
Yaguchi et al.50 describe prominent light scattering in ulating up to 20 years. Modulation transfer function
AcrySof IOLs when the angle of incident light under was also unchanged. The authors concluded that the
slitlamp evaluation was around 30 degrees. The phe- IOL light scattering was caused by a surface-bound
nomenon was described at the 10-year postoperative biofilm, which was removed by cleaning the IOLs in
examination of 5 eyes implanted with AcrySof IOLs the first study, and was not present in the second study
that were not plasma treated. (All currently available due to absence of biological material in the distilled
AcrySof IOLs are treated by plasma discharge.) The water.

More recently, Matsushima et al.55 investigated the through compression molding or lathe cutting and
light-scattering phenomenon (referred to as whitening found that the other IOLs showed little or no glisten-
by them) based on the analyses of 3 AcrySof IOLs ings. Wilkins and Olson5 performed a 4-year prospec-
explanted because of dislocation occurring at least tive study of 73 eyes of 51 patients implanted with
5 years postoperatively, which exhibited slight opaci- Surgidev B20/20 IOLs (injection-molded) with
fication of the optic surface. X-ray microanalyses ruled a mean follow-up of 98 G 27 months. They reported
out the presence of calcium/phosphate deposits on the that 89% of the eyes had glistenings, which increased
IOLs. Results from Fourier transform infrared spectro- in frequency and size with increasing follow-up. No
photometry demonstrated that organic deposits as glistenings were observed earlier than 3 years after
well as hydrolysis of the IOL material after long- surgery, and all IOLs with over 7 years of follow-up
term implantation were also not involved in the pro- showed changes. The glistenings first appeared in
cess. The opacification disappeared after the IOLs the superficial layer of the IOLs (posterior and anterior
were dried and reappeared over time when they equally) and then became diffuse through the optic.
were immersed again in physiologic saline. The No impact of the glistenings on the visual function of
authors therefore concluded that the phenomenon is the patients could be documented. Maki et al.4 evalu-
related to water aggregates of much smaller size ated 163 eyes of 127 patients implanted with PMMA
than glistenings distributed close to the IOL surfaces. IOLs and found glistenings in 15 eyes. Glistenings
Whether the surface light scattering originally de- were observed in IOLs manufactured by lathe cutting
scribed with non-plasma-treated AcrySof IOLs is a re- or injection molding, and some of the IOLs had an ul-
sult of phase separation water, surface deposition of traviolet (UV) filter. In this series, glistenings usually
a biofilm, or a mixture of both,50–55 there is confusion developed 6 years or more after surgery and all
in the literature about the use of Scheimpflug photog- affected eyes exhibited reduced contrast sensitivity
raphy to evaluate the phenomenon and differentiate it under conditions of glare.
from glistenings (see ‘‘Grading, Location, and Size’’). It is important to differentiate glistenings (Figure 11)
According to Ayaki et al.,19 the location and size of from lesions that can be observed in the condition that
the area where the measurement is taken can be cho- has been called ‘‘snowflake’’ degeneration.56,57 This is
sen by the operator. Therefore, if an area inside the a slowly progressive opacification of PMMA IOLs
IOL optic is chosen, the measured light scattering that sometimes occurs 10 or more years after implanta-
would suggest the density of glistenings, which would tion. Snowflake degeneration has been observed in
be different from measuring the surface light scatter- 3-piece PMMA IOLs implanted between the early 1980s
ing as described above (Figures 4 and 5). The study and the mid 1990s, which were generally manufactured
by Yoshida et al.44 clarifies this distinction. Twelve by injection molding. It has been hypothesized that this
eyes implanted with AcrySof IOLs were followed for degeneration is a result of long-term UV exposure. The
5 years. Light scattering within the optic and light scat- explanted IOLs had spherical lesions, which were inter-
tering on the surface were measured in CCT at differ- preted as foci of degenerated PMMA material clustered
ent intervals. There was a progressive increase in the in the central zone and midperipheral portion of the op-
internal light scattering (glistenings) over time up to tic. This led to the hypothesis that the central optic was
3 years. Regarding the IOL surface, after a decrease exposed to UV light over an extended period, whereas
in the light scattering values for 1 year, a progressive the peripheral optic may be protected by the iris. There-
increase was observed up to the end of the 5-year fore, snowflake lesions are generally not observed in the
follow-up, with values above those at 1 month postop- optic periphery, they generally involve the anterior
eratively (31.0 G 10.6 and 42.8 G 21.6 CCT at 1 month one-third of the optic substance, and they do not disap-
and 5 years, respectively). However, as mentioned pear when the IOL is in the dry state. Although the
earlier, in a recently published letter, Mackool and snowflake lesions are dry, it has been observed that
Colin21 state that they believe there is no demonstra- an unusual amount of water is collected in the affected
tion of the ability of the Scheimpflug technique to dis- optic area upon hydration of explanted PMMA IOLs
tinguish between glistening formation and surface with this condition, leading to more significant optic
light scattering. opacification (Figure 12).57 Therefore, the clinical signif-
icance of snowflake degeneration may depend on the
GLISTENINGS IN POLY(METHYL METHACRYLATE) amount of water collected in the IOL optic.
INTRAOCULAR LENSES
In a 1984 letter, Ballin3 reported the observation of glis-
tenings in an injection-molded Leiske PMMA IOL GLISTENINGS IN SILICONE INTRAOCULAR LENSES
manufactured by Surgidev. He compared this appear- Miyata et al.15 investigated glistening formation in sil-
ance with that of other Leiske IOLs manufactured icone IOLs in an in vitro setting. SI40NB (Allergan,

and 20 in the CeeOn Edge group had a thorough ex-

amination. The AcrySof IOLs had a significantly high-
er mean vacuolar density, but this was not clinically
significant.
The study of glistenings in 7 types of foldable IOLs
for 720 days by Tognetto et al.2 included 39 eyes im-
planted with the CeeOn Edge 911A IOL and 45 eyes
implanted with the SI40NB (Figure 13). Nine percent
of the eyes with the CeeOn Edge IOL had glistenings
7 days after surgery. This rate increased to 50% up to
90 days postoperatively, remaining stable after that.
The mean grade of glistenings continuously increased
over time. Forty-seven percent of the eyes with the
SI40NB IOL had glistenings 7 days after surgery.
This rate increased to 50% up to 30 days postopera-
tively, remaining stable after that. The mean grade of
glistenings increased up to 30 days after surgery and
remained stable after that at a lower level than in the
CeeOn Edge IOL.
Glistenings were also observed in silicone iris-
fixated phakic IOLs.14 Twenty eyes of 13 patients
implanted with the Artiflex IOL (Ophtec) were pro-
spectively evaluated. Four IOLs developed glistenings
ranging from grade 1C to 4C under slitlamp evalua-
tion between 6 days and 6 months of surgery. The glis-
tenings did not increase over time and were not
clinically significant.
Excessive water influx within the optic of silicone
IOLs leading to opacification/discoloration has been
reported. In those cases, the condition was seen as a ho-
Figure 11. Slitlamp photographs of 3-piece PMMA IOL explanted mogeneous and generalized optic haze. We reported
because of decentration (Above), which exhibited glistenings (Below).
significant opacification observed as early as a few
(Photographs provided by Angelo Passos, MD, Brazil.)
hours after implantation because cleaning agents and
fumigants used in storage areas apparently penetrated
Inc.) and AQ110NV IOLs (Canon Staar) were im- the semipermeable packages contaminating the sili-
mersed in physiological saline at 50 C for 2 hours cone IOLs preoperatively, causing changes that lead
and then immersed in physiological saline at 35 C to influx of water and therefore opacification of the
for 90 days. Slitlamp inspection of the SI40NB IOLs re- IOL optic (Figure 14).59,60 Other studies have de-
vealed the presence of a ‘‘granular’’ opacity. Its inten- scribed similar cases but without a clear history of pre-
sity decreased over time, but a mild degree of opacity operative contamination of the IOLs by exogenous
remained up to 90 days. Inspection of the same IOLs molecules.61,62
under a light microscope revealed the presence of mi- Brown discoloration and central haze in silicone
crovacuoles smaller than 5 mm in diameter. A slight IOLs observed from 15 to 60 months after implanta-
optic opacity was noted in the AQ110NV IOLs, with tion were described in the early 1990s.63–68 This
the aspect of a brown discoloration under slitlamp in- complication was generally considered clinically
spection. The degree of opacity decreased over time, insignificant; IOL explantation was rarely performed.
but the opacity could be seen up to 90 days. With The reports suggested that the brown haze was due
both IOL types, the optic changes disappeared when to light scattering from water vapor that may diffuse
the IOLs were removed from the solution and allowed into the silicone when immersed in an aqueous me-
to dry. dium. This might have been caused by some anomaly
Glistenings were also observed in the silicone of the curing process during the manufacture of those
CeeOn Edge 911A IOL (Pharmacia) in a clinical study IOLs or by incomplete extraction of large polymers.
comparing 25 eyes implanted with this IOL and 25 Additional filtration steps in the manufacturing pro-
eyes implanted with a 3-piece AcrySof IOL.58 At the cess of silicone IOLs seemed to solve the problem.
3-year follow-up visit, 21 patients in the AcrySof group More recently, we reported 12 cases of late

Figure 12. Photographs of a 3-piece

PMMA IOL explanted because of
snowflake degeneration (case of
Fernando Trindade, MD, Brazil). A:
Slitlamp photograph taken approxi-
mately 20 years after implantation
showing multiple intraoptical le-
sions. B and C: Gross photographs
of the explant taken a few minutes
after explantation (B) and after
complete dehydration of the IOL
(C). D: High-magnification photomi-
crograph (original magnification
200) of the explanted IOL showing
individual intraoptical snowflake
lesions, which are significantly
larger than glistenings (approxi-
mately 100 mm in diameter) and do
not disappear in the dry state.
postoperative (4 weeks to 2 years) opacification of sil- and 34 eyes implanted with the Stabibag IOL (IOL-
icone IOLs.J The degree of optic opacification was not tech). Twenty-five percent of eyes with the ACR6D
as marked as the opacification related to the IOLs with IOL had glistenings 7 days after surgery; this rate in-
an earlier onset (Figure 15). creased to 45% by 180 days and remained stable after
that. Twenty-three percent of eyes with the Hydro-
GLISTENINGS IN HYDROPHILIC ACRYLIC INTRAOCULAR view IOL had glistenings at 7 days, with an increase
LENSES to 43% up to 90 days. Twenty-five percent of eyes
with the Stabibag IOL had glistenings at 7 days, with
The study of 7 types of foldable IOLs by Tognetto
an increase to 44% up to 30 days. The mean grade of
et al.2 included 36 eyes implanted with the ACR6D
glistenings with these 3 IOL designs increased up to
IOL (Corneal Laboratories; Figure 16), 36 eyes im-
90 days postoperatively and remained stable
planted with the Hydroview IOL (Bausch & Lomb),
thereafter.
Glistenings in hydrophilic acrylic IOLs should not
be confounded with granular structures that can be
observed on the surface or within the substance of
the IOLs in cases of postoperative calcification
(Figure 17).69–71 This complication has been exten-
sively reported since 1999. The 4 major designs manu-
factured in the U.S. involved in the problem were the
Hydroview, the MemoryLens (Ciba Vision), the
SC60B-OUV (Medical Developmental Research, Inc.),
and the Aqua-Sense (Ophthalmic Innovations Interna-
tional, Inc.). The deposits causing the opacification
were found primarily on the optic surfaces of the Hy-
droview and the MemoryLens, whereas they were
found predominantly within the substance of the
Figure 13. Slitlamp photograph of a 3-piece silicone IOL (SI40NB) SC60B-OUV and the Aqua-Sense. Surface deposits
showing intraoptical glistenings. (Photograph provided by Daniele were also significantly observed with the latter design.
Tognetto, MD, Italy.) Histochemical methods as well as surface analyses

Figure 14. Photographs of a 3-piece

silicone IOL explanted because of
early optic opacification (case of
Christiana Hilgert, MD, Brazil). A:
Slitlamp photograph taken 2 days
after implantation showing homo-
geneous white opacification of the
IOL optic. B and C: Gross photo-
graphs of the explant taken in the
hydrated (B) and dehydrated (C)
states. D: High-magnification pho-
tomicrograph (original magnifica-
tion 100) of the explanted IOL
showing a yellow optic discolor-
ation corresponding to the clinical
white optic opacity. As the IOL be-
gan to dry under the light micro-
scope, the optic periphery started
to clear.
demonstrated the composition of the deposits to be at formation with other hydrophobic acrylic IOLs is rela-
least partly of calcium and phosphate. The deposits tively scarce. There are differences in wettability or
cannot be removed with Nd:YAG laser applications, water content of different hydrophobic acrylic IOLs
they do not disappear when the IOL is in the dry state, as a function of temperature changes, which may ac-
and explantation is usually necessary as calcification count for different tendencies for glistening formation
adversely affected visual function. among these IOLs, in addition to possible influences of
the manufacturing technique. Intraocular lens manu-
facturers have made efforts to improve manufacturing
CONCLUSIONS methods, carrying out the polymerization process as
Glistenings can be observed with any type of IOL, but uniformly as possible to obtain polymer structures
most of the currently available literature describes with minimal voids.
them in relation to hydrophobic acrylic IOLs, espe- Although it is difficult to compare clinical studies
cially the AcrySof IOL. This was the first commercially because of differences in patient population and grad-
available foldable hydrophobic acrylic IOL and more ing systems, among others, most studies show an in-
than 40 million have been implanted since the intro- crease in the incidence and/or severity of glistenings
duction in 1995.K Literature regarding glistenings up to approximately 3 years postoperatively. One
Figure 15. Slitlamp photographs of

bilaterally implanted silicone
IOLs. The optic of the IOL in the
left eye (913) exhibits a mild degree
of optic opacification, which was
noted approximately 7 months af-
ter implantation. The IOL in the
right eye (SI40NB) is not opacified
and is shown for comparison. (Pho-
tographs provided by Arthur
Weinstein, MD, Albuquerque,
New Mexico, USA.)

studies are necessary to confirm this hypothesis. In

terms of clinical impact, most clinical studies show
no influence on visual acuity; there are a few reports
of a possible influence on contrast sensitivity under
specific test conditions. Review of the available litera-
ture and database mechanisms, such as FDA report-
ing, reveal that explantation due to glistenings has
rarely been reported, although under-reporting of
such cases remains a possibility. However, in most of
these cases, it has also been challenging to establish
a direct relationship between the degree of glistenings
and the patient symptoms leading to explantation.
The phenomenon of surface light scattering (known
Figure 16. Slitlamp photograph of a 1-piece hydrophilic acrylic IOL
(ACR60D) showing intraoptical glistenings. (Photograph provided
as whitening in Japan) has also been described in asso-
by Daniele Tognetto, MD, Italy.) ciation with hydrophobic acrylic IOLs. It has been re-
garded as reflected white light from the IOL surface
(both anterior and posterior surfaces) and, thus far,
study following 12 eyes implanted with AcrySof IOLs with no apparent clinical significance. The mechanism
for 5 years showed stabilization of the degree of glis- of formation is controversial, but it may originate from
tenings between 3 years and 5 years, as indicated by long-term phase separation water near the IOL surface
light scattering within the IOL optic using Scheimp- in a process similar to glistenings formation, although
flug photography. It is therefore reasonable to hypoth- not seen as microvacuoles. It should be noted that
esize that the incidence and degree of glistenings may currently available clinical studies of glistenings and
increase until the IOL is completely hydrated and all surface light scattering are generally based on monofo-
available voids within the polymer network are visible cal spherical IOLs. Further studies are necessary to as-
as glistenings, under the influence of temperature fluc- sess their clinical significance in IOLs with advanced
tuations. Further long-term, prospective clinical optics, including multifocal, toric, and aspheric IOLs.
Figure 17. Photographs of hydrophilic acrylic IOLs explanted because of postoperative calcification. A to C: Slitlamp, gross, and light micro-
scopic photographs of calcified MemoryLens IOLs. The optic opacification is caused by the presence of fine granules composed of calcium/phos-
phate, located primarily on the optic surfaces. D to F: Sitlamp, gross, and light microscopic photographs of calcified SC60B-OUV IOLs. The
IOL opacification is caused by the presence of fine granules composed of calcium/phosphate, mostly located within the IOL substance.
(A and D: Clinical photographs provided by Thomas Neuhann, MD, Germany, and Mahmut Kaskaloglu, MD, Turkey. C and F: Original
magnification 100.)

REFERENCES 21. Mackool RJ, Colin J. Limitations of Scheimpflug photography in

quantifying glistenings [letter]. J Cataract Refract Surg 2009;
1. Miyata A. [Water accumulation in polymers]. [Japanese]
35:1480–1481
IOL&RS 2007; 21:59–62
22. Miura M, Osako M, Elsner AE, Kajizuka H, Yamada K, Usui M.
2. Tognetto D, Toto L, Sanguinetti G, Ravalico G. Glistenings in
Birefringence of intraocular lenses. J Cataract Refract Surg
foldable intraocular lenses. J Cataract Refract Surg 2002;
2004; 30:1549–1555
28:1211–1216
23. Mitooka K, Tsuneoka H. [Glistening – changes that occur to the
3. Ballin N. Glistenings in injection-molded lens [letter]. Am Intra-
intraocular lens]. [Japanese]. In: Maruo T, Honda Y, Usui M
Ocular Implant Soc J 1984; 10:473
Tano Y, eds, [Practical Ophthalmology] [Japanese]. Tokyo,
4. Maki T, Izumi S, Ayaki M, Koide R. Glistenings in PMMA intraoc-
Japan, Bunkodo Publishers, 1999; 66–67
ular lenses. Showa Univ J Med Sci 2004; 16:75–82
24. Obara Y, Nishi O, Matsushima H. [Glistening]. [Japanese]. In:
5. Wilkins E, Olson RJ. Glistenings with long-term follow-up of the
Gannairenzu wo kagakusuru (Sci Intraocular Lens). Tokyo,
Surgidev B20/20 polymethylmethacrylate intraocular lens. Am J
Japan, Medical Aoi Publication, 2006; 59–60
Ophthalmol 2001; 132:783–785
25. Kato K, Nishida M, Yamane H, Nakamae K, Tagami Y,
6. Miyata A, Suzuki K, Boku C, Kinohira Y, Aramaki T, Ando M,
Tetsumoto K. Glistening formation in an AcrySof lens initiated
Suzuki Y, Kizaki H, Yaguchi S. [Glistening particles on the im-
by spinodal decomposition of the polymer network by tempera-
planted acrylic intraocular lens]. [Japanese] Rinsho Ganka
ture change. J Cataract Refract Surg 2001; 27:1493–1498
1997; 51:729–732
26. Matsui E, Matsushima H, Senoo T, Takahashi K, Mukai K,
7. Miyata A, Uchida N, Nakajima K, Yaguchi S. [Clinical and ex-
Aose M, Obara Y, Yoshida S, Yoshida T. [Generation of glisten-
perimental observation of glistening in acrylic intraocular
ing particles in the intraocular lens]. [Japanese] Rinsho Ganka
lenses]. [Japanese] Nippon Ganka Gakkai Zasshi 2000; 104:
2006; 60:201–204
349–353
27. Shiba T, Mitooka K, Tsuneoka H. [In vitro analysis of AcrySof in-
8. Dhaliwal DK, Mamalis N, Olson RJ, Crandall AS, Zimmerman P,
traocular lens glistening]. [Japanese] IOL&RS 2000; 14:41–44
Alldredge OC, Durcan FJ, Omar O. Visual significance of glisten-
28. Shiba T, Mitooka K, Tsuneoka H. In vitro analysis of AcrySof in-
ings seen in the AcrySof intraocular lens. J Cataract Refract Surg
traocular lens glistening. Eur J Ophthalmol 2003; 13:759–763
1996; 22:452–457
29. Saylor DM, Richardson DC, Dair BJ, Pollack SK. Osmotic cavi-
9. Peetermans E, Hennekes R. Long-term results of Wagon Wheel
tation of elastomeric intraocular lenses. Acta Biomater 2010;
packed acrylic intra-ocular lenses (AcrySofÒ). Bull Soc Belge
6:1090–1098
Ophtalmol 1999; 271:45–48
30. Nishihara H, Kageyama T, Ohnishi T, Koike M, Imai M,
10. Christiansen G, Durcan FJ, Olson RJ, Christiansen K. Glisten-
Shibuya A, Yaguchi S. [Glistenings in lathe-cut acrylic intraocu-
ings in the AcrySof intraocular lens: pilot study. J Cataract
lar lens]. [Japanese] Ganka Shujutsu 2000; 13:227–230
Refract Surg 2001; 27:728–733
31. Omar O, Pirayesh A, Mamalis N, Olson RJ. In vitro analysis of
11. Davison JA. Clinical performance of Alcon SA30AL and SA60AT
AcrySof intraocular lens glistenings in AcryPak and Wagon
single-piece acrylic intraocular lenses. J Cataract Refract Surg
Wheel packaging. J Cataract Refract Surg 1998; 24:107–113
2002; 28:1112–1123
32. Dick HB, Olson RJ, Augustin AJ, Schwenn O, Magdowski G,
12. Waite A, Faulkner N, Olson RJ. Glistenings in the single-piece,
Pfeiffer N. Vacuoles in the AcrySofä intraocular lens as factor
hydrophobic, acrylic intraocular lenses. Am J Ophthalmol
of the presence of serum in aqueous humor. Ophthalmic Res
2007; 144:143–144
2001; 33:61–67
13. Gunenc U, Oner FH, Tongal S, Ferliel M. Effects on visual
33. Moreno-Montañés J, Alvarez A, Rodrı́guez-Conde R, Fernán-
function of glistenings and folding marks in AcrySof intra-
dez-Hortelano A. Clinical factors related to the frequency and in-
ocular lenses. J Cataract Refract Surg 2001; 27:1611–
tensity of glistenings in AcrySof intraocular lenses. J Cataract
1614
Refract Surg 2003; 29:1980–1984
14. Cisneros-Lanuza A, Hurtado-Sarrió M, Duch-Samper A, Galle-
34. Ayaki M, Nishihara H, Yaguchi S, Koide R. Effect of ophthalmic
go-Pinazo R, Menezo-Rozalén JL. Glistenings in the Artiflex
solution components on acrylic intraocular lenses. J Cataract
phakic intraocular lens. J Cataract Refract Surg 2007;
Refract Surg 2007; 33:122–126
33:1405–1408
35. Colin J, Orignac I, Touboul D. Glistenings in a large series of hy-
15. Miyata A, Uchida N, Nakajima K, Yaguchi S. [Experimental
drophobic acrylic intraocular lenses. J Cataract Refract Surg
study of glistening in silicone intraocular lenses]. [Japanese]
2009; 35:2121–2126
Nippon Ganka Gakkai Zasshi 2002; 106:112–114
36. Miyake K, Ota I, Maekubo K, Ichihashi S, Miyake S. Latanoprost
16. Miyata A. [Glistening in new acrylic lenses]. [Japanese] IOL&RS
accelerates disruption of the blood-aqueous barrier and the inci-
2002; 16:82–84
dence of angiographic cystoid macular edema in early postoper-
17. Miyata A, Yaguchi S. Equilibrium water content and glistenings
ative pseudophakia. Arch Ophthalmol 1999; 117:34–40.
in acrylic intraocular lenses. J Cataract Refract Surg 2004;
Available at: http://archopht.ama-assn.org/cgi/reprint/117/1/34.
30:1768–1772
Accessed May 15, 2010
18. Klos KM, Richter R, Schnaudigel OE, Ohrloff C. Image analysis
37. Cunanan CM, Ghazizadeh M, Buchen SY, Knight PM. Contact-
of implanted rigid and foldable intraocular lenses in human eyes
angle analysis of intraocular lenses. J Cataract Refract Surg
using Scheimpflug photography. Ophthalmic Res 1999; 31:130–
1998; 24:341–351
133
38. Yamamura T, Kazama S, Sasaki M, Shinzato E, Shima C. [Glis-
19. Ayaki M, Nishihara H, Yaguchi S, Koide R. Surfactant induced
tening, surface irregularity, tilting and decentration of acrylic in-
glistenings: Surface active ingredients in ophthalmic solutions
traocular lenses]. [Japanese] IOL&RS 2004; 18:157–162
may enhance water entry into the voids of implanted acrylic in-
39. Oshika T, Shiokawa Y, Amano S, Mitomo K. Influence of glisten-
traocular lenses. J Long Term Eff Med Implants 2006; 16:451–
ings on the optical quality of acrylic foldable intraocular lens. Br J
457
Ophthalmol 2001; 85:1034–1037. Available at: http://www.ncbi.
20. Behndig A, Mönestam E. Quantification of glistenings in intraoc-
nlm.nih.gov/pmc/articles/PMC1724105/pdf/v085p01034.pdf.
ular lenses using Scheimpflug photography. J Cataract Refract
Accessed May 15, 2010
Surg 2009; 35:14–17

40. Gregori NZ, Spencer TS, Mamalis N, Olson RJ. In vitro compar- chamber intraocular lens optic material; a newly described clin-
ison of glistening formation among hydrophobic acrylic intraocu- ical condition caused by unexpected late opacification of poly-
lar lenses. J Cataract Refract Surg 2002; 28:1262–1268 methyl methacrylate. Ophthalmology 2002; 109:1666–1675
41. Dogru M, Tetsumoto K, Tagami Y, Kato K, Nakamae K. Optical 57. Dahle N, Werner L, Fry L, Mamalis N. Localized, central optic
and atomic force microscopy of an explanted AcrySof intraocu- snowflake degeneration of a polymethyl methacrylate intraocu-
lar lens with glistenings. J Cataract Refract Surg 2000; 26: lar lens: clinical report with pathological correlation. Arch Oph-
571–575 thalmol 2006; 124:1350–1353
42. Shiokawa Y, Oshika T. [Effect of glistenings on the optical quality 58. Schauersberger J, Amon M, Kruger A, Abela C, Schild G,
of soft acrylic intraocular lens]. [Japanese] Shikaku no Kagaku Kolodjaschna J. Comparison of the biocompatibility of 2 foldable
2000; 21:18–24 intraocular lenses with sharp optic edges. J Cataract Refract
43. Minami H, Torii K, Hiroi K, Kazama S. [Glistening of the acrylic Surg 2001; 27:1579–1585
intraocular lenses]. [Japanese] Rinsho Ganka 1999; 53: 59. Hilgert CR, Hilgert A, Höfling-Lima AL, Farah ME, Werner L.
991–994 Early opacification of SI-40NB silicone intraocular lenses.
44. Yoshida S, Fujikake F, Matsushima H, Obara Y, Rin S. J Cataract Refract Surg 2004; 30:2225–2229
[Induction of glistening and visual function of eyes with acrylic 60. Werner L, Dornelles F, Hilgert CR, Botelho F, Conte PF,
intraocular lenses inserted]. [Japanese] IOL&RS 2000; 14: Rozot P, Andrenyak DM, Mamalis N, Olson RJ. Early opacifica-
289–292 tion of silicone intraocular lenses: laboratory analyses of six ex-
45. Allers A, Baumeister M, Steinkamp GWK, Ohrloff C, Kohnen T. plants. J Cataract Refract Surg 2006; 32:499–509
Intraindividueller Vergleich von Intraokularlinsen aus hochre- 61. Tanaka T, Saika S, Hashizume N, Ohnishi Y. Brown haze in an
fraktivem Silikon (Allergan SI40NB) und hydrophobem Acrylat Allergan SI-40NB silicone intraocular lens. J Cataract Refract
(Alcon Acrysof MA60BM); 1-Jahresergebnisse [Intraindividual Surg 2004; 30:250–252
comparison of intraocular lenses made of highly refractive sili- 62. Elgohary M, Zaheer A, Werner L, Ionides A, Sheldrick J,
cone (Allergan SI40NB) and hydrophobic acrylate (Alcon Acry- Ahmed N. Opacification of Array SA40N silicone multifocal intra-
Sof MA60BM); 1-year results]. Ophthalmologe 2000; 97: ocular lens. J Cataract Refract Surg 2007; 33:342–347
669–675 63. Milauskas AT. Silicone intraocular lens implant discoloration in
46. Mori H. [Long-term course of glistening developed in soft acrylic humans [letter]. Arch Ophthalmol 1991; 109:913
single-piece intraocular lenses]. [Japanese] IOL&RS 2009; 64. Kershner RM. In reply to Milauskas AT. Silicone intraocular lens
23:210–213 implant discoloration in humans [letter]. Arch Ophthalmol 1991;
47. Mitooka K, Shiba T, Tsuneoka H, Kitahara K. [A case of IOL eye 109:913–914
with decrease of visual function by glistening]. [Japanese] Gan- 65. Ziemba SL. In reply to Milauskas AT. Silicone intraocular lens
ka 1998; 40:1501–1504 implant discoloration in humans [letter]. Arch Ophthalmol
48. Werner L, Storsberg J, Mauger O, Brasse K, Gerl R, Müller M, 1991; 109:914–915
Tetz M. Unusual pattern of glistening formation on a 3-piece hy- 66. Watt RH. Discoloration of a silicone intraocular lens 6 weeks
drophobic acrylic intraocular lens. J Cataract Refract Surg 2008; after surgery [letter]. Arch Ophthalmol 1991; 109:1494
34:1604–1609 67. Milauskas AT. In reply to Watt RH. Discoloration of a silicone in-
49. Werner L. Causes of intraocular lens opacification or discolor- traocular lens 6 weeks after surgery [letter]. Arch Ophthalmol
ation. J Cataract Refract Surg 2007; 33:713–726 1991; 109:1495
50. Yaguchi S, Chida M, Nishihara H, Ohnishi T, Ayaki M. [Light 68. Koch DD, Heit LE. Discoloration of silicone intraocular lenses
scattering observed on the surface of acrylic intraocular lenses [letter]. Arch Ophthalmol 1992; 110:319–320
ten years after implantation]. [Japanese] Nippon Ganka Gakkai 69. Werner L, Apple DJ, Escobar-Gomez M, Öhrström A,
Zasshi 2002; 106:109–111 Crayford BB, Bianchi R, Pandey SK. Postoperative deposition
51. Nishihara H, Yaguchi S, Onishi T, Chida M, Ayaki M. Surface of calcium on the surfaces of a hydrogel intraocular lens. Oph-
scattering in implanted hydrophobic intraocular lenses. thalmology 2000; 107:2179–2185
J Cataract Refract Surg 2003; 29:1385–1388 70. Werner L, Apple DJ, Kaskaloglu M, Pandey SK. Dense opacifi-
52. Nishihara H, Ayaki M, Watanabe T, Ohnishi T, Kageyama T, cation of the optical component of a hydrophilic acrylic intraocu-
Yaguchi S. [Comparison of surface light scattering of acrylic in- lar lens; a clinicopathological analysis of 9 explanted lenses.
traocular lenses made by lathe-cutting and cast molding J Cataract Refract Surg 2001; 27:1485–1492
methods –long-term observation and experimental study–]. 71. Werner L, Hunter B, Stevens S, Chew JJL, Mamalis N. Role of
[Japanese] Nippon Ganka Gakkai Zasshi 2004; 108: silicon contamination on calcification of hydrophilic acrylic intra-
157–161 ocular lenses. Am J Ophthalmol 2006; 141:35–43
53. Yaguchi S, Nishihara H, Kambhiranond W, Stanley D, Apple DJ.
Light scatter on the surface of AcrySofÒ intraocular lenses: part
I. Analysis of lenses retrieved from pseudophakic postmortem OTHER CITED MATERIAL
human eyes. Ophthalmic Surg Lasers Imaging 2008; 39: A. Tom McNicholas, Senior Director, Research & Development,
209–213 Hoya Surgical Optics. E-mail communication on November 9,
54. Yaguchi S, Nishihara H, Kambhiranond W, Stanley D, Apple DJ. 2009
Light scatter on the surface of AcrySofÒ intraocular lenses: part B. Amzallag T, ‘‘One-Year European Results for the EC-3 Hydropho-
II. Analysis of lenses following hydrolytic stability testing. bic Clinical Trial: Material Clarity and Visual Outcomes,’’ paper
Ophthalmic Surg Lasers Imaging 2008; 39:214–216 presented at the ASCRS Symposium on Cataract, IOL and
55. Matsushima H, Mukai K, Nagata M, Gotoh N, Matsui E, Senoo T. Refractive Surgery, San Francisco, California, USA, April 2009
Analysis of surface whitening of extracted hydrophobic acrylic C. Bosc J-M, Werner L, Mamalis N, ‘‘Initial Impressions and Early
intraocular lenses. J Cataract Refract Surg 2009; 35:1927–1934 Clinical Results of a New Single-Piece Hydrophobic Yellow
56. Apple DJ, Peng Q, Arthur SN, Werner L, Merritt JH, Vargas LG, Acrylic IOL,’’ paper presented at the ASCRS Symposium on
Hoddinott DSM, Escobar-Gomez M, Schmidbauer JM. Snow- Cataract, IOL and Refractive Surgery, San Francisco, Califor-
flake degeneration of polymethyl methacrylate posterior nia, USA, April 2009

D. Tetz MR, Werner L, Schwahn-Bendig S, Batlle JF, ‘‘Prospective I. U.S. Food and Drug Administration. Maude - Manufacturer and
Clinical Study to Quantify Glistenings in New Hydrophobic User Facility Device Experience. Available at: http://www.
Acrylic IOL,’’ paper presented at the ASCRS Symposium on accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
Cataract, IOL and Refractive Surgery, San Francisco, Califor- Accessed May 27, 2010 (Go to Simple Search)
nia, USA, April 2009 J. Werner L, Mamalis N, Olson RJ. ‘‘Postoperative Optic Opacifica-
E. Mentak K, El Achchabi A, Goldberg E, ‘‘Hydrophobic Character tion of Silicone IOLs: Analyses of 20 Explants,’’ paper presented
and Aqueous Wettability of Hydrophobic Acrylic IOLs,’’ paper at the annual meeting of the American Academy of Ophthalmol-
presented at the XXVI Congress of the European Society of Cat- ogy. New Orleans, Louisiana, USA, November 2007
aract and Refractive Surgery, Berlin, Germany, September 2008 K. Diane Houtman, Od, MBA, Associate Director, Surgical IOL,
F. van der Mooren M, Coppens J, Piers P, van den Berg T, ‘‘Pro- Clinical Science, Alcon Laboratories. E-mail communication on
posal for in Vivo Testing Based on Light Scatter Characteristics November 25, 2009
of Acrylic Intraocular Lenses in Vitro,’’ paper presented at the
XXVI Congress of the European Society of Cataract and Refrac-
tive Surgeons, Berlin, Germany, September 2008
G. van der Mooren M, Coppens J, Bandhauer M, Piers P, van den First author:
Berg T, ‘‘In Vitro Light Scatter in Acrylic Intraocular Lenses,’’ pa- Liliana Werner, MD, PhD
per presented at the XXV Congress of the European Society of
Cataract and Refractive Surgeons, Stockholm, Sweden, Sep- John A. Moran Eye Center, University
tember 2007 of Utah, Salt Lake City, Utah, USA, and
H. Fry LL, Fry EL, ‘‘Glistenings in Hydrophobic Acrylic IOLs,’’ paper Berlin Eye Research Institute, Berlin,
presented at the ASCRS Symposium on Cataract, IOL and Re- Germany
fractive Surgery, Boston, Massachusetts, USA, April 2010

Werner 2010

Uploaded by

Copyright:

Available Formats

Werner 2010

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Werner 2010

Uploaded by

Copyright:

Available Formats

REVIEW/UPDATE

Glistenings and surface light scattering

1398 Q 2010 ASCRS and ESCRS 0886-3350/$dsee front matter

semiquantitative slitlamp grading of glistening den-

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 2. Slitlamp photographs of eyes implanted with hy-

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 3. Slitlamp photographs of

MECHANISM OF FORMATION have different components, including different mono-

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 5. Scheimpflug photographs

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

propose an analytical method to predict the propen-

FACTORS INFLUENCING GLISTENING FORMATION

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Table 1. Characteristics of currently available hydrophobic acrylic IOLs.

IOL/Manufacturer Material Composition (All With UV filters) Refractive Index

3-piece and 1-piece Copolymer of phenylethyl acrylate and phenylethyl 1.555

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

!0.5% 72 Dry Direct lens molding technology Yes

!0.5 88 Dry Precision cryolathing technology Yes

!0.3 85 Dry Lathe cut Yes

˜4.0 76 Prehydrated in Lathe cut at room temperature Yes

!0.5 Not provided Dry Lathe cut No

!0.3 Not provided Dry Cryolathing No (currently completing

!0.5 75o Dry Cast molding No

!0.5 81.7 Dry Molding No

!0.5 72 Dry Cast molding No

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

80 to that present in a 70-year-old crystalline lens.F,G

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 9. Photographs of explanted

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 10. Photographs of explanted

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

and 20 in the CeeOn Edge group had a thorough ex-

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 12. Photographs of a 3-piece

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

Figure 14. Photographs of a 3-piece

Figure 15. Slitlamp photographs of

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

studies are necessary to confirm this hypothesis. In

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

REFERENCES 21. Mackool RJ, Colin J. Limitations of Scheimpflug photography in

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

J CATARACT REFRACT SURG - VOL 36, AUGUST 2010

You might also like

!0.5% 72 Dry Direct lens molding technology Yes

!0.5 88 Dry Precision cryolathing technology Yes

!0.3 85 Dry Lathe cut Yes

˜4.0 76 Prehydrated in Lathe cut at room temperature Yes

!0.5 81.7 Dry Molding No

!0.5 72 Dry Cast molding No