Glistenings in Alcon Acrysof

Intraocular Lenses

GEORGE H.H. BEIKO, B.M.,B.Ch.,FRCSC

ST. CATHARINES, CANADA
ASSIST PROF, MCMASTER UNIV
LECTURER, UNIV OF TORONTO
george.beiko@sympatico.ca

GRADE 3+
5500 10m

DJ Apple AAO 2008

ASCRS sent out alert on

glisteningson March 16,
1995.

DJ Apple AAO 2008

DJ Apple AAO 2008

DJ Apple AAO 2008

Factors Influencing
Glistenings

Tognetto D, et al. Glistenings in foldable intraocular lenses. J Cataract Refract Surg 2002; 28:12111216

Glistenings Formation in
Hydrophobic Acrylic*
Non-homogenous polymerization of optic material allows gaps to form; water
vapour collects in these gaps; temperature changes allow water droplets to
form
Light is refracted and scattered at the waterpolymer interfaces, leading to a
sparkling appearance of the fluid-filled vacuoles (thus, the term glistenings).
The size of individual glistenings range from 1 to 20 mm
Manufacture by molding results in greater number of gaps than lathe cutting
The combination of injection molding and temperature sensitivity leads to
significantly more glistening formation with AcrySof IOLs
Nishihara H, et al. [Glistenings in lathe-cut acrylic intraocular lens]. [Japanese] Ganka Shujutsu 2000; 13:227230
Miyata, et al. Equilibrium water content and glistenings in acrylic intraocular lenses. J Cataract Refract Surg 2004; 30:17681772
Werner L. Glistenings and surface light scattering in intraocular lenses. J Cat Refract Surg. 2010 36: 1398-1420.

Glistenings Formation in
Hydrophobic Acrylic*

that glistenings (referred to as cavitation) are the result of relatively

slow-moving hydrophilic impurities represented by oligomeric
species that contain some fraction of hydrophilic monomers, are
generated during polymerization. They would preferentially segregate
out of the matrix material into polymer voids (cavities), giving rise to
an osmotic pressure difference between the cavity and the external
media in which the IOL is immersed.

the influx of water into the cavity deforms the surrounding polymer until the
stress reaches a critical value when permanent deformation occurs (ie,
cracking or tearing) and the cavity grows. This process would continue until
equilibrium is achieved.

Saylor DM, et al. Osmotic cavitation of elastomeric intraocular lenses. Acta Biomater 2010; 6:10901098

Factors Influencing
Glistenings

Mean density score of glistenings is higher if lenses are incubated in aqueous humour with
serum at body temperature
Diabetes:
Occurrence of glistenings was 46.5% among nondiabetic patients but 75.5%
among diabetic patients. If considering cases with grade 3C of the Miyata scoring system,
5.5% of the patients were not diabetic and 20.5% were diabetic.
Glaucoma: Statistically significant association between the incidence and severity of
glistenings and glaucoma. Authors unsure if effect was due to glaucoma or antiglaucoma
medications
Depression: Glistenings were associated with depression.

Mitooka K, Tsuneoka H. [Glistening changes that occur to the intraocular lens]. [Japanese]. In: Maruo T, Honda Y, Usui M Tano Y,
eds, [Practical Ophthalmology] [Japanese]. Tokyo, Japan, Bunkodo Publishers, 1999; 6667.
Dick HB, et al. Vacuoles in the AcrySof intraocular lens as factor of the presence of serum in aqueous humor. Ophthalmic Res2001;
33:6167
Moreno-Montanes J, et al. Clinical factors related to the frequency and intensity of glistenings in AcrySof intraocular lenses. J
CataractRefract Surg 2003; 29:19801984
Colin J, Orignac I, Touboul D. Glistenings in a large series of hydrophobic acrylic intraocular lenses. J Cataract Refract Surg 2009;
35:2121212.

Glistenings

Patient with Acrysof in one eye and silicone in other eye

Courtesy of J. Singer

Glistenings

Patient with Acrysof in one eye and PMMA in other eye

Courtesy of J. Singer

Glistenings

Acrysof IQ

Acrysof ReSTOR

Courtesy of J. Singer

Determining Severity Grade of

Microvacuoles
Grade

Scattering
Area
(% of 2 x 2
mm)

Numbers

Typical
Sizes

Description

< 0.5%

0-50

20

Mild

< 2%

51-250

20

Moderate

< 10%

251-2500

20

High

> 10%

> 2500

10

Severe

Determining Severity Grade of

Microvacuoles

Courtesy of R. Olson

In House Prevalence Study

20 Patients Recalled at Random
6 Groups:
1Day Post-OP
6 Months Post Op (+-1 Month)
1 Year Post Op (+- 2 Months)
2 Years Post-Op (+- 3 Months)
3 Years Post-Op (+- 4 Months)
4+ Years Post-Op
L. Fry, ASCRS 2008

Results:

1 Day: 0/20
6 Months: 3/20 (1-1+; 2-2+)
1 Year: 7/20 (5-1+, 2-2+)
2 Years: 13/21 (5-1+, 8-2+)
3 Years: 21/25 (10-1+,9-2+, 2-3+)
4+ Years: 9/20 (6-1+, 3-2+)

L. Fry, ASCRS 2008

Preliminary Conclusions:
Glistenings in Acrysof Acrylic IOLs are not present
on day one, but appear to be acquired, increasing
in both incidence and severity with time, affecting
the majority of Implanted Lenses by 3 years
1+ and 2+ Glistenings do not appear to significantly
affect Vision, Glare Disability, or Contrast
Sensitivity; 3+ glistenings may adversely affect
Vision, Glare and Contrast
L. Fry, ASCRS 2008

Glistenings, Incidence

42 patients, AcrySof MA30BA or MA60BM, 2.4 years =/- 0.3 (SD) (range 6 to
46 months) after implantation, all IOLs had glistenings.

53 consecutive patients with the SA60 IOL at 12, 24, and 36 months and
patients with the SN60 at 12 months; all 53 IOLs showed some degree of
glistenings.

115 eyes, AcrySof MA60BM no glistenings were found 1 month after

surgery;20% at 3 months, 51% at 6 months, and 55% at 1 year.

115 eyes implanted, AcrySof MA60BM, incidence of 55.7% at 14 months and

87.3% at 28 months.

Miyata A, et al. [Glistening particles on the implanted acrylic intraocular lens]. [Japanese] Rinsho Ganka
1997; 51:729732.
Miyata A, et al. [Clinical and experimental observation of glistening in acrylic intraocular lenses]. [Japanese] Nippon Ganka Gakkai
Zasshi 2000; 104:349353
Peetermans E, Hennekes R. Long-termresults of Wagon Wheel packed acrylic intra-ocular lenses (AcrySof). Bull Soc Belge
Ophtalmol 1999; 271:4548
Christiansen G, et al. Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract Surg 2001; 27:728733.
Tognetto D, et al. Glistenings in foldable intraocular lenses. J Cataract Refract Surg 2002; 28:12111216.
Moreno-Montanes J, et al. Clinical factors related to the frequency and intensity of glistenings in AcrySof intraocular lenses. J
CataractRefract Surg 2003; 29:19801984.
Waite A, Faulkner N, Olson RJ. Glistenings in the single-piece, hydrophobic, acrylic intraocular lenses. Am J Ophthalmol 2007;
144:143144

DJ Apple AAO 2008

Glistenings Present in all Acrysof

Lenses and Continue to Increase
with Time

Behndig A, Monestam E. Quantification of Glistenings in Intraocular Lenses using Scheimpflug

Phtography. J Cat Refract Surg 2009; 35: 14-1

The Light Scatter Effect:

Comparison of Acrylic
Materials

Van der Mooren M, Coppens J, Bandhauer M, Van den Berg T. Presented at ARVO 2007.

Backward
scatter

Forward
scatter

80m

10mm

The Light Scatter Effect:

Comparison of Acrylic
*
Materials
The forward light scatter of
AcrySof lenses is relatively
large compared to the
backward scatter, so
functional significance may be
underestimated in the clinic

Initially, scatter of all IOLs

was < 20yr old healthy
crystalline lens
Lenses with glistenings can
cause scatter greater than
that present in a 70 year olds
crystalline lens

*Van der Mooren M, Coppens J, Bandhauer M, Van den Berg T. Presented at ARVO 2007.

The Light Scatter Effect:

Comparison of Acrylic
Materials*

With multifocal IOLs,

backward scatter is similar
but forward scatter is
greater with the ReSTOR

*Van der Mooren M, Coppens J, Bandhauer M, Van den Berg T. Presented at ARVO 2007.

J Colin AAO 2010

Acrysof lenses,
J Colin, 2010

Vision as predicted by lowest

grade of gisitenings, from Colin
data, AAO 2010

Simulations by T. Van der Berg

Vision as predicted by lowest

grade of gisitenings, from Colin
data, AAO 2010

Simulations by T. Van der Berg

Clinical Significance of
Glistenings

Glistenings, unless very severe, do not adversely affect the MTF, UV/Visible spectral
transmittance, light scattering and resolving power performance of intraocular lenses
Oshika T, et al. Influence of glistenings on the optical quality of acrylic foldable intraocular lens. Br

J Ophthalmol 2001; 85:10341037.1

Loss in contrast sensitivity

A study on visual function has shown that glistenings in AcrySof IOLs (MA30BA and MA60BA) were related
to a statistically significant loss of up to 40% in contrast sensitivity at high spatial frequencies (12 cycles per
degree)
Gunenc U, et al. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. J
2001; 27:16111614
Fry LL, Fry EL, Glistenings in Hydrophobic Acrylic IOLs, paper presented at the ASCRS Symposium on
Refractive Surgery, Boston, Massachusetts, USA, April 2010

Cataract Refract Surg

Cataract, IOL and

Decreased visual acuity

Eyes with higher grades of glistenings had a small but significantly greater decrease in visual acuity than
those with lesser grades
Christiansen G, et al. Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract Surg 2001;

27:728733

Clinical Significance of
Glistenings

Search of adverse reports related to glistenings was

performed on the FDA web site using the search
term intraocular lens glistenings

106 records between July 3, 1997 and June 4, 2009

were found

96 were regarding Acrysof lenses in cases with decreased visual

acuity or other symptoms leading to a decrease in visual quality

Fourteen reports were related to IOL explantation of Acrysof lenses

Werner L. Glistenings and surface light scattering in intraocular lenses. J Cat Refract Surg. 2010
36: 1398-1420.

Clinical Significance of
Glistenings
1) "We conclude that the Acrysof Natural IOLs
do not demonstrate substantial clinical benefit
in comparison with currently available
IOLs" (p. 1010)
2) "Moreover, in our review......regarding the
blue light filtering optic, we found evidence suggesting that the bluefiltering lenses could decrease best possible vision." (p. 1006)
3) "Finally, this commentor stated that the glistenings associated with
Acrysof Natural lenses that develops overtime causes disability
glare rather than reduces it." (p. 1009)
Department of Health and Human Services, Centers for Medicare and Medicaid (2010) when asked
to consider the Acrysof Naturale for NT-IOL status, which was declined.

Glistenings
We as a group are the first ones to publish

a study with regard to intraocular lens

glistenings (1995).
We do know that(glistenings).. occur in
the majority if not 100% of all Acrysof
lenses over time and that they are clearly
continuing to get worse after ten years.
RJ Olson MD, 2010

Glistenings
The development and progression of glistenings in
AcrySof IOLs is the fault of the optical material
manufacturing process, not the surgeon.
Most ophthalmologists would be outraged if
glistenings developed in their camera lenses, so its
surprising that glistenings are often ignored in their
patients implanted IOLs. "

MA Mainster, 2010
(introduced concept of UV protection in IOLs,1978)

Glistenings
The bottom line is that these defects due to

the size and nature would not be acceptable

for use on NIF (National Ignition Facility) or
any other laser (or)any high precision
system."
D Walmer, 2010
Master Optician,
Senior Engineering Associate,
Lawrence Livermore National Laboratory

The LLNL engineering activities include micro- and nanotechnology, lasers and optics, biotechnology, precision
engineering, nondestructive characterization, modeling and simulation, systems and decision science, and
sensors, imaging and communications.

Glistenings
one is justified in asking the question "Why

implant..(an Acrysof).. lens when the

potential for .. (glistenings).. exists, if there
is indeed an equivalent quality IOL
available that carries out all functions of the
lens but is not encumbered with
'glistenings'?

DJ Apple MD, 2010

Which lens would you choose

for yourself ?

Thank you for your kind attention