Transcript No Slide Title

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
[email protected]
GRADE 3+
5500 10µm
DJ Apple AAO 2008
ASCRS sent out alert on
“glistenings”on March 16,
1995.
DJ Apple AAO 2008
DJ Apple AAO 2008
DJ Apple AAO 2008
Factors Influencing Glistenings
• Different degrees of glistenings were found in all foldable IOLs
manufactured from all materials (including 2 silicone, 3
hydrophilic acrylic, and 2 hydrophobic acrylic (Acrysof and
Sensar)).
•The percentage of patients with
glistenings generally increased up to
90 days postoperatively and then
became stable in all groups, with the
exception of the AcrySof IOL group,
which had a continuous increase
over time (up to 720 days).
Tognetto D, et al. Glistenings in foldable intraocular lenses. J Cataract Refract Surg 2002; 28:1211–1216
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 water–polymer 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; 13:227–230
Miyata, et al. Equilibrium water content and glistenings in acrylic intraocular lenses. J Cataract Refract Surg 2004; 30:1768–1772
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; 6:1090–1098
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; 66–67.
Dick HB, et al. Vacuoles in the AcrySof intraocular lens as factor of the presence of serum in aqueous humor. Ophthalmic Res2001;
33:61–67
Moreno-Montane´s J, et al. Clinical factors related to the frequency and intensity of glistenings in AcrySof intraocular lenses. J
CataractRefract Surg 2003; 29:1980–1984
Colin J, Orignac I, Touboul D. Glistenings in a large series of hydrophobic acrylic intraocular lenses. J Cataract Refract Surg 2009;
35:2121–212.
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
1
< 0.5%
0-50
20μ
Mild
2
< 2%
51-250
20μ
Moderate
3
< 10%
251-2500
20μ
High
4
> 10%
> 2500
10μ
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; 51:729–732.
Miyata A, et al. [Clinical and experimental observation of glistening in acrylic intraocular lenses]. [Japanese] Nippon Ganka Gakkai
Zasshi 2000; 104:349–353
Peetermans E, Hennekes R. Long-termresults of Wagon Wheel packed acrylic intra-ocular lenses (AcrySof). Bull Soc Belge
Ophtalmol 1999; 271:45–48
Christiansen G, et al. Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract Surg 2001; 27:728–733.
Tognetto D, et al. Glistenings in foldable intraocular lenses. J Cataract Refract Surg 2002; 28:1211–1216.
Moreno-Montane´s J, et al. Clinical factors related to the frequency and intensity of glistenings in AcrySof intraocular lenses. J
CataractRefract Surg 2003; 29:1980–1984.
Waite A, Faulkner N, Olson RJ. Glistenings in the single-piece, hydrophobic, acrylic intraocular lenses. Am J Ophthalmol 2007;
144:143–144
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
80µm
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
old’s 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; 85:1034–1037.1
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
Cataract Refract Surg 2001; 27:1611–1614
Fry LL, Fry EL, ‘‘Glistenings in Hydrophobic Acrylic IOLs,’’ paper presented at the ASCRS Symposium on
Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, April 2010
Decreased visual acuity
•
Eyes with higher grades of glistenings had a small but significantly greater decrease in
visual acuity than those with lesser grades
Surg 2001;
Christiansen G, et al. Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract
27:728–733
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 it’s
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