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 Post subject: Phakic IOLs/ICLs
PostPosted: Thu Jul 26, 2007 7:58 pm 
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Outcomes of ZB5M Angle-supported Anterior Chamber Phakic Intraocular Lenses at 12 Years

Journal of Refractive Surgery Vol. 23 No. 2 February 2007

Jaime Javaloy, MD, PhD; Jorge L. Alió, MD, PhD; Maria T. Iradier, MD; Ayman M. Abdelrahman, MD, MSc; Tomas Javaloy, MD; Fernando Borrás, MD, PhD

Quote:
For the IOL models analyzed in this study, a constant greater loss of endothelial cell density has been found. Considering a physiological rate of decrease in the endothelial cell density of 0.56% per year, a nonoperated healthy eye would reach age 85 years with >1900 cells/mm2. For these calculations, an amortization equation for accounting
has to be used:

(formula)

where ECDi is the current cell density estimated at any moment, ECD0 is the cell density at the fi rst considered instant, and n the number of years for calculating ECDi.

As we estimate a 10.69% surgically induced decrease in the endothelial cell density in the first year and an average rate of 1.78% every year after that, a hypothetical 25-year-old patient with an endothelial cell density of 2500 cells/mm2 who received a ZB5M angle-supported PIOL would reach the advisable explantation number of 1500 cells/mm2 at age 49 years (24 years after implantation). Later enhancements in the design of these angle-supported PIOLs may reduce long-term endothelial damage. The absence of a definitive physiopathological model of endothelial injury after angle-supported PIOL implantation and the large number of eyes implanted, especially in young patients, should oblige surgeons to perform periodic endothelial cell analysis in these patients.

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PostPosted: Fri Oct 26, 2007 10:28 am 
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J Cataract Refract Surg. 2007 Aug;33(8):1477-81.
Comment in:
J Cataract Refract Surg. 2007 Aug;33(8):1347.

Severe endothelial cell loss following uneventful angle-supported phakic intraocular lens implantation for high myopia.

Coullet J, Mahieu L, Malecaze F, Fournié P, Leparmentier A, Moalic S, Arné JL.
Department of Ophthalmology, Purpan Hospital, Toulouse, France. coullet.j@chu-toulouse.fr

Endothelial decompensation is a serious complication of phakic intraocular lens (pIOL) implantation and is a major concern during the postoperative period. We report 3 eyes in which the same foldable angle-supported pIOL was implanted to correct high myopia. Rapid and severe postoperative endothelial cell loss occurred in all 3 eyes. An over-sized pIOL that induced excessive vaulting into the anterior chamber was the main risk factor. In 2 eyes, the pIOL was explanted uneventfully; 1 eye required Descemet's stripping automated endothelial keratoplasty because of total endothelial decompensation. These cases illustrate the importance of accurate sizing of foldable angle-supported anterior chamber pIOLs to avoid excessive vaulting. They also highlight the importance of regular follow-up and preventive pIOL explantation as soon as significant endothelial cell loss is detected.

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"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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PostPosted: Fri Jun 13, 2008 7:26 am 
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Anterior Subcapsular Opacities and Cataracts 5 Years After Surgery in the Visian Implantable Collamer Lens FDA Trial

Journal of Refractive Surgery Vol. 24 No. 6 June 2008
Donald R. Sanders MD, PhD

PURPOSE
To use the techniques of survival analysis to analyze the incidence of anterior subcapsular opacities (symptomatic and asymptomatic) and clinically significant cataract in the US Food and Drug Administration clinical trial of the Visian Implantable Collamer Lens (ICL).

METHODS
Five hundred twenty-six eyes were followed for an average of 4.7 years; 89% (468 eyes), 73% (384 eyes), and 59% (311 eyes) were seen at 3, 4, and 5 years or later, respectively. Anterior subcapsular opacities were defined as trace or more (>0.6 LOCS III opacity). Clinically significant cataract required loss of 2 or more lines of best spectacle-corrected visual acuity (BSCVA), a significant increase in glare symptoms, or cataract extraction. Kaplan-Meier analyses of opacities and cataract were performed.

RESULTS
The Kaplan-Meier cumulative probability estimate for anterior subcapsular opacities over 7+ years of follow-up was 7% whereas 31 (5.9%) eyes were actually observed. Anterior subcapsular opacities generally occurred early with 58% seen in the first year, 68% in the first 2 years, and 74% in the first 3 years. The cumulative probability estimate for clinically significant cataracts over the 7+ years of follow-up was 2% whereas 7 (1.3%) were actually observed. The difference between the Kaplan-Meier estimate and the actual observed percentage is due to the fact that the former takes into account the differences in postoperative follow-up time of individual eyes. Preoperative myopia (>12.00 diopters) and patient age (>40 years) were significant factors in the development of cataract. No loss of BSCVA was observed in any eye following cataract extraction.

CONCLUSIONS
Approximately 6% to 7% of eyes develop anterior subcapsular opacities at 7+ years following ICL implantation but only 1% to 2% progress to clinically significant cataract during the same period, especially very high myopes and older patients. Visual outcome following cataract extraction was good. [J Refract Surg. 2008;24:566-570.]

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PostPosted: Wed Jun 25, 2008 6:38 am 
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http://www.osnsupersite.com/view.asp?rID=29077

OSN SuperSite Breaking News 6/24/2008

Phakic IOL has good outcomes but higher endothelial cell loss than previous studies

Quote:
"The rate of endothelial cell loss was significantly higher than has been reported in previous studies," they said.


Quote:
However, endothelial cell density averaged 2,156 cells/mm² at 5 years follow-up, representing a 14.05% decrease from the average value at baseline (P = .01), according to the study, published in the June issue of Archives of Ophthalmology.

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 Post subject:
PostPosted: Mon Jul 14, 2008 6:16 pm 
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http://www.fda.gov/cdrh/phakic/

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 Post subject:
PostPosted: Mon Jul 14, 2008 6:24 pm 
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Visian
http://www.fda.gov/cdrh/pdf3/P030016.html

Visian ICL™ - P030016
http://www.fda.gov/cdrh/mda/docs/p030016.html

ARTISAN/Verisyse
http://www.fda.gov/cdrh/pdf3/P030028.html

Verisyse™ Phakic IOL - P030028
http://www.fda.gov/cdrh/mda/docs/p030028.html

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 Post subject:
PostPosted: Fri Jun 05, 2009 11:30 am 
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New Links:

http://www.accessdata.fda.gov/scripts/c ... um=p030028

http://www.accessdata.fda.gov/scripts/c ... um=p030016

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