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Iris diaphragm improves vision in eyes with aniridia
J Cataract Refract Surg. 2008;34:1674-1680.
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A single-piece polymethylmethacrylate iris diaphragm significantly reduced glare and enhanced best corrected visual acuity in eyes with partial or complete aniridia, according to preliminary data from an ongoing prospective clinical trial.
“Because the primary cause of aniridia in most patients in this study was ocular trauma, we advise surgeons who treat similar patients to be alert to the possibility of significant comorbidity that might affect surgical outcomes and postoperative recovery,” the study authors said.
They received a compassionate use individual device exemption from the U.S. Food and Drug Administration to implant Morcher iris diaphragms in patients with congenital or trauma-derived aniridia.
Thirteen eyes of 13 patients were examined at 1-year follow-up.
Data showed statistically significant improvement in median BCVA (two Snellen lines, P = .002) and best corrected glare acuity (10 Snellen lines, P < .001). One patient lost two letters of BCVA on the 20/20 line. Daytime glare improved five points and nighttime glare sensitivity improved three points on a subjective scale of 0 to 10.
This is an important study because of the relatively large size of the series and the analysis of both objective and subjective outcomes. While several of us have described anecdotal success with these implants, our patients have not been studied as thoroughly, and there is a paucity of published results. The present paper confirms that the Morcher artificial iris implants appear to be safe and effective for reducing glare symptoms in these high-risk eyes. Trauma is the most common indication and is often accompanied by ocular comorbidities. The Ophtec 311 artificial iris implant is an alternative device being used through a U.S. Food and Drug Administration clinical trial, for which I am an investigator. However, this single-piece implant requires a much larger incision and is ideally suited for the ciliary sulcus. Although relatively few in number, patients with significant iris defects would clearly benefit if U.S. surgeons had both of these options available without the burden of obtaining a compassionate use status every time.
– David F. Chang, MD
OSN Cataract Surgery
Section Member