Collamer intraocular lens: clinical results from the US FDA core study.

摘要

PURPOSE: To assess the safety and efficacy of the Staar Collamer intraocular lens (IOL) 1 year postoperatively. SETTING: Fifteen private ophthalmology practices geographically distributed throughout the United States. METHODS: Six hundred eighty-six cases with a mean age of 72.1 years were enrolled in a 2-phase U.S. Food and Drug Administration (FDA) clinical study of the Collamer IOL implanted during phacoemulsification for cataract removal. The 12 month follow-up comprised data from 502 cases. RESULTS: Twelve months postoperatively, 96.2% of all cases and 95.6% without preexisting pathology achieved 20/40 or better best corrected visual acuity. Both results were better than FDA Grid values. No persistent sight-threatening complications, IOL dislocations, or IOL removals were reported. CONCLUSIONS: Results show that the Collamer IOL is safe and effective for use in small incision cataract surgery.