Abstract
Purpose: To assess the early postoperative efficacy and safety of the Staar Collamer™ intraocular lens (IOL) in small incision cataract surgery.Setting: Six private ophthalmology practices geographically distributed throughout the United States.Methods: One hundred twenty-five patients with a mean age of 72.1 years were enrolled in the U.S. Food and Drug Administration (FDA) Phase I clinical study of the Staar Collamer IOL after having cataract removal by phacoemulsification. Of these, 107 completed 4 to 6 months of follow-up.Results: At 4 to 6 months postoperatively, 97.1 % of patients achieved 20/40 or better corrected visual acuity; 100% of patients without pre-existing pathology (best case) achieved the same result; both results were better than FDA grid values. No persistent sight-threatening complications were reported. Through 6 months, 4.7% of patients required a neodymium:YAG capsulotomy. No IOL dislocations or removals were reported.Conclusion: Results indicate that the Collamer material is safe and effective for platehaptic IOLs used in small incision cataract surgery.
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