Staar Collamer intraocular lens: Clinical results from the Phase I FDA core study

Purpose: To assess the early postoperative efficacy and safety of the Staar Collamer(TM). 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 month 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 plate-haptic IOLs used in small incision cataract surgery.