Staar Collamer intraocular lens: clinical results from the phase I FDA core study

To assess the early postoperative efficacy and safety of the Staar Collamer intraocular lens (IOL) in small incision cataract surgery.

Six private ophthalmology practices geographically distributed throughout the United States.

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 1 clinical study of the Staar Collamer IOL after having cataract removal by phacoemulsification. Of these, 107 completed 4 to 6 months of follow-up.

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.

Results indicate that the Collamer material is safe and effective for platehaptic IOLs used in small incision cataract surgery.