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Staar Collamer intraocular lens: clinical results from the phase I FDA core study
D C Brown1, H B Grabow, R G Martin
1Eye Centers of Florida, Ft. Myers, USA.
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 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.
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.