Staar Collamer intraocular lens: clinical results from the phase I FDA core study.
OBJECTIVE
To assess the early postoperative efficacy and safety of the Staar Collamer intraocular lens (IOL) in small incision cataract surgery.


METHODS
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.


CONCLUSIONS
Results indicate that the Collamer material is safe and effective for platehaptic IOLs used in small incision cataract surgery.
Eye Centers of Florida, Ft. Myers, USA.
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Brown
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Grabow
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Martin
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Rowen
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Shepherd
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Williamson
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Ziémba
D000368:Aged; D000369:Aged, 80 and over; D003315:Cornea / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011102:Polyhydroxyethyl Methacrylate; D012449:Safety; D013536:Suture Techniques; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity
D011102:Polyhydroxyethyl Methacrylate