Collamer intraocular lens: clinical results from the US FDA core study.
OBJECTIVE
To assess the safety and efficacy of the Staar Collamer intraocular lens (IOL) 1 year postoperatively.


METHODS
Fifteen private ophthalmology practices geographically distributed throughout the United States.


METHODS
Six hundred eighty-six cases with a mean age of 72.1 years were enrolled in a 2-phase U.S. Food and Drug Administration (FDA) clinical study of the Collamer IOL implanted during phacoemulsification for cataract removal. The 12 month follow-up comprised data from 502 cases.


RESULTS
Twelve months postoperatively, 96.2% of all cases and 95.6% without preexisting pathology achieved 20/40 or better best corrected visual acuity. Both results were better than FDA Grid values. No persistent sight-threatening complications, IOL dislocations, or IOL removals were reported.


CONCLUSIONS
Results show that the Collamer IOL is safe and effective for use in small incision cataract surgery.
Brown
D C
DC
Eye Centers of Florida, Ft. Myers, Florida, USA.
Ziémba
S L
SL
D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D018795:Device Approval; D005260:Female; D006801:Humans; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification / Q000379:methods; D011183:Postoperative Complications; D011474:Prosthesis Design; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity / Q000502:physiology*