Long-term clinical results of AMO PhacoFlex model SI-18 intraocular lens implantation.
The AMO PhacoFlex Model SI-18 was the first commercially available three-piece silicone intraocular lens (IOL) for use in small incision cataract surgery. Allergan Medical Optics' silicone IOLs have been implanted in more than 750,000 patients worldwide over the past eight years. This report of the FDA clinical investigation of the AMO PhacoFlex model SI-18 IOL summarizes one year follow-up data from the initial premarket approval clinical trial on 500 core patients implanted with the SI-18 lens. One-year follow-up data from 5,860 patients in the modified core group and three-year follow-up data on the 500 patient core/modified core group are also presented. At three years postoperatively, 91.3% of best case core/modified core patients achieved 20/40 or better corrected visual acuity. Overall incidence of persistent complications at three years was 3.2%.
Steinert
R F
RF
Center for Eye Research, Boston, Massachusetts, USA.
Bayliss
B
B
Brint
S F
SF
Giamporcaro
J E
JE
Hunkeler
J D
JD
D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials; D002387:Cataract Extraction; D018795:Device Approval; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007910:Lenses, Intraocular / Q000009:adverse effects; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011379:Prognosis; D012826:Silicone Elastomers / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity / Q000502:physiology
D001672:Biocompatible Materials; D012826:Silicone Elastomers