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Published byDwain Wheeler Modified over 8 years ago
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O.I.I. EC-3 Hydrophobic Acrylic Intraocular Lens: The European Experience Thierry Amzallag, M.D. Institut Ophtalmique Somain, France
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EC-3 Three-Piece IOL with UV Blocker Hydrophobic acrylic optic and PVDF haptics 6.0mm optic/13.0mm overall Square Edge CE-marked Over 10,000 EU implants
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One-year clinical study in EU in support of US FDA Registration Study began April 2007 254 subjects (eyes) enrolled in study 5 sites in EU
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Minimum 50 years of age Best Corrected VA no better than 20/40 with glare Corneal cylinder < 1.5 D No significant retinal or corneal pathology Clear intraocular media Research Protocol Subject Selection
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Research Protocol Postoperative Examinations Corrected and uncorrected visual acuity by ETDRS standard Slit lamp exam for anterior segment and IOL changes (e.g., “glistenings”) Expected and unexpected complications 1 day, 1 week, 1 month, 6 months, and one year follow-ups required
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Clinical Results (all 5 EU sites 1-week/1-month data) Best Corrected Visual Acuity
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Reported Complications (all EU subjects with available 1-month data; n=71) –Viral keratitis (n=1) –CME (n=3) None determined to be IOL-related
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Personal Experience T. Amzallag, M.D. 24 subjects (eyes) at 6 months UCVA at six months: –92% 20/32 or better (2 @ 20/50; other factors) 7 @ 20/32 14 @ 20/25 1 @ 20/20 BCVA at six months: –96% 20/25 or better (1 @ 20/40; ARMD) 9 @ 20/25 14 @ 20/20 No complications
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Slit-Lamp Views: Three patients at 6 months
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Hydrophobic acrylic implants have been associated with “glistenings” and vacuoles 1.Christiansen, et al, 2000 (JCRS 27:728-733) 2.Gunenc, et al, 2001 (JCRS 27:1611-1614) 3.Tognetto, et al, 2002 (JCRS 28:1211-1216) 4.Moreno-Montanes, 2003 (JCRS 29:1980-1984) Temperature-cycling experiments in the laboratory have shown that the EC-3 hydrophobic acrylic optic does not form “glistenings”.
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Clinical slit lamp observations made at 6 months have confirmed that no glistenings or vacuoles are present with the EC-3 lens.
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Conclusions EC-3 lens implantation is easy and predictable (see associated video) Expected visual and refractive results are achieved at 6 months No PCO at 6 months EC-3 is an excellent IOL with a very good intra capsular behavior
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