O.I.I. EC-3 Hydrophobic Acrylic Intraocular Lens: The European Experience Thierry Amzallag, M.D. Institut Ophtalmique Somain, France.

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Presentation transcript:

O.I.I. EC-3 Hydrophobic Acrylic Intraocular Lens: The European Experience Thierry Amzallag, M.D. Institut Ophtalmique Somain, France

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

One-year clinical study in EU in support of US FDA Registration Study began April subjects (eyes) enrolled in study 5 sites in EU

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

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

Clinical Results (all 5 EU sites 1-week/1-month data) Best Corrected Visual Acuity

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

Personal Experience T. Amzallag, M.D. 24 subjects (eyes) at 6 months UCVA at six months: –92% 20/32 or better 20/50; other factors) 20/32 20/25 20/20 BCVA at six months: –96% 20/25 or better 20/40; ARMD) 20/25 20/20 No complications

Slit-Lamp Views: Three patients at 6 months

Hydrophobic acrylic implants have been associated with “glistenings” and vacuoles 1.Christiansen, et al, 2000 (JCRS 27: ) 2.Gunenc, et al, 2001 (JCRS 27: ) 3.Tognetto, et al, 2002 (JCRS 28: ) 4.Moreno-Montanes, 2003 (JCRS 29: ) Temperature-cycling experiments in the laboratory have shown that the EC-3 hydrophobic acrylic optic does not form “glistenings”.

Clinical slit lamp observations made at 6 months have confirmed that no glistenings or vacuoles are present with the EC-3 lens.

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