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O.I.I. EC-3 Hydrophobic Acrylic Intraocular Lens: The European Experience

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.

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O.I.I. EC-3 Hydrophobic Acrylic Intraocular Lens: The European Experience

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

  2. 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

  3. 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

  4. Research ProtocolSubject Selection • 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

  5. Research ProtocolPostoperative 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

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

  7. 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

  8. Personal ExperienceT. 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

  9. Slit-Lamp Views: Three patients at 6 months

  10. Hydrophobic acrylic implants have been associated with “glistenings” and vacuoles • Christiansen, et al, 2000 (JCRS 27:728-733) • Gunenc, et al, 2001 (JCRS 27:1611-1614) • Tognetto, et al, 2002 (JCRS 28:1211-1216) • 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”.

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

  12. 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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