J. Colin, MD ASCRS 2008 Visual and Safety Performance of the AcrySof ® Phakic IOL in Global Clinical Trials Prof. Joseph Colin, MD Chef du Service d'Ophtalmologie - CHU Pellegrin Bordeaux, France (Financial Disclosure: Consultant, Alcon) EU Phase 3 Clinical Investigators •J. Alió, MD (Alicante, Spain) •J.L. Arné, MD (Toulouse, France) •R. Bellucci, MD (Verona, Italy) •B. Cochener MD (Brest, France) •J. Colin, MD (Bordeaux, France) •R.H. Gerl, MD (Ahaus, Germany) •M. Knorz, MD (Mannheim, Germany) •T. Kohnen, MD (Frankfurt, Germany) •A. Marinho, MD/F. Vaz, MD (Porto, Canada Phase 3 Clinical Investigators • T. Demong, MD (Calgary, Alberta) • S. Holland, MD (Vancouver, British Columbia) • M. Pop, MD (Montreal, Quebec) • T. Rabinovitch, MD (Downsview, Ontario) • F. Roy, MD (Trois-Rivieres, Quebec) US Phase 2 Clinical Investigators J. D. Horn, MD (Nashville, Tennessee ) R. Krueger, MD (Cleveland, Ohio) S. S. Lane, MD (Stillwater, Minnesota) W. A. Maxwell, MD, PhD (Fresno, California)
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J. Colin, MD ASCRS 2008 Visual and Safety Performance of the AcrySof ® Phakic IOL in Global Clinical Trials Prof. Joseph Colin, MD Chef du Service d'Ophtalmologie.
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J. Colin, MDASCRS 2008
Visual and Safety Performance of the AcrySof® Phakic IOL in Global Clinical Trials
Prof. Joseph Colin, MDChef du Service d'Ophtalmologie - CHU PellegrinBordeaux, France(Financial Disclosure: Consultant, Alcon)
Canada Phase 3 Clinical Investigators• T. Demong, MD (Calgary, Alberta)• S. Holland, MD (Vancouver, British Columbia)• M. Pop, MD (Montreal, Quebec)• T. Rabinovitch, MD (Downsview, Ontario)• F. Roy, MD (Trois-Rivieres, Quebec)
US Phase 2 Clinical InvestigatorsJ. D. Horn, MD (Nashville, Tennessee )R. Krueger, MD (Cleveland, Ohio)S. S. Lane, MD (Stillwater, Minnesota)W. A. Maxwell, MD, PhD (Fresno, California)K. Solomon, MD (Charleston, South Carolina)
J. Colin, MDASCRS 2008
Clinical Study Design
Clinical Objective: Investigate safety & effectiveness Study design: Non-randomized, open label, single arm,
multicenter clinical investigations Pooled analysis of global clinical studies
360 subjects included in total analysis European Phase 3 Clinical Study: 190 subjects Canadian Phase 3 Clinical Study: 120 subjects US Phase 2 Clinical Study: 50 subjects
3 to 5 year follow-up duration Results reported for 2 year follow-up visit (n=204)
Main Inclusion Criteria Adults >18 years of age, with cap of 49 years of age
for US and Canadian study Stable, moderate to high myopia (refraction within ±0.5
D at least 12 months prior to surgery) Able & willing to sign informed consent
Main Exclusion Criteria Previous ocular surgery Glaucoma or family history of glaucoma Mesopic pupil size >7.0 mm Astigmatism >2.0 D Anterior chamber depth <3.2 mm Non-qualifying endothelial cell density per age criteria
J. Colin, MDASCRS 2008
Postoperative Evaluation
Endothelial Cell Density (ECD) & Morphology Adverse Events (AE) Maintenance of Best Spectacle-Corrected
Safety Outcomes Minimal effects on ECD at 2 years postop BSCVA maintained No chronic inflammation or persistently raised IOP Low rate of adverse events observed
Effectiveness Outcomes Excellent visual acuity High rate of predictability Refraction stable over time