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STAAR Surgical Collamer(R) Accommodating Study Team Reports First Phase Assessments at AAO
Date:10/26/2009

nt premium IOLs on the market. The average distance-corrected intermediate vision with the nanoFLEX IOL was 20/25, which was superior to all standard and premium IOLs where similar data is available.

"In my practice the nanoFLEX IOL has clearly demonstrated the excellent near vision results found by the CAST when compared to both standard and premium IOLs in the market," said Dr. James S. Lewis, CAST member. "It seems quite likely that with design enhancements the accommodative properties of the nanoFLEX can be expanded to compete very effectively in the premium IOL segment."

"Longer term patient data on a Collamer IOL provided by Dr. Liviu Saimovici showed superior distance-corrected near vision results when compared to all premium IOLs including the accommodating and multifocal IOLs in his analysis," said Mr. Felberg. "For the balance of 2009, the CAST will continue the current follow up activity on all patient eyes implanted. Within six months we hope to have preliminary data for the Second Phase which will compare the accommodating performance of the existing nanoFLEX versus the redesigned nanoFLEX. Then, based on the comparison, we plan to pursue a clinical trial to attain a claim of accommodation or less spectacle dependence from the FDA. The plan is to complete that FDA trial in 18 months, at which point in time we would submit a PMA supplement file to the FDA for their review."

"Based on the CAST evaluations we believe STAAR has the best standard IOL on the market today," continued Mr. Caldwell. "The CAST information indicates nanoFLEX provides better distance-corrected near vision than competitive standard lenses and perhaps more importantly, better intermediate vision than even the premium IOL comparisons. The standard IOL segment continues to be the largest volume of all IOLs sold today. We plan to expand our marketing message aggressively on the effectiveness of nanoFLEX in the standard IOL channel, while we det
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SOURCE STAAR Surgical Company
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