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SurgiLight Seeks Trials of Laser Treatment For Reading Inability

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ORLANDO, Fla., Oct. 31 -- SurgiLight Inc. has filed an Investigational Device Exemption (IDE) with the Food and Drug Administration (FDA) seeking clearance of a procedure to treat presbyopia. The filing requests the initiation of clinical trials at seven US sites, involving 350 patients. Prior clinical data was collected at four overseas sites, wherein the SurgiLight OptiVision (formerly the IR-3000) Er:YAG laser was employed to remove certain eye tissue. Results showed reversal of the presbyopia condition in nine of every ten eyes of the more than 100 eyes treated, extending up to one year after surgery. This data, together with results from extensive long-term animal studies and acute laboratory studies, is being presented to the FDA for review.
Oct 2001
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