Intelligent Surgical Lasers
This article was originally published in The Gray Sheet
Executive SummaryGearing up for Phase I clinical trial of its Eye Laser System for intrastromal ablation to correct nearsightedness, following the receipt of investigational device exemption (IDE) approval from FDA. Slated to begin in the first quarter of 1994, the study will be conducted on 10 patients at the New York Eye and Ear Infirmary and the Anheuser-Busch Eye Institute in St. Louis. ISL says its intrastromal photorefractive keratectomy procedure (ISPRK) is designed to be less invasive than radial keratotomy or photorefractive keratectomy. The company is planning to file additional IDEs to use ISPRK in treating hyperopia and astigmatism
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