This article was originally published in The Gray Sheet
Executive SummaryConditional approval is received from FDA to begin a study of laser thermal keratoplasty for patients with overcorrection (hyperopia) resulting from photorefractive keratectomy or laser in situ keratomileusis (LASIK) treatments for myopia. Enrollment of 10 patients (five post-PRK and five post-LASIK) will begin at the Hunkeler Eye Center at the University of Kansas. The approval is conditioned upon minor changes to the company's study protocol. Sunrise will seek to expand the patient population after one-to-three month follow-up of the initial patient population is complete. The Fremont, California-based company will include data from the study in a premarket approval application, which is slated to be submitted sometime in 1999, for its Corneal Sparing LTK system for the correction of hyperopia, presbyopia and overcorrection resulting from PRK or LASIK
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