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PRK LASER CLINICAL TESTING REQUIREMENTS SHAVED IN FDA GUIDANCE; LASIK SURGERY DATA SHOULD MEET STANDARDS SIMILAR TO THOSE FOR PRK, PANEL SAYS

This article was originally published in The Gray Sheet

Executive Summary

Retreatment for undercorrection of a patient's vision in clinical trials for photorefractive keratectomy should not be considered a "treatment failure" by FDA in its PRK guidance, the agency's Ophthalmic Devices Panel agreed at an April 1 meeting in Gaithersburg, Maryland. Panel members noted that physicians often intentionally undercorrect, choosing to alter a patient's vision in stages, which differs from retreatments because of complications such as haze or regression.
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