REFRACTIVE SURGERY LASER REVISED DRAFT IDE GUIDANCE INCLUDES HIGH MYOPIA AND HYPEROPIA, WITH OR WITHOUT ASTIGMATISM; POLICY SLATED FOR PANEL REVIEW OCT. 21
This article was originally published in The Gray Sheet
Executive Summary
Refractive lasers used to treat high myopia should provide uncorrected visual acuity (UCVA) of 20/40 or better in at least 75% of postoperative eyes, FDA says in a draft revision of its "Checklist of Information Usually Submitted in an Investigational Device Exemption for Refractive Surgery Lasers." The draft, released Sept. 5, defines high myopia as greater than -7.00 diopters, with or without astigmatism. For hyperopia (with or without astigmatism), the target endpoint for UCVA of 20/40 cited is 85%.