OPHTHALMIC DEVICE STANDARDIZED CLINICAL STUDY PROCEDURES
This article was originally published in The Gray Sheet
Executive Summary
OPHTHALMIC DEVICE STANDARDIZED CLINICAL STUDY PROCEDURES will be presented by FDA to the agency's Ophthalmic Devices Panel at the Jan. 26 meeting, according to FDAers. The standard operating procedures (SOPs) were agreed upon by representatives from industry, academia, FDA and the National Institutes of Health at the Dec. 1-2 eye care technology forum at the NIH campus in Bethesda, Maryland. The forum participants agreed on SOPs for measuring visual acuity; intraocular pressure and visual fields. Testing contrast sensitivity was also discussed, but the forum failed to reach a consensus on the issue.