Separate Phakic IOL Trials Recommended For Young, Old Patients
This article was originally published in The Gray Sheet
Executive Summary
Refractive implant manufacturers pursuing claims for device implantation in phakic eyes - those with a natural lens - should conduct separate studies on younger and older patient populations to examine the risk of cataractogenesis, FDA's Ophthalmic Devices Advisory Panel recommended at a May 12 meeting.