The purpose of OptymEdge ophthalmic certification is to ensure quality and consistency of clinical trial data related to visual function tests and provide a means for Visual Function Examiners to demonstrate proficiency by meeting our high standards for certification. OptymEdge most commonly certifies clinical center staff in trial frame refraction and best-corrected visual function, as measuring a change in visual acuity is often the primary endpoint in ophthalmic clinical trials.
Use of the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and modified versions where needed to perform manifest refraction and assess visual acuity serve as the gold standard in the conduct of these assessments for ophthalmic clinical trials. The protocol helps to ensure uniformity of measurements when gathering important outcome data. Study sponsors are assured that personnel at clinical centers are applying the protocol consistently and correctly.