599-P: Diabetic Retinopathy (DR) Screening Performance of General Ophthalmologists, Retina Specialists, and Artificial Intelligence (AI): Analysis from a Pivotal Multicenter Prospective Clinical Trial

A prospective study (NCT03112005) evaluated DR screening using the EyeArt AI eye screening system and dilated ophthalmoscopy by board-certified ophthalmologists against the ETDRS clinical reference standard (CRS) of adjudicated expert grading of 4-wide field stereoscopic fundus photographs. A total of 497 subjects with diabetes from 10 U.S. clinical centers underwent undilated 2-field fundus photography for analysis by the EyeArt system, dilated ophthalmoscopy, and dilated 4-wide field stereo fundus photography for the CRS. Performance (Table) of dilated ophthalmoscopy against CRS for identifying referable DR [moderate non-proliferative or higher on the International Clinical Diabetic Retinopathy severity scale or clinically significant macular edema] indicates significant variability across retina specialists and general ophthalmologists. In a previous study, this AI system has been shown to achieve sensitivity 89.0% [95% CI: 87.7-90.2%] and specificity 91.6% [95% CI: 91.0-92.2%] against 7-field ETDRS reference standard. We await the results of the EyeArt system in this multicenter study to verify its ability to provide a more consistent performance for detection of referable DR to facilitate DR screening in primary care and endocrinology clinics. Disclosure E. Ipp: Research Support; Self; Eyenuk Inc., Novartis Pharmaceuticals Corporation. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. S.R. Sadda: Consultant; Self; Carl Zeiss Meditec, Centervue, Heidelberg Engineering, Optos. Other Relationship; Self; Nidek. Other Relationship; Spouse/Partner; Topcon. Funding Eyenuk Inc.