37-LB: Diabetic Retinopathy (DR) Screening Performance of an Artificial Intelligence (AI) System: Analysis from a Pivotal Multicenter Prospective Clinical Trial

Abstract

A prospective study (NCT03112005) evaluated DR screening using the EyeArt AI eye screening system against the ETDRS clinical reference standard (CRS). A total of 893 subjects with diabetes were enrolled at 15 U.S. clinical centers and completed 2-field fundus photography for analysis by the EyeArt system and dilated 4-wide field stereo fundus photography for adjudicated expert grading to establish CRS. The EyeArt system provided eye-level results for referable DR (rDR) [moderate non-proliferative DR (NPDR) or higher on the International Clinical DR (ICDR) severity scale or clinically significant diabetic macular edema (CSDME)] and for vision-threatening DR (vtDR) [severe NPDR or higher on the ICDR scale or CSDME]. Out of 1718 eyes with gradable CRS for rDR, 1392 eyes were negative and 326 were positive. Out of 1702 eyes with gradable CRS for vtDR, 1588 were negative and 114 were positive. The EyeArt system was evaluated against CRS for identifying rDR and vtDR under an undilated protocol and a dilate-if-needed protocol (where dilated images were used for subjects with ungradable EyeArt results on undilated images). Results (Table) indicate that the EyeArt AI system compares favorably with the clinical reference standard and meets the predetermined study endpoints for the detection of referable and vision-threatening DR in people with diabetes. Disclosure 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. E. Ipp: Research Support; Self; Eyenuk Inc., Novartis Pharmaceuticals Corporation. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. S.R. Sadda: Consultant; Self; Carl Zeiss Meditec, Centervue, Heidelberg Engineering, Optos. Other Relationship; Self; Nidek. Other Relationship; Spouse/Partner; Topcon. Funding National Institutes of Health (EY027241, EY026864)