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Peer-Reviewed Publication
JAMA Netw Open2021;4(11):e2134254.November 1, 2021Clinical Trial

Pivotal Evaluation of an Artificial Intelligence System for Autonomous Detection of Referrable and Vision-Threatening Diabetic Retinopathy.

Eli Ipp1, David Liljenquist2, Bruce Bode3, Viral N Shah4, Steven Silverstein5, Carl D Regillo6, Jennifer I Lim7, SriniVas Sadda8, Amitha Domalpally9, Gerry Gray10, Malavika Bhaskaranand11, Chaithanya Ramachandra11, Kaushal Solanki11,
1The Lundquist Institute, Harbor-UCLA Medical Center, Torrance, California.
2Rocky Mountain Diabetes Center, Idaho Falls, Idaho.
3Atlanta Diabetes Associates, Atlanta, Georgia.
4Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
5Silverstein Eye Centers, Kansas City, Missouri.
6Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania.
7Department of Ophthalmology, Illinois Eye and Ear Infirmary, University of Illinois University of Illinois at Chicago, Chicago, Illinois.
8Doheny Eye Center, Arcadia, California.
9Fundus Photograph Reading Center, University of Wisconsin-Madison, Madison, Wisconsin.
10Data-Fi, LLC, Silver Spring, Maryland.
11Eyenuk Inc, Los Angeles, California.

Abstract

IMPORTANCE: Diabetic retinopathy (DR) is a leading cause of blindness in adults worldwide. Early detection and intervention can prevent blindness; however, many patients do not receive their recommended annual diabetic eye examinations, primarily owing to limited access. OBJECTIVE: To evaluate the safety and accuracy of an artificial intelligence (AI) system (the EyeArt Automated DR Detection Sys…

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