The trial enrolled 900 patients with diabetes who had no history of diabetic retinopathy by comparing the AI system to Wisconsin Fundus Photograph Reading Center (FPRC) widefield stereoscopic photography and macular OCT by FPRC-certified photographers. FPRC grading of Early Treatment Diabetic Retinopathy Study Severity Scale was used as the reference standard.
Participant median age was 59 years, with 47.5% male; 16.1% were Hispanic, 63.4% were white, 28.6% were African American, and 1.6% were Asian.
A total of 198 (23.8%) had more than mild diabetic retinopathy.
The AI system exceeded all pre-specified superiority endpoints at a sensitivity of 87.2%, specificity of 90.7% and imageability rate of 96.1%, according to researchers.
In the clinical study, LumineticsCore™ (formerly known as IDx-DR) achieved high diagnostic accuracy when compared to the most rigorous determination of the severity of diabetic retinopathy using advanced imaging techniques – wide-field stereo fundus imaging and OCT evaluated by the Wisconsin FPRC, according to a press release from IDx LLC.