AEYE Health Publishes Diabetic Retinopathy Screening Trial Results

AEYE Health said in a press release that peer reviewed results from three prospective controlled trials of its AEYE DS diabetic retinopathy screening system were published in Frontiers in Digital Health. The AEYE 1, AEYE 2, and AEYE 3 trials included more than 1,200 patients with diabetes.

AEYE DS is a fully autonomous AI screening system cleared by the U.S. Food and Drug Administration (FDA). It supports portable handheld and tabletop retinal cameras, uses one image per eye, and generally does not require dilation.

The system analyzed more than 99% of patient images. Sensitivity for detecting more than mild diabetic retinopathy was 92% to 93% with the portable system and 93% with the tabletop system. Specificity was 89% to 94% and 91.4%, respectively. Across all three trials, AEYE DS recorded 100% sensitivity for ETDRS scores of at least 43 and 99% repeatability when used by general clinic staff.