Real-world performance of the AI diagnostic system IDx-DR in the diagnosis of diabetic retinopathy and its main confounders.

The escalating prevalence of diabetes mellitus (DM) emphasizes the critical need for early detection of diabetic retinopathy (DR). This study assesses the performance of the autonomous AI-based diagnostic system IDx-DR in detecting DR and its associated confounders in a real-world clinical setting. This prospective cross-sectional study involved 875 diabetic patients with a mean age of 52 years (range: 8-92). Retinal images were captured by trained assistants. IDx-DR results were compared with mydriatic fundus examination (gold standard) and Ophthalmologists' image analysis. Factors impacting image acquisition or analyzability were examined. Among all patients, 10.5% yielded no image in miosis, and 26.1% were unanalyzable by IDx-DR. Confounders affecting image acquisition were examiner, pupil size, patient age and patients' visual acuity. When good quality images were achieved, IDx-DR performed well, particularly in detection of severe DR (sensitivity 94.4%; specificity 90.5%). IDx-DR results exactly matched Ophthalmologists' mydriatic fundoscopy gradings in 54.2% if images of sufficient quality were obtainable. Undergrading of DR severity by IDx-DR was rare (4.8%). IDx-DR shows promise in detecting DR, especially in resource-limited settings and in detecting severe DR. One remaining challenge is good image acquisition in miotic patients.