Artificial Intelligence Screening for Diabetic Retinopathy: Analysis from a Pivotal Multi-center Prospective Clinical Trial

Purpose Evaluate an artificial intelligence (AI) system to screen people with diabetes at point-of-care for diabetic retinopathy (DR) including diabetic macular edema (DME). Methods We conducted a prospective multi-center study (NCT03112005) in which patients with diabetes were enrolled consecutively initially and later preferentially based on enrichment criteria. The study subjects underwent undilated 2-field fundus photography