The diagnostic accuracy of AI-assisted diabetic retinopathy screening in primary care: a prospective validation study.

OBJECTIVES: This study investigated the diagnostic accuracy of AI-assisted diabetic retinopathy screening in primary care, using ophthalmologist-led screening as the reference standard. METHODS: Patients with type 2 diabetes attending routine appointments at 10 primary care clinics underwent AI-assisted screening, followed by re-screening at an ophthalmology clinic. The quality of fundus images captured in primary care was independently assessed, and diagnostic accuracy was evaluated by comparing AI-assisted results with ophthalmologist results, including sensitivity, specificity, PPV, NPV, and AUC. Two analyses were conducted: one including all images and one excluding those of poor quality. RESULTS: Among 183 patients (336 images), 18.6% of images were classified as poor quality. When all images were included, the AI-assisted screening achieved a sensitivity of 73.7%, specificity of 90.2%, PPV of 31.1%, NPV of 98.3%, and AUC of 0.82. Excluding poor-quality images improved sensitivity to 80.0%, NPV to 98.7%, and AUC to 0.84. Additional ocular findings unrelated to diabetic retinopathy were observed in 96 patients, including confirmed or non-specific signs of glaucoma, cataract, age-macular degeneration, benign nevus and reduced visual acuity. CONCLUSION: AI-assisted screening in primary care shows potential for clinical application, but further validation in larger populations and improvements in image quality are needed before clinical implementation.