Diabetic Retinopathy Telemedicine Outcomes With Artificial Intelligence-Based Image Analysis, Reflex Dilation, and Image Overread.

Abstract

To examine real-world telemedicine outcomes of diabetic retinopathy (DR) screening with artificial intelligence (AI)-based image analysis, reflex dilation, and secondary image overread in a primary care setting. Validity and reliability analysis. Single institution review of 1052 consecutive adult patients who received diabetic retinopathy photoscreening in the primary care setting over an 18-month period. Nonmydriatic fundus photographs were acquired and analyzed by the IDx-DR AI-based system. When nonmydriatic images were ungradable, reflex dilation (1% tropicamide) and mydriatic photography were performed for repeat AI-based analysis. Manual overread was performed on all images. Patient demographics, clinical characteristics, and screening outcomes were recorded. A total of 965 of 1052 patients (91.7%) had AI-gradable fundus photographs: 580 had gradable nonmydriatic imaging (55.1%) and 440 of 472 patients with ungradable nonmydriatic photographs had reflex dilation (93.2%). One hundred thirty-eight of 965 patients (14.3%) were AI-graded as "positive" (greater than mild NPDR) and 827 of 965 were "negative" (85.7%), with 100% sensitivity (95% CI 90.8-100%), 89.2% specificity (95% CI 87.0-91.1%), 27.5% positive predictive value (95% CI 24.0-31.4%), and 100% negative predictive value (95% CI 99.6-100%) compared with manual overread assessment of greater than mild NPDR requiring further evaluation with a comprehensive dilated examination. Image gradeability was inversely related to patient age: 93.5% gradable (61.9% nonmydriatic) for patients aged <70 years vs 85.3% (31.0% nonmydriatic) for patients aged 70+ years (P < .001). Incorporation of AI-based image analysis into real-world primary care diabetic retinopathy screening yielded no false negative results and offered excellent image gradeability within a protocol combining nonmydriatic fundus photography and pharmacologic dilation, as needed. Image gradeability was lower with increasing patient age.