Clinical validation of artificial intelligence algorithms for the detection of different central-involved retinal pathologies and glaucoma from non-mydriatic images.

UNLABELLED: The use of Artificial intelligence (AI) algorithms for detecting different ophthalmic diseases, especially diabetic retinopathy (DR), has become increasingly popular. In this paper, we evaluate the screening performance of different AI algorithms based on convolutional neural networks (CNNs) in a real-world scenario. To that aim, we conducted an observational and cross-sectional study on patients aged ≥18 years with type-2 diabetes mellitus, who had undergone fundus examination for DR screening using a teleophthalmology program. We used the UPRETINA diagnostic system, which consists of 8 AI algorithms based on CNNs. A total of 1,652 eyes from 871 patients were analyzed. The AI algorithms had a sensitivity/specificity of 86.8%/95.6% for detecting DR; 94.9%/94.3% for detecting age-related macular degeneration (AMD); 82.7%/92.4% for detecting glaucomatous optic neuropathy (GON); 87.0%/87.5% for detecting epiretinal membrane; and 89.7%/98.0% for detecting nevus. Additionally, the sensitivity/specificity for correctly classifying images as right eye/left eye and to correctly classifying images gradeability (medium or high quality) were 100% /100 and 92.9%/90.5%, respectively. The AUROC of the AI algorithms ranged between 0.9777 (AMD) and 0.9122 (GON). UPRETINA system was capable of automatically and accurately classifying the screening retinographies, reducing workload and leading to a scenario of more efficient optimization of resources.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04132401 NCT04132401.