Evaluation of an AI System for the Detection of Diabetic Retinopathy from Images Captured with a Handheld Portable Fundus Camera: the MAILOR AI study
This addresses the problem of deploying AI in real-world clinical settings for diabetic retinopathy screening, but it is incremental as it highlights transferability challenges.
The study evaluated an AI system (Pegasus) for detecting diabetic retinopathy from images taken with a handheld portable fundus camera, finding it achieved an AUROC of 89.4% for referable DR and 94.3% for proliferative DR, with performance dropping significantly for referable DR compared to a desktop camera benchmark.
Objectives: To evaluate the performance of an Artificial Intelligence (AI) system (Pegasus, Visulytix Ltd., UK), at the detection of Diabetic Retinopathy (DR) from images captured by a handheld portable fundus camera. Methods: A cohort of 6,404 patients (~80% with diabetes mellitus) was screened for retinal diseases using a handheld portable fundus camera (Pictor Plus, Volk Optical Inc., USA) at the Mexican Advanced Imaging Laboratory for Ocular Research. The images were graded for DR by specialists according to the Scottish DR grading scheme. The performance of the AI system was evaluated, retrospectively, in assessing Referable DR (RDR) and Proliferative DR (PDR) and compared to the performance on a publicly available desktop camera benchmark dataset. Results: For RDR detection, Pegasus performed with an 89.4% (95% CI: 88.0-90.7) Area Under the Receiver Operating Characteristic (AUROC) curve for the MAILOR cohort, compared to an AUROC of 98.5% (95% CI: 97.8-99.2) on the benchmark dataset. This difference was statistically significant. Moreover, no statistically significant difference was found in performance for PDR detection with Pegasus achieving an AUROC of 94.3% (95% CI: 91.0-96.9) on the MAILOR cohort and 92.2% (95% CI: 89.4-94.8) on the benchmark dataset. Conclusions: Pegasus showed good transferability for the detection of PDR from a curated desktop fundus camera dataset to real-world clinical practice with a handheld portable fundus camera. However, there was a substantial, and statistically significant, decrease in the diagnostic performance for RDR when using the handheld device.