Background: The prevalence of diabetic retinopathy (DR) is expected to increase. This will put an increasing strain on health care resources. Recently, artificial intelligence-based, autonomous DR screening systems have been developed. A direct comparison between different systems is often difficult and only two such comparisons have been published so far. As different screening solutions are now available commercially, with more in the pipeline, choosing a system is not a simple matter. Based on the images gathered in a local DR screening program we performed a retrospective comparison of IDx-DR and Retinalyze. Methods: We chose a non-representative sample of all referable DR positive screening subjects (n = 60) and a random selection of DR negative patient images (n = 110). Only subjects with four good quality, 45-degree field of view images, a macula-centered and disc-centered image from both eyes were chosen for comparison. The images were captured by a Topcon NW-400 fundus camera, without mydriasis. The images were previously graded by a single ophthalmologist. For the purpose of this comparison, we assumed two screening strategies for Retinalyze—where either one or two out of the four images needed to be marked positive by the system for an overall positive result at the patient level. Results: Percentage agreement with a single reader in DR positive and DR negative cases respectively was: 93.3%, 95.5% for IDx-DR; 89.7% and 71.8% for Retinalyze strategy 1; 74.1% and 93.6% for Retinalyze under strategy 2. Conclusions: Both systems were able to analyse the vast majority of images. Both systems were easy to set up and use. There were several limitations to the current pilot study, concerning sample choice and the reference grading that need to be addressed before attempting a more robust future study.
Multicenter, Head-to-Head, Real-World Validation Study of Seven Automated Artificial Intelligence Diabetic Retinopathy Screening Systems. Diabetes Care 2021;44:XXXX–XXXX
