Abstract
PURPOSE: Real-world evaluation of a deep learning model that prioritizes patients based on risk of progression to moderate or worse (MOD+) diabetic retinopathy (DR). METHODS: This nonrandomized, single-arm, prospective, interventional study included patients attending DR screening at four centers across Thailand from September 2019 to January 2020, with mild or no DR. Fundus photographs were input into the model, and patients were scheduled for their subsequent screening from September 2020 to January 2021 in order of predicted risk. Evaluation focused on model sensitivity, defined as correctly ranking patients that developed MOD+ within the first 50% of subsequent screens. RESULTS: We analyzed 1,757 patients, of which 52 (3.0%) developed MOD+. Using the model-proposed order, the model's sensitivity was 90.4%. Both the model-proposed order and mild/no DR plus HbA1c had significantly higher sensitivity than the random order (P < 0.001). Excluding one major (rural) site that had practical implementation challenges, the remaining sites included 567 patients and 15 (2.6%) developed MOD+. Here, the model-proposed order achieved 86.7% versus 73.3% for the ranking that used DR grade and hemoglobin A1c. CONCLUSIONS: The model can help prioritize follow-up visits for the largest subgroups of DR patients (those with no or mild DR). Further research is needed to evaluate the impact on clinical management and outcomes. TRANSLATIONAL RELEVANCE: Deep learning demonstrated potential for risk stratification in DR screening. However, real-world practicalities must be resolved to fully realize the benefit.