Deep-Learning-Based Pre-Diagnosis Assessment Module for Retinal Photographs: A Multicenter Study

Purpose: Artificial intelligence (AI) deep learning (DL) has been shown to have significant potential for eye disease detection and screening on retinal photographs in different clinical settings, particular in primary care. However, an automated pre-diagnosis image assessment is essential to streamline the application of the developed AI-DL algorithms. In this study, we developed and validated a DL-based pre- diagnosis assessment module for retinal photographs, targeting image quality (gradable vs. ungradable), field of view (macula- centered vs. optic-disc-centered), and laterality of the eye (right vs. left). Methods: A total of 21,348 retinal photographs from 1914 subjects from various clinical settings in Hong Kong, Singapore, and the United Kingdom were used for training, internal validation, and external testing for the DL module, developed by two DL-based algorithms (EfficientNet-B0 and MobileNet-V2). Results: For image-quality assessment, the pre-diagnosis module achieved area under the receiver operating characteristic curve (AUROC) values of 0.975, 0.999, and 0.987 in the internal validation dataset and the two external testing datasets, respectively. For field- of-view assessment, the module had an AUROC value of 1.000 in all of the datasets. For laterality-of-the- eye assessment, themodule had AUROC values of 1.000, 0.999, and 0.985 in the internal validation dataset and the two external testing datasets, respectively. Conclusions: Our study showed that this three-in- one DL module for assessing image quality, field of view, and laterality of the eye of retinal photographs achieved excellent performance and generalizability across different centers and ethnicities. Translational Relevance: The proposed DL-based pre-diagnosis module realized accurate and automated assessments of image quality, field of view, and laterality of