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Background:   Portable retinal cameras and deep learning (DL) algorithms are novel tools adopted by diabetic retinopathy (DR) screening programs. Our objective is to evaluate the diagnostic accuracy of a DL algorithm and the performance of portable handheld retinal cameras in the detection of DR in a large and heterogenous type 2 diabetes population in a real-world, high burden setting.Method:   Participants underwent fundus photographs of both eyes with a portable retinal camera (Phelcom Eyer). Classification of DR was performed by human reading and a DL algorithm (PhelcomNet), consisting of a convolutional neural network trained on a dataset of fundus images captured exclusively with the portable device; both methods were compared. We calculated the area under the curve (AUC), sensitivity, and specificity for more than mild DR.Results:   A total of 824 individuals with type 2 diabetes were enrolled at Itabuna Diabetes Campaign, a subset of 679 (82.4%) of whom could be fully assessed. The algorithm sensitivity/specificity was 97.8 % (95% CI 96.7-98.9)/61.4 % (95% CI 57.7-65.1); AUC was 0·89. All false negative cases were classified as moderate non-proliferative diabetic retinopathy (NPDR) by human grading.Conclusions:   The DL algorithm reached a good diagnostic accuracy for more than mild DR in a real-world, high burden setting. The performance of the handheld portable retinal camera was adequate, with over 80% of individuals presenting with images of sufficient quality. Portable devices and artificial intelligence tools may increase coverage of DR screening programs.

Diabetic Retinopathy Screening Using Artificial Intelligence and Handheld Smartphone-Based Retinal Camera