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Abstract Background Diabetic Retinopathy (DR) is a leading cause of blindness worldwide, affecting people with diabetes. The timely diagnosis and treatment of DR are essential in preventing vision loss. Non-mydriatic fundus cameras and artificial intelligence (AI) software have been shown to improve DR screening efficiency. However, few studies have compared the diagnostic performance of different non-mydriatic cameras and AI software. Methods This clinical study was conducted at the endocrinology clinic of Akdeniz University with 900 volunteer patients that were previously diagnosed with diabetes but not with diabetic retinopathy. Fundus images of each patient were taken using three non-mydriatic fundus cameras and EyeCheckup AI software was used to diagnose more than mild diabetic retinopathy, vision-threatening diabetic retinopathy, and clinically significant diabetic macular oedema using images from all three cameras. Then patients underwent dilation and 4 wide-field fundus photography. Three retina specialists graded the 4 wide-field fundus images according to the diabetic retinopathy treatment preferred practice patterns of the American Academy of Ophthalmology. The study was pre-registered on clinicaltrials.gov with the ClinicalTrials.gov Identifier: NCT04805541. Results The Canon CR2 AF AF camera had a sensitivity and specificity of 95.65% / 95.92% for diagnosing more than mild DR, the Topcon TRC-NW400 had 95.19% / 96.46%, and the Optomed Aurora had 90.48% / 97.21%. For vision threatening diabetic retinopathy, the Canon CR2 AF had a sensitivity and specificity of 96.00% / 96.34%, the Topcon TRC-NW400 had 98.52% / 95.93%, and the Optomed Aurora had 95.12% / 98.82%. For clinically significant diabetic macular oedema, the Canon CR2 AF had a sensitivity and specificity of 95.83% / 96.83%, the Topcon TRC-NW400 had 98.50% / 96.52%, and the Optomed Aurora had 94.93% / 98.95%. Conclusion The study demonstrates the potential of using non-mydriatic fundus cameras combined with artificial intelligence software in detecting diabetic retinopathy. Several cameras were tested and, notably, each camera exhibited varying but adequate levels of sensitivity and specificity. The Canon CR2 AF emerged with the highest accuracy in identifying both more than mild diabetic retinopathy and vision-threatening cases, while the Topcon TRC-NW400 excelled in detecting clinically significant diabetic macular oedema. The findings from this study emphasize the importance of considering a non mydriatic camera and artificial intelligence software for diabetic retinopathy screening. However, further research is imperative to explore additional factors influencing the efficiency of diabetic retinopathy screening using AI and non mydriatic cameras such as costs involved and effects of screening using and on an ethnically diverse population.
Doğan et al. (Mon,) studied this question.