Clinical validation of a smartphone-based retinal camera for diabetic retinopathy screening

AI Generated Summary*

In 327 people with diabetes at three Brazilian centers, a smartphone-based handheld fundus camera was compared with tabletop devices for retinopathy and macular edema detection. Pupils were dilated, and macula and disk centered fields from each device were read independently by two masked ophthalmologists under ICDR criteria, with a senior grader settling disagreements and tabletop readings treated as the reference. Weighted kappa for severity was 0.808 and kappa for macular edema 0.809. Referable disease agreement was 85.88% (kappa 0.716), sensitivity 0.906, specificity 0.808. Gradable images totalled 85.31% for handheld versus 84.02% for tabletop. Disagreement concentrated within nonproliferative categories. Hypertension (OR 3.603) and male sex (OR 1.687) tracked with referable retinopathy; handheld performance was deemed comparable.

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