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

Aims This study aims to compare the performance of a handheld fundus camera (Eyer) and standard tabletop fundus cameras (Visucam 500, Visucam 540, and Canon CR-2) for diabetic retinopathy and diabetic macular edema screening. Methods This was a multicenter, cross-sectional study that included images from 327 individuals with diabetes. The participants underwent pharmacological mydriasis and fundus photography in two fields (macula and optic disk centered) with both strategies. All images were acquired by trained healthcare professionals, de-identified, and graded independently by two masked ophthalmologists, with a third senior ophthalmologist adjudicating in discordant cases. The International Classification of Diabetic Retinopathy was used for grading, and demographic data, diabetic retinopathy classification, artifacts, and image quality were compared between devices. The tabletop senior ophthalmologist adjudication label was used as the ground truth for comparative analysis. A univariate and stepwise multivariate logistic regression was performed to determine the relationship of each independent factor in referable diabetic retinopathy. Results The mean age of participants was 57.03 years (SD 16.82, 9–90 years), and the mean duration of diabetes was 16.35 years (SD 9.69, 1–60 years). Age ( P = .005), diabetes duration ( P = .004), body mass index ( P = .005), and hypertension ( P < .001) were statistically different between referable and non-referable patients. Multivariate logistic regression analysis revealed a positive association between male sex (OR 1.687) and hypertension (OR 3.603) with referable diabetic retinopathy. The agreement between devices for diabetic retinopathy classification was 73.18%, with a weighted kappa of 0.808 (almost perfect). The agreement for macular edema was 88.48%, with a kappa of 0.809 (almost perfect). For referable diabetic retinopathy, the agreement was 85.88%, with a kappa of 0.716 (substantial), sensitivity of 0.906, and specificity of 0.808. As for image quality, 84.02% of tabletop fundus camera images were gradable and 85.31% of the Eyer images were gradable. Conclusions Our study shows that the handheld retinal camera Eyer performed comparably to standard tabletop fundus cameras for diabetic retinopathy and macular edema screening. The high agreement with tabletop devices, portability, and low costs makes the handheld retinal camera a promising tool for increasing coverage of diabetic retinopathy screening programs, particularly in low-income countries. Early diagnosis and treatment have the potential to prevent avoidable blindness, and the present validation study brings evidence that supports its contribution to diabetic retinopathy early diagnosis and treatment.