Sensitivity and specificity of handheld fundus cameras for eye disease: A systematic review and pooled analysis.

In order to evaluate the accuracy of commercially available handheld fundus cameras for a variety of ophthalmic diagnoses, we conducted a systematic review, searching PubMed and PubMed Central and performing a bivariate analysis to determine the pooled sensitivity and specificity of handheld fundus cameras. Eleven studies validating handheld fundus cameras against a gold-standard method for disease diagnosis were included. For nonmydriatic images, pooled sensitivity was 83% (95% confidence interval (CI): 77-88%) and specificity was 92% (95% CI: 79-97%). For mydriatic images, pooled sensitivity was 87% (95% CI: 79-92%) and specificity was 90% (95% CI: 78-96%). Overall pooled sensitivity was 85% (95% CI: 80-89%) and specificity was 91% (95% CI: 83-95%). Of the 11 studies included, 5 assessed the diagnosis of diabetic retinopathy, for which sensitivity was 87% (95% CI: 80-92%) and specificity was 95% (95% CI: 85-98%). For all other diagnoses combined, sensitivity was 81% (95% CI: 74-87%) and specificity was 83% (95% CI: 76-89%). These findings suggest that handheld fundus cameras are capable of achieving acceptable sensitivity and specificity values for eye disease, with mydriatic images being more sensitive for disease. Diabetic retinopathy was the single diagnosis with the strongest data to support the use of handheld fundus cameras for disease screening.