Purpose: The aim of this study is to investigate the efficacy of a mobile platform that combines smartphone-based retinal imaging with automated grading for determining the presence of referral-warranted diabetic retinopathy (RWDR).
Methods: A smartphone-based camera (RetinaScope) was used by non-ophthalmic personnel to image the retina of patients with diabetes. Images were analyzed with the Eyenuk EyeArt® system, which generated referral recommendations based on presence of diabetic retinopathy (DR) and/or markers for clinically significant macular oedema. Images were independently evaluated by two masked readers and categorized as refer/no refer. The accuracies of the graders and automated interpretation were determined by comparing results to gold standard clinical diagnoses.
Results: A total of 119 eyes from 69 patients were included. RWDR was present in 88 eyes (73.9%) and in 54 patients (78.3%). At the patient-level, automated interpretation had a sensitivity of 87.0% and specificity of 78.6%; grader 1 had a sensitivity of 96.3% and specificity of 42.9%; grader 2 had a sensitivity of 92.5% and specificity of 50.0%. At the eye-level, automated interpretation had a sensitivity of 77.8% and specificity of 71.5%; grader 1 had a sensitivity of 94.0% and specificity of 52.2%; grader 2 had a sensitivity of 89.5% and specificity of 66.9%.
Discussion: Retinal photography with RetinaScope combined with automated interpretation by EyeArt achieved a lower sensitivity but higher specificity than trained expert graders. Feasibility testing was performed using non-ophthalmic personnel in a retina clinic with high disease burden. Additional studies are needed to assess efficacy of screening diabetic patients from general population.