Diabetic retinopathy screening using smartphone-based fundus imaging in India.

Purpose: Early detection and treatment can prevent irreversible blindness from diabetic retinopathy (DR), which is the leading cause of visual impairment among working-aged adults worldwide. Some 80% of affected persons live in low- and middle-income countries, yet lack of resources has largely prevented DR screening implementation in these world regions. Smartphone-based fundus imaging (SBFI) allows for low-cost mobile fundus examination using an adapter on a smartphone; however, key aspects such as image quality, diagnostic accuracy, and comparability of different approaches have not been systematically assessed to date. Design: Evaluation of diagnostic technology. Participants: A total of 381 eyes of 193 patients with diabetes were recruited at outreach eye clinics in South India. Methods: We compared 4 technically different approaches of SBFI (3 approaches based on direct and 1 approach based on indirect ophthalmoscopy) in terms of image quality and diagnostic accuracy for DR screening. Main Outcome Measures: Image quality (sharpness/focus, reflex artifacts, contrast, and illumination), fieldof-view, examination time, and diagnostic accuracy for DR screening were analyzed against conventional fundus photography and clinical examination. Results: Smartphone-based fundus imaging based on indirect ophthalmoscopy yielded the best image quality (P < 0.01), the largest field-of-view, and the longest examination time (111 vs. 68e86 seconds, P < 0.0001). Agreement with the reference standard (Cohen's kappa 0.868) and sensitivity/specificity to detect DR were highest for the indirect SBFI approach (0.79/0.99 for any DR and 1.0/1.0 for severe DR, 0.79/1.0 for diabetic maculopathy). Conclusions: Smartphone-based fundus imaging can meet DR screening requirements in an outreach setting; however, not all devices are suitable in terms of image quality and diagnostic accuracy. Smartphone-based fundus imaging might aid in alleviating the burden of DR screening in low- and middle-income countries, and these results will allow for a better selection of SBFI devices in field trials for DR screening. (C) 2020 by the American Academy of Ophthalmology