Abstract

Artificial Intelligence has showcased clear capabilities to automatically grade diabetic retinopathy (DR) on mydriatic retinal images captured by clinical experts on fixed table-top retinal cameras within hospital settings. However, in many low- and middle-income countries, screening for DR revolves around minimally trained field workers using handheld non-mydriatic cameras in community settings. This prospective study evaluated the diagnostic accuracy of a deep learning algorithm developed using mydriatic retinal images by the Singapore Eye Research Institute, commercially available as Zeiss VISUHEALTH-AI DR, on images captured by field workers on a Zeiss Visuscout® 100 non-mydriatic handheld camera from people with diabetes in a house-to-house cross-sectional study across 20 regions in India. A total of 20,489 patient eyes from 11,199 patients were used to evaluate algorithm performance in identifying referable DR, non-referable DR, and gradability. For each category, the algorithm achieved precision values of 29.60 (95% CI 27.40, 31.88), 92.56 (92.13, 92.97), and 58.58 (56.97, 60.19), recall values of 62.69 (59.17, 66.12), 85.65 (85.11, 86.18), and 65.06 (63.40, 66.69), and F-score values of 40.22 (38.25, 42.21), 88.97 (88.62, 89.31), and 61.65 (60.50, 62.80), respectively. Model performance reached 91.22 (90.79, 91.64) sensitivity and 65.06 (63.40, 66.69) specificity at detecting gradability and 72.08 (70.68, 73.46) sensitivity and 85.65 (85.11, 86.18) specificity for the detection of all referable eyes. Algorithm accuracy is dependent on the quality of acquired retinal images, and this is a major limiting step for its global implementation in community non-mydriatic DR screening using handheld cameras. This study highlights the need to develop and train deep learning-based screening tools in such conditions before implementation.

Highlights

  • There are 463 million people with diabetes in the world. 80% of this population reside in low- and middle-income countries (LMIC), where resources are limited, and 30% present diabetic retinopathy (DR) [1,2]

  • We evaluated the diagnostic accuracy of the Deep Learning algorithm developed by the Singapore Eye Research Institute (SERI) on mydriatic retinal images, which is commercially deployed in Zeiss VISUHEALTH-AI DR, for grading non-mydriatic retinal images captured by field workers using handheld cameras through non-dilated pupils versus human graders in a real-world community DR screening in India

  • We evaluated the accuracy of an offline automated screening algorithm to identify referable DR from fundus images of people with diabetes captured by minimally trained field workers using non-mydriatic handheld cameras in a home environment

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Summary

Introduction

There are 463 million people with diabetes in the world. 80% of this population reside in low- and middle-income countries (LMIC), where resources are limited, and 30% present diabetic retinopathy (DR) [1,2]. Many high-income countries have established DR screening as a public health programme, recommending yearly screening of people with diabetes [4]. DR screening is conducted at fixed locations, and images of the central retina acquired after pupil dilation by trained screeners using standardised, table-top fixed retinal cameras are graded for DR by qualified graders. Patients with VTDR, or if images are ungradable, are referred to ophthalmic departments for further management. This successful DR screening is laborious and cannot be translated to LMIC [5], where opportunistic DR screening is performed by minimally trained field workers in medical camps or public spaces, and pupil dilation is not routinely carried out due to restrictive policies. Image acquisition by field workers in communities with limited healthcare access can be challenging due to the increased prevalence of undiagnosed co-pathologies, especially cataract [7]

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