Abstract
Screening diabetic retinopathy, a major cause of blindness, is time-consuming for ophthalmologists and has some constrains in achieving full coverage and attendance. The handheld fundus camera EyeFundusScope was recently developed to expand the scale of screening, drawing on images acquired in primary care and telescreening made by ophthalmologists or a computer-aided diagnosis (CADx) system. This study aims to assess the diagnostic accuracy of the interpretation of images captured using EyeFundusScope and perform its technical evaluation, including image quality, functionality, usability, and acceptance in a real-world clinical setting. Physicians and nurses without training in ophthalmology will use EyeFundusScope to take pictures of the retinas of patients with diabetes and the images will be classified for the presence or absence of diabetic retinopathy and image quality by a panel of ophthalmologists. A subgroup of patients will also be examined with the reference standard tabletop fundus camera. Screening results provided by the CADx system on images taken with EyeFundusScope will be compared against the ophthalmologists’ analysis of images taken with the tabletop fundus camera. Diagnostic accuracy measures with 95% confidence intervals (CIs) will be calculated for positive and negative test results. Proportion of each category of image quality will be presented. Usability and acceptance results will be presented qualitatively.
Highlights
We aim to provide that evidence for EyeFundusScope and its integrated CADx system
Evidence from this study of clinical validation will be useful for paving the way of obtaining a Conformité Européenne (CE) mark for EyeFundusScope and for EyeFundusScope + CADx system for diabetic retinopathy
The results of this study will inform the decision makers about the implementation of opportunistic diabetic retinopathy screenings, as well as of extended screening programmes to areas underserved by clinic infrastructure and to people with limitations in mobility
Summary
Patients’ attendance rates range between 61% and 88.9% [17], for reasons such as lack of awareness or misinformation regarding the need for eye screening, not receiving screening invitation, and being unable to drive because of the effect of eye drops for pupil dilation [17,18]. This represents an important loss of opportunity to diagnose early and treat diabetic retinopathy [18], which can, be responsible for patients’ vision loss and blindness [18]. As more and more patients are diagnosed with diabetes and as the human lifespan increases, healthcare services throughout the world need to adapt quickly to ensure that screenings are delivered [20]
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