ABSTRACT
PURPOSE: Diabetic retinopathy (DR) is a leading cause of preventable blindness, particularly in underserved regions where access to ophthalmic care is limited. This study presents a proof of concept for utilizing a portable handheld retinal camera with an embedded artificial intelligence (AI) platform, complemented by a synchronous remote confirmation by retina specialists, for DR screening in an underserved rural area. DESIGN: Retrospective cohort study. SUBJECTS: A total of 1115 individuals with diabetes. METHODS: A retrospective analysis of a screening initiative conducted in 4 municipalities in Northeastern Brazil, targeting the diabetic population. A portable handheld retinal camera captured macula-centered and disc-centered images, which were analyzed by the AI system. Immediate push notifications were sent out to retina specialists upon the detection of significant abnormalities, enabling synchronous verification and confirmation, with on-site patient feedback within minutes. Referral criteria were established, and all referred patients underwent a complete ophthalmic work-up and subsequent treatment. MAIN OUTCOME MEASURES: Proof-of-concept implementation success. RESULTS: Out of 2052 invited individuals, 1115 participated, with a mean age of 60.93 years and diabetes duration of 7.52 years; 66.03% were women. The screening covered 2222 eyes, revealing various retinal conditions. Referable eyes for DR were 11.84%, with an additional 13% for other conditions (diagnoses included various stages of DR, media opacity, nevus, drusen, enlarged cup-to-disc ratio, pigmentary changes, and other). Artificial intelligence performance for overall detection of referable cases (both DR and other conditions) was as follows: sensitivity 84.23% (95% confidence interval (CI), 82.63-85.84), specificity 80.79% (95% CI, 79.05-82.53). When we assessed whether AI matched any clinical diagnosis, be it referable or not, sensitivity was 85.67% (95% CI, 84.12-87.22), specificity was 98.86 (95% CI, 98.39-99.33), and area under the curve was 0.92 (95% CI, 0.91-0.94). CONCLUSIONS: The integration of a portable device, AI analysis, and synchronous medical validation has the potential to play a crucial role in preventing blindness from DR, especially in socially unequal scenarios. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
ABSTRACT
AIMS: This study aims to compare the performance of a handheld fundus camera (Eyer) and standard tabletop fundus cameras (Visucam 500, Visucam 540, and Canon CR-2) for diabetic retinopathy and diabetic macular edema screening. METHODS: This was a multicenter, cross-sectional study that included images from 327 individuals with diabetes. The participants underwent pharmacological mydriasis and fundus photography in two fields (macula and optic disk centered) with both strategies. All images were acquired by trained healthcare professionals, de-identified, and graded independently by two masked ophthalmologists, with a third senior ophthalmologist adjudicating in discordant cases. The International Classification of Diabetic Retinopathy was used for grading, and demographic data, diabetic retinopathy classification, artifacts, and image quality were compared between devices. The tabletop senior ophthalmologist adjudication label was used as the ground truth for comparative analysis. A univariate and stepwise multivariate logistic regression was performed to determine the relationship of each independent factor in referable diabetic retinopathy. RESULTS: The mean age of participants was 57.03 years (SD 16.82, 9-90 years), and the mean duration of diabetes was 16.35 years (SD 9.69, 1-60 years). Age (P = .005), diabetes duration (P = .004), body mass index (P = .005), and hypertension (P < .001) were statistically different between referable and non-referable patients. Multivariate logistic regression analysis revealed a positive association between male sex (OR 1.687) and hypertension (OR 3.603) with referable diabetic retinopathy. The agreement between devices for diabetic retinopathy classification was 73.18%, with a weighted kappa of 0.808 (almost perfect). The agreement for macular edema was 88.48%, with a kappa of 0.809 (almost perfect). For referable diabetic retinopathy, the agreement was 85.88%, with a kappa of 0.716 (substantial), sensitivity of 0.906, and specificity of 0.808. As for image quality, 84.02% of tabletop fundus camera images were gradable and 85.31% of the Eyer images were gradable. CONCLUSIONS: Our study shows that the handheld retinal camera Eyer performed comparably to standard tabletop fundus cameras for diabetic retinopathy and macular edema screening. The high agreement with tabletop devices, portability, and low costs makes the handheld retinal camera a promising tool for increasing coverage of diabetic retinopathy screening programs, particularly in low-income countries. Early diagnosis and treatment have the potential to prevent avoidable blindness, and the present validation study brings evidence that supports its contribution to diabetic retinopathy early diagnosis and treatment.
