The screening process can be performed through a trained ophthalmologist's clinical examinations or remote retinal fundus photograph image evaluation via teleophthalmology. The International Council of Ophthalmology recommends an annual examination for individuals with type 1 diabetes five years after the onset of the disease and for those with type 2 diabetes from the time of diagnosis. However, DR-related blindness has increased by approximately 68% in the last 30 years, mainly in LMICs, due to the increasing prevalence of DM. Screening programs and evidence-based strategies have the potential to prevent 95% of DR-related blindness cases, making DR the leading cause of preventable blindness in the working-age population in the industrialized world. While individuals with DR experience no symptoms until the onset of diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR), early screening and treatment can effectively prevent irreversible visual impairment. Diabetic retinopathy (DR) affects approximately one-third of diabetics and can lead to sight-threatening complications in 10% of them. The prevalence and underdiagnosis of DM are particularly higher in low- and middle-income countries (LMICs) due to the economic transition of most nations, the westernization of lifestyle, and improved longevity. 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.ĭiabetes mellitus (DM) is considered a global epidemic, with estimated 537 million adult diabetic worldwide and projected 784 million by 2045, according to the International Diabetes Federation. 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. Our study shows that the handheld retinal camera Eyer performed comparably to standard tabletop fundus cameras for diabetic retinopathy and macular edema screening. As for image quality, 84.02% of tabletop fundus camera images were gradable and 85.31% of the Eyer images were gradable. 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. The agreement for macular edema was 88.48%, with a kappa of 0.809 (almost perfect). The agreement between devices for diabetic retinopathy classification was 73.18%, with a weighted kappa of 0.808 (almost perfect). Multivariate logistic regression analysis revealed a positive association between male sex (OR 1.687) and hypertension (OR 3.603) with referable diabetic retinopathy. 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. 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). A univariate and stepwise multivariate logistic regression was performed to determine the relationship of each independent factor in referable diabetic retinopathy. The tabletop senior ophthalmologist adjudication label was used as the ground truth for comparative analysis. The International Classification of Diabetic Retinopathy was used for grading, and demographic data, diabetic retinopathy classification, artifacts, and image quality were compared between devices. 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 participants underwent pharmacological mydriasis and fundus photography in two fields (macula and optic disk centered) with both strategies. This was a multicenter, cross-sectional study that included images from 327 individuals with diabetes. 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.
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