Comparison of 50° handheld fundus camera versus ultra-widefield table-top fundus camera for diabetic retinopathy detection and grading.

OBJECTIVES: To compare the performance of a handheld fundus camera with standard 50° visual field to ultra-widefield (UWF) table-top fundus camera in diabetic retinopathy (DR) detection and grading. METHODS: Patients affected by diabetes mellitus and referred to our diabetic retinopathy clinic were enroled and underwent fundus photography in mydriasis. All photos were taken using the ultra-widefield table-top fundus camera Zeiss Clarus™ 500 (four fields per eye) and the Optomed Aurora® handheld fundus camera (3 fields per eye). The following parameters were analysed: the gradability of the images, the grade of DR, and diabetic maculopathy (DM), the presence of hypertensive retinopathy (HR) and the presence of other ocular diseases. RESULTS: We enroled 759 eyes of 384 diabetic patients and analysed 5313 fundus photos. The handheld fundus camera obtained a sensitivity of 84.2% and specificity of 95.4% for referable cases. Moreover, it obtained, compared to UWF, an almost perfect agreement with linear weighting for DR, DM and HR (k = 0.877, k = 0.854, and k = 0.961, respectively). The lowest sensitivity was achieved for proliferative DR (58.7% sensitivity, 100% specificity). CONCLUSIONS: Optomed Aurora® handheld fundus camera imaging showed a strong agreement compared to UWF in grading DR, considering all DR and DM grades, in mydriasis. However, the use of UWF imaging increases the detection of referable eyes.

Handheld Fundus Camera for Diabetic Retinopathy Screening: A Comparison Study with Table-Top Fundus Camera in Real-Life Setting.

The aim of the study was to validate the performance of the Optomed Aurora® handheld fundus camera in diabetic retinopathy (DR) screening. Patients who were affected by diabetes mellitus and referred to the local DR screening service underwent fundus photography using a standard table-top fundus camera and the Optomed Aurora® handheld fundus camera. All photos were taken by a single, previously unexperienced operator. Among 423 enrolled eyes, we found a prevalence of 3.55% and 3.31% referable cases with the Aurora® and with the standard table-top fundus camera, respectively. The Aurora® obtained a sensitivity of 96.9% and a specificity of 94.8% in recognizing the presence of any degree of DR, a sensitivity of 100% and a specificity of 99.8% for any degree of diabetic maculopathy (DM) and a sensitivity of 100% and specificity of 99.8% for referable cases. The overall concordance coefficient k (95% CI) was 0.889 (0.828-0.949) and 0.831 (0.658-1.004) with linear weighting for DR and DM, respectively. The presence of hypertensive retinopathy (HR) was recognized by the Aurora® with a sensitivity and specificity of 100%. The Optomed Aurora® handheld fundus camera proved to be effective in recognizing referable cases in a real-life DR screening setting. It showed comparable results to a standard table-top fundus camera in DR, DM and HR detection and grading. The Aurora® can be integrated into telemedicine solutions and artificial intelligence services which, in addition to its portability and ease of use, make it particularly suitable for DR screening.