Midena Edoardo, Zennaro Luca, Lapo Cristian, Torresin Tommaso, Midena Giulia, Pilotto Elisabetta, Frizziero Luisa
Department of Neuroscience-Ophthalmology, University of Padova, 35128 Padova, Italy.
IRCCS-Fondazione Bietti, 00198 Rome, Italy.
J Clin Med. 2022 Apr 22;11(9):2352. doi: 10.3390/jcm11092352.
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.
本研究的目的是验证Optomed Aurora手持式眼底相机在糖尿病视网膜病变（DR）筛查中的性能。患有糖尿病并转诊至当地DR筛查服务机构的患者，使用标准台式眼底相机和Optomed Aurora手持式眼底相机进行眼底摄影。所有照片均由同一位此前无经验的操作人员拍摄。在423只纳入研究的眼中，我们发现使用Aurora相机和标准台式眼底相机的可转诊病例患病率分别为3.55%和3.31%。Aurora相机在识别任何程度的DR时，灵敏度为96.9%，特异性为94.8%；在识别任何程度的糖尿病黄斑病变（DM）时，灵敏度为100%，特异性为99.8%；在识别可转诊病例时，灵敏度为100%，特异性为99.8%。对于DR和DM，线性加权后的总体一致性系数k（95%CI）分别为0.889（0.828 - 0.949）和0.831（0.658 - 1.004）。Aurora相机识别高血压视网膜病变（HR）的灵敏度和特异性均为100%。Optomed Aurora手持式眼底相机在实际的DR筛查环境中被证明在识别可转诊病例方面是有效的。在DR、DM和HR的检测及分级方面，它与标准台式眼底相机显示出相当的结果。Aurora相机可集成到远程医疗解决方案和人工智能服务中，除了其便携性和易用性外，使其特别适合DR筛查。
