Piatti A, Rui C, Gazzina S, Tartaglino B, Romeo F, Manti R, Doglio M, Nada E, Giorda C B
Eye-Unit, Primary Care, ASL TO5, Regione Piemonte, Italy.
Centervue SpA, Padova, Italy.
Eur J Ophthalmol. 2025 Mar;35(2):679-688. doi: 10.1177/11206721241272229. Epub 2024 Aug 7.
Screening for diabetic retinopathy (DR) by ophthalmologists is costly and labour-intensive. Artificial Intelligence (AI) for automated DR detection could be a clinically and economically alternative. We assessed the performance of a confocal fundus imaging system (DRSplus, Centervue SpA), coupled with an AI algorithm (RetCAD, Thirona B.V.) in a real-world setting.
45° non-mydriatic retinal images from 506 patients with diabetes were graded both by an ophthalmologist and by the AI algorithm, according to the International Clinical Diabetic Retinopathy severity scale. Less than moderate retinopathy (DR scores 0, 1) was defined as non-referable, while more severe stages were defined as referable retinopathy. The gradings were then compared both at eye-level and patient-level. Key metrics included sensitivity, specificity all measured with a 95% Confidence Interval.
The percentage of ungradable eyes according to the AI was 2.58%. The performances of the AI algorithm for detecting referable DR were 97.18% sensitivity, 93.73% specificity at eye-level and 98.70% sensitivity and 91.06% specificity at patient-level.
DRSplus paired with RetCAD represents a reliable DR screening solution in a real-world setting. The high sensitivity of the system ensures that almost all patients requiring medical attention for DR are referred to an ophthalmologist for further evaluation.
眼科医生筛查糖尿病视网膜病变(DR)成本高昂且劳动强度大。用于自动检测DR的人工智能(AI)可能是一种临床和经济上的替代方案。我们在实际环境中评估了一种共焦眼底成像系统(DRSplus,Centervue SpA)与一种AI算法(RetCAD,Thirona B.V.)的性能。
根据国际临床糖尿病视网膜病变严重程度量表,由一名眼科医生和AI算法对506例糖尿病患者的45°免散瞳视网膜图像进行分级。轻度以下视网膜病变(DR评分为0、1)定义为无需转诊,而更严重阶段定义为需转诊的视网膜病变。然后在眼水平和患者水平上比较分级结果。关键指标包括敏感性、特异性,均以95%置信区间进行测量。
根据AI无法分级的眼睛比例为2.58%。AI算法检测需转诊DR的性能在眼水平上敏感性为97.18%,特异性为93.73%;在患者水平上敏感性为98.70%,特异性为91.06%。
DRSplus与RetCAD相结合在实际环境中是一种可靠的DR筛查解决方案。该系统的高敏感性确保了几乎所有需要因DR接受医疗关注的患者都被转诊给眼科医生进行进一步评估。