基于真实环境的人工智能辅助免散瞳眼底照相筛查糖尿病视网膜病变的临床应用研究

Clinical study of the application of artificial intelligence-assisted non-dilated fundus photography for diabetic retinopathy screening in a real-world setting

  • 摘要: 目的探讨真实临床场景下人工智能(AI)辅助免散瞳眼底照相技术在糖尿病眼底病变(DR)筛查中的效率,及其诊断与眼科医师结论的一致性。方法采用前瞻性观察性研究设计,以2018年10月至2024年12月在天津市第四中心医院内分泌科代谢性疾病管理中心接受免散瞳眼底检查的14 305例2型糖尿病患者为研究对象。观察免散瞳检查与AI结合后眼底病变筛查情况及对免散瞳获取的眼底照片,通过加权Kappa检验评估AI系统与眼科专家诊断一致性,并分析筛查失败原因。结果DR总检出率为21.4%(3 056/14 305),其中病程<1年患者DR阳性率达17.2%。AI系统与眼科专家诊断总体一致性Kappa=0.817(95%CI 0.797~0.838,P < 0.001),对中度以上DR识别灵敏度97.3%、特异度95.9%。2023年9月至2024年12月筛查失败率3.7%(115/3 085),主要原因为瞳孔小(70.4%)及白内障等导致介质不清(24.3%)。结论在内分泌诊区设置免散瞳眼底检查可促进DR早期筛查,AI辅助免散瞳筛查在真实临床场景中展现出良好效能。

     

    Abstract: ObjectiveTo investigate the efficiency of artificial intelligence (AI)-assisted non-dilated fundus photography in diabetic retinopathy (DR) screening in a real-world clinical setting and evaluate its diagnostic consistency with ophthalmologists’ assessments. MethodsIn this prospective observational study, 14, 305 type 2 diabetes mellitus (T2DM) patients who underwent non-dilated fundus examination at the Metabolic Disease Management Center (MMC) of Tianjin Fourth Central Hospital between October 2018 and December 2024 were enrolled. The AI system (VoxelCloud) was used to analyze images captured during non-dilated fundus photography. The weighted Kappa test was employed to assess the agreement between the AI system and expert ophthalmologists. Screening failure rates and causes were also analyzed. ResultsThe overall DR prevalence was 21.4% (3, 056/14, 305), with a DR positivity rate of 17.2% among patients with T2DM duration of <1 year. The AI system demonstrated substantial agreement with ophthalmologists Kappa = 0.817(95%CI 0.797-0.838), P < 0.001. For moderate-to-severe DR, the AI system achieved a sensitivity of 97.3% and specificity of 95.9%. The screening failure rate was 3.7% (115/3, 085), primarily due to small pupil size (70.4%) and media opaque caused by conditions such as cataracts (24.3%). ConclusionImplementing non-dilated fundus photography in endocrine clinics facilitates early DR screening. AI-assisted non-dilated screening demonstrates high efficacy in real-world clinical practice.

     

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