Clinical evaluation of patients with diabetic retinopathy - Accuracy of the Inoveon Diabetic Retinopathy-3DT System
Clinical evaluation of patients with diabetic retinopathy - Accuracy of the Inoveon Diabetic Retinopathy-3DT System
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DOI：
10.1016/s0161-6420(01)00990-3
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发表时间：
2002-03-01
期刊：
影响因子：
13.7
通讯作者：
Hildebrand, PL
中科院分区：
文献类型：
--
作者：
Fransen, SR;Leonard-Martin, TC;Hildebrand, PL
目的：本研究分析了Inoveon糖尿病视网膜病变（DR-3DT）系统（Inoveon Corp.，俄克拉荷马州市），一种使用高质量数字视网膜成像管理糖尿病视网膜病变的可扩展评估方法。设计：一项独立的、设盲的、横断面的、临床验证研究。参与者：来自俄克拉荷马州阿达市奇克索国家卡尔阿尔伯特印第安人健康机构的290名糖尿病成人患者。方法：所有参与者都使用蔡司FF 450眼底照相机进行了DRS 7成像，图像记录在35 mm胶片和柯达DCS 520数码相机上。经独立第三读片人裁定的盲法双重分级得出每只眼睛的早期治疗糖尿病视网膜病变研究（ETDRS）最终视网膜病变严重程度量表水平（ETDRS水平）和黄斑水肿分期。存在大于或等于ETDRS 53级，可疑或明确的任何一只眼睛的临床显著性黄斑水肿，或无法分级的图像被定义为需要转诊的阈值事件。主要结果指标：准确性（灵敏度，特异性，预测值）的数字系统相对于电影“金标准”的阈值转诊标准每名患者。所有至少有一只眼睛有可分级35 mm载玻片的患者均被纳入该每例患者分析（n = 290）。阈值事件发生率为19.3%。数字系统检测阈值事件的灵敏度为98.2%（95%置信区间[CI]，90.5%-100.0%），特异性为89.7%（95% CI，85.1%-93.3%）。结论：与“金标准”相比，Inoveon的DR-3DT系统提供了高度准确的糖尿病视网膜病变转诊决策，鉴于其固有的优势，高质量的数字成像系统可以取代胶片“金标准”，作为可扩展、可访问的糖尿病视网膜病变评估的基础。眼科学2002;709：595-601（C）2002，美国眼科学会。
Purpose: This study analyzed the accuracy of the Inoveon Diabetic Retinopathy (DR-3DT) system (Inoveon Corp., Oklahoma City, OK), a scalable evaluation method for the management of diabetic retinopathy using high-quality digital retinal imaging.Design: An independent, masked, cross-sectional, clinical validation study.Participants: Two hundred ninety adult patients with diabetes from the Chickasaw Nation's Carl Albert Indian Health Facility in Ada, Oklahoma.Methods: All participants underwent DRS7 imaging using a Zeiss FF450 fundus camera with images recorded on 35-mm film and a Kodak DCS520 digital camera back. Masked double grading with independent third reader adjudication yielded an Early Treatment Diabetic Retinopathy Study (ETDRS) Final Retinopathy Severity Scale Level (ETDRS Level) and macular edema stage for each eye. The presence of greater than or equal to ETDRS Level 53, questionable or definite clinically significant macular edema in either eye, or ungradeable images was defined as a threshold event requiring referral.Main Outcome Measures: Accuracy (sensitivity, specificity, predictive values) of the digital system relative to the film "gold standard" on the threshold referral criteria per patient.Results: All patients with gradeable 35-mm slides from at least one eye were included in this per patient analysis (n = 290). The prevalence of threshold events was 19.3%. The sensitivity of the digital system in detecting threshold events was 98.2% (95% confidence interval [CI], 90.5%-100.0%) and specificity 89.7% (95% CI, 85.1%-93.3%). The positive predictive value was 69.5% and negative predictive value 99.5% for this sample.Conclusions: When compared with the "gold standard," Inoveon's DR-3DT system provides highly accurate diabetic retinopathy referral decisions, Given their inherent advantages, high-quality digital imaging systems could replace the film "gold standard" as the basis for scalable, accessible, diabetic retinopathy evaluation. Ophthalmology 2002;709:595-601 (C) 2002 by the American Academy of Ophthalmology.