摘要目的 观察免散瞳超广角成像系统与免散瞳2个视野45°数码成像系统对糖尿病视网膜病变(DR)筛查结果的一致性及差异性.方法 由2名技术人员在同一天分别对社区规范化管理的2型糖尿病患者同一患者的同一只眼行免散瞳超广角成像系统和免散瞳2个视野45°数码成像系统检查,同时成功采集两组图像的717例患者1434只眼纳入统计.图像采集后由2名经验丰富的眼底病专科医生分别对两组图像进行阅片和DR分期.对于分期结果不一致的图像,由第3位眼底病专家单独进行图像并排式对比判别,并选择用于评估DR的首选方法.以免散瞳2个视野45°数码成像判读结果为标准,评价免散瞳超广角成像系统判读结果的一致性.统计指标包括敏感性、特异性、Youden指数、诊断试验一致性(Kappa值);同时采用配对t检验对比分析两种方法的差异性.结果 免散瞳超广角成像系统分级,无明显DR(NDR)1062只眼,占74.1％;DR 340只眼,占23.7％;无法判读32只眼,占2.2％.DR 340只眼中,轻度非增生型DR(NPDR)48只眼;中度NPDR 216只眼;重度NPDR 57只眼;增生型DR (PDR) 19只眼.免散瞳2个视野45°数码成像系统分级,NDR 1080只眼,占75.3％;DR 270只眼,占18.8％;无法判读84只眼,占5.6％.DR 270只眼中,轻度NPDR 36只眼;中度NPDR 175只眼;重度NPDR 53只眼;PDR 6只眼.与免散瞳2个视野45°数码成像系统分级结果比较,免散瞳超广角成像系统DR检测敏感性、特异性分别为98.0％、95.0％,Kappa值为0.87;重度NPDR及以上分期患者,敏感性、特异性分别为100.0％、99.0％,Kappa值为0.94.两种检查方法在DR检出率及图像无法判读的比率方面差异均有统计学意义(P=0.00).结论 免散瞳超广角成像系统与免散瞳2个视野45°数码成像系统DR筛查结果具有高度一致性;免散瞳超广角成像系统有更好的适应性、更全面严谨.

abstractsObjective To compare the consistency and difference of nonmydriatic ultrawide field retinal imaging system versus nonmydriatic 2-field 45°digital fundus photography system in a large-scale diabetic retinopathy (DR) screening.Methods A total of 733 with type 2 diabetic patients (1466 eyes) underwent nonmydriatic ultrawide field retinal imaging and nonmydriatic 2-field 45°digital fundus photography examination.Two independent readers graded images respectively to determine the stage of DR.A third masked retinal specialist adjudicated discrepancies.Using nonmydriatic 2-field 45°digital fundus photography examination as the standard,the consistency of nonmydriatic ultrawide field retinal imaging was evaluated.The statistic index included sensitivity,specificity,Youden index and Kappa value.The difference of two methods was analyzed by comparative t-test.Results Based on nonmydriatic ultrawide field retinal imaging,the results were as follows:non DR (NDR) in 1062 eyes (74.1％),DR in 340 eyes (23.7％),ungradable in 32 eyes (2.2％).Among 340 DR eyes,there were mild nonproliferative DR (NPDR) in 48 eyes,moderate NPDR in 216 eyes,severe NPDR in 57 eyes,proliferative DR (PDR) in 19 eyes.Based on nonmydriatic 2-field 45°digital fundus photography,the results were as follows:NDR in 1080 eyes (75.3％),DR in 270 eyes (18.8％),ungradable in 84 eyes (5.6％).Among 270 DR eyes,there were NPDR in 36 eyes,moderate NPDR in 175 eyes,severe NPDR in 53 eyes,PDR in 6 eyes.Compared with nonmydriatic 2-field 45°digital fundus photography for screening DR,the sensitivity was 98.0％,the specificity was 95.0％,and the kappa value was 0.87.For screening severe NPDR and PDR,the sensitivity was 100.0％,the specificity was 99.0％,and the kappa value was 0.94.The DR detection rate and the ratio of the picture can't interpretation between two methods both had significant difference (P =0.00).Conclusions In rapid large-scale DR screening,there is high consistency between nonmydriatic ultrawide field retinal imaging versus nonmydriatic 2-field 45°digital fundus photography.Nonmydriatic ultrawide field retinal imaging is proved to be more adaptive,and more comprehensive and precise.