免散瞳双视野45°眼底成像系统与两种免散瞳超广角眼底成像系统在糖尿病视网膜病变快速筛查中的对比评估

Compared non-mydriatic two-field 45°fundus imaging methods with non-mydriatic two ultra-widefield fundus imaging in a large-scale diabetic retinopathy screening

目的对比观察免散瞳双视野45°眼底成像系统与两种超广角眼底成像系统在糖尿病视网膜病变(DR)快速筛查结果中的一致性及检出率的差异性。方法诊断方法学研究。2020年11月至2021年8月于河南省人民医院眼科就诊的2型糖尿病患者277例526只眼纳入研究。其中,男性175例328只眼,女性102例198只眼;年龄(53±10)岁。由同一名经验丰富的技术人员在同一天对患者进行免散瞳双视野45°眼底成像以及免散瞳超广角成像系统Optos、Clarus500单视野眼底成像检查,获得双视野45°眼底像及Optos、Clarus500单视野眼底像。应用Photoshop软件截取与双视野45°眼底像相同区域的Optos、Clarus500单视野眼底像,获得Optos、Clarus500双视野眼底像。其后由两名经验丰富的眼科医师分别对5组图像进行阅片和DR分级。对于分级结果不一致的图像,由第3位眼科医师单独进行判读,并将其作为最终分级结果。以免散瞳双视野45°眼底成像判读结果为标准,评价两种超广角眼底成像系统在DR快速筛查结果中的一致性和检出率差异。采用加权Kappa(κ)检验分析双视野45°眼底成像与Optos、Clarus500眼底成像对DR诊断的一致性;不同成像系统间DR检出率比较行χ^(2)检验。结果与双视野45°眼底像比较,Clarus500单视野眼底像DR检出率更高(χ^(2)=24.965,P<0.001),Optos双视野眼底像DR检出率更低(χ^(2)=49.559,P<0.001),差异均有统计学意义;Optos单视野眼底像、Clarus500双视野眼底像与之差异无统计学意义(χ^(2)=2.572、0.649,P=0.109、0.421)。Optos、Clarus500单视野、双视野眼底像DR检出率比较,差异均有统计学意义(χ^(2)=43.214、61.216,P<0.001)。DR分级结果一致性评估:双视野45°眼底像与Clarus500双视野眼底像(κ值=0.932,95%可信区间(CI)0.907~0.956)呈高度一致性;双视野45°眼底像与Optos单视野眼底像[κ值=0.474,95%CI 0.417~0.532]、Optos双视野眼底像(κ值=0.495,95%CI 0.438~0.551)以及Optos双视野眼底像与Clarus500双视野眼底像(κ值=0.452,95%CI 0.395~0.506)均呈中度一致性;双视野45°眼底像与Clarus500单视野眼底像(κ值=0.354,95%CI 0.303~0.403)以及Optos单视野眼底像与Clarus500单视野眼底像(κ值=0.347,95%CI 0.287~0.393)呈一般一致性。结论与Optos双视野眼底像比较,双视野45°眼底像与Clarus500双视野眼底像在DR快速筛查中分级结果具有较高一致性;与Optos单视野眼底像比较,Clarus500单视野眼底像的DR检出率更高。

Objective To compare the consistency and difference of non-mydriatic two-field 45°ultra-wide field Optos and Clarus500 fundus imaging in a large-scale diabetic retinopathy(DR)screening.Methods A diagnostic methodology study.From November 2020 to August 2021,526 eyes of 277 patients with type 2 diabetes who diagnosed in Department of Ophthalmology,Henan Provincial People's Hospital were included in the study.Among them,there were 175 males with 328 eyes and 102 females with 198 eyes;the age was 53±10 years old.The same experienced technician performed the non-mydriatic dual-field 45°fundus imaging and the non-mydriatic ultra-wide-angle imaging system Optos,Clarus500 single-field fundus imaging examination on the patient on the same day,and obtained the dual-field 45°fundus image and Optos,Clarus500 single-field fundus image.The Optos and Clarus500 single-field fundus images in the same area as the dual-field 45°fundus image were captured by Photoshop software,and the Optos and Clarus500 dual-field fundus images were obtained.Subsequently,two experienced ophthalmologists performed interpretation and DR grading of the 5 groups of images,respectively.Images with inconsistent grading results were interpreted by a third ophthalmologist and used as the final grading result.In order to avoid the mydriatic dual-field 45°imaging interpretation results as the standard,the consistency and detection rate difference of the two ultra-wide-angle imaging systems in the rapid DR screening results were evaluated.The weighted Kappa(κ)test was used to analyze the consistency of DR diagnosis between dual-field 45°fundus imaging and Optos and Clarus500 fundus imaging;χ^(2) test was used to compare the detection rates of DR between different imaging systems.Results Compared with the dual-field 45°fundus image,the Clarus500 single-field had a higher DR detection rate(χ^(2)=24.965,P<0.001),and the Optos dual-field fundus image had a lower DR detection rate(χ^(2)=49.559,P<0.001).Compared with the DR detection rate of dual-field 45°fundus image,Optos single-field fundus image,Clarus500 double-field fundus image had no significant difference(χ^(2)=2.572,0.649;P=0.109,0.421).Compared with Optos,Clarus500 single-field and dual-field fundus images DR detection rate,the difference was statistically significant(χ^(2)=43.214,61.216;P<0.001).Consistency assessment of DR grading results:dual-field 45°fundus images and Clarus500 dual-field fundus images(κvalue=0.932,95%confidence interval(CI)0.907-0.956)were highly consistent;dual-field 45°fundus images and Optos single-field fundus images[κvalue=0.474,95%CI 0.417-0.532],Optos dual-field fundus image(κvalue=0.495,95%CI 0.438-0.551),Optos dual-field fundus image(κvalue=0.495,95%CI 0.438-0.551)and Clarus500 dual-field fundus image(κvalue=0.452,95%CI 0.395-0.506)were moderately consistent;dual-field 45°fundus images and Clarus500 single-field fundus images(κvalue=0.354,95%CI 0.303-0.403)and Optos single-field fundus images and Clarus500 single-field fundus images(κvalue=0.347,95%CI 0.287-0.393)showed general agreement.Conclusions Compared with Optos dual-field fundus image,dual-field 45°fundus image and Clarus500 dual-field fundus image have high consistency in the grading results of DR rapid screening.Compared with Optos single-field fundus image,the detection rate of the DR of Clarus500 single-field fundus image is higher.