Domalpally Amitha, Barrett Nancy, Reimers James, Blodi Barbara
Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
McPherson Eye Research Institute, University of Wisconsin-Madison, Madison, Wisconsin.
Ophthalmol Sci. 2021 May 26;1(2):100029. doi: 10.1016/j.xops.2021.100029. eCollection 2021 Jun.
To compare Early Treatment Diabetic Retinopathy Study (ETDRS) severity levels between standard 7-field imaging and ultra-widefield (UWF) imaging and to incorporate peripheral diabetic retinopathy (DR) lesions into the ETDRS grading system.
Cross-sectional Study.
Paired images from 192 eyes (189 participants) with diabetic retinopathy were included.
The ETDRS levels were determined by masked graders in 3 ways: standard 7-field imaging, UWF within the 7-field region (7-field UWF imaging), and the entire UWF image (global ETDRS imaging).
Percentage agreement between 7-field and UWF imaging for ETDRS levels.
Of the 166 paired images evaluated, exact agreement was found in 48.8% of eyes between standard 7-field and 7-field UWF ETDRS levels with a weighted κ value of 0.59 (95% confidence interval [CI], 0.5-0.68). Agreement rates varied with DR severity and were least in early DR (30.8%) and moderate nonproliferative DR (26.5%) groups. In 156 eyes with 7-field UWF ETDRS and global UWF ETDRS levels, exact agreement was found in 143 eyes (92%), with a weighted κ value of 0.9 (95% CI, 0.9-0.98). The peripheral lesions contributed to a higher DR severity in 8% and changed the eye to a proliferative DR level in 2%. Reproducibility of the 3 ETDRS evaluations was comparable with a weighted κ value of 0.57 with standard 7-field imaging, 0.65 with 7-field UWF imaging, and 0.60 with global ETDRS scale imaging.
Moderate agreement was found in the ETDRS DR severity scale between standard 7-field and UWF imaging, indicating caution in interchanging data from the 2 methods. Both methods showed good reproducibility for clinical trial outcome of 2-step change. The global ETDRS scale provides a comprehensive score to incorporate peripheral changes into the ETDRS scale. The implications of the global scale on progression rate are yet to be determined.
比较标准7视野成像与超广角（UWF）成像之间的糖尿病视网膜病变早期治疗研究（ETDRS）严重程度水平，并将周边糖尿病视网膜病变（DR）病变纳入ETDRS分级系统。
横断面研究。
纳入了192只眼睛（189名参与者）患有糖尿病视网膜病变的配对图像。
ETDRS水平由经过遮蔽的分级人员通过3种方式确定：标准7视野成像、7视野区域内的UWF（7视野UWF成像）以及整个UWF图像（整体ETDRS成像）。
7视野和UWF成像在ETDRS水平上的一致性百分比。
在评估的166对图像中，标准7视野和7视野UWF ETDRS水平之间，48.8%的眼睛完全一致，加权κ值为0.59（95%置信区间[CI]，0.5 - 0.68）。一致性率随DR严重程度而异，在早期DR组（30.8%）和中度非增殖性DR组（26.5%）中最低。在156只眼睛的7视野UWF ETDRS和整体UWF ETDRS水平中，143只眼睛（92%）完全一致，加权κ值为0.9（95% CI，0.9 - 0.98）。周边病变使8%的患者DR严重程度升高，2%的患者病变进展为增殖性DR水平。3种ETDRS评估的可重复性相当，标准7视野成像的加权κ值为0.57，7视野UWF成像为0.65，整体ETDRS量表成像为0.60。
标准7视野和UWF成像在ETDRS DR严重程度量表上的一致性为中等，这表明在互换这两种方法的数据时需谨慎。两种方法在两步变化的临床试验结果方面均显示出良好的可重复性。整体ETDRS量表提供了一个综合评分，可将周边变化纳入ETDRS量表。整体量表对进展率的影响尚待确定。
