PURPOSE To prospectively determine the relationship of OCT angiography (OCTA) metrics to diabetic retinopathy (DR) progression and development of diabetic macular edema (DME). DESIGN Prospective, observational study. PARTICIPANTS A total of 205 eyes from 129 patients with diabetes mellitus followed up for at least 2 years. METHODS All participants underwent OCTA with a swept-source OCT device (DRI-OCT Triton, Topcon, Inc, Tokyo, Japan). Individual OCTA images of superficial capillary plexus (SCP) and deep capillary plexus (DCP) were generated by IMAGEnet6 (Basic License 10). After a quality check, automated measurements of foveal avascular zone (FAZ) area, FAZ circularity, vessel density (VD), and fractal dimension (FD) of both SCP and DCP were then obtained. MAIN OUTCOME MEASURES Progression of DR and development of DME. RESULTS Over a median follow-up of 27.14 months (interquartile range, 24.16-30.41 months), 28 of the 205 eyes (13.66%) developed DR progression. Of the 194 eyes without DME at baseline, 17 (8.76%) developed DME. Larger FAZ area (hazard ratio [HR], 1.829 per SD increase; 95% confidence interval [CI], 1.332-2.512), lower VD (HR, 1.908 per SD decrease; 95% CI, 1.303-2.793), and lower FD (HR, 4.464 per SD decrease; 95% CI, 1.337-14.903) of DCP were significantly associated with DR progression after adjusting for established risk factors (DR severity, glycated hemoglobin, duration of diabetes, age, and mean arterial blood pressure at baseline). Lower VD of SCP (HR, 1.789 per SD decrease; 95% CI, 1.027-4.512) was associated with DME development. Compared with the model with established risk factors alone, the addition of OCTA metrics improved the predictive discrimination of DR progression (FAZ area of DCP, C-statistics 0.723 vs. 0.677, P < 0.001; VD of DCP, C-statistics 0.727 vs. 0.677, P = 0.001; FD of DCP, C-statistics 0.738 vs. 0.677, P < 0.001) and DME development (VD of SCP, C-statistics 0.904 vs. 0.875, P = 0.036). CONCLUSIONS The FAZ area, VD, and FD of DCP predict DR progression, whereas VD of SCP predicts DME development. Our findings provide evidence to support that OCTA metrics improve the evaluation of risk of DR progression and DME development beyond traditional risk factors.

中文翻译：

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OCT血管造影术指标可预测糖尿病性视网膜病变的进展和糖尿病性黄斑水肿的发展：一项前瞻性研究。

目的前瞻性确定OCT血管造影（OCTA）指标与糖尿病性视网膜病变（DR）进展和糖尿病性黄斑水肿（DME）的关系。设计前瞻性观察研究。参加者对来自129名糖尿病患者的205眼进行了至少2年的随访。方法所有参加者均使用扫描源OCT设备（DRI-OCT Triton，Topcon，Inc，东京，日本）进行OCTA。通过IMAGEnet6（基本许可证10）生成了浅表毛细血管丛（SCP）和深毛细血管丛（DCP）的OCTA图像。在进行质量检查之后，然后自动测量了SCP和DCP的中央凹无血管区域（FAZ）面积，FAZ圆形度，血管密度（VD）和分形维数（FD）。主要观察指标DR的进展和DME的发展。结果在平均随访27.14个月（四分位间距为24.16-30.41个月）中，205眼中的28眼（13.66％）发展为DR进展。在基线时没有DME的194眼中，有17眼（8.76％）发生了DME。较大的FAZ区域（危险比[HR]，每SD增加1.829； 95％置信区间[CI]，1.332-2.512），更低的VD（HR，每SD降低1.908； 95％CI，1.303-2.793），以及更低的FD在调整已确定的危险因素（DR严重程度，糖化血红蛋白，糖尿病持续时间，年龄和基线平均动脉血压）后，DCP（HR，每SD降低4.464； 95％CI，1.337-14.903）与DR进展显着相关）。SCP的较低VD（HR，每SD降低1.789； 95％CI，1.027-4.512）与DME的发展有关。与仅建立风险因素的模型相比，加入OCTA指标可改善对DR进展的预测辨别力（DCP的FAZ区域，C统计量为0.723 vs.0.677，P <0.001; DCP的VD，C统计量为0.727 vs.0.677，P = 0.001; DCP的FD， C统计量0.738对0.677，P <0.001）和DME发展（SCP的VD，C统计量0.904对0.875，P = 0.036）。结论DCP的FAZ区域，VD和FD可以预测DR的进展，而SCP的VD可以预测DME的发展。我们的发现提供了证据，证明OCTA指标超越了传统的风险因素，可以改善对DR进展和DME发展的风险的评估。904对0.875，P = 0.036）。结论DCP的FAZ区域，VD和FD可以预测DR的进展，而SCP的VD可以预测DME的发展。我们的发现提供了证据，证明OCTA指标超越了传统的风险因素，可以改善对DR进展和DME发展的风险的评估。904比0.875，P = 0.036）。结论DCP的FAZ区域，VD和FD可以预测DR的进展，而SCP的VD可以预测DME的发展。我们的发现提供了证据，证明OCTA指标超越了传统的风险因素，可以改善对DR进展和DME发展的风险的评估。