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 血管造影指标预测糖尿病视网膜病变的进展和糖尿病黄斑水肿的发展：一项前瞻性研究。


目的前瞻性确定 OCT 血管造影 (OCTA) 指标与糖尿病视网膜病变 (DR) 进展和糖尿病黄斑水肿 (DME) 发展的关系。设计 前瞻性、观察性研究。参与者 对 129 名糖尿病患者的 205 只眼睛进行了至少 2 年的随访。方法 所有参与者均使用扫频 OCT 设备（DRI-OCT Triton，Topcon，Inc，东京，日本）接受 OCTA。浅毛细血管丛 (SCP) 和深部毛细血管丛 (DCP) 的单独 OCTA 图像由 IMAGEnet6（基本许可证 10）生成。经过质量检查后，获得了 SCP 和 DCP 的中心凹无血管区 (FAZ) 面积、FAZ 圆度、血管密度 (VD) 和分形维数 (FD) 的自动测量结果。主要指标 DR 的进展和 DME 的发展。结果 在中位随访 27.14 个月（四分位距，24.16-30.41 个月）中，205 只眼睛中的 28 只（13.66%）出现了 DR 进展。在基线时没有 DME 的 194 只眼睛中，17 只 (8.76%) 出现了 DME。 FAZ 面积较大（风险比 [HR]，每 SD 增加 1.829；95% 置信区间 [CI]，1.332-2.512）、较低 VD（HR，每 SD 减少 1.908；95% CI，1.303-2.793）和较低 FD调整既定危险因素（DR 严重程度、糖化血红蛋白、糖尿病病程、年龄和基线平均动脉血压）后，DCP（HR，4.464/SD 降低；95% CI，1.337-14.903）与 DR 进展显着相关）。 SCP 较低的 VD（HR，每 SD 降低 1.789；95% CI，1.027-4.512）与 DME 发展相关。与单独建立危险因素的模型相比，加入 OCTA 指标提高了 DR 进展的预测辨别力（DCP 的 FAZ 面积，C 统计量 0.723 vs. 0.677，P < 0。001； DCP 的 VD，C 统计量 0.727 与 0.677，P = 0.001； DCP 的 FD，C 统计量 0.738 与 0.677，P < 0.001）和 DME 开发（SCP 的 VD，C 统计量 0.904 与 0.875，P = 0.036）。结论 FAZ 面积、DCP 的 VD 和 FD 预测 DR 进展，而 SCP 的 VD 预测 DME 发展。我们的研究结果提供了证据支持 OCTA 指标可以改善对 DR 进展和 DME 发展风险的评估，超越传统风险因素。