PURPOSE To evaluate the utility of extended field swept-source Optical Coherence Tomography Angiography (SS-OCTA) imaging biomarkers in predicting the occurrence of clinically significant outcomes in eyes with Non-Proliferative Diabetic Retinopathy (NPDR). DESIGN Retrospective clinical case-control study. METHODS Single-center clinical study. 88 eyes with NPDR from 57 participants (median age: 64.0 years; mean duration of diabetes: 15.8 years) with at least two consecutive SS-OCTA scans over a follow-up period of at least six months were included. The presence of intraretinal microvascular abnormalities (IRMAs) at baseline and the stability of IRMAs during follow-up period on 12 × 12-mm angiograms were evaluated. Baseline nonperfusion ischemia index (ISI) and other SS-OCTA metrics were calculated on FIJI and ARI Network. Significant clinical outcomes were defined as occurrence of one or more of the following events at the last available clinical visit:1. significant DR progression (2-step DR progression or progression to proliferative DR (PDR)); 2) development of new center-involving diabetic macular edema (CI-DME); and 3) initiation of treatment with PRP or anti-VEGF injections during the follow-up period. Mixed-effects Cox regression models was used to explore these outcomes. RESULTS Following a clinical follow-up period lasting 25.1 ± 10.8 months, we observed significant clinical outcomes in 17 eyes (19.3%). Among these, 7 eyes (8.0%) experienced significant progression and 4 eyes (4.5%) developed CI-DME. Anti-VEGF injections were initiated in 15 eyes (17.0%), while PRP was initiated in 2 eyes (2.3%). Upon adjusting for age, the duration of DM, and prior Anti-VEGF treatments, our analysis revealed that non-stable IRMAs during the follow-up periods and a higher ischemia index at baseline were significantly associated with the occurrence of significant clinical outcomes with HRs of 3.88 (95% CI: 1.56-9.64; p=0.004) and 1.05 (95% CI: 1.02-1.09; p=0.004), respectively. CONCLUSIONS In conclusion, NPDR eyes with non-stable IRMAs over time and more ischemia at baseline are in higher risk of developing significant clinical outcomes. Our findings suggest that expanded field SS-OCTA may offer additional prognostic benefits for clinical DR staging and predicting high-risk patients.

中文翻译：

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扩展视野 OCT 血管造影生物标志物用于预测非增殖性糖尿病视网膜病变的临床显着结果。


目的 评估扩展视野扫描源光学相干断层扫描血管造影 （SS-OCTA） 成像生物标志物在预测非增殖性糖尿病视网膜病变 （NPDR） 眼睛发生临床显着结果中的效用。设计 回顾性临床病例对照研究。方法 单中心临床研究。纳入了 57 名参与者 （中位年龄： 64.0 岁;糖尿病平均病程： 15.8 年） 的 88 只患有 NPDR 的眼睛，在至少 6 个月的随访期内至少连续进行了两次 SS-OCTA 扫描。评估基线时视网膜内微血管异常 （IRMAs） 的存在以及 12 × 12 mm 血管造影随访期间 IRMAs 的稳定性。在 FIJI 和 ARI 网络上计算基线非灌注缺血指数 （ISI） 和其他 SS-OCTA 指标。显着的临床结果定义为在最后一次可用的临床就诊时发生以下一项或多项事件：1。显着的 DR 进展（2 步 DR 进展或进展为增殖性 DR （PDR））;2） 新的涉及中心的糖尿病性黄斑水肿 （CI-DME） 的发展;3） 在随访期间开始接受 PRP 或抗 VEGF 注射治疗。使用混合效应 Cox 回归模型来探索这些结局。结果 在持续 25.1 ± 10.8 个月的临床随访期后，我们在 17 只眼睛 （19.3%） 中观察到显着的临床结果。其中，7 只眼 （8.0%） 出现显着进展，4 只眼 （4.5%） 出现 CI-DME。15 只眼 （17.0%） 开始抗 VEGF 注射，而 2 只眼 （2.3%） 开始 PRP。 在调整年龄、DM 持续时间和既往抗 VEGF 治疗后，我们的分析显示，随访期间不稳定的 IRMA 和基线时较高的缺血指数与显着临床结果的发生显着相关，HR 分别为 3.88 （95% CI： 1.56-9.64;p=0.004） 和 1.05 （95% CI： 1.02-1.09;p=0.004）。结论 总之，随着时间的推移 IRMA 不稳定且基线时缺血较多的 NPDR 眼发生显着临床结果的风险更高。我们的研究结果表明，扩展视野 SS-OCTA 可能为临床 DR 分期和预测高危患者提供额外的预后益处。