预测糖尿病视网膜病变视力威胁并发症的进展

IF 4.6 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2025-06-17 DOI:10.1016/j.xops.2025.100859

C. Quentin Davis PhD , Nadia K. Waheed MD , Mitchell Brigell PhD

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引用次数: 0

摘要

目的评价视网膜电图(ERG)/瞳孔测量、彩色眼底摄影（FP）、OCT血管造影（OCTA）和超宽视场荧光素血管造影（UWF-FA） 56项参数的性能，以预测非增生性糖尿病视网膜病变（NPDR）患者在48周内进展为视力威胁并发症（VTCs）。设计一项来自美国44个试验点的纵向前瞻性研究。受试者有中度至重度NPDR，无中心累及性糖尿病黄斑水肿。162名受试者的平均年龄为57岁，其中58%为男性。干预：虽然这项研究测试了一种实验性药物，但没有迹象表明有治疗效果。对所有受试者的结果进行分析，而不考虑研究治疗方法。主要结果测量：专业阅读中心测量了4种测试方式（ERG/瞳孔测量、FP、OCTA和UWF-FA）中的56个参数来评估糖尿病视网膜病变（DR）状态。对每个参数应用Kaplan-Meier分析和Cox比例风险模型，以确定VTC进展的重要预测因素，VTC的定义为进展为增殖性DR、糖尿病性黄斑水肿或其治疗。结果在56个参数中，在接下来的48周内，RETeval DR评分是最能预测病情进展的指标，它结合了ERG和瞳孔反应。DR评分≥26.9的相对危险度（RR）为5.6 (P <；0.0001)。其他方式最具预测性的参数是UWF-FA的总缺血指数≥0.125，RR为5.3 (P <；0.0001)， OCTA中央凹无血管区面积≥0.295 mm2， RR为3.6 (P <；0.05)， FP的糖尿病视网膜病变严重程度量表≥47（中度NPDR）， RR为2.1 (P <；0.05)。结论功能测试（ERG、瞳孔反应）和结构测试（FP、OCTA、UWF-FA）均可预测DR发展为VTC，其中DR评分预测能力最强。这些结果表明，改进DR分期系统是可能的，从而可以更好地分配卫生保健资源。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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Predicting Progression to Vision-Threatening Complications in Diabetic Retinopathy

Objective

To characterize the performance of 56 parameters from electroretinography (ERG)/pupillometry, color fundus photography (FP), OCT angiography (OCTA), and ultra-widefield fluorescein angiography (UWF-FA) for predicting which subjects with nonproliferative diabetic retinopathy (NPDR) will progress to vision-threating complications (VTCs) within 48 weeks.

Design

A longitudinal prospective study from 44 trial sites in the United States.

Participants

Subjects had moderate-to-severe NPDR and no center-involved diabetic macular edema. Among the 162 subjects, the mean age was 57 years and 58% were male.

Intervention

Although this study tested an experimental drug, there was no indication of a treatment effect. Results are analyzed over all subjects regardless of study treatment.

Main Outcome Measures

Specialized reading centers measured 56 parameters from 4 testing modalities (ERG/pupillometry, FP, OCTA, and UWF-FA) to evaluate diabetic retinopathy (DR) status. Kaplan–Meier analysis and a Cox proportional hazards model were applied to each parameter to identify significant predictors of progression to VTC, defined as progression to proliferative DR, diabetic macular edema, or treatment thereof.

Results

Of the 56 parameters, the strongest predictor of progression in the following 48 weeks was the RETeval DR score, which combines ERG and pupil response. A DR score ≥26.9 had a relative risk (RR) of 5.6 (P < 0.0001). The most predictive parameter from the other modalities were UWF-FA's total ischemia index ≥0.125 with an RR of 5.3 (P < 0.0001), OCTA's foveal avascular zone area ≥0.295 mm² with an RR of 3.6 (P < 0.05), and FP's diabetic retinopathy severity scale ≥47 (moderate NPDR) with an RR of 2.1 (P < 0.05).

Conclusions

Both functional (ERG, pupil response) and structural (FP, OCTA, UWF-FA) testing can predict progression to VTC from DR, with the DR score having the best predictive capability. These results suggest it is possible to improve the DR staging system which in turn may enable better allocation of health care resources.