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预测新生血管性年龄相关性黄斑变性视力预后的基线光学相干断层扫描生物标志物:一项荟萃分析。

Baseline OCT Biomarkers Predicting Visual Outcomes in Neovascular Age-Related Macular Degeneration: A Meta-Analysis.

作者信息

Nanji Keean, Grad Justin, Hatamnejad Amin, McKechnie Tyler, Phillips Mark, Gemmy Cheung Chui Ming, Patel Praveen J, Marco Rosa Dolz, Borrelli Enrico, Steel David H, Sadda SriniVas R, Wong Tien Yin, Sivaprasad Sobha, Guymer Robyn, Wykoff Charles C, Chaudhary Varun

机构信息

Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.

Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.

出版信息

Ophthalmology. 2025 Jun 24. doi: 10.1016/j.ophtha.2025.06.018.

Abstract

TOPIC

To determine the effect estimates and certainty of evidence for baseline OCT biomarkers predicting visual acuity (VA) and changes in VA from baseline at 6, 12, and 24 months after anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration.

CLINICAL RELEVANCE

Understanding the prognostic utility of biomarkers can improve treatment decisions.

METHODS

Results were reported in ETDRS letters. Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) guidelines for prognostic studies informed certainty of evidence. Results were interpreted using a 5-letter minimally important difference.

RESULTS

Twenty-nine reports (8863 eyes) evaluating 80 biomarkers were included. Two biomarkers predicted better VA at 12 months with a low-certainty: the presence of an intact external limiting membrane (+14.0; 95% confidence interval [CI], +3.1 to +24.8) and the presence of an intact ellipsoid zone (+6.8; 95% CI, +2.8 to +10.8). Three biomarkers predicted worse VA at 12 months with a low certainty; the presence of intraretinal fluid (IRF; -5.6; 95% CI, -9.7 to -1.5), the presence of IRF in the foveal center point (-7.4; 95% CI, -10.1 to -4.7), and the presence of subretinal hyperreflective material (-8.7; 95% CI, -19.0 to 1.6). No other biomarker predicted an effect size that crossed the minimally important difference. However, noteworthy results occurred when interpreting biomarkers with statistically significant findings relative to a threshold of 0 letters and moderate certainty: the presence of a pigment epithelial detachment, geographic atrophy (GA), and both IRF and subretinal fluid (SRF) predicted reduced vision at 12 months. The presence of SRF predicted a positive change in VA at 12 months. The absence of a posterior vitreous detachment predicted a negative change in VA at 12 months. Finally, the presence of IRF in the central 1 mm, retinal pigment epithelial elevation, and GA predicted negative changes in VA at 24 months.

DISCUSSION

With low-certainty evidence, the baseline presence of an intact external limiting membrane and ellipsoid zone predicted better VA at 12 months, and the presence of IRF, IRF in the foveal center point, and subretinal hyperreflective material predicted worse VA at 12 months. Improved standardization in biomarker classification and control of confounding variables is needed.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

摘要

主题

确定抗血管内皮生长因子治疗新生血管性年龄相关性黄斑变性后,基线光学相干断层扫描(OCT)生物标志物预测视力(VA)以及6、12和24个月时VA相对于基线变化的效应估计值和证据确定性。

临床相关性

了解生物标志物的预后效用可改善治疗决策。

方法

结果以ETDRS字母报告。预后研究的推荐分级、评估、制定与评价(GRADE)指南为证据确定性提供依据。结果使用5字母最小重要差异进行解释。

结果

纳入了29篇评估80种生物标志物的报告(8863只眼)。两种生物标志物在12个月时预测视力较好,但证据确定性较低:完整的外界膜存在(+14.0;95%置信区间[CI],+3.1至+24.8)和完整的椭圆体带存在(+6.8;95%CI,+2.8至+10.8)。三种生物标志物在12个月时预测视力较差,证据确定性较低;视网膜内液(IRF)存在(-5.6;95%CI,-9.7至-1.5)、黄斑中心点IRF存在(-7.4;95%CI,-10.1至-4.7)以及视网膜下高反射物质存在(-8.7;95%CI,-19.0至1.6)。没有其他生物标志物预测的效应大小超过最小重要差异。然而,在将具有统计学显著结果的生物标志物相对于0字母阈值和中等确定性进行解释时,出现了值得注意的结果:色素上皮脱离、地图样萎缩(GA)以及IRF和视网膜下液(SRF)同时存在预测12个月时视力下降。SRF存在预测12个月时VA有正向变化。无玻璃体后脱离预测12个月时VA有负向变化。最后,中央1mm范围内IRF存在、视网膜色素上皮隆起和GA预测24个月时VA有负向变化。

讨论

证据确定性较低,基线时完整的外界膜和椭圆体带存在预测12个月时视力较好,而IRF、黄斑中心点IRF和视网膜下高反射物质存在预测12个月时视力较差。需要改进生物标志物分类标准化以及混杂变量控制。

财务披露

专有或商业披露信息可在本文末尾的脚注和披露中找到。

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