与视网膜静脉阻塞相关的黄斑水肿的解剖学生物标志物。
Anatomic Biomarkers of Macular Edema Associated with Retinal Vein Occlusion.
机构信息
Clearside Biomedical, Alpharetta, Georgia.
Clearside Biomedical, Alpharetta, Georgia.
出版信息
Ophthalmol Retina. 2022 Dec;6(12):1206-1220. doi: 10.1016/j.oret.2022.06.016. Epub 2022 Jun 30.
PURPOSE
To assess the relationship between best-corrected visual acuity (BCVA) and anatomic features in patients with macular edema (ME) related to retinal vein occlusion (RVO).
DESIGN
Post hoc analysis of 3 clinical trials, which included verified diagnoses, protocol refractions, and the assessment of OCT and fluorescein angiography (FA) images at a masked reading center.
PARTICIPANTS
Patients diagnosed with RVO-ME.
METHODS
Correlation analyses were performed to determine the correlation between BCVA and macular anatomy at baseline and at 12 and 24 weeks and between changes from baseline to 12 and 24 weeks.
MAIN OUTCOME MEASURES
The correlations between BCVA and central subfield thickness (CST), ellipsoid zone (EZ) integrity, intraretinal fluid (IRF), subretinal fluid, central leakage, and ischemia were assessed.
RESULTS
In a total of 828 eyes with RVO-ME, the mean age, BCVA, and CST at baseline was 64.7 years, 51.1 letters, and 656.9 μm, respectively. At baseline, a moderate negative correlation was observed between BCVA and CST (r = - 0.56, P < 0.001). At weeks 12 and 24, the mean BCVA of eyes with definitely abnormal (absent) EZ was statistically significantly worse than that of eyes with normal EZ. At week 12, a moderate negative correlation was observed between changes in BCVA and changes in CST (r = - 0.35, P < 0.001), with a similar degree of association noted at week 24 (r = - 0.35, P < 0.001). At weeks 12 and 24, eyes that showed any improvement in central IRF showed a greater improvement in BCVA than eyes that showed no improvement worsening (week 12: 463 eyes, 18.3 letters vs. 177 eyes, 13.0 letters, respectively, P < 0.001) and (week 24: 332 eyes, 20.2 letters vs. 131 eyes, 13.3 letters, respectively, P < 0.001). With respect to the correlation between baseline BCVA and fluorescein leakage or capillary nonperfusion, the Pearson correlation coefficients were - 0.41 (P < 0.001) and - 0.16 (P = 0.060), respectively.
CONCLUSIONS
In addition to CST, there are important clinically relevant relationships between BCVA and both OCT and FA anatomic features in patients with RVO-ME.
目的
评估与视网膜静脉阻塞（RVO）相关的黄斑水肿（ME）患者的最佳矫正视力（BCVA）与解剖特征之间的关系。
设计
3 项临床试验的事后分析，其中包括已确诊的病例、方案屈光度以及在盲法阅读中心评估 OCT 和荧光素血管造影（FA）图像。
参与者
被诊断为 RVO-ME 的患者。
方法
进行相关分析，以确定基线时、第 12 周和第 24 周时 BCVA 与黄斑解剖结构之间的相关性，以及从基线到第 12 周和第 24 周的变化之间的相关性。
主要观察指标
评估 BCVA 与中心视网膜下厚度（CST）、椭圆体带（EZ）完整性、视网膜内液（IRF）、视网膜下液、中心渗漏和缺血之间的相关性。
结果
在总共 828 只患有 RVO-ME 的眼中，平均年龄、基线时的 BCVA 和 CST 分别为 64.7 岁、51.1 个字母和 656.9μm。在基线时，BCVA 与 CST 之间存在中度负相关（r = -0.56，P < 0.001）。在第 12 周和第 24 周时，EZ 明显异常（缺失）的眼的平均 BCVA 明显差于 EZ 正常的眼。在第 12 周时，BCVA 的变化与 CST 的变化之间存在中度负相关（r = -0.35，P < 0.001），第 24 周时也观察到类似程度的相关性（r = -0.35，P < 0.001）。在第 12 周和第 24 周时，中央 IRF 有任何改善的眼的 BCVA 改善程度大于没有改善或恶化的眼（第 12 周：463 只眼，18.3 个字母与 177 只眼，13.0 个字母，分别，P < 0.001）和（第 24 周：332 只眼，20.2 个字母与 131 只眼，13.3 个字母，分别，P < 0.001）。关于基线时 BCVA 与荧光素渗漏或毛细血管无灌注之间的相关性，Pearson 相关系数分别为 -0.41（P < 0.001）和 -0.16（P = 0.060）。
结论
除 CST 外，RVO-ME 患者的 BCVA 与 OCT 和 FA 解剖特征之间存在重要的临床相关关系。
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