Clearside Biomedical, Alpharetta, Georgia.
Clearside Biomedical, Alpharetta, Georgia.
Ophthalmol Retina. 2021 Jul;5(7):633-647. doi: 10.1016/j.oret.2020.10.016. Epub 2020 Oct 29.
This study assessed relationships between best-corrected visual acuity (BCVA), central subfield thickness (CST), and ellipsoid zone (EZ) integrity in macular edema (ME) patients.
Post hoc analysis of 6 clinical trials, which included verified diagnoses, protocol refractions, and reading center assessment of OCT images.
Participants (n = 1063) were diagnosed with ME from retinal vein occlusion (RVO), diabetic retinopathy (DR; diabetic macular edema, DME), or noninfectious uveitis (NIU).
For CST, 2 clinical trials for each disorder were analyzed. For EZ, 3 studies across 2 disorders were analyzed.
Primary outcomes were correlations between BCVA and CST, and between BCVA and 4 central subfield EZ grades.
For baseline BCVA and CST, Pearson correlation coefficients were: ME from RVO, -0.56 (774 eyes; 95% confidence interval [CI], -0.61 to -0.51; P < 0.001); DME, -0.50 (91 eyes; 95% CI, -0.64 to -0.33; P < 0.001); and ME from NIU, -0.38 (198 eyes; 95% CI, -0.49 to -0.26; P < 0.001). Regarding change from baseline to 24 weeks for both BCVA and CST, Pearson correlation coefficients were: ME from RVO, -0.35 (95% CI, -0.43 to -0.27; P < 0.001); DME, -0.30 (95% CI, -0.48 to -0.09; P = 0.006); and ME from NIU, -0.42 (95% CI, -0.53 to -0.29; P < 0.001). Acute and chronic ME showed similar baseline and 24-week change linear correlations. With lower baseline CST, a trend of decreased baseline and 24-week change correlations was found. For central subfield EZ at baseline, mean BCVA progressively worsened with each of 4 EZ grades in 185 eyes with gradable EZ (DME, 41 eyes; NIU, 144 eyes; P ≤ 0.050 for all pairwise comparisons except between normal and questionably abnormal EZ grades). Eyes with normal baseline central subfield EZ showed greater 24-week change in BCVA than those with abnormal baseline EZ (15.00 letters vs. 8.16 letters; P = 0.0005, with baseline BCVA, CST, and age as covariates).
Despite these correlations, CST and EZ integrity, as graded herein, account for the minority of BCVA variation in patients with ME resulting from RVO, DR, and NIU.
本研究评估了黄斑水肿（ME）患者最佳矫正视力（BCVA）、中心视网膜厚度（CST）和椭圆体带（EZ）完整性之间的关系。
对 6 项临床试验进行了事后分析，这些试验包括经过验证的诊断、方案折射和阅读中心对 OCT 图像的评估。
参与者（n=1063）被诊断为视网膜静脉阻塞（RVO）、糖尿病视网膜病变（DR；糖尿病性黄斑水肿，DME）或非感染性葡萄膜炎（NIU）引起的 ME。
对于 CST，对每种疾病的 2 项临床试验进行了分析。对于 EZ，对 2 种疾病的 3 项研究进行了分析。
主要结局是 BCVA 与 CST 之间以及 BCVA 与 4 个中央视网膜厚度 EZ 等级之间的相关性。
对于基线 BCVA 和 CST，Pearson 相关系数为：RVO 引起的 ME，-0.56（774 只眼；95%置信区间[CI]，-0.61 至-0.51；P<0.001）；DME，-0.50（91 只眼；95%CI，-0.64 至-0.33；P<0.001）；NIU 引起的 ME，-0.38（198 只眼；95%CI，-0.49 至-0.26；P<0.001）。对于基线至 24 周时 BCVA 和 CST 的变化，Pearson 相关系数为：RVO 引起的 ME，-0.35（95%CI，-0.43 至-0.27；P<0.001）；DME，-0.30（95%CI，-0.48 至-0.09；P=0.006）；NIU 引起的 ME，-0.42（95%CI，-0.53 至-0.29；P<0.001）。急性和慢性 ME 表现出相似的基线和 24 周变化线性相关性。随着基线 CST 的降低，发现基线和 24 周变化相关性的趋势降低。对于基线中央视网膜厚度 EZ，在可分级 EZ（DME，41 只眼；NIU，144 只眼）的 185 只眼中，随着 4 个 EZ 等级的增加，平均 BCVA 逐渐恶化（P≤0.050，除正常和可疑异常 EZ 等级之间的比较外）。基线中央视网膜厚度 EZ 正常的眼比基线 EZ 异常的眼 24 周时 BCVA 的变化更大（15.00 个字母 vs. 8.16 个字母；P=0.0005，基线 BCVA、CST 和年龄作为协变量）。
尽管存在这些相关性，但 CST 和 EZ 完整性，如本文所述，在 RVO、DR 和 NIU 引起的 ME 患者的 BCVA 变化中仅占少数。
