椭圆体区面积与黄斑毛细血管扩张症2型注视稳定性的关联。
完整摘要 · 中文译文
目的：确定椭圆体区（EZ）面积缺失（光感受器变性的生物标志物）是否与2型黄斑毛细血管扩张症（MacTel）中的注视稳定性相关。 方法：这项回顾性分析纳入了来自两项关于revakinagene taroretcel-lwey治疗MacTel的3期试验中的212名成人。EZ面积缺失通过光学相干断层扫描进行量化。注视稳定性（P1指数）通过微视野计测量。线性和逻辑回归评估了24个月内EZ面积缺失与P1之间的关联。中位数分组将人群分层，以评估基线EZ面积缺失是否影响植入物与假手术的治疗效果。受试者工作特征分析确定了不稳定注视的结构阈值。 结果：EZ面积缺失在基线时（P = 0.002）和第24个月时（P = 0.01）与注视稳定性降低显著相关。EZ面积缺失每增加1 mm²，注视稳定性差（定义为P1 <80%）的几率翻倍（比值比，2.07；P = 0.047）。P1变化在治疗组和假手术组之间无显著差异。在探索性分析中，按基线EZ面积缺失中位数分层，尽管治疗与基线的交互作用不显著（P = 0.17），但显示假手术眼的注视稳定性下降更大（平均值，-3.8%），而植入物组为（+0.6%）。受试者工作特征分析确定了不稳定注视的EZ面积缺失阈值为1.075 mm²。 结论：在MacTel中，更大的EZ面积缺失与更差的注视稳定性相关。 EZ区域损失阈值约1 mm²可能作为注视不稳定性风险的探索性标志，但该阈值需独立验证。
完整摘要 · 英文原文
PURPOSE: To determine whether ellipsoid zone (EZ) area loss, a biomarker of photoreceptor degeneration, is associated with fixation stability in macular telangiectasia type 2 (MacTel). METHODS: This retrospective analysis included 212 adults from two Phase 3 trials of revakinagene taroretcel-lwey for MacTel. EZ area loss was quantified with optical coherence tomography. Fixation stability (P1 index) was measured by microperimetry. Linear and logistic regressions evaluated associations between EZ area loss and P1 over 24 months. A median split stratified the population to evaluate whether baseline EZ area loss influenced the therapeutic effect of the implant versus sham. A receiver operating characteristic analysis identified a structural threshold for unstable fixation. RESULTS: EZ area loss was significantly associated with reduced fixation stability at baseline (P = 0.002) and month 24 (P = 0.01). Each 1-mm² increase in EZ area loss doubled the odds of poor fixation stability (defined as a P1 <80%) (odds ratio, 2.07; P = 0.047). P1 change did not significantly differ between the treatment and sham groups. In exploratory analyses, stratification by median baseline EZ area loss, despite a nonsignificant treatment-by-baseline interaction (P = 0.17), revealed a greater decline in fixation stability in sham-treated eyes (mean, -3.8%) versus the implant group (+0.6%). The receiver operating characteristic analysis identified an EZ area loss threshold of 1.075 mm² for unstable fixation. CONCLUSIONS: Greater EZ area loss is associated with poorer fixation stability in MacTel. An EZ area loss threshold of ∼1 mm² may serve as an exploratory marker of fixation instability risk, though this threshold requires independent validation.