Efficacy of Botulinum Toxin Type A for Acute Acquired Comitant Esotropia: An Age-Stratified Two-Year Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- the cumulative motor success rate
研究概览
简要总结
The goal of this clinical trial is to assess and compare the efficacy of two-year follow-up botulinum toxin type A （BTXA) in the treatment of acute acquired comitant esotropia (AACE) across five age groups: ≤6 years, >6 to ≤12 years, >12 to ≤20 years, >20 to ≤30 years, and >30 years. For patients >12 years presenting with large-angle esotropia (>50 PD), primary surgical intervention was recommended as the preferred approach to minimize failure and recurrence risk. Conversely, for patients ≤12 years, BTXA injection was maintained as the first-line treatment regardless of the deviation angle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute acquired comitant esotropia (AACE) with sudden onset and diplopia
- •Normal eye movements with deviation difference ≤5 prism diopters (PD) in all gaze directions
- •Hyperopia < +3.00 diopters
- •<10 PD reduction in esotropia with hypermetropic spectacle correction
- •No prior extraocular muscle surgery
- •Absence of congenital/developmental anomalies affecting treatment outcomes
排除标准
- •Deviation difference >5 PD in any gaze direction
- •Hyperopia ≥ +3.00 diopters
- •History of extraocular muscle surgery
- •Presence of congenital/developmental anomalies potentially impacting outcomes
结局指标
主要结局
the cumulative motor success rate
时间窗: 2 years
Kaplan-Meier survival analyses were conducted to evaluate the cumulative motor success rate. A successful motor outcome was defined as achieving orthotropic alignment within 8 PD at both near (33 cm) and distance (6 m) fixation, accompanied by complete resolution of diplopia.
次要结局
- the sensory success rate(2 years)