NCT04308538Unknown不适用
Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Motor success rate
研究概览
简要总结
comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
- •Basic, pseudo- divergence excess and divergence excess types are included.
- •If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).
排除标准
- •Intermittent exotropia of the convergence insufficiency type.
- •Intermittent exotropia with angle of deviation greater than 50 prism diopters.
- •Patients with previous squint surgery.
- •Patients with secondary deviation due to a sensory lesion or neurological condition.
研究组 & 干预措施
Standard Recession
Active Comparator
Bilateral lateral rectus muscle recession using standard tables stated by Parks.
干预措施: Standard Recession (Procedure)
Reduced Recession
Experimental
Bilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables.
干预措施: Reduced Recession (Procedure)
结局指标
主要结局
Motor success rate
时间窗: 6 months
Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)
次要结局
- Pattern strabismus(6 months)
研究者
Ahmed Awadein
Prof.Ahmed Awadein
Cairo University
研究点 (1)
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