Comparison Between Bilateral Lateral Rectus Recession and Bilateral Primary Medial Rectus Resection in Basic Type Intermittent Exotropia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Motor alignment in primary position
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of bilateral lateral rectus recession and bilateral primary medial rectus resection in basic type intermittent exotropia
Participants will be randomized into two groups: bilateral lateral rectus (BLR) recession and bilateral medial rectus (BMR) resection groups then followed up in the clinic for 6 months to compare motor alignment and sensory functions
详细描述
Study location: Cairo university hospitals
Methodology:
Patients with basic type intermittent exotropia who are indicated to undergo surgical intervention will be grouped into two groups one group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection.
- Preoperatively, all patients will be subjected to:
- A detailed history taking including presence of asthenopia, monocular closure, disfigurement or diplopia. The previous use of glasses for optical correction, use of minus lenses, or prior part time occlusion will be documented.
- A detailed ophthalmological examination; including uncorrected and best corrected visual acuity whenever possible, cycloplegic refraction, anterior segment examination and dilated fundus examination.
- Motor Evaluation:
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with basic type intermittent exotropia
- •Measurable angle 25-40 prism diopters
排除标准
- •Restrictive or paralytic deviation or if forced duction test is positive on horizontal muscles
- •Incomitant deviation, vertical or oblique muscles surgery and significant A or V pattern
- •Previous strabismus, orbital or buckle surgery
结局指标
主要结局
Motor alignment in primary position
时间窗: 12 months
Success rate defined as orthophoria between exotropia/phoria ≤ to 8 prism diopters \& esotropia/phoria ≤ 4 prism diopters
次要结局
- Palpebral fissure height(12 months)
- Lateral gaze comitance/incomitance(12 months)
- Stereopsis(12 months)