Comparison of Medial Rectus Resection and Plication in Exotropic Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 52
- 主要终点
- Postoperative ocular deviation
研究概览
简要总结
Purpose: To determine the surgical outcomes of the plication technique in comparison with the resection method on exotropic patients.
Methods: In this randomized clinical trial, a total of 52 exotropic patients (female, 51.9%) who are candidate for medial rectus strengthening will be randomly classified into plication (n=24) and resection (n=28) groups. The comprehensive visual and ocular examinations will be performed on all study subjects and they will be followed- up for three months postoperatively. Plication technique is the same as resection up to muscle suturing, in the next step, the sutures are passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures.
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 (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a residual exotropia and history of uni- or bilateral lateral rectus recession or recession and resection (R &R) and those exotropic patients who were going to have already recession and resection (R & R) operation due to unilateral constant exotropia will be considered as eligible cases to be included.
排除标准
- •Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity) subjects with systemic or other ocular diseases, neurological disorders, uncooperative patients and participants with less than three-month postoperative follow-up will be excluded from this study.
研究组 & 干预措施
Undergoing plication strabismus surgery
干预措施: Plication strabismus surgery (Procedure)
Undergoing resection strabismus surgery
干预措施: Resection strabismus surgery (Procedure)
结局指标
主要结局
Postoperative ocular deviation
时间窗: three months
Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.
次要结局
未报告次要终点
研究者
Hamideh Sabbaghi
PhD student, Teacher Assistant
Shahid Beheshti University of Medical Sciences