Comparison of Conjunctival- Scleral thickness after Medial Rectus Plication versus Resection
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparision of Conjunctival-scleral (as measured on ASOCT), between plication and resection of medial rectus at 1st,3rd,4th months after surgery.
研究概览
简要总结
This prospective,randomized,comparative study compares the effect of two surgical procedures i.e. resection and plication in patients with primary exotropia.It would be conducted in guru nanak eye centre,comprising 2 groups of 25 patients per group.The primary outcome is to compare conjunctival-scleral thickness after medical rectus resection vs plication on anterior segment OCT at 1st,3rd and 4th months after surgery. The secondary objective is to compare tear-meniscus height ,non invasive tear break up time,difference in meibography scores and difference in ocular surface disease index(OSDI) between two groups at 1st,3rd and 4th months post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •a)primary exotropia without oblique overaction b)Age more than 12 years c)deviation more than or equal to 30 prism dioptres.
排除标准
- •a)H/o previous strabismus surgery b)Pre-existing conjunctival scarring c)Restrictive or paralytic strabismus d)Inability to position at the ASOCT machine/ e)uncooperative patients.
- •Patients with nystagmus and patients with anatomic abnormalities (eg, microcornea, anterior segment dysgenesis etc., where scleral spur on ASOCT is unclear).
结局指标
主要结局
Comparision of Conjunctival-scleral (as measured on ASOCT), between plication and resection of medial rectus at 1st,3rd,4th months after surgery.
时间窗: Comparision of Conjunctival-scleral (as measured on ASOCT), between plication and resection of medial rectus at baseline ,1st month,3rd month,4th months after surgery.
次要结局
- a)Comparision of tear meniscus height (TMH), non invasive tear break-up time (NIBUT) between the groups(b)Difference in Meibography scores between the groups.)