Minimally Invasive Strabismus Surgery versus the conventional surgical technique for the Inferior Oblique muscle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Conjunctival injection (4-step standard reference scale), chemosis (4-grade scale), periorbital edema (4-grade scale)
研究概览
简要总结
This study is a randomized, single blind, parallel group, single centre trial comparing the cosmetic and surgical outcomes of Minimally Invasive Strabismus Surgery and the conventional perilimbal surgical technique in 40 squint patients with inferior oblique muscle overaction that will be conducted at a tertiary care eye hospital in Delhi, India. The primary outcome measures will be conjunctival injection, chemosis and periorbital edema on the first postoperative day. The secondary outcomes will be conjunctival injection, chemosis and periorbital edema at 1 week and 6 weeks; the degree of inferior oblique overaction on the first postoperative day, at 1 week and 6 weeks; and ocular alignment on the first postoperative day, at 1 week and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients with primary or secondary, unilateral or bilateral inferior oblique muscle overaction Inferior oblique overaction defined as hypertropia of 20 prism diopters or more in adduction.
排除标准
- •Patients with previous surgery for the inferior oblique muscle Patients requiring other vertical muscle surgery in addition to inferior oblique surgery Patients with pre-existing bleeding diatheses.
结局指标
主要结局
Conjunctival injection (4-step standard reference scale), chemosis (4-grade scale), periorbital edema (4-grade scale)
时间窗: First postoperative day
次要结局
- Conjunctival injection (4-step standard reference scale), chemosis (4-grade scale), periorbital edema (4-grade scale)(1 week, 6 weeks)
- Ocular alignment in nine gaze photography(First postoperative day, 1 week, 6 weeks)
- Degree of inferior oblique overaction in prism diopters(First postoperative day, 1 week, 6 weeks)