A prospective, randomized, parallel design study to compare two conjunctival approaches in horizontal strabismus surgery: forniceal versus single snip paralimbal.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total inflammatory score:an aggregate of the 5 individual clinical inflammatory markers.
研究概览
简要总结
To compare the post-operative inflammation (redness, congestion, chemosis, foreign body sensation and drop intolerance) on day1, at 2 weeks +_ 2-3days and 4-6weeks, scar visibility and success rate at 4-6weeks in cases of horizontal strabismus surgery randomized to two conjunctival approaches: forniceal versus single snip paralimbal. In addition to compare time taken to do surgery, lax length of conjunctiva at the end od suturing and number of sutures used to close conjunctival incision. Patient will be asked which of his/her eye feels more comfortable: right eye, left eye, or cannot say. This will be done post-operatively on day 1 and week 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting adults patients with informed consent; and adolescents and children, with their assent, while parents would provide consent.
- •Patients with horizontal (esotropia (ET) or exotropia (XT)) strabismus, qualifying for bilateral symmetrical surgery.
排除标准
- •Patients requiring vertical rectus or oblique surgery.
- •Patients unable to cooperate due to neurological illness.
- •Patients with recent ocular surgery within 3 months or less.
结局指标
主要结局
Total inflammatory score:an aggregate of the 5 individual clinical inflammatory markers.
时间窗: Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) scored as nil,mild, moderate, severe.
时间窗: Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
Surgical success:success being defined as less than 10 PD or orthotropia.
时间窗: Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
Scar visibility from one meter.
时间窗: Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
次要结局
- Duration of surgery in minutes.(Lax length of conjunctival incision at the end of suturing.)