Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pterygium recurrence
研究概览
简要总结
The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.
详细描述
Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an additional technique to prevent recurrence which may be as high as 50%.
Suturing a conjunctival auto-graft has become one of the most popular and effective methods in preventing recurrence. However suturing requires long operative time (10-20 minutes with removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very inconvenient to the patient.
Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we believe it will be as effective as suturing the graft, will use much less OR time (reduce surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary pterygium
- •healthy subject
- •ability to attend follow-up visits
排除标准
- •recurrent pterygium
- •underwent previous surgery / intervention to treat pterygium
- •ocular surface disease 0 minor
结局指标
主要结局
Pterygium recurrence
时间窗: one year
Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.
次要结局
- operation time(one year)
研究者
Dr. Guy Ben-Simon, MD
Prof
Sheba Medical Center