NCT00457223已完成2 期
Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pain and discomfort during and after surgery using visual analog scale
研究概览
简要总结
The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.
详细描述
There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.
Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.
- Preserve healthy superior conjunctiva for future glaucoma filtering surgery
- Can use in big or 2-headed pterygium
- Not contract as conjunctival graft esp. in case of fibrin glue
- Potential easier to use with fibrin glue
- Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary pterygium
排除标准
- •Pregnant women
- •Recurrent pterygium
- •Pseudopterygium
- •Uncontrolled systemic disease.
- •Known allergy to any of the study agents or preservatives used in the formulations.
结局指标
主要结局
Pain and discomfort during and after surgery using visual analog scale
时间窗: during surgery and after surgery up to 30 days
次要结局
- Surgical time(start and to the end of surgery)
- Healing of epithelial defect on cornea and AMT(until 30 days)
- Postoperative inflammation(up to 30 days)
- Complications e.g. Recurrent, graft loss/dehiscent, re-operation(until last follow up)
研究者
研究点 (2)
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