Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Recurrence of pterygium
研究概览
简要总结
The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence
详细描述
Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.
Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous 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
- Single (Outcomes Assessor)
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
- •Recurrent pterygium
- •Willingness to participate in research project and to attend research time
- •At least 6 months after last pterygium surgery
排除标准
- •Pregnant,breast-feeding women or poor general health
- •Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
- •Patients with allergy to mitomycin C,tobramycin or local anesthetics
结局指标
主要结局
Recurrence of pterygium
时间窗: One year
次要结局
- Visual acuity(One year)
- Healing time of corneal epithelium(Four weeks)
- Healing time of conjunctival epithelium(Four weeks)
- Postoperative complications(One year)
研究者
Shiyou Zhou
MD,PhD
Sun Yat-sen University