Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 5
- 主要终点
- Recurrence of pterygium
研究概览
简要总结
The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.
详细描述
Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.
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
- •Primary pterygium
- •Willingness to participate in research project and to attend research follow-up
- •Adults (age 18 to 80 years old)
- •Patients must not meet any of the following
排除标准
- •Exclusion Criteria:
- •Pregnant,breast-feeding women or patients with poor general health
- •Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma
- •Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery
- •Patients with allergy to intraoperative or postoperative drugs, such as mitomycin C, tobramycin or local anesthetics
结局指标
主要结局
Recurrence of pterygium
时间窗: One year
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
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
M.D., Ph.D
Sun Yat-sen University