Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Iop and Bleb height,extent and vascularity
研究概览
简要总结
purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure .
Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy&phaco which not respond to high frequent topical steroids or removal of releasable sutures
排除标准
- •Injected bleb due to complications of surgery such as button hole formation
- •Injected bleb due to blebitis
- •Bleb leakage
- •Pregnant or nursing mothers
- •Injected bleb after bleb reconstruction
研究组 & 干预措施
1
5-FU injection has been done
干预措施: 5-FU and Mitomycin (Drug)
2
Mitomycin drop has been administrated
干预措施: 5-FU and Mitomycin (Drug)
结局指标
主要结局
Iop and Bleb height,extent and vascularity
时间窗: At least in 3 months of follow up
次要结局
- complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure