Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.
详细描述
To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •require glaucoma bleb needle revision with Mitomycin-C
排除标准
- •pregnant, nursing, or not using adequate contraception
- •other glaucoma eye surgery involving tube shunts
- •prior retinal detachments surgery with scleral buckle
- •infection, inflammation, or any abnormality preventing eye pressure measurement
- •enrolled in another investigational study
研究组 & 干预措施
Bevacizumab
subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
干预措施: bevacizumab (Drug)
balanced salt solution
patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
干预措施: balanced salt solution (Other)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 6 months
mmHg (millimeters of mercury)
次要结局
- Number of Participants With Surgical Success(6 months)
研究者
Marlene Moster, MD
Principal Investigator
Wills Eye