Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bleb vascularity grading
研究概览
简要总结
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
详细描述
trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •post uneventful trabeculectomy with mitomycin c application during surgery
排除标准
- •usage of 5-fluorouracil in trabeculectomy
- •post-operative complications
- •ischemic heart disease
- •s/p cerebrovascular accident
- •allergy to bevacizumab
研究组 & 干预措施
1
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
干预措施: Bevacizumab (Drug)
2
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Bleb vascularity grading
时间窗: 1, 2, 3, 4, 5. 6. montes post operative.
次要结局
- Indiana Bleb Appearance Grading Scale (IBAGS)(1, 2, 3, 4, 5, 6 months post operative)
- Intra-ocular pressure(1, 2, 3, 4, 5, 6 months post operative)
- Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no(1, 2, 3, 4, 5, 6 months post operative)