NCT01263834已完成2 期
The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).
详细描述
Prospective interventional clinical trial
Single center, outcome assessor-masked, active control, randomized controlled trial
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 open angle glaucoma with primary mmc-trabeculectomy indication
排除标准
- •combined phacoemulsification with trabeculectomy
- •no more than 6 month of cataract surgery before trabeculectomy
- •revised trabeculectomy
- •active uveitic glaucoma
- •neovascular glaucoma
- •par planar vitrectomy
- •conjunctival surgery
- •allergy to bevacizumab or mitomycin C
- •ischemic heart disease
- •cerebrovascular disease
- •renal failure
- •liver failure
研究组 & 干预措施
Mitomycin c
Active Comparator
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
干预措施: Mitomycin C (Drug)
Bevacizumab
Experimental
Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 6 month
次要结局
- Bleb characteristic grading(6 month)
- systemic Blood pressure(6 months)
研究者
Weerawat Kiddee
Dr.Weerawat Kiddee
Prince of Songkla University
研究点 (1)
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