Evaluation of Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- surgical success
研究概览
简要总结
To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.
详细描述
Recurrent pediatric glaucoma following Ahmed Glaucoma Valve (AGV) implantation presents a therapeutic challenge. This study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.
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 (Investigator)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children under 12 years with previous AGV implantation for primary congenital glaucoma
排除标准
- •age >12 years, eyes with no light perception, and those with prior cyclodestructive procedures.
研究组 & 干预措施
Group I
subconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle
干预措施: AGV plate (Procedure)
Group II
AGV plate using a 27-gauge needle
干预措施: AGV plate (Procedure)
Group I
subconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle
干预措施: bevacizumab injection (Procedure)
结局指标
主要结局
surgical success
时间窗: for 12 months
IOP ≤ 21 mmHg and ≥ 5 mmHg without medications
次要结局
未报告次要终点
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer
Benha University