Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- IOP Reduction
研究概览
简要总结
A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients
详细描述
A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices.
Patients will be followed up for at least one year during which the following data are collected.
Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded
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
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood glaucoma patients (whether primary or secondary) including Juvenile open angle glaucoma if the age at the time of surgery was ≤18 years.
- •The included patients are those with refractory glaucoma who require a tube to control their intraocular pressure.
排除标准
- •Any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.
结局指标
主要结局
IOP Reduction
时间窗: 1 year
More than 20% change from baseline without development of vision threatening complications
次要结局
- Post-operative complications(1 year)
- Glaucoma Medication Alterations(1 year)
研究者
Mohamed El Baharwy
Clinical Professor
Al Watany Eye Hospital