Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- surgical success: intraocular pressure lowered by 30% and functional filtering bleb
研究概览
简要总结
In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.
详细描述
The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.
Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.
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
- •18 years of age
- •One of the following diagnoses:
- •primary open angle glaucoma
- •chronic angle closure glaucoma
- •pseudo exfoliation glaucoma
- •pigment dispersion glaucoma
排除标准
- •unable to provide consent or return for follow up
结局指标
主要结局
surgical success: intraocular pressure lowered by 30% and functional filtering bleb
时间窗: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery
次要结局
- Need for laser suture lysis(any point post operatively)
- complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing(any time post operatively)
研究者
Dr. Robert Campbell
Principal Investigator
Queen's University