Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Intraocular Pressure
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
详细描述
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race ≥ 18 years and ≤ 80 years of age.
- •Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
- •Elevated intraocular pressure > 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
- •Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
- •Subject is willing and able to sign the informed consent.
排除标准
- •Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
- •History of prior drainage implant surgery in the study eye.
- •History of cyclophotocoagulation of the study eye.
- •Pregnancy.
- •Prisoner.
结局指标
主要结局
Change in Intraocular Pressure
时间窗: 12 months
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
次要结局
- Anti-Glaucoma Medications(12 months)
- Surgical Success(12 months)
研究者
Peter Netland, MD
Chair, Department of Ophthalmology
University of Virginia