NCT00971061已完成3 期
Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
Vanak Eye Surgery Center1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2003年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Intra Ocular pressure (IOP)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.
排除标准
- •age less than 40 years
- •a visual acuity of no light perception
- •lens opacity
- •elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
- •previous cyclodestructive treatment
- •increased risk of endophthalmitis posterior segment disorders
- •pre-existing ocular comorbidities.
结局指标
主要结局
Intra Ocular pressure (IOP)
时间窗: Month 24
次要结局
- Intra Ocular pressure (IOP)(day 1,week 1, and months 1, 3, 6, 9, 12 and 18)
- Changes in visual acuity(day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.)
- Number of anti-glaucoma medications(week 1, and months 1, 3, 6, 9, 12, 18, and 24)
- Mean deviation of visual field,(week 1, and months 1, 3, 6, 9, 12, 18, and 24)
- Rate of intra- and postoperative complications(week 1, and months 1, 3, 6, 9, 12, 18, and 24)
研究者
研究点 (1)
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