NCT03151577Unknown不适用
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
Swiss Vision Network0 个研究点目标入组 150 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Intraocular pressure
研究概览
简要总结
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
详细描述
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
Follow-up period is 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Mild to moderate glaucoma patients
- •Have given written informed consent
- •Aged 18 years or older of either sex
排除标准
- •Patients not able to understand the character of the study
- •Participation in other clinical research within the last 4 weeks
- •Patients with end-stage glaucoma
- •Patients with glaucoma surgery done before
结局指标
主要结局
Intraocular pressure
时间窗: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Change in IOP before and after XEN® Gel Stent implantation
次要结局
- Number of needlings(2 years)
- Number of antiglaucomatous medications(Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2)
研究者
Dr. Kaweh Mansouri
MD, MPH
Swiss Vision Network
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