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临床试验/NCT03478293
NCT03478293
终止
不适用

A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications

Glaukos Corporation1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年2月27日最近更新:

概览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
IOP reduction at 12 and 24 months on same number or fewer medications

概览

简要总结

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

详细描述

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.

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

盲法说明

Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with primary open angle glaucoma (POAG)
  • Subject on two ocular hypotensive medications

排除标准

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled

结局指标

主要结局

IOP reduction at 12 and 24 months on same number or fewer medications

时间窗: 12 months and 24 months

IOP reduction at 12 and 24 months on same number or fewer medications

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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