跳至主要内容
临床试验/NCT03255798
NCT03255798终止不适用

A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent

Glaukos Corporation1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
20% IOP reduction

研究概览

简要总结

Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

详细描述

Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

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

IOP outcome is masked

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

  • Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

排除标准

  • Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

结局指标

主要结局

20% IOP reduction

时间窗: Month 12

IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg

次要结局

  • IOP less than or equal to 18 mm Hg(Month 12)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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