临床试验/NCT01252888

NCT01252888已完成4 期

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents

Glaukos Corporation2 个研究点分布在 1 个国家目标入组 39 人开始时间: 2010年12月最近更新: 2022年9月7日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Glaukos Corporation
入组人数: 39
试验地点: 2
主要终点: mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

详细描述

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.

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: 是

入选标准

•Diagnosed with primary open-angle glaucoma (POAG)
•Subjects on two topical 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

mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline

时间窗: 12 months

次要结局

Mean diurnal IOP < 18 mmHg at month 12(12 months)

研究者

发起方

Glaukos Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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