临床试验/NCT01640756

NCT01640756已完成3 期

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

AqueSys, Inc.27 个研究点分布在 1 个国家目标入组 60 人开始时间: 2012年7月最近更新: 2016年2月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: AqueSys, Inc.
入组人数: 60
试验地点: 27
主要终点: Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications

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

To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

详细描述

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

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: 45 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of Refractory Glaucoma
•Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
•Visual field mean deviation score of -3 dB or worse
•Shaffer Angle Grade ≥ 3
•Area of free, healthy and mobile conjunctiva in the targeted quadrant

排除标准

•Active Neovascular Glaucoma
•Previous glaucoma shunt/valve in the targeted quadrant
•History of corneal surgery, opacities or disease/pathology
•Anticipated need for ocular surgery
•Non-study eye with BCVA of 20/200 or worse

结局指标

主要结局

Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications

时间窗: 12 Months

次要结局

Mean change in IOP from baseline(12 Months)

研究者

发起方

AqueSys, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (27)

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