Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

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Detailed Description

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Conditions

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Primary Open Angle Glaucoma (POAG)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CyPass Micro-Stent

Subjects receive the CyPass Micro-Stent

Group Type EXPERIMENTAL

CyPass Micro-Stent

Intervention Type DEVICE

The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.

Interventions

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CyPass Micro-Stent

The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of POAG
* Medicated IOP ≥ 21 and ≤ 35 mmHg
* Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria

* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
* Use of oral hypotensive medication treatment for glaucoma
* Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
* Clinically significant ocular pathology other than POAG

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No