A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma.

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Detailed Description

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The study compares 1 stent versus 2 stents.

Conditions

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Open-Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Stent

Intervention Type DEVICE

implantation of 1 Glaukos iStent versus 2 Glaukos iStents

2

Group Type ACTIVE_COMPARATOR

Stent

Intervention Type DEVICE

implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Interventions

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Stent

implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Intervention Type DEVICE

Other Intervention Names

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iStent

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with open-angle glaucoma (OAG)
* Subject on at least one glaucoma medication
* Signed informed consent

Exclusion Criteria

* Angle closure glaucoma
* Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Fellow eye already enrolled

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No