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Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

NCT ID: NCT01252849

Last Updated: 2022-08-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2019-10-08

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

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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

RANDOMIZED

Intervention Model

PARALLEL

iStent 1, 2, or 3 stents
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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First Arm: One iStent, medication

Device: One iStent, medication

Group Type EXPERIMENTAL

iStent

Intervention Type DEVICE

Implantation of One iStent through a small temporal clear corneal incision.

Second Arm: Two iStents, medication

Device: Two iStent devices, medication

Group Type EXPERIMENTAL

iStent

Intervention Type DEVICE

Implantation of Two iStents through a small temporal clear corneal incision

Third Arm: Three iStents, medication

Device: Three iStent devices, medication

Group Type EXPERIMENTAL

iStent

Intervention Type DEVICE

Implantation of Three iStents through a small temperal clear corneal incision

Interventions

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iStent

Implantation of One iStent through a small temporal clear corneal incision.

Intervention Type DEVICE

iStent

Implantation of Two iStents through a small temporal clear corneal incision

Intervention Type DEVICE

iStent

Implantation of Three iStents through a small temperal clear corneal incision

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on two topical hypotensive medications

Exclusion Criteria

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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S.V. Malayan's Ophthalmology Centre

Yerevan, , Armenia

Site Status

Countries

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Armenia

Other Identifiers

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GCF-016

Identifier Type: -

Identifier Source: org_study_id

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