Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

NCT ID: NCT01841450

Last Updated: 2021-10-20

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

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2021-11-30

Brief Summary

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The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Detailed Description

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The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iStent

Implantation of one iStent in conjunction with cataract surgery

Group Type EXPERIMENTAL

iStent

Intervention Type DEVICE

Implantation of one iStent in conjunction with cataract surgery

Cataract surgery

Cataract surgery alone

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery alone

Interventions

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iStent

Implantation of one iStent in conjunction with cataract surgery

Intervention Type DEVICE

Cataract surgery

Cataract surgery alone

Intervention Type PROCEDURE

Other Intervention Names

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GTS100

Eligibility Criteria

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Inclusion Criteria

* mild to moderate primary open-angle glaucoma
* currently treated with ocular hypotensive medication
* pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
* subject scheduled to undergo cataract surgery

Exclusion Criteria

* primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
* retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Irvine, California, United States

Site Status

Montebello, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Atlanta, Georgia, United States

Site Status

Edgewood, Kentucky, United States

Site Status

Louisville, Kentucky, United States

Site Status

Jackson, Michigan, United States

Site Status

Saint Joseph, Michigan, United States

Site Status

Kansas City, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Mentor, Ohio, United States

Site Status

Kingston, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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GTS100-PAS2 (Rev1 04-11-2016)

Identifier Type: -

Identifier Source: org_study_id