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Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

NCT ID: NCT01841437

Last Updated: 2017-12-18

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

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-06-21

Brief Summary

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

Detailed Description

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Conditions

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Primary Open-angle Glaucoma

Keywords

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Primary open-angle glaucoma (POAG) Trabecular meshwork iStent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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iStent

iStent

Intervention Type DEVICE

Interventions

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iStent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria

* Please refer to approved indications in Directions for Use
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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Chico, California, United States

Site Status

Huntington Beach, California, United States

Site Status

Napa, California, United States

Site Status

Santa Maria, California, United States

Site Status

Ventura, California, United States

Site Status

Parker, Colorado, United States

Site Status

Portland, Maine, United States

Site Status

Quincy, Massachusetts, United States

Site Status

Bloomington, Minnesota, United States

Site Status

Westwood, New Jersey, United States

Site Status

Durham, North Carolina, United States

Site Status

Fayetteville, North Carolina, United States

Site Status

Southern Pines, North Carolina, United States

Site Status

Brecksville, Ohio, United States

Site Status

Youngstown, Ohio, United States

Site Status

Ladson, South Carolina, United States

Site Status

Sioux Falls, South Dakota, United States

Site Status

Appleton, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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GTS100-PAR

Identifier Type: -

Identifier Source: org_study_id