Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

NCT ID: NCT01836042

Last Updated: 2016-04-15

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

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-04-30

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 GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Detailed Description

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The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Conditions

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Primary Open Angle Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Randomized iStent

Implantation of one iStent in conjunction with cataract surgery, patients randomized to group

No interventions assigned to this group

Randomized cataract surgery

Cataract surgery alone, patients randomized to group

No interventions assigned to this group

Non-randomized iStent

Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Exclusion Criteria

* Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
* Patients not previously enrolled in Glaukos Study GC-003
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

Principal Investigators

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Jeff Wells, PharmD, MBA

Role: STUDY_DIRECTOR

Glaukos Corporation

Jay Katz, MD

Role: STUDY_CHAIR

Wills Eye Institute; Thomas Jefferson University

Locations

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Beverly Hills, California, United States

Site Status

Petaluma, California, United States

Site Status

Sacramento, California, United States

Site Status

San Clemente, California, United States

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Santa Maria, California, United States

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Parker, Colorado, United States

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Boynton Beach, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Morrow, Georgia, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Saint Joseph, Michigan, United States

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Bloomington, Minnesota, United States

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Edina, Minnesota, United States

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Independence, Missouri, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Brookville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Beaumont, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GTS100-PAS

Identifier Type: -

Identifier Source: org_study_id

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