iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

NCT ID: NCT04624685

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

Total Enrollment

475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-12-31

Brief Summary

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Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

Detailed Description

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To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

Conditions

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Glaucoma, Open-Angle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Randomized subject followed for 24 months in the GC-008 study
* Able to understand study requirements
* Willing to attend scheduled follow-up exams for 5 years post-operatively
* Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Exclusion Criteria

* None
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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Arizona Advanced Eye Research Institute

Glendale, Arizona, United States

Site Status

Vold Vision, PLLC

Fayetteville, Arkansas, United States

Site Status

North Bath Eye Associates, Inc.

Santa Rosa, California, United States

Site Status

Eye Center of northern Colorado, PC

Fort Collins, Colorado, United States

Site Status

Argus Research

Cape Coral, Florida, United States

Site Status

International Research Center

Tampa, Florida, United States

Site Status

Center for Sight

Venice, Florida, United States

Site Status

Clayton Eye Clinical Research, LLC.

Morrow, Georgia, United States

Site Status

Chicago Eye Specialists

Chicago, Illinois, United States

Site Status

Arbor Center for Eye Care

Orland Park, Illinois, United States

Site Status

Stiles Eyecare Excellence

Overland Park, Kansas, United States

Site Status

D'Ambrosio Eye Care

Lancaster, Massachusetts, United States

Site Status

Kresge Eye Institute / Wayne State University

Detroit, Michigan, United States

Site Status

Discover Vision Centers

Independence, Missouri, United States

Site Status

Northern New Jersey Eye Institute

South Orange, New Jersey, United States

Site Status

Glaucoma Consultants of the Capital Region

Slingerlands, New York, United States

Site Status

Oklahoma eye Surgeons, PLLC

Oklahoma City, Oklahoma, United States

Site Status

Keystone Research

Austin, Texas, United States

Site Status

Ophthalmology Associates

Fort Worth, Texas, United States

Site Status

Parkhurst Nuvision

San Antonio, Texas, United States

Site Status

R and R Eye Resarch, LLC

San Antonio, Texas, United States

Site Status

Vistar Eye Center

Roanoke, Virginia, United States

Site Status

Spokane Eye Clinical Research

Spokane, Washington, United States

Site Status

The Eye Center of Racine and Kenosha

Racine, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IG2M-104-CONT

Identifier Type: -

Identifier Source: org_study_id