GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

Last updated: May 18, 2015
Sponsor: Glaukos Corporation
Overall Status: Completed

Phase

3

Condition

Glaucoma

Vision Loss

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT01052558
GC-006
  • Ages 18-90
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma in the study eye

  • Subject must be on 1 to 3 glaucoma medications

  • Subject able and willing to attend follow up visits for two years postop

  • Subject able and willing to sign informed consent

Exclusion

Exclusion Criteria:

  • Pseudoexfoliative and pigmentary glaucoma

  • Prior glaucoma surgery of any type

Study Design

Total Participants: 164
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2013

Study Description

Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

Connect with a study center

  • Boozman-Hof Regional Eye Clinic

    Rogers, Arkansas 72756
    United States

    Site Not Available

  • North Bay Eye Associates, Inc.

    Petaluma, California 94954
    United States

    Site Not Available

  • Glaucoma Consultants of Colorado

    Parker, Colorado 80134
    United States

    Site Not Available

  • The Center for Excellence in Eye Care

    Miami, Florida 33176
    United States

    Site Not Available

  • International Eye Center

    Tampa, Florida 33603
    United States

    Site Not Available

  • Clayton Eye Center / Eye Care Centers Management, Inc.

    Morrow, Georgia 30260
    United States

    Site Not Available

  • Chicago Eye Specialists

    Chicago, Illinois 60619
    United States

    Site Not Available

  • Whitson Vision, PC

    Indianapolis, Indiana 46240
    United States

    Site Not Available

  • D'Ambrosio Eye Care

    Lancaster, Massachusetts 01523
    United States

    Site Not Available

  • Kresge Eye Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Discover Vision Centers

    Independence, Missouri 64055
    United States

    Site Not Available

  • Silverstein Eye Centers

    Kansas City, Missouri 64133
    United States

    Site Not Available

  • St. John's Medical Research Institute

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Las Vegas Physician Research Group

    Henderson, Nevada 75965
    United States

    Site Not Available

  • Shepherd Eye Center

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Ophthalmic Consultants of Long Island

    Rockville Center, New York 11570
    United States

    Site Not Available

  • Thomas Mundorf, MD

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Laurel Eye Clinic

    Brookville, Pennsylvania 15825
    United States

    Site Not Available

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Vance Thompson Vision / Sanford Clinic

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Texan Eye

    Austin, Texas 78731
    United States

    Site Not Available

  • Lehmann Eye Center

    Nacogdoches, Texas 75965
    United States

    Site Not Available

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