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

May 18, 2015 updated by: Glaukos Corporation

A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72756
        • Boozman-Hof Regional Eye Clinic
    • California
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates, Inc.
    • Colorado
      • Parker, Colorado, United States, 80134
        • Glaucoma Consultants of Colorado
    • Florida
      • Miami, Florida, United States, 33176
        • The Center for Excellence in Eye Care
      • Tampa, Florida, United States, 33603
        • International Eye Center
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Center / Eye Care Centers Management, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60619
        • Chicago Eye Specialists
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Whitson Vision, PC
    • Massachusetts
      • Lancaster, Massachusetts, United States, 01523
        • D'Ambrosio Eye Care
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute
    • Missouri
      • Independence, Missouri, United States, 64055
        • Discover Vision Centers
      • Kansas City, Missouri, United States, 64133
        • Silverstein Eye Centers
      • Springfield, Missouri, United States, 65807
        • St. John's Medical Research Institute
    • Nevada
      • Henderson, Nevada, United States, 75965
        • Las Vegas Physician Research Group
      • Las Vegas, Nevada, United States, 89121
        • Shepherd Eye Center
    • New York
      • Rockville Center, New York, United States, 11570
        • Ophthalmic Consultants of Long Island
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Thomas Mundorf, MD
    • Pennsylvania
      • Brookville, Pennsylvania, United States, 15825
        • Laurel Eye Clinic
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare Physicians
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Vance Thompson Vision / Sanford Clinic
    • Texas
      • Austin, Texas, United States, 78731
        • Texan Eye
      • Nacogdoches, Texas, United States, 75965
        • Lehmann Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Criteria:

  • Pseudoexfoliative and pigmentary glaucoma
  • Prior glaucoma surgery of any type

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cataract Surgery Only
Procedure: Cataract Surgery
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
EXPERIMENTAL: Treatment with Cataract Surgery & Stents
Ab interno trabecular micro-bypass stent surgery
Device: iStent Inject (GTS400)
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
Other Names:
  • Cataract surgery, stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (ESTIMATE)

January 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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