A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

December 14, 2017 updated by: Glaukos Corporation

A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

The purpose of this study is to evaluate the safety and efficacy of the iStent 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

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.

Study Type

Interventional

Enrollment (Actual)

240

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
    • California
      • Beverly Hills, California, United States, 90210
        • Assil Eye Institute
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates Inc
      • Sacramento, California, United States, 95817
        • Ellison Ambulatory Care Center
      • San Clemente, California, United States, 92673
        • Harvard Eye Associates
      • Santa Maria, California, United States, 93454
        • Shepard Eye Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Glaucoma Consultants of Colorado
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute, Inc.
      • 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
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Indiana University
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Stiles Eyecare Excellence
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute Building
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Williamson Nelson Eye Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute
      • Saint Joseph, Michigan, United States, 49085
        • Great Lakes Eye Care
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Chu Vision Institute
      • Minneapolis, Minnesota, United States, 55404
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Independence, Missouri, United States, 64055
        • Discover Vision Centers
      • Kansas City, Missouri, United States, 64133
        • Silverstein Eye Centers
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • The Shepherd Eye Center
    • New York
      • Slingerlands, New York, United States, 12159
        • Glaucoma Consultants of Capital Region
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Donald J. Digby and Associates
      • Winston-Salem, North Carolina, United States, 27101
        • James Branch MD
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cinicinnati Eye Institute
    • Pennsylvania
      • Brookville, Pennsylvania, United States, 15825
        • Laurel Eye Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Eye Center
      • Pittsburgh, Pennsylvania, United States, 15122
        • Associates in Ophthalmology
    • Texas
      • Beaumont, Texas, United States, 77702
        • Southeast Texas Medical Association, L.L.P.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
  • Subject on at least one glaucoma medication
  • Able and willing to attend follow up visits for two years post operative
  • Able and willing to sign informed consent

Exclusion Criteria:

  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Angle closure glaucoma
  • Fellow eye already enrolled

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A--iStent plus Cataract Surgery
iStent plus Cataract Surgery
Device: iStent plus Cataract Surgery
ab interno trabecular bypass stent surgery
Other Names:
  • iStent Surgery
Active Comparator: B--Cataract Surgery Only
Cataract Surgery only
Procedure: Cataract surgery only
Cataract surgery only
Other Names:
  • Phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
Time Frame: 12 months
Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 12 months
Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months
12 months

Collaborators and Investigators

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

Sponsor

Glaukos Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 6, 2006

First Submitted That Met QC Criteria

May 6, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-003

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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