Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty

December 20, 2022 updated by: Glaukos Corporation
To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

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
    • Arizona
      • Glendale, Arizona, United States, 85306
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
    • California
      • Hemet, California, United States, 92545
    • Florida
      • Cape Coral, Florida, United States, 33904
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Fort Worth, Texas, United States, 76102
      • San Antonio, Texas, United States, 78229
    • Wisconsin
      • Racine, Wisconsin, United States, 53405

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

31 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Open angle Glaucoma

Exclusion Criteria:

  • Active corneal inflammation or edema
  • Choroidal detachment, effusion, choroiditis

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical
Implantation of two Trabecular Meshwork stents into the study eye
Device: Stents
Two Trabecular meshwork Micro-Bypass stents into the study eye
Active Comparator: Laser
Laser Trabeculoplasty
Procedure: Laser
Laser Trabeculoplasty
Device: Laser Trabeculoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP reduction
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
% IOP reduction
Time Frame: up to 24 months
up to 24 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 (Actual)

December 16, 2014

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

August 11, 2020

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-004

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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