Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

December 14, 2017 updated by: Glaukos Corporation
The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

191

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
      • Chico, California, United States, 95926
      • Huntington Beach, California, United States, 92647
      • Napa, California, United States, 94558
      • Santa Maria, California, United States, 93454
      • Ventura, California, United States, 93003
    • Colorado
      • Parker, Colorado, United States, 80134
    • Maine
      • Portland, Maine, United States, 04102
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
    • New Jersey
      • Westwood, New Jersey, United States, 07675
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Fayetteville, North Carolina, United States, 28304
      • Southern Pines, North Carolina, United States, 28387
    • Ohio
      • Brecksville, Ohio, United States, 44141
      • Youngstown, Ohio, United States, 44502
    • South Carolina
      • Ladson, South Carolina, United States, 29456
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
    • Wisconsin
      • Appleton, Wisconsin, United States, 54914

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites

Description

Inclusion Criteria:

  • Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

  • Please refer to approved indications in Directions for Use

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iStent
Device: iStent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of sight-threatening adverse events
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Other ocular adverse events
Time Frame: 36 months
36 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

September 1, 2013

Primary Completion (Actual)

February 16, 2016

Study Completion (Actual)

June 21, 2016

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTS100-PAR

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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