Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

March 16, 2016 updated by: Glaukos Corporation

Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Study Type

Observational

Enrollment (Actual)

108

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
      • Petaluma, California, United States, 94954
      • Sacramento, California, United States, 95817
      • San Clemente, California, United States, 92673
      • Santa Maria, California, United States, 93454
    • Colorado
      • Parker, Colorado, United States, 80134
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Miami, Florida, United States, 33176
      • Tampa, Florida, United States, 33603
    • Georgia
      • Morrow, Georgia, United States, 30260
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kansas
      • Overland Park, Kansas, United States, 66213
    • Kentucky
      • Louisville, Kentucky, United States, 40206
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
    • Michigan
      • St. Joseph, Michigan, United States, 49085
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
      • Edina, Minnesota, United States, 55435
    • Missouri
      • Independence, Missouri, United States, 64055
      • Kansas City, Missouri, United States, 64133
    • Nevada
      • Las Vegas, Nevada, United States, 89121
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101
    • Ohio
      • Cincinnati, Ohio, United States, 45242
    • Pennsylvania
      • Brookville, Pennsylvania, United States, 15825
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15122
    • Texas
      • Beaumont, Texas, United States, 77702

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

Extended follow-up of subjects previously enrolled in Glaukos Study GC-003

Description

Inclusion Criteria:

  • Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Exclusion Criteria:

  • Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
  • Patients not previously enrolled in Glaukos Study GC-003

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
Randomized iStent
Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
Randomized cataract surgery
Cataract surgery alone, patients randomized to group
Non-randomized iStent
Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Sight-threatening Adverse Events
Time Frame: 80 Month average
The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.
80 Month average

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

July 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTS100-PAS

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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