Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

October 18, 2021 updated by: Glaukos Corporation

A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Study Overview

Status

Active, not recruiting

Detailed Description

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Study Type

Interventional

Enrollment (Anticipated)

360

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

    • California
      • Irvine, California, United States, 92604
      • Montebello, California, United States, 90640
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
      • Louisville, Kentucky, United States, 40217
    • Michigan
      • Jackson, Michigan, United States, 49202
      • Saint Joseph, Michigan, United States, 49085
    • Missouri
      • Kansas City, Missouri, United States, 64151
      • Saint Louis, Missouri, United States, 63131
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Mentor, Ohio, United States, 44060
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704

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

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild to moderate primary open-angle glaucoma
  • currently treated with ocular hypotensive medication
  • pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
  • subject scheduled to undergo cataract surgery

Exclusion Criteria:

  • primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
  • retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cataract surgery
Cataract surgery alone
Cataract surgery alone
Experimental: iStent
Implantation of one iStent in conjunction with cataract surgery
Implantation of one iStent in conjunction with cataract surgery
Other Names:
  • GTS100

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
Measure Description
Time Frame
Other adverse events
Time Frame: 36 months
For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.
36 months

Other Outcome Measures

Outcome Measure
Time Frame
Diurnal IOP reduction ≥ 20%
Time Frame: Baseline and 24 months
Baseline and 24 months

Collaborators and Investigators

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

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)

July 1, 2013

Primary Completion (Actual)

August 1, 2021

Study Completion (Anticipated)

November 1, 2021

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)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • GTS100-PAS2 (Rev1 04-11-2016)

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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