- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841450
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
Conditions
Intervention / Treatment
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
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California
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Irvine, California, United States, 92604
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Montebello, California, United States, 90640
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Colorado
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Aurora, Colorado, United States, 80045
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Georgia
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Atlanta, Georgia, United States, 30342
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Kentucky
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Edgewood, Kentucky, United States, 41017
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Louisville, Kentucky, United States, 40217
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Michigan
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Jackson, Michigan, United States, 49202
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Saint Joseph, Michigan, United States, 49085
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Missouri
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Kansas City, Missouri, United States, 64151
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Saint Louis, Missouri, United States, 63131
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North Carolina
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Winston-Salem, North Carolina, United States, 27101
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Ohio
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Cincinnati, Ohio, United States, 45242
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Mentor, Ohio, United States, 44060
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Pennsylvania
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Kingston, Pennsylvania, United States, 18704
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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
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Cataract surgery alone
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Experimental: iStent
Implantation of one iStent in conjunction with cataract surgery
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Implantation of one iStent in conjunction with cataract surgery
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of sight-threatening adverse events
Time Frame: 36 months
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other adverse events
Time Frame: 36 months
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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.
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36 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diurnal IOP reduction ≥ 20%
Time Frame: Baseline and 24 months
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Baseline and 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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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