Back to resultsMulticenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Primary Purpose
Primary Open-angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iStent inject
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Primary open-angle glaucoma, POAG, Trabecular meshwork, iStent inject
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate open-angle glaucoma
- Characteristics consistent with mild/moderate glaucoma
- Use of one (1) to three (3) medications at time of screening exam
Exclusion Criteria:
- Pigmentary or pseudoexfoliative glaucoma
- Prior incisional glaucoma surgery
Sites / Locations
- Eye Centers of Racine and Kenosha
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iStent inject
Cataract surgery
Arm Description
Implantation of two GTS400 stents using G2-M-IS iStent inject
Cataract surgery alone
Outcomes
Primary Outcome Measures
≥ 20% Reduction in Intraocular Pressure (IOP)
Secondary Outcome Measures
Diurnal IOP Reduction from Baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01461291
Brief Title
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Official Title
A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2012 (Actual)
Primary Completion Date
August 4, 2017 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
Primary open-angle glaucoma, POAG, Trabecular meshwork, iStent inject
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
505 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iStent inject
Arm Type
Experimental
Arm Description
Implantation of two GTS400 stents using G2-M-IS iStent inject
Arm Title
Cataract surgery
Arm Type
Active Comparator
Arm Description
Cataract surgery alone
Intervention Type
Device
Intervention Name(s)
iStent inject
Intervention Description
Implantation of two GTS400 stents using G2-M-IS iStent inject
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract surgery alone
Primary Outcome Measure Information:
Title
≥ 20% Reduction in Intraocular Pressure (IOP)
Time Frame
Baseline and Month 24
Secondary Outcome Measure Information:
Title
Diurnal IOP Reduction from Baseline
Time Frame
Baseline and Month 24
Other Pre-specified Outcome Measures:
Title
Safety follow-up post-PMA to be through 36 months
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate open-angle glaucoma
Characteristics consistent with mild/moderate glaucoma
Use of one (1) to three (3) medications at time of screening exam
Exclusion Criteria:
Pigmentary or pseudoexfoliative glaucoma
Prior incisional glaucoma surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Stephens, O.D.
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Eye Centers of Racine and Kenosha
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
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