Back to resultsInvestigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Model iS3 three-stent trabecular micro-bypass system
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring refractory
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.
- Phakic or pseudophakic.
- Males or females, 45 years of age or older.
Exclusion Criteria:
- Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
Sites / Locations
- Glaucoma Associates of Tx
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implant Group
Arm Description
Qualified eyes with refractory glaucoma will be implanted unilaterally with the Glaukos® Trabecular Micro-Bypass System Model iS3 (three G2-W stents per study eye), and will be followed through 12 months postoperative.
Outcomes
Primary Outcome Measures
Primary effectiveness endpoint
The change in mean diurnal IOP from baseline at 12 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03639870
Brief Title
Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
Official Title
A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.
Detailed Description
This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The three G2-W stents are heparin-coated and manufactured from implant grade titanium.
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implant Group
Arm Type
Experimental
Arm Description
Qualified eyes with refractory glaucoma will be implanted unilaterally with the Glaukos® Trabecular Micro-Bypass System Model iS3 (three G2-W stents per study eye), and will be followed through 12 months postoperative.
Intervention Type
Device
Intervention Name(s)
Model iS3 three-stent trabecular micro-bypass system
Other Intervention Name(s)
Implant Group
Intervention Description
Provided in Arm/Group descriptions.
Primary Outcome Measure Information:
Title
Primary effectiveness endpoint
Description
The change in mean diurnal IOP from baseline at 12 months
Time Frame
Month 12 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.
Phakic or pseudophakic.
Males or females, 45 years of age or older.
Exclusion Criteria:
Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.
Active corneal inflammation or edema.
Retinal disorders not associated with glaucoma.
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
Glaucoma Associates of Tx
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
We'll reach out to this number within 24 hrs