Back to resultsiStent Inject New Enrollment Post-Approval Study
Primary Purpose
Glaucoma, Open-Angle, Glaucoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iStent Inject Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 22 years of age
- Mild to moderate primary open-angle glaucoma
- Scheduled to undergo cataract surgery
- Able and willing to attend scheduled follow-up exams for three years postoperatively
Able and willing to provide written informed consent on the IRB approved Informed Consent Form
Operative Inclusion Criterion:
- Successful, uncomplicated cataract surgery
Exclusion Criteria:
- Angle closure glaucoma
- Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
- Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Sites / Locations
- Eye Doctors of Arizona, PLLC
- Wolstan and Goldberg Eye Associates
- Glaucoma Associates of Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implantation
Arm Description
Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.
Outcomes
Primary Outcome Measures
iStent inject placement and stability
The rate of clinically relevant complications associated with iStent inject placement and stability
Secondary Outcome Measures
Sight-threatening adverse events
Rate of occurrence of sight-threatening adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04624698
Brief Title
iStent Inject New Enrollment Post-Approval Study
Official Title
iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.
Detailed Description
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
358 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implantation
Arm Type
Experimental
Arm Description
Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.
Intervention Type
Device
Intervention Name(s)
iStent Inject Implantation
Intervention Description
Subjects will be implanted with the iStent Injection Micro-Bypass device
Primary Outcome Measure Information:
Title
iStent inject placement and stability
Description
The rate of clinically relevant complications associated with iStent inject placement and stability
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
Sight-threatening adverse events
Description
Rate of occurrence of sight-threatening adverse events
Time Frame
36 Months
Other Pre-specified Outcome Measures:
Title
Other adverse events
Description
Rate of other adverse events
Time Frame
36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 22 years of age
Mild to moderate primary open-angle glaucoma
Scheduled to undergo cataract surgery
Able and willing to attend scheduled follow-up exams for three years postoperatively
Able and willing to provide written informed consent on the IRB approved Informed Consent Form
Operative Inclusion Criterion:
Successful, uncomplicated cataract surgery
Exclusion Criteria:
Angle closure glaucoma
Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Facility Information:
Facility Name
Eye Doctors of Arizona, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Facility Name
Wolstan and Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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iStent Inject New Enrollment Post-Approval Study
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