Back to resultsPurpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
Primary Purpose
Primary Open Angle Glaucoma (POAG)
Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
iStent
iStent
iStent
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma (POAG) focused on measuring Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on two topical hypotensive medications
Exclusion Criteria:
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Sites / Locations
- S.V. Malayan's Ophthalmology Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
First Arm: One iStent, medication
Second Arm: Two iStents, medication
Third Arm: Three iStents, medication
Arm Description
Device: One iStent, medication
Device: Two iStent devices, medication
Device: Three iStent devices, medication
Outcomes
Primary Outcome Measures
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Secondary Outcome Measures
Mean diurnal IOP <18 mmHg at month 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01252849
Brief Title
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
Official Title
A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma (POAG)
Keywords
Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
iStent 1, 2, or 3 stents
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Arm: One iStent, medication
Arm Type
Experimental
Arm Description
Device: One iStent, medication
Arm Title
Second Arm: Two iStents, medication
Arm Type
Experimental
Arm Description
Device: Two iStent devices, medication
Arm Title
Third Arm: Three iStents, medication
Arm Type
Experimental
Arm Description
Device: Three iStent devices, medication
Intervention Type
Device
Intervention Name(s)
iStent
Intervention Description
Implantation of One iStent through a small temporal clear corneal incision.
Intervention Type
Device
Intervention Name(s)
iStent
Intervention Description
Implantation of Two iStents through a small temporal clear corneal incision
Intervention Type
Device
Intervention Name(s)
iStent
Intervention Description
Implantation of Three iStents through a small temperal clear corneal incision
Primary Outcome Measure Information:
Title
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Mean diurnal IOP <18 mmHg at month 12
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed with primary open-angle glaucoma (POAG)
Subject on two topical hypotensive medications
Exclusion Criteria:
Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled
Facility Information:
Facility Name
S.V. Malayan's Ophthalmology Centre
City
Yerevan
ZIP/Postal Code
375108
Country
Armenia
12. IPD Sharing Statement
Learn more about this trial
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
We'll reach out to this number within 24 hrs