Back to resultsOpen-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
Primary Purpose
Open-angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
One iStent
Two iStent
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open angle glaucoma, Pigmentary glaucoma, Pseudoexfoliative glaucoma
Eligibility Criteria
Inclusion Criteria:
- Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
- Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
Exclusion Criteria:
- Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
- Prior stent implantations (study eye)
Sites / Locations
- S.V. Malayan Ophthalmological Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
One iStent
Two iStent
Arm Description
Implantation of one iStent in conjunction with cataract surgery
Implantation of two iStent devices in conjunction with cataract surgery
Outcomes
Primary Outcome Measures
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
Secondary Outcome Measures
Full Information
NCT ID
NCT01455467
First Posted
September 28, 2011
Last Updated
August 29, 2022
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01455467
Brief Title
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
Official Title
A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 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
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
Keywords
Open angle glaucoma, Pigmentary glaucoma, Pseudoexfoliative glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One iStent
Arm Type
Active Comparator
Arm Description
Implantation of one iStent in conjunction with cataract surgery
Arm Title
Two iStent
Arm Type
Active Comparator
Arm Description
Implantation of two iStent devices in conjunction with cataract surgery
Intervention Type
Device
Intervention Name(s)
One iStent
Intervention Description
Implantation of one iStent in conjunction with cataract surgery
Intervention Type
Device
Intervention Name(s)
Two iStent
Intervention Description
Implantation of two iStent in conjunction with cataract surgery
Primary Outcome Measure Information:
Title
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
Exclusion Criteria:
Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
Prior stent implantations (study eye)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilit A Voskanyan, MD, PhD
Organizational Affiliation
S.V. Malayan Ophthalmological Center, Yerevan, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.V. Malayan Ophthalmological Center
City
Yerevan
ZIP/Postal Code
0001
Country
Armenia
12. IPD Sharing Statement
Learn more about this trial
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
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