Back to resultsA Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
Primary Purpose
Subject With Primary Open-angle Glaucoma (POAG)
Status
Completed
Phase
Phase 4
Locations
Armenia
Study Type
Interventional
Intervention
iStent Supra Stent
Sponsored by
About this trial
This is an interventional treatment trial for Subject With Primary Open-angle Glaucoma (POAG) focused on measuring Open angle, Glaucoma, Surgery, Ocular Hypertension, Eye Diseases
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with primary open-angle glaucoma (POAG)
- Subjects on two topical hypotensive medications
Exclusion Criteria:
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Sites / Locations
- S.V. Malayan Ophthalmology Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One iStent Supra Stent and medication
Arm Description
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
Outcomes
Primary Outcome Measures
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
Secondary Outcome Measures
Mean diurnal Intraocular Pressure < 18 mmHg at month 12
Full Information
NCT ID
NCT01252914
First Posted
December 1, 2010
Last Updated
September 2, 2022
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01252914
Brief Title
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
Official Title
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 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 assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Detailed Description
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subject With Primary Open-angle Glaucoma (POAG)
Keywords
Open angle, Glaucoma, Surgery, Ocular Hypertension, Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One iStent Supra Stent and medication
Arm Type
Experimental
Arm Description
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
Intervention Type
Device
Intervention Name(s)
iStent Supra Stent
Intervention Description
Implantation of one iStent Supra Stent through a small temporal clear corneal incision
Primary Outcome Measure Information:
Title
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean diurnal Intraocular Pressure < 18 mmHg at month 12
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Safety
Description
Rate of ocular adverse events through 61 months
Findings from Intraocular Pressure, best corrected visual acuity, visual field, specular microscopy measurements
Findings from slit-lamp, fundus and gonioscopic examinations
Time Frame
0-61 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)
Subjects on two topical hypotensive medications
Exclusion Criteria:
Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilit Voskanyan, MD
Organizational Affiliation
SV Malayan Ophthalmological Center, Yerevan, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.V. Malayan Ophthalmology Centre
City
Yerevan
ZIP/Postal Code
375108
Country
Armenia
12. IPD Sharing Statement
Learn more about this trial
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
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