Back to resultsProspective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
Primary Purpose
Subjects With Primary Open-angle Glaucoma (POAG)
Status
Completed
Phase
Phase 4
Locations
Armenia
Study Type
Interventional
Intervention
iStent
Sponsored by
About this trial
This is an interventional treatment trial for Subjects 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)
- Subject on one topical hypotensive medication
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 Type
Experimental
Arm Label
Two iStents devices
Arm Description
Two iStents devices will be implanted
Outcomes
Primary Outcome Measures
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline
Secondary Outcome Measures
IOP < 18 mm Hg at Month 12
Full Information
NCT ID
NCT01252862
First Posted
December 1, 2010
Last Updated
December 14, 2017
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01252862
Brief Title
Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
Official Title
A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (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 intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma
Detailed Description
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects 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
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Two iStents devices
Arm Type
Experimental
Arm Description
Two iStents devices will be implanted
Intervention Type
Device
Intervention Name(s)
iStent
Intervention Description
Implantation of two iStents through a small temporal 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
IOP < 18 mm Hg 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 one topical hypotensive medication
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
Citations:
PubMed Identifier
26604675
Citation
Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, Katz LJ. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015 Nov 3;9:2057-65. doi: 10.2147/OPTH.S91732. eCollection 2015.
Results Reference
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Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents
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