Back to resultsProspective Evaluation of Open-angle Glaucoma Subjects on Two 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
iStents
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, Glaucoma Open-Angle, 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. Malayna's Ophthalmology Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Two iStent devices and medication
Arm Description
Implantation of two iStents through small temporal clear corneal incision
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
NCT ID
NCT01252888
First Posted
December 1, 2010
Last Updated
September 2, 2022
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01252888
Brief Title
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
Official Title
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two 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 assess efficacy and safety of two iStents for the reduction of intraocular pressure associated 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, Glaucoma Open-Angle, 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
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Two iStent devices and medication
Arm Type
Experimental
Arm Description
Implantation of two iStents through small temporal clear corneal incision
Intervention Type
Device
Intervention Name(s)
iStents
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
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)
Subjects on two topical hypotensive medications
Exclusion Criteria:
Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled
Facility Information:
Facility Name
S.V. Malayna's Ophthalmology Centre
City
Yerevan
ZIP/Postal Code
375108
Country
Armenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25088627
Citation
Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, Samuelson TW. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014 Aug;40(8):1295-300. doi: 10.1016/j.jcrs.2014.07.004.
Results Reference
background
PubMed Identifier
28352151
Citation
Chang DF, Donnenfeld ED, Katz LJ, Voskanyan L, Ahmed II, Samuelson TW, Giamporcaro JE, Hornbeak DM, Solomon KD. Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up. Clin Ophthalmol. 2017 Mar 15;11:523-528. doi: 10.2147/OPTH.S121041. eCollection 2017.
Results Reference
background
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Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
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