Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 September 2022 |
Main ID: |
NCT01517477 |
Date of registration:
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23/01/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
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Scientific title:
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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 |
Date of first enrolment:
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January 2012 |
Target sample size:
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119 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01517477 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Armenia
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Open Angle Glaucoma (POAG)
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Intervention(s)
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Device: iStent
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Primary Outcome(s)
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Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline
[Time Frame: 12 Months]
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Secondary Outcome(s)
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Mean diurnal IOP <18 mmHg at month 12
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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