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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19 September 2022 |
Main ID: |
NCT03478293 |
Date of registration:
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20/03/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
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Scientific title:
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A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications |
Date of first enrolment:
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February 27, 2018 |
Target sample size:
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6 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03478293 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Kerry Stephens, OD |
Address:
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Telephone:
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Email:
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Affiliation:
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Glaukos Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with primary open angle glaucoma (POAG)
- Subject on two ocular 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 inject surgery
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Primary Outcome(s)
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IOP reduction at 12 and 24 months on same number or fewer medications
[Time Frame: 12 months and 24 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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