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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 June 2015 |
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Main ID: |
NCT00911924 |
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Date of registration:
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01/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
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Scientific title:
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A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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112 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00911924 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Armenia
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Austria
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France
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Germany
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Greece
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Italy
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Spain
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Contacts
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Name:
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Jeff Wells, PharmD, MBA |
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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:
- Diagnosis of primary open-angle glaucoma
- Male or female at least 18 years of age and able to provide written informed
consent
- Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm
Hg and no greater than 38 mm Hg
- Likely to be available and willing to attend follow-up visits
Exclusion Criteria:
- Angle closure glaucoma
- Secondary glaucomas
- Prior glaucoma procedures
- Elevated episcleral venous pressure from history of active thyroid orbitopathy,
carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Eye Diseases
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Glaucoma, Open-Angle
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Glaucoma
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Intervention(s)
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Device: iStent
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Primary Outcome(s)
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IOP 18 mm Hg or less with or without medications
[Time Frame: 12 months]
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IOP 18 mm Hg or less without medications
[Time Frame: At 6 months]
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Secondary Outcome(s)
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Mean IOP
[Time Frame: 12 months]
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Secondary ID(s)
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Synergy Trial
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Synergy
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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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