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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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12 December 2020 |
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Main ID: |
NCT03114059 |
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Date of registration:
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04/04/2017 |
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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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5 Years Long Term Results After Standalone CyPass-Implantation
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Scientific title:
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Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation |
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Date of first enrolment:
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February 1, 2017 |
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Target sample size:
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130 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03114059 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Helmut Hoeh, MD,FEBO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Ophthalmology, Neubrandenburg, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients who have undergone a standalone cypass implantation at least 3 years ago
- signed inform consent
Exclusion Criteria:
- Patients with to much travel distance between study center and home
- Patients who cannot visit the studycenter due to health problems
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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Glaucoma
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Intervention(s)
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Diagnostic Test: Glaucoma diagnostics
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Primary Outcome(s)
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Number of additional Medication
[Time Frame: up to 7 years]
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Pressure Change vs Baseline
[Time Frame: up to 7 years]
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Target Pressure
[Time Frame: up to 7 years]
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Secondary glaucoma procedures
[Time Frame: up to 7 years]
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Secondary Outcome(s)
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Stability of Stent tissue interaction
[Time Frame: up to 7 years]
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Intra-and postoperative complications
[Time Frame: up to 7 years]
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Stability of the Retinal Nerve Fiber Layer Thickness
[Time Frame: up to 7 years]
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Stability of Stent Position
[Time Frame: up to 7 years]
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Stability of Visual Field
[Time Frame: up to 7 years]
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Stability of optic nerve
[Time Frame: up to 7 years]
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Suprachoroidal Bleb
[Time Frame: up to 7 years]
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Secondary ID(s)
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STI 06/16
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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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