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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: |
NCT02448875 |
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Date of registration:
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12/05/2015 |
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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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Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma
ViscoPass |
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Scientific title:
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Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma |
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Date of first enrolment:
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June 21, 2013 |
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Target sample size:
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192 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02448875 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel 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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Germany
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Panama
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Poland
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Spain
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Contacts
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Name:
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Alcon Research |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alcon Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of open angle glaucoma;
- Unmedicated IOP between 21 - 36 mmHg, inclusive;
- Normal angle anatomy at site of intended CyPass Micro-Stent implantation.
Exclusion Criteria:
- Advanced glaucoma;
- Prior incisional glaucoma surgery;
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular
glaucoma;
- Clinically significant ocular pathology other than glaucoma.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Open Angle Glaucoma
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Intervention(s)
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Device: CyPass Micro-Stent
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Device: Viscoelastic
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Primary Outcome(s)
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Percentage of Subjects With = 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
[Time Frame: Baseline (Day -1), Month 12 PostOperative]
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Secondary Outcome(s)
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Mean Change From Baseline to 12 Months Postoperative in Medicated IOP
[Time Frame: Baseline (Day -1), Month 12 PostOperative]
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Percentage of Subjects With Device-related Ocular Adverse Events
[Time Frame: Up to Month 12 PostOperative]
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Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used
[Time Frame: Screening (Day -2), Month 12 PostOperative]
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Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months
[Time Frame: Month 12 PostOperative]
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Secondary ID(s)
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TMI-13-01
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GLD122-P001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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