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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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29 June 2015 |
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Main ID: |
NCT01338467 |
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Date of registration:
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15/04/2011 |
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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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Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
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Scientific title:
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Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01338467 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Laurent FARCY |
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Address:
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Telephone:
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Email:
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Affiliation:
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EyeTechCare |
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Name:
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Florent APTEL, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital - Grenoble - France |
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Name:
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Philippe DENIS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Croix Rousse Hospital - Lyon - France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary
glaucoma in the study eye with maximally tolerated medical treatment
- Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg
- Subject has failed a conventional intraocular glaucoma filtering surgery
- Patient must be aged 18 years or more
- No previous intraocular glaucoma surgery or laser treatment in the study eye during
the 3 months before HIFU treatment
- No previous cyclophotocoagulation procedure in the study eye
- Patient able and willing to provide informed consent and to complete post-operative
follow-up requirements.
Exclusion Criteria:
- History of previous glaucoma surgery with implantation of glaucoma drainage device in
the study eye
- History of ocular or retrobulbar tumor
- Retinal detachment, choroidal hemorrhage or detachment
- Ocular infectious disease within 14 days before HIFU treatment
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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Glaucoma
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Intervention(s)
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Device: EYEOP device
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Primary Outcome(s)
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Primary efficacy measure :
[Time Frame: 6 months]
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Secondary Outcome(s)
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Safety measures
[Time Frame: 6 months]
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Secondary ID(s)
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EYEMUST
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2011-A00196-35
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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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