Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
NCT ID: NCT01338467
Last Updated: 2015-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2011-04-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EYEOP Treatment
Open label, all subject treated by the EYEOP device
EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
Interventions
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EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
Eligibility Criteria
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Inclusion Criteria
* 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 ocular or retrobulbar tumor
* Retinal detachment, choroidal hemorrhage or detachment
* Ocular infectious disease within 14 days before HIFU treatment
18 Years
ALL
No
Sponsors
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EyeTechCare
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe DENIS, MD
Role: PRINCIPAL_INVESTIGATOR
Croix Rousse Hospital - Lyon - France
Laurent FARCY
Role: STUDY_DIRECTOR
EyeTechCare
Florent APTEL, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital - Grenoble - France
Locations
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University Hospital
Dijon, , France
University Hospital
Grenoble, , France
University Hospital - Cl Huriez
Lille, , France
Clinique du Parc - Private Hospital
Lyon, , France
Croix Rousse Hospital
Lyon, , France
XV-XX National Ophthalmologic Hospital
Paris, , France
XV-XX Ophthalmologic Hospital
Paris, , France
Saint-Joseph Hospital
Paris, , France
Val de Grace Hospital
Paris, , France
Countries
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References
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Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.
Other Identifiers
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2011-A00196-35
Identifier Type: OTHER
Identifier Source: secondary_id
EYEMUST
Identifier Type: -
Identifier Source: org_study_id
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