Clinical trial NCT01338467: Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Refractory glaucoma
Cyclocoagulation
High Intensity Focused Ultrasound
Lead sponsor: EyeTechCare
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.


Eligibility criteria: 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

Primary outcomes:
measure: Primary efficacy measure :
timeFrame: 6 months
Secondary outcomes:
measure: Safety measures
timeFrame: 6 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: University Hospital
city: Grenoble
country: France
facility: University Hospital
city: Lille
country: France
facility: University Hospital - Cl Huriez
city: Lyon
country: France
facility: Clinique du Parc - Private Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Paris
country: France
facility: XV-XX National Ophthalmologic Hospital
city: Paris
country: France
facility: XV-XX Ophthalmologic Hospital
city: Paris
country: France
facility: Saint-Joseph Hospital
city: Paris
country: France
facility: Val de Grace Hospital
Study officials:
affiliation: Croix Rousse Hospital - Lyon - France
name: Philippe DENIS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EyeTechCare
name: Laurent FARCY
role: STUDY_DIRECTOR
affiliation: University Hospital - Grenoble - France
name: Florent APTEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.