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Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device

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ClinicalTrials.gov Identifier: NCT01338467
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):

April 15, 2011
April 19, 2011
June 16, 2015
April 2011
June 2012   (Final data collection date for primary outcome measure)
Primary efficacy measure : [ Time Frame: 6 months ]
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
Same as current
Complete list of historical versions of study NCT01338467 on ClinicalTrials.gov Archive Site
Safety measures [ Time Frame: 6 months ]
The incidence of device and procedure-related complications during the follow-up
Same as current
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Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
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
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.
Not Provided
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Device: EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
Experimental: EYEOP Treatment
Open label, all subject treated by the EYEOP device
Intervention: Device: EYEOP device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2013
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2011-A00196-35 ( Other Identifier: French Health Product Safety Agency (AFSSAPS) )
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Principal Investigator: Philippe DENIS, MD Croix Rousse Hospital - Lyon - France
Study Director: Laurent FARCY EyeTechCare
Principal Investigator: Florent APTEL, MD University Hospital - Grenoble - France
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP