Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01791673
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):

Brief Summary:
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

Condition or disease Intervention/treatment
Glaucoma Device: Ultrasound glaucoma treatment

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
Study Start Date : November 2012
Primary Completion Date : May 2013
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound Glaucoma treatment
Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Device: Ultrasound glaucoma treatment
Ultrasound glaucoma treatment with EYEOP1 device
Other Name: UCP

Primary Outcome Measures :
  1. Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20% [ Time Frame: up to 12 months ]
    Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)

Secondary Outcome Measures :
  1. Average change in IOP (mm Hg) [ Time Frame: 3, 6 and 12 months ]
  2. Percentage change in IOP from baseline [ Time Frame: 3, 6 and 12 months ]
  3. Average change in glaucoma hypotensive medications [ Time Frame: 3, 6 and 12 months ]
  4. Incidence of device and procedure-related complications during follow-up [ Time Frame: 3, 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma
  • IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
  • Patient must be aged 18 years and more
  • No previous cyclophotocoagulation procedure in the eye
  • No previous laser treatment in the eye during the 3 months before HIFU procedure

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 diseasee within 14 days before HIFU procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01791673

University Hospital
Dijon, France
Michallon University Hospital
Grenoble, France
Huriez University Hospital
Lille, France
Croix Rousse University Hospital
Lyon, France
HIA - Val de Grace Hospital
Paris, France
Sponsors and Collaborators
Principal Investigator: Philippe DENIS, MD Croix Rousse University Hospital

Responsible Party: EyeTechCare Identifier: NCT01791673     History of Changes
Other Study ID Numbers: EYEMUST-3
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: February 2013

Keywords provided by EyeTechCare:
HIFU - High Intensity Focused Ultrasound
Ciliary Body

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases