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Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791673
First Posted: February 15, 2013
Last Update Posted: June 16, 2015
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.
Information provided by (Responsible Party):
EyeTechCare
  Purpose
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

Condition Intervention
Glaucoma Device: Ultrasound glaucoma treatment

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by EyeTechCare:

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

Enrollment: 30
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound Glaucoma treatment
Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Device: Ultrasound glaucoma treatment
Ultrasound glaucoma treatment with EYEOP1 device
Other Name: UCP

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01791673


Locations
France
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
EyeTechCare
Investigators
Principal Investigator: Philippe DENIS, MD Croix Rousse University Hospital
  More Information

Responsible Party: EyeTechCare
ClinicalTrials.gov Identifier: NCT01791673     History of Changes
Other Study ID Numbers: EYEMUST-3
First Submitted: February 13, 2013
First Posted: February 15, 2013
Last Update Posted: June 16, 2015
Last Verified: February 2013

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases