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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01338467
First received: April 15, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Glaucoma
 Device: EYEOP device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by EyeTechCare:

Primary Outcome Measures:
  • Primary efficacy measure : [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment


Secondary Outcome Measures:
  • Safety measures [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The incidence of device and procedure-related complications during the follow-up


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EYEOP Treatment
Open label, all subject treated by the EYEOP device
 Device: EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338467

Locations
France
University Hospital
Dijon, France, 21000
University Hospital
Grenoble, France, 38000
University Hospital - Cl Huriez
Lille, France, 59000
Croix Rousse Hospital
Lyon, France
Clinique du Parc - Private Hospital
Lyon, France, 69006
XV-XX National Ophthalmologic Hospital
Paris, France, 75012
Saint-Joseph Hospital
Paris, France, 75014
XV-XX Ophthalmologic Hospital
Paris, France, 75012
Val de Grace Hospital
Paris, France, 75235
Sponsors and Collaborators
EyeTechCare
Investigators
Principal Investigator: Philippe DENIS, MD Croix Rousse Hospital - Lyon - France
Study Director: Laurent FARCY EyeTechCare
Principal Investigator: Florent APTEL, MD University Hospital - Grenoble - France
  More Information

No publications provided

Responsible Party: EyeTechCare
ClinicalTrials.gov Identifier: NCT01338467     History of Changes
Other Study ID Numbers: EYEMUST, 2011-A00196-35
Study First Received: April 15, 2011
Last Updated: March 8, 2013
Health Authority: France : French Health Products Safety Agency (AFSSAPS)

Keywords provided by EyeTechCare:
Glaucoma
Refractory glaucoma
Cyclocoagulation
High Intensity Focused Ultrasound

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013