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

June 15, 2015 updated by: EyeTechCare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • University Hospital
      • Grenoble, France, 38000
        • University Hospital
      • Lille, France, 59000
        • University Hospital - Cl Huriez
      • Lyon, France, 69006
        • Clinique du Parc - Private Hospital
      • Lyon, France
        • Croix Rousse Hospital
      • Paris, France, 75012
        • XV-XX National Ophthalmologic Hospital
      • Paris, France, 75012
        • XV-XX Ophthalmologic Hospital
      • Paris, France, 75014
        • Saint-Joseph Hospital
      • Paris, France, 75235
        • Val de Grace Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EYEOP Treatment
Open label, all subject treated by the EYEOP device
Device: EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary efficacy measure :
Time Frame: 6 months
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measures
Time Frame: 6 months
The incidence of device and procedure-related complications during the follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeTechCare

Investigators

  • Principal Investigator: Philippe DENIS, MD, Croix Rousse Hospital - Lyon - France
  • Principal Investigator: Florent APTEL, MD, University Hospital - Grenoble - France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYEMUST
  • 2011-A00196-35 (Other Identifier: French Health Product Safety Agency (AFSSAPS))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Clinical Trials on EYEOP device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe