Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

June 15, 2015 updated by: EyeTechCare

Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
        • University Hospital
      • Grenoble, France
        • Michallon University Hospital
      • Lille, France
        • Huriez University Hospital
      • Lyon, France
        • Croix Rousse University Hospital
      • Paris, France
        • HIA - 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

14 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
  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • UCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 12 months

Secondary Outcome Measures

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

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

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYEMUST-3

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.

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