Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)

June 15, 2015 updated by: EyeTechCare

Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.

The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

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

  • Israel
      • Tel Hashomer, Israel, 52621
        • The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
  • Italy
      • Milano, Italy, 20142
        • Ospedale San Paolo
      • Parma, Italy, 43121
        • Institute Ophthalmology - Universita di Parma
      • Torino, Italy, 10149
        • Clinica Oculistica Universitaria - P-O Oftalmico
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
  • Switzerland
      • Genève, Switzerland, CH-1211
        • Hôpitaux universitaires de Genève
      • Lausanne, Switzerland, CH-1006
        • Clinique de Montchoisi - Glaucoma center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Refractory Glaucoma
  • IOP > 21 mm Hg
  • No previous intraocular surgery or laser treatment during the 90 days before HIFU day
  • Age > 18 years
  • Informed consent sgned by the subject

Exclusion Criteria:

  • Normal Tension Glaucoma
  • Glaucoma drainage device implanted and still present in the eye to be treated
  • History of ocular or retrobulbar tumor
  • Ocular infection within 14 days prior to the HIFU procedure
  • Aphakic patient
  • Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
  • Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EYEOP1 device
cyclocoagulation HIFU
Device: EYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy endpoint : Success / failure rate at 1 year
Time Frame: 12 months
IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measures
Time Frame: 12 months
Number of device and procedure-related and others complications during follow-up
12 months

Collaborators and Investigators

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

Sponsor

EyeTechCare

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

May 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (ESTIMATE)

May 7, 2012

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-2

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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