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

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. Identifier: NCT01592955
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Glaucoma Device: EYEOP1 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.
Study Start Date : May 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Ultrasound

Arm Intervention/treatment
Experimental: EYEOP1 device
cyclocoagulation HIFU
Device: EYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Safety measures [ Time Frame: 12 months ]
    Number of device and procedure-related and others complications during follow-up

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01592955

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

Publications of Results:
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Responsible Party: EyeTechCare Identifier: NCT01592955     History of Changes
Other Study ID Numbers: EYEMUST-2
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: March 2013
Keywords provided by EyeTechCare:
HIFU High Intensity Focused Ultrasound
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases