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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by EyeTechCare
Sponsor:
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01592955
First received: May 4, 2012
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Glaucoma
Device: EYEOP1
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.

Resource links provided by NLM:


Further study details as provided by EyeTechCare:

Primary Outcome Measures:
  • Efficacy endpoint : Success / failure rate at 1 year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Safety measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of device and procedure-related and others complications during follow-up


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EYEOP1 device
cyclocoagulation HIFU
Device: EYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592955

Contacts
Contact: Laurent FARCY lfarcy@eyetechcare.com

Locations
Israel
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center Completed
Tel Hashomer, Israel, 52621
Italy
Ospedale San Paolo Completed
Milano, Italy, 20142
Institute Ophthalmology - Universita di Parma Recruiting
Parma, Italy, 43121
Contact: Stefano Gandolfi, MD         
Principal Investigator: Stefano Gandolfi, MD         
Sub-Investigator: Nicola Ungaro, MD         
Clinica Oculistica Universitaria - P-O Oftalmico Recruiting
Torino, Italy, 10149
Contact: Antonio FEA, MD         
Principal Investigator: Antonio FEA, MD         
Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Julian Garcia-Feijoo, MD         
Principal Investigator: Julian Garcia-Feijoo, MD         
Switzerland
Hôpitaux Universitaires de Genève Recruiting
Genève, Switzerland, CH-1211
Contact: Tarek Shaarawy, MD         
Principal Investigator: Tarek Shaarawy, MD         
Clinique de Montchoisi - Glaucoma center Completed
Lausanne, Switzerland, CH-1006
Sponsors and Collaborators
EyeTechCare
Investigators
Study Director: Laurent FARCY EyeTechCare
  More Information

No publications provided

Responsible Party: EyeTechCare
ClinicalTrials.gov Identifier: NCT01592955     History of Changes
Other Study ID Numbers: EYEMUST-2
Study First Received: May 4, 2012
Last Updated: March 8, 2013
Health Authority: Israel : Ministry Of Health (MOH)

Keywords provided by EyeTechCare:
Glaucoma
Cyclocoagulation
HIFU High Intensity Focused Ultrasound

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014