Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01791673
First received: February 13, 2013
Last updated: June 15, 2015
Last verified: February 2013
  Purpose

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


Condition Intervention
Glaucoma
Device: Ultrasound glaucoma treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

Resource links provided by NLM:


Further study details as provided by EyeTechCare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)


Secondary Outcome Measures:
  • Average change in IOP (mm Hg) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Percentage change in IOP from baseline [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Average change in glaucoma hypotensive medications [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Incidence of device and procedure-related complications during follow-up [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound Glaucoma treatment
Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Device: Ultrasound glaucoma treatment
Ultrasound glaucoma treatment with EYEOP1 device
Other Name: UCP

  Eligibility

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

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
  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: NCT01791673

Locations
France
University Hospital
Dijon, France
Michallon University Hospital
Grenoble, France
Huriez University Hospital
Lille, France
Croix Rousse University Hospital
Lyon, France
HIA - Val de Grace Hospital
Paris, France
Sponsors and Collaborators
EyeTechCare
Investigators
Principal Investigator: Philippe DENIS, MD Croix Rousse University Hospital
  More Information

No publications provided

Responsible Party: EyeTechCare
ClinicalTrials.gov Identifier: NCT01791673     History of Changes
Other Study ID Numbers: EYEMUST-3
Study First Received: February 13, 2013
Last Updated: June 15, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Institutional Ethical Committee

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

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on August 27, 2015