Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by EyeTechCare
Sponsor:
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01791673
First received: February 13, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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: Ultrasonic Circular Cyclocoagulation with EYEOP1 Device

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 ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasonic Circular cyclocoagulation using HIFU Device: Ultrasonic Circular Cyclocoagulation with EYEOP1 Device

  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 Recruiting
Dijon, France
Contact: Alain BRON, MD       Alain.bron@chu-dijon.fr   
Principal Investigator: Alain BRON, MD         
Michallon University Hospital Recruiting
Grenoble, France
Contact: Florent APTEL, MD       faptel@chu-grenoble.fr   
Principal Investigator: Florent APTEL, MD         
Huriez University Hospital Recruiting
Lille, France
Contact: Jean-François ROULAND, MD       jean-francois.rouland@chru-lille.fr   
Principal Investigator: Jean-François ROULAND, MD         
Croix Rousse University Hospital Recruiting
Lyon, France
Contact: Philippe DENIS, MD       philippe.denis@chu-lyon.fr   
Principal Investigator: Philippe DENIS, MD         
HIA - Val de Grace Hospital Recruiting
Paris, France
Contact: Jean-Paul RENARD, MD       pr_renard@yahoo.fr   
Principal Investigator: Jean-Paul RENARD, MD         
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: February 13, 2013
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
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014