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Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

This study is currently recruiting participants.
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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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
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 June 18, 2013