We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

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.
ClinicalTrials.gov Identifier: NCT01791673
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):

February 13, 2013
February 15, 2013
June 16, 2015
November 2012
May 2013   (Final data collection date for primary outcome measure)
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 ]
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
Same as current
Complete list of historical versions of study NCT01791673 on ClinicalTrials.gov Archive Site
  • Average change in IOP (mm Hg) [ Time Frame: 3, 6 and 12 months ]
  • Percentage change in IOP from baseline [ Time Frame: 3, 6 and 12 months ]
  • Average change in glaucoma hypotensive medications [ Time Frame: 3, 6 and 12 months ]
  • Incidence of device and procedure-related complications during follow-up [ Time Frame: 3, 6 and 12 months ]
Same as current
Not Provided
Not Provided
 
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients
Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma
Device: Ultrasound glaucoma treatment
Ultrasound glaucoma treatment with EYEOP1 device
Other Name: UCP
Experimental: Ultrasound Glaucoma treatment
Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Intervention: Device: Ultrasound glaucoma treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2014
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01791673
EYEMUST-3
Yes
Not Provided
Not Provided
EyeTechCare
EyeTechCare
Not Provided
Principal Investigator: Philippe DENIS, MD Croix Rousse University Hospital
EyeTechCare
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP