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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

February 13, 2013
February 13, 2013
November 2012
March 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 ] [ Designated as safety issue: No ]
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
Same as current
No Changes Posted
  • 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Device: Ultrasonic Circular Cyclocoagulation with EYEOP1 Device
Experimental: Ultrasonic Circular cyclocoagulation using HIFU
Intervention: Device: Ultrasonic Circular Cyclocoagulation with EYEOP1 Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2014
March 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
Both
18 Years and older
No
France
 
NCT01791673
EYEMUST-3
Yes
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