Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01338467
First received: April 15, 2011
Last updated: March 8, 2013
Last verified: March 2013

April 15, 2011
March 8, 2013
April 2011
June 2012   (final data collection date for primary outcome measure)
Primary efficacy measure : [ Time Frame: 6 months ] [ Designated as safety issue: No ]
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
Same as current
Complete list of historical versions of study NCT01338467 on ClinicalTrials.gov Archive Site
Safety measures [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The incidence of device and procedure-related complications during the follow-up
Same as current
Not Provided
Not Provided
 
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Device: EYEOP device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
Experimental: EYEOP Treatment
Open label, all subject treated by the EYEOP device
Intervention: Device: EYEOP device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment
  • Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg
  • Subject has failed a conventional intraocular glaucoma filtering surgery
  • Patient must be aged 18 years or more
  • No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment
  • No previous cyclophotocoagulation procedure in the study eye
  • Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.

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 disease within 14 days before HIFU treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01338467
EYEMUST, 2011-A00196-35
Yes
EyeTechCare
EyeTechCare
Not Provided
Principal Investigator: Philippe DENIS, MD Croix Rousse Hospital - Lyon - France
Study Director: Laurent FARCY EyeTechCare
Principal Investigator: Florent APTEL, MD University Hospital - Grenoble - France
EyeTechCare
March 2013

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