Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by EyeTechCare
Sponsor:
Information provided by (Responsible Party):
EyeTechCare
ClinicalTrials.gov Identifier:
NCT01592955
First received: May 4, 2012
Last updated: March 8, 2013
Last verified: March 2013

May 4, 2012
March 8, 2013
May 2012
March 2013   (final data collection date for primary outcome measure)
Efficacy endpoint : Success / failure rate at 1 year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg)
Same as current
Complete list of historical versions of study NCT01592955 on ClinicalTrials.gov Archive Site
Safety measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Number of device and procedure-related and others complications during follow-up
Safety measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Incidence of device and procedure-related and others complications during follow-up
Not Provided
Not Provided
 
Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)
Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.

The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Device: EYEOP1
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
Experimental: EYEOP1 device
cyclocoagulation HIFU
Intervention: Device: EYEOP1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2014
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Refractory Glaucoma
  • IOP > 21 mm Hg
  • No previous intraocular surgery or laser treatment during the 90 days before HIFU day
  • Age > 18 years
  • Informed consent sgned by the subject

Exclusion Criteria:

  • Normal Tension Glaucoma
  • Glaucoma drainage device implanted and still present in the eye to be treated
  • History of ocular or retrobulbar tumor
  • Ocular infection within 14 days prior to the HIFU procedure
  • Aphakic patient
  • Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
  • Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child
Both
18 Years and older
No
Contact: Laurent FARCY lfarcy@eyetechcare.com
Israel,   Italy,   Spain,   Switzerland
 
NCT01592955
EYEMUST-2
Yes
EyeTechCare
EyeTechCare
Not Provided
Study Director: Laurent FARCY EyeTechCare
EyeTechCare
March 2013

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