NCT01338467CompletedNot Applicable
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
EyeTechCare16 sites in 1 country52 target enrollmentStarted: April 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 16
- Primary Endpoint
- Primary efficacy measure :
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
EYEOP Treatment
Experimental
Open label, all subject treated by the EYEOP device
Intervention: EYEOP device (Device)
Outcomes
Primary Outcomes
Primary efficacy measure :
Time Frame: 6 months
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
Secondary Outcomes
- Safety measures(6 months)
Investigators
Study Sites (16)
Loading locations...
Similar Trials
Completed
Phase 4
Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)GlaucomaNCT01592955EyeTechCare84
Completed
Not Applicable
Glaucoma treatment using UltrasoundCTRI/2014/05/004639EyeTechCare15
Completed
Phase 3
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular HypertensionOpen-angle GlaucomaOcular HypertensionNCT00293787Alcon Research156
Withdrawn
Phase 2
OSIG-eye Drops Treatment for Dry Eye DiseaseDry EyeNCT04510428University of Illinois at Chicago
Completed
Phase 2
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)Dry Eye DiseaseNCT03292809Novaliq GmbH328