Back to resultsCircular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound glaucoma treatment
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Cyclocoagulation, HIFU - High Intensity Focused Ultrasound, Ciliary Body
Eligibility Criteria
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
Sites / Locations
- University Hospital
- Michallon University Hospital
- Huriez University Hospital
- Croix Rousse University Hospital
- HIA - Val de Grace Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound Glaucoma treatment
Arm Description
Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Outcomes
Primary Outcome Measures
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
Secondary Outcome Measures
Average change in IOP (mm Hg)
Percentage change in IOP from baseline
Average change in glaucoma hypotensive medications
Incidence of device and procedure-related complications during follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01791673
Brief Title
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients
Official Title
Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeTechCare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Cyclocoagulation, HIFU - High Intensity Focused Ultrasound, Ciliary Body
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Glaucoma treatment
Arm Type
Experimental
Arm Description
Cyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Intervention Type
Device
Intervention Name(s)
Ultrasound glaucoma treatment
Other Intervention Name(s)
UCP
Intervention Description
Ultrasound glaucoma treatment with EYEOP1 device
Primary Outcome Measure Information:
Title
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
Description
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Average change in IOP (mm Hg)
Time Frame
3, 6 and 12 months
Title
Percentage change in IOP from baseline
Time Frame
3, 6 and 12 months
Title
Average change in glaucoma hypotensive medications
Time Frame
3, 6 and 12 months
Title
Incidence of device and procedure-related complications during follow-up
Time Frame
3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DENIS, MD
Organizational Affiliation
Croix Rousse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Dijon
Country
France
Facility Name
Michallon University Hospital
City
Grenoble
Country
France
Facility Name
Huriez University Hospital
City
Lille
Country
France
Facility Name
Croix Rousse University Hospital
City
Lyon
Country
France
Facility Name
HIA - Val de Grace Hospital
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients
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