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.
1 other identifier
interventional
30
1 country
5
Brief Summary
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2012
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 16, 2015
February 1, 2013
6 months
February 13, 2013
June 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
up to 12 months
Secondary Outcomes (4)
Average change in IOP (mm Hg)
3, 6 and 12 months
Percentage change in IOP from baseline
3, 6 and 12 months
Average change in glaucoma hypotensive medications
3, 6 and 12 months
Incidence of device and procedure-related complications during follow-up
3, 6 and 12 months
Study Arms (1)
Ultrasound Glaucoma treatment
EXPERIMENTALCyclocoagulation using High Intensity Focused Ultrasound (HIFU)
Interventions
Ultrasound glaucoma treatment with EYEOP1 device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EyeTechCarelead
Study Sites (5)
University Hospital
Dijon, France
Michallon University Hospital
Grenoble, France
Huriez University Hospital
Lille, France
Croix Rousse University Hospital
Lyon, France
HIA - Val de Grace Hospital
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe DENIS, MD
Croix Rousse University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2013
First Posted
February 15, 2013
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
June 1, 2014
Last Updated
June 16, 2015
Record last verified: 2013-02