Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)
1 other identifier
interventional
84
4 countries
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2012
Typical duration for phase_4
7 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
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 16, 2015
March 1, 2013
1.8 years
May 4, 2012
June 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy endpoint : Success / failure rate at 1 year
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)
12 months
Secondary Outcomes (1)
Safety measures
12 months
Study Arms (1)
EYEOP1 device
EXPERIMENTALcyclocoagulation HIFU
Interventions
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EyeTechCarelead
Study Sites (7)
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel Litwinsky, 52621, Israel
Ospedale San Paolo
Milan, 20142, Italy
Institute Ophthalmology - Universita di Parma
Parma, 43121, Italy
Clinica Oculistica Universitaria - P-O Oftalmico
Torino, 10149, Italy
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hôpitaux Universitaires de Genève
Geneva, CH-1211, Switzerland
Clinique de Montchoisi - Glaucoma center
Lausanne, CH-1006, Switzerland
Related Publications (1)
Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
PMID: 25982212RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laurent FARCY
EyeTechCare
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 7, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2015
Last Updated
June 16, 2015
Record last verified: 2013-03