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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel Litwinsky, Israel
Ospedale San Paolo
Milan, Italy
Institute Ophthalmology - Universita di Parma
Parma, Italy
Clinica Oculistica Universitaria - P-O Oftalmico
Torino, Italy
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)
Time frame: 12 months
Safety measures
Number of device and procedure-related and others complications during follow-up
Time frame: 12 months
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Hospital Clinico San Carlos
Madrid, Spain
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Clinique de Montchoisi - Glaucoma center
Lausanne, Switzerland