The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound
UZ Leuven - University Hospital
Leuven, Belgium
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel Litwinsky, Israel
Cisanello Hospital
Pisa, Italy
Santa Maria Hospital - Faculty of Medicine of Lisbon
Lisbon, Portugal
Efficacy endpoint : Reduction of intraocular pressure
Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months
Time frame: 24 months
Safety : rate of per and post-operative complications/adverse effects
rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits
Time frame: 24 months
Efficacy endpoint : Mean IOP (mmHg)
Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)
Time frame: 24 months
Efficacy Endpoint : Mean IOP variation (%)
Mean IOP variation (%) at each visit during the follow-up period
Time frame: 24 months
Mean Number of ocular hypotensive medications
Mean number of ocular hypotensive medication at each visit during the followup period
Time frame: 24 months
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