Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Study Overview
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Brief Summary
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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.

Official Title
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Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

Conditions
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Glaucoma

Intervention / Treatment
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* Device: EyeOP1 device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF)) Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction) Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and <30 mmHg No previous intraocular surgery or laser treatment during the 90 days before HIFU Day Age > 18 years and < 90 years Patient able and willing to complete postoperative follow-up requirements Exclusion Criteria: Patient who has been diagnosed for normal tension glaucoma Ocular or retrobulbar tumor Ocular infection within 14 days prior to the HIFU procedure Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema…)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused Ultrasound treatment<br>Ultrasound ciliary pasty (UCP) using focused ultrasound | Device: EyeOP1 device<br>* Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 24 months | 
| Efficacy Endpoint : Mean IOP variation (%) | Mean IOP variation (%) at each visit during the follow-up period | 24 months | 
| Mean Number of ocular hypotensive medications | Mean number of ocular hypotensive medication at each visit during the followup period | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Ultrasound, Ciliary body