UCP Glaucoma Treatment for Primary Glaucoma in China

Study Overview
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Brief Summary
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To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.

Official Title
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Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China

Conditions
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Glaucoma Treatment Using Focused Ultrasound

Intervention / Treatment
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* Device: Ultrasound Cyclo Plasty (UCP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Open Angle and primary Angle Closure glaucoma Subject where the IOP is not adequately controlled with glaucoma medication, and can not or not agree for incisional glaucoma surgery IOP ≥ 21 mmHg and ≤ 40 mmHg Best Corrected Visual Acuity > Hand Motion Patient able and willing to sign the informed consent and complete postoperative followup requirements Exclusion Criteria: History of ocular or retrobulbar tumor Ocular infection within 14 days prior to the procedure of Ultrasound Cyclo Plasty (UCP) History of Cyclo-destructive procedures (cryotherapy, Laser transscleral cyclophotocoagulation; Laser endophotocoagulation) Congenital glaucoma History of ciliary body surgery or vitrectomy in the study eye 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, clinical significant macular edema, retinal detachment)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Ultrasound Cyclo Plasty (UCP)<br>Ultrasound Cyclo Plasty (UCP) using focused ultrasound | Device: Ultrasound Cyclo Plasty (UCP)<br>* Cyclocoagulation using High Intensity Focused Ultrasound<br>* Other names: UCP by EyeOP1 device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy endpoint : reduction of the intraocular pressure | Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint: rate of per operative complications | Rate of per-operative device and/or procedure related adverse events | 6 months | 
| Safety endpoint: rate of post-operative complications | Rate of post-operative complications during the follow-up period | 6 months | 
| Efficacy endpoint: Number of ocular hypotensive medications | Mean number of IOP lowering medications at each visit during the follow-up period | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, ciliary body, ultrasound