UCP Glaucoma Treatment for Primary Glaucoma in China

N/ACompletedNCT04145830

EyeTechCare30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Treatment Using Focused Ultrasound

Interventions

Ultrasound Cyclo Plasty (UCP)DEVICE

Cyclocoagulation using High Intensity Focused Ultrasound

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (2)

Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology

Shanghai, China

E&ENT Fudan University

Shanghai, China

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Safety endpoint: rate of per operative complications

Rate of per-operative device and/or procedure related adverse events

Time frame: 6 months

Safety endpoint: rate of post-operative complications

Rate of post-operative complications during the follow-up period

Time frame: 6 months

Efficacy endpoint: Number of ocular hypotensive medications

Mean number of IOP lowering medications at each visit during the follow-up period

Time frame: 6 months

Data from ClinicalTrials.gov

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