UCP Glaucoma Treatment for Primary Glaucoma in China

EyeTechCare

Status: Completed

Conditions: Glaucoma Treatment Using Focused Ultrasound

Treatments: Device: Ultrasound Cyclo Plasty (UCP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04145830

CS18-CHN-04

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ultrasound Cyclo Plasty (UCP)

Experimental group

Description:

Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Treatment:

Device: Ultrasound Cyclo Plasty (UCP)