UCP Glaucoma Treatment for Primary Glaucoma in China

Not Applicable

Completed

• Conditions: Glaucoma Treatment Using Focused Ultrasound
• Interventions: Device: Ultrasound Cyclo Plasty (UCP)

• Registration Number: NCT04145830
• Lead Sponsor: EyeTechCare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Primary Completion: 2020-04-29
• Study Completion: 2020-11-02
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Cyclo Plasty (UCP)	Ultrasound Cyclo Plasty (UCP)	Ultrasound Cyclo Plasty (UCP) using focused ultrasound

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint : reduction of the intraocular pressure	6 months	Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology; 🇨🇳 Shanghai, China

E&ENT Fudan University; 🇨🇳 Shanghai, China