UCP Glaucoma Treatment for Primary Glaucoma in China

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04145830

Enrollment

Registered

2019-10-31

Start date

2019-09-01

Completion date

2020-11-02

Last updated

2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Treatment Using Focused Ultrasound

Keywords

Glaucoma, ciliary body, ultrasound

Brief summary

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

Interventions

DEVICEUltrasound Cyclo Plasty (UCP)

Cyclocoagulation using High Intensity Focused Ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026