Clinical trial NCT04321122: UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Official title: Observation on the Clinical Safety and Efficacy of UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Glaucoma, Primary Open Angle
Keywords: Primary open-angle glaucoma
UCP(ultrasound cyclo plasty)
Efficacy and Safety
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Traditional ciliary body photocoagulation treatment uses the photocoagulation of long-wavelength laser to destroy the ciliary body tissue that can produce aqueous humor. Therefore, it is a kind of palliative treatment which has proved efficacy but causes great pain to patients. The "ultrasonic glaucoma treatment instrument" produced by French EYE TECH CARE company is referred to as EyeOP1. It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast.

Detailed description: 1. Efficacy: 1. Main objective: (1)Assess the decrease in postoperative intraocular pressure from baseline and evaluate the final results (the percentage of patients whose conditions have significant improved and the variation of the percentage of median intraocular pressure. (2)Assess the amount of medication after surgery.
2. Secondary goals:(1) Compare median intraocular pressure with baseline at each postoperative follow-up and access the variation of median intraocular pressure from baseline at each postoperative follow-up. (2) Count the number of intraocular pressure lowering drugs at each postoperative follow-up.

b.Safety: Investigate the incidence of all device-related(or procedure-related) adverse events during the study (intraoperative and postoperative follow-up).

Eligibility criteria: Inclusion Criteria:

* The target eye was diagnosed as primary open-angle glaucoma; diagnostic criteria: IOP(intraocular pressure)≥ 21, open angle, typical glaucoma visual field and optic disc damage;
* Patients treated with glaucoma medications cannot control intraocular pressure effectively;
* Patients with 21mmHg ≤ IOP ≤ 30mmHg;
* VA(visual acuity)≥HM(hand motions);
* Patients that have failed conventional glaucoma surgery (trabeculectomy) or are not suitable for surgery;
* Patients who have not received intraocular surgery or laser treatment 90 days before receiving HIFU;
* Aged from 18 to 90 years old;
* Sign informed consent and be willing to provide visit data;

Exclusion Criteria:

* Either eye have any infections two weeks before the surgery;
* The target eye has history of ciliary surgery, intraocular or retrobulbar tumor;
* The target eye is neovascular glaucoma;
* The target eye is aphakic eye;
* Anterior anatomical abnormalities cause scleral expansion or ciliary body ectopic;
* Non-glaucoma intraocular diseases that affect intraocular pressure;
* Within 30 days, the patient participated in or was simultaneously included in other clinical trials;
* Patients during pregnancy or lactation;
* Any systemic disease that may affect patient follow-up.

Primary outcomes:
measure: IOP(intraocular pressure)
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Jian Ge, M.D,Ph.D
role: STUDY_CHAIR
References: