UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321122
• Other study ID #: 2018QXPJ005
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2018
• Est. completion date: June 12, 2020

Study information

• Verified date: June 2019
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Chengguo Zuo, M.D,Ph.D
• Phone: : 020-66615461
• Email: chengguozuo[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

Intervention

Procedure:
• ultrasound cyclo plasty
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.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP(intraocular pressure)	To evaluate the success rate of IOP control at 6 months after UCP(5mmHg=IOP=21mmHg, and at least 20% lower than the baseline)	6 months after surgery