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

Observation on the Clinical Safety and Efficacy of UCP (Ultrasound Cyclo Plasty) in the Treatment of Chinese Patients With Primary Open-angle Glaucoma

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Glaucoma, Primary Open Angle
• Intervention / Treatment: Procedure: ultrasound cyclo plasty

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Ge, M.D,Ph.D; Phone Number: 020-66615461; Email: gejian@mail.sysu.edu.cn
• Study Contact Backup: Name: Chengguo Zuo, M.D,Ph.D; Phone Number: : 020-66615461; Email: chengguozuo@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhognshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Chengguo Zuo, M.D,Ph.D; Phone Number: 02066615461; Email: chengguozuo@163.com
      • Contact: Weixin Zheng, M.D; Phone Number: 02066615461; Email: zhengweixin@gzzoc.com
      • Principal Investigator: Jian Ge, M.D,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ultrasound cyclo plasty(UCP); Ultrasound cyclo plasty treatment for primary open-angle glaucoma patients.

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.; Other Names: UCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Chair: Jian Ge, M.D,Ph.D, Zhognshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2018
• Primary Completion (Actual): March 12, 2020
• Study Completion (Anticipated): June 12, 2020

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Efficacy and Safety; Primary open-angle glaucoma; UCP(ultrasound cyclo plasty)
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2018QXPJ005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The archived documents and materials are not loaned. If the management department needs to access the original data, it should be agreed by the PI of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No