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

Not Applicable

• Conditions: Glaucoma, Primary Open Angle; Glaucoma
• Interventions: Procedure: ultrasound cyclo plasty

• Registration Number: NCT04321122
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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).

Study Timeline

• Study Start: 2018-08-12
• Status Verified: 2019-06
• Primary Completion: 2020-03-12
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-25
• Last Update Posted: 2020-03-25
• Study Completion: 2020-06-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound cyclo plasty(UCP)	ultrasound cyclo plasty	Ultrasound cyclo plasty treatment for primary open-angle glaucoma patients.

Primary Outcome Measures

Name	Time	Method
IOP(intraocular pressure)	6 months after surgery	To evaluate the success rate of IOP control at 6 months after UCP(5mmHg≤IOP≤21mmHg, and at least 20% lower than the baseline)

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China