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

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04321122
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Glaucoma, Primary Open Angle	Procedure: ultrasound cyclo plasty	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 12, 2018
• Actual Primary Completion Date: Mar 12, 2020
• Anticipated Study Completion Date: Jun 12, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT04321122
• Other Study ID Numbers: 2018QXPJ005
• First Posted: Mar 25, 2020
• Last Update Posted: Mar 25, 2020
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhongshan Ophthalmic Center, Sun Yat-sen University: Primary open-angle glaucoma; UCP(ultrasound cyclo plasty); Efficacy and Safety
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 25, 2020