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

Primary Purpose

Glaucoma, Glaucoma, Primary Open Angle

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound cyclo plasty
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Primary open-angle glaucoma, UCP(ultrasound cyclo plasty), Efficacy and Safety

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound cyclo plasty(UCP)

Arm Description

Ultrasound cyclo plasty treatment for primary open-angle glaucoma patients.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
March 23, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04321122
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 12, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Primary Open Angle
Keywords
Primary open-angle glaucoma, UCP(ultrasound cyclo plasty), Efficacy and Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound cyclo plasty(UCP)
Arm Type
Experimental
Arm Description
Ultrasound cyclo plasty treatment for primary open-angle glaucoma patients.
Intervention Type
Procedure
Intervention Name(s)
ultrasound cyclo plasty
Other Intervention Name(s)
UCP
Intervention Description
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.
Primary Outcome Measure Information:
Title
IOP(intraocular pressure)
Description
To evaluate the success rate of IOP control at 6 months after UCP(5mmHg≤IOP≤21mmHg, and at least 20% lower than the baseline)
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengguo Zuo, M.D,Ph.D
Phone
: 020-66615461
Email
chengguozuo@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Ge, M.D,Ph.D
Phone
020-66615461
Email
gejian@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Ge, M.D,Ph.D
Organizational Affiliation
Zhognshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weixin Zheng, M.D
Phone
02066615461
Email
zhengweixin@gzzoc.com
First Name & Middle Initial & Last Name & Degree
Chengguo Zuo, M.D,Ph.D
Phone
02066615461
Email
chengguozuo@163.com
First Name & Middle Initial & Last Name & Degree
Jian Ge, M.D,Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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