NCT04321122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

March 25, 2020

Status Verified

June 1, 2019

Enrollment Period

1.6 years

First QC Date

March 23, 2020

Last Update Submit

March 23, 2020

Conditions

GlaucomaGlaucoma, Primary Open Angle

Keywords

Primary open-angle glaucomaUCP(ultrasound cyclo plasty)Efficacy and Safety

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Ultrasound cyclo plasty(UCP)

EXPERIMENTAL

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

Procedure: ultrasound cyclo plasty

Interventions

ultrasound cyclo plastyPROCEDURE

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.

Also known as: UCP
Ultrasound cyclo plasty(UCP)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jian Ge, M.D,Ph.D

    Zhognshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Chengguo Zuo, M.D,Ph.D

CONTACT

: 020-66615461chengguozuo@163.com

Jian Ge, M.D,Ph.D

CONTACT

020-66615461gejian@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

August 12, 2018

Primary Completion

March 12, 2020

Study Completion

June 12, 2020

Last Updated

March 25, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)