UCP Glaucoma Treatment for Primary Glaucoma in China

August 18, 2021 updated by: EyeTechCare

Efficacy and Safety of UCP in the Treatment of Primary Glaucoma in China

To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 2000040
        • Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology
      • Shanghai, China
        • E&ENT Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary Open Angle and primary Angle Closure glaucoma
  • Subject where the IOP is not adequately controlled with glaucoma medication, and can not or not agree for incisional glaucoma surgery
  • IOP ≥ 21 mmHg and ≤ 40 mmHg
  • Best Corrected Visual Acuity > Hand Motion
  • Patient able and willing to sign the informed consent and complete postoperative followup requirements

Exclusion Criteria:

  • History of ocular or retrobulbar tumor
  • Ocular infection within 14 days prior to the procedure of Ultrasound Cyclo Plasty (UCP)
  • History of Cyclo-destructive procedures (cryotherapy, Laser transscleral cyclophotocoagulation; Laser endophotocoagulation)
  • Congenital glaucoma
  • History of ciliary body surgery or vitrectomy in the study eye
  • Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema, retinal detachment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound Cyclo Plasty (UCP)
Ultrasound Cyclo Plasty (UCP) using focused ultrasound
Device: Ultrasound Cyclo Plasty (UCP)
Cyclocoagulation using High Intensity Focused Ultrasound
Other Names:
  • UCP by EyeOP1 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy endpoint : reduction of the intraocular pressure
Time Frame: 6 months
Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoint: rate of per operative complications
Time Frame: 6 months
Rate of per-operative device and/or procedure related adverse events
6 months
Safety endpoint: rate of post-operative complications
Time Frame: 6 months
Rate of post-operative complications during the follow-up period
6 months
Efficacy endpoint: Number of ocular hypotensive medications
Time Frame: 6 months
Mean number of IOP lowering medications at each visit during the follow-up period
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeTechCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

April 29, 2020

Study Completion (Actual)

November 2, 2020

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS18-CHN-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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