Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

August 18, 2021 updated by: EyeTechCare
The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven - University Hospital
  • Israel
      • Tel Hashomer, Israel, 52621
        • The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
  • Italy
      • Pisa, Italy
        • Cisanello Hospital
  • Portugal
      • Lisboa, Portugal, 1649-028
        • Santa Maria Hospital - Faculty of Medicine of Lisbon

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
  • Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
  • Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and <30 mmHg
  • No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
  • Age > 18 years and < 90 years
  • Patient able and willing to complete postoperative follow-up requirements

Exclusion Criteria:

  • Patient who has been diagnosed for normal tension glaucoma
  • Ocular or retrobulbar tumor
  • Ocular infection within 14 days prior to the HIFU procedure
  • 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, clinically significant macular edema…)

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: Focused Ultrasound treatment
Ultrasound ciliary pasty (UCP) using focused ultrasound
Device: EyeOP1 device
Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy endpoint : Reduction of intraocular pressure
Time Frame: 24 months
Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety : rate of per and post-operative complications/adverse effects
Time Frame: 24 months
rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits
24 months
Efficacy endpoint : Mean IOP (mmHg)
Time Frame: 24 months
Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)
24 months
Efficacy Endpoint : Mean IOP variation (%)
Time Frame: 24 months
Mean IOP variation (%) at each visit during the follow-up period
24 months
Mean Number of ocular hypotensive medications
Time Frame: 24 months
Mean number of ocular hypotensive medication at each visit during the followup period
24 months

Collaborators and Investigators

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

Sponsor

EyeTechCare

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)

May 1, 2016

Primary Completion (Actual)

October 12, 2017

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETC-EU-BN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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