Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02789293
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
EyeTechCare

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: EyeOP1 device Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Ultrasound

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Efficacy Endpoint : Mean IOP variation (%) [ Time Frame: 24 months ]
    Mean IOP variation (%) at each visit during the follow-up period

  4. Mean Number of ocular hypotensive medications [ Time Frame: 24 months ]
    Mean number of ocular hypotensive medication at each visit during the followup period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789293


Locations
Layout table for location information
Belgium
UZ Leuven - University Hospital
Leuven, Belgium, 3000
Israel
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
Cisanello Hospital
Pisa, Italy
Portugal
Santa Maria Hospital - Faculty of Medicine of Lisbon
Lisboa, Portugal, 1649-028
Sponsors and Collaborators
EyeTechCare
Layout table for additonal information
Responsible Party: EyeTechCare
ClinicalTrials.gov Identifier: NCT02789293    
Other Study ID Numbers: ETC-EU-BN02
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by EyeTechCare:
Glaucoma
Ultrasound
Ciliary body
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases