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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. Identifier: NCT02789293
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 19, 2021
Information provided by (Responsible Party):

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

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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

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

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 identifier (NCT number): NCT02789293

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UZ Leuven - University Hospital
Leuven, Belgium, 3000
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel Hashomer, Israel, 52621
Cisanello Hospital
Pisa, Italy
Santa Maria Hospital - Faculty of Medicine of Lisbon
Lisboa, Portugal, 1649-028
Sponsors and Collaborators
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Responsible Party: EyeTechCare 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:
Ciliary body
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases