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CompletedNCT02789293Updated Aug 19, 2021

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

An interventional study of EyeOP1 device in Glaucoma, sponsored by EyeTechCare. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-08-19.

Sponsored by EyeTechCare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma

Keywords

  • Glaucoma
  • Ultrasound
  • Ciliary body
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 80 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

EyeTechCare is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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...)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Focused Ultrasound treatment

    Ultrasound ciliary pasty (UCP) using focused ultrasound

    Device: EyeOP1 device

Interventions

  • DeviceEyeOP1 device

    Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

06

What researchers measure

Primary outcomes

  1. Efficacy endpoint : Reduction of intraocular pressure

    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

    Time frame: 24 months

Secondary outcomes

  1. Safety : rate of per and post-operative complications/adverse effects

    rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits

    Time frame: 24 months

  2. Efficacy endpoint : Mean IOP (mmHg)

    Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)

    Time frame: 24 months

  3. Efficacy Endpoint : Mean IOP variation (%)

    Mean IOP variation (%) at each visit during the follow-up period

    Time frame: 24 months

  4. Mean Number of ocular hypotensive medications

    Mean number of ocular hypotensive medication at each visit during the followup period

    Time frame: 24 months

07

Study locations

4 sites
  • UZ Leuven - University Hospital
    Leuven, 3000, Belgium
  • The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
    Tel Hashomer, 52621, Israel
  • Cisanello Hospital
    Pisa, Italy
  • Santa Maria Hospital - Faculty of Medicine of Lisbon
    Lisboa, 1649-028, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02789293
Lead sponsor
EyeTechCare
Responsible party
Sponsor
First posted
Jun 2, 2016
Start date
May 2016
Primary completion
Oct 12, 2017
Completion
Oct 4, 2019
Last update
Aug 19, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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