GlaucomaNCT02789293
Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
A study testing EyeOP1 device in people with Glaucoma, run by EyeTechCare at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- EyeOP1 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2016to 4 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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…)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Israel1 site
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel HaShomer, 52621
Portugal1 site
Santa Maria Hospital - Faculty of Medicine of Lisbon
Lisbon, 1649-028
About this study
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.
- Conditions
- Glaucoma
- Being tested
- EyeOP1 device
- Keywords
- Glaucoma, Ultrasound, Ciliary body
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeOP1 deviceDevice
Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Focused Ultrasound treatment | Experimental | Ultrasound ciliary pasty (UCP) using focused ultrasound Receives: Device: EyeOP1 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (4)
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
Measured: 24 months
Efficacy endpoint : Mean IOP (mmHg)
Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)
Measured: 24 months
Efficacy Endpoint : Mean IOP variation (%)
Mean IOP variation (%) at each visit during the follow-up period
Measured: 24 months
Mean Number of ocular hypotensive medications
Mean number of ocular hypotensive medication at each visit during the followup period
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion12 Oct 2017
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeTechCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789293
- Sponsor's protocol ID
- ETC-EU-BN02
- Status last verified
- Jul 2019
- First submitted
- 24 May 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
- ClinicalTrials.gov ID
- NCT02789293
- Acronym / sponsor ID
- ETC-EU-BN02
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Ultrasound, Ciliary body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- EyeTechCareIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound treatment | Experimental | Device: EyeOP1 deviceUltrasound ciliary pasty (UCP) using focused ultrasound |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeOP1 deviceUltrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound | Device | Focused Ultrasound treatment |
Primary outcome
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
4 secondary outcomes
Safety : rate of per and post-operative complications/adverse effects
Time frame: 24 months
Efficacy endpoint : Mean IOP (mmHg)
Time frame: 24 months
Efficacy Endpoint : Mean IOP variation (%)
Time frame: 24 months
Mean Number of ocular hypotensive medications
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeOP1 device in people with Glaucoma, run by EyeTechCare at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Israel, Italy, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint : Reduction of intraocular pressure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.