GlaucomaNCT01791673
Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients
A study testing Ultrasound glaucoma treatment in people with Glaucoma, run by EyeTechCare at 5 sites in France.
Trial summary
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ultrasound glaucoma treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2012to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma
- IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
- Patient must be aged 18 years and more
- No previous cyclophotocoagulation procedure in the eye
- No previous laser treatment in the eye during the 3 months before HIFU procedure
Who cannot join
- History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
- History of ocular or retrobulbar tumor
- retinal detachment, choroidal hemorrhage or detachment
- Ocular infectious diseasee within 14 days before HIFU procedure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital
Dijon
Michallon University Hospital
Grenoble
Huriez University Hospital
Lille
Croix Rousse University Hospital
Lyon
HIA - Val de Grace Hospital
Paris
About this study
Official title: Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
- Conditions
- Glaucoma
- Being tested
- Ultrasound glaucoma treatment
- Keywords
- Glaucoma, Cyclocoagulation, HIFU - High Intensity Focused 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.
Ultrasound glaucoma treatmentDevice
Also called UCP
Ultrasound glaucoma treatment with EYEOP1 device
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Glaucoma treatment | Experimental | Cyclocoagulation using High Intensity Focused Ultrasound (HIFU) Receives: Device: Ultrasound glaucoma treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
Measured: up to 12 months
Secondary outcomes (4)
Average change in IOP (mm Hg)
Measured: 3, 6 and 12 months
Percentage change in IOP from baseline
Measured: 3, 6 and 12 months
Average change in glaucoma hypotensive medications
Measured: 3, 6 and 12 months
Incidence of device and procedure-related complications during follow-up
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionJun 2014
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeTechCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe DENIS, MD, Principal investigator, Croix Rousse University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791673
- Sponsor's protocol ID
- EYEMUST-3
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.
- ClinicalTrials.gov ID
- NCT01791673
- Acronym / sponsor ID
- EYEMUST-3
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Cyclocoagulation, HIFU - High Intensity Focused Ultrasound, Ciliary Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EyeTechCareIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Feb 2013 (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 aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Glaucoma treatment | Experimental | Device: Ultrasound glaucoma treatmentCyclocoagulation using High Intensity Focused Ultrasound (HIFU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary Open-angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma
- IOP > 21 mm Hg on glaucoma medications, and indicated for filtering glaucoma surgery
- Patient must be aged 18 years and more
- No previous cyclophotocoagulation procedure in the eye
- No previous laser treatment in the eye during the 3 months before HIFU procedure
Key exclusion criteria (4 listed)
- History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye
- History of ocular or retrobulbar tumor
- retinal detachment, choroidal hemorrhage or detachment
- Ocular infectious diseasee within 14 days before HIFU procedure
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 |
|---|---|---|
| Ultrasound glaucoma treatmentAlso: UCPUltrasound glaucoma treatment with EYEOP1 device | Device | Ultrasound Glaucoma treatment |
Primary outcome
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20%
Time frame: up to 12 months
Success rate = complete success rate (achieved without ocular hypotensive medication) + qualified success (achieved with ocular hypotensive medication)
4 secondary outcomes
Average change in IOP (mm Hg)
Time frame: 3, 6 and 12 months
Percentage change in IOP from baseline
Time frame: 3, 6 and 12 months
Average change in glaucoma hypotensive medications
Time frame: 3, 6 and 12 months
Incidence of device and procedure-related complications during follow-up
Time frame: 3, 6 and 12 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 16 Jun 2015.
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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.
Philippe DENIS, MD principal investigator
Croix Rousse University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound glaucoma treatment in people with Glaucoma, run by EyeTechCare at 5 sites in France.
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 5 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 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Success rate : Proportion of eyes that achieve an IOP of > 5 mmHg and <21 mmHg or an IOP reduction > 20% (time frame: up to 12 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 16 Jun 2015.