GlaucomaNCT01338467
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
A study testing EYEOP device in people with Glaucoma, run by EyeTechCare at 9 sites in France.
Trial summary
The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory 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?
- EYEOP device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 9 sitesFrance
- Study dates
- Apr 2011to Nov 2013
- 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 in the study eye with maximally tolerated medical treatment
- Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg
- Subject has failed a conventional intraocular glaucoma filtering surgery
- Patient must be aged 18 years or more
- No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment
- No previous cyclophotocoagulation procedure in the study eye
- Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.
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 disease within 14 days before HIFU treatment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
University Hospital
Dijon, 21000
University Hospital
Grenoble, 38000
University Hospital - Cl Huriez
Lille, 59000
Clinique du Parc - Private Hospital
Lyon, 69006
Croix Rousse Hospital
Lyon
XV-XX National Ophthalmologic Hospital
Paris, 75012
XV-XX Ophthalmologic Hospital
Paris, 75012
Saint-Joseph Hospital
Paris, 75014
Val de Grace Hospital
Paris, 75235
About this study
Official title: Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma
The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.
- Conditions
- Glaucoma
- Being tested
- EYEOP device
- Keywords
- Glaucoma, Refractory glaucoma, Cyclocoagulation, High Intensity Focused Ultrasound
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYEOP deviceDevice
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
| Study group | Role | What they receive |
|---|---|---|
| EYEOP Treatment | Experimental | Open label, all subject treated by the EYEOP device Receives: Device: EYEOP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy measure :
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
Measured: 6 months
Secondary outcomes (1)
Safety measures
The incidence of device and procedure-related complications during the follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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 Hospital - Lyon - FranceLaurent FARCY, Study director, EyeTechCareFlorent APTEL, MD, Principal investigator, University Hospital - Grenoble - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338467
- Sponsor's protocol ID
- EYEMUST
- Other IDs
- 2011-A00196-35
- Status last verified
- Mar 2013
- First submitted
- 15 Apr 2011
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.
PubMed 25604688
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
- Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT01338467
- Acronym / sponsor ID
- EYEMUST
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Refractory glaucoma, Cyclocoagulation, High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- EyeTechCareIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Apr 2011 (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 EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EYEOP Treatment | Experimental | Device: EYEOP deviceOpen label, all subject treated by the EYEOP device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment
- Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg
- Subject has failed a conventional intraocular glaucoma filtering surgery
- Patient must be aged 18 years or more
- No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment
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 disease within 14 days before HIFU treatment
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 |
|---|---|---|
| EYEOP deviceCyclocoagulation using High Intensity Focused Ultrasound with EYEOP device | Device | EYEOP Treatment |
Primary outcome
Primary efficacy measure :
Time frame: 6 months
IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment
1 secondary outcome
Safety measures
Time frame: 6 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.
- Results publication: PubMed 25604688Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.
Related trials for Glaucoma
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
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 Hospital - Lyon - France
Laurent FARCY study director
EyeTechCare
Florent APTEL, MD principal investigator
University Hospital - Grenoble - France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EYEOP device in people with Glaucoma, run by EyeTechCare at 9 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 7 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 9 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?
Primary efficacy measure : (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338467, which also lists 1 linked publication.
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.