GlaucomaOBAMAgNCT02178085
Ocular Blood Flow Assessment in Glaucoma
A study testing Flow imaging in people with Glaucoma, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Flow imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Mar 2015to 26 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants
- Diagnosis of primary open angle glaucoma or normal-tension glaucoma
- Never received any anti glaucoma therapy
- Patients included in the group " normal pressure glaucoma " are patients where the diagnosis of optic neuropathy have been worn by the ophthalmologist with measured intraocular pressure <21 mmHg.
- Healthy controls will be examined by an ophthalmologist before inclusion
Who cannot join
- Anyone with a classic contraindication to MRI
- Cardiovascular comorbidities or neurovascular : uncontrolled systemic hypertension , Diabetes, heart failure , carotid stenosis , ischemic stroke or transient ischemic attack.
- Already treated glaucoma
- Prescription by the ophthalmologist another treatment than prostaglandin analogue treatment.
- Other clinical forms of glaucoma : angle closure glaucoma, neovascular glaucoma, exfoliative glaucoma, secondary glaucomas, pigment dispersion glaucoma, traumatic glaucoma, congenital glaucoma
- Presence of other ocular pathology (simple refractive error allowing 10/10 of best corrected visual acuity and mild and moderate cataracts will not be considered as a criterion for non- inclusion).
- History of intraocular or orbital surgery of less than 6 months .
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Amiens
Amiens, Picardie, 80054
Centre d'ophtalmologie Victor Pauchet
Amiens, Picardie, 80090
About this study
Official title: Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma
Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension glaucoma).
Purpose :Involvement of vascular factors in the development of glaucoma and scalability has been proved, associated with a possible loss of vascular autoregulation. The objective of this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma untreated comparison with control subjects.
Read the detailed description
Eye vascularization, supplied by ophthalmic artery and superior ophthalmic vein is not easily accessible to routine explorations to date. Similarly the potential oscillations of the cerebrospinal fluid (CSF) around the optic nerve have not been described. Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood and CSF flows through phase contrast MRI also called "flow MRI". Our hypothesis is that the ability of MRI to measure intracranial flow is applicable to the vasculature of the eye.
The MRI protocol will be applied to control adult subjects previously examined by an ophthalmologist. Structures to be imaged will be identified on a morphological sequence. Each MRI phase contrast slice (flow MRI) will be positioned perpendicularly to the flow direction. The flow MRI data will be analysed by a dedicated image processing tool which performs the vessels segmentation. For each curve of the vessel flow evolution during the cardiac cycle is reconstructed.
Glaucomatous patients will undergo a six-month follow-up to determine if they respond to their therapy.
- Conditions
- Glaucoma
- Being tested
- Flow imaging
- Keywords
- glaucoma, phase-contrast MRI, blood flow, cerebrospinal fluid
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow imagingOther
Also called Flow MRI, Cine phase-constrast magnetic resonance imaging, Cerebral blood flow
Participants will undergo morphological and then flow MRI. Flow MR images will be processed adequately to obtain quantitative values of arterial and venous flow as well as CSF flow.
| Study group | Role | What they receive |
|---|---|---|
| Flow imaging | Experimental | Glaucoma patients and healthy subjects who will undergo ocular flow imaging Receives: Other: Flow imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood flow
Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
Measured: Day 1
Secondary outcomes (3)
Vascular flow curves
Temporal and amplitude parameters of vascular flow curves (arteries and veins)
Measured: Day 1
Cerebrospinal fluid (CSF) dynamic
Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
Measured: Day 1
Treatment response
Determination of treatment response
- Measurement of ocular tone (21 mmHg threshold under which the patient may be responder to treatment value)
- Extent of the visual field (if stable patient responder)
- Measure optic disc (if stable patient responder)
The three conditions must be true to declare a patient responder to treatment.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study start5 Mar 2015
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Balédent, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178085
- Sponsor's protocol ID
- PI2014_843_0007
- Other IDs
- 2014-A00847-40
- Acronym
- OBAMAg
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2014
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma
- ClinicalTrials.gov ID
- NCT02178085
- Acronym / sponsor ID
- OBAMAg / PI2014_843_0007
- Conditions
- Glaucoma
- Keywords
- glaucoma, phase-contrast MRI, blood flow, cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 30 Jun 2014 (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.
Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension glaucoma).
Purpose :Involvement of vascular factors in the development of glaucoma and scalability has been proved, associated with a possible loss of vascular autoregulation. The objective of this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma untreated comparison with control subjects.
Detailed description
Eye vascularization, supplied by ophthalmic artery and superior ophthalmic vein is not easily accessible to routine explorations to date. Similarly the potential oscillations of the cerebrospinal fluid (CSF) around the optic nerve have not been described. Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood and CSF flows through phase contrast MRI also called "flow MRI". Our hypothesis is that the ability of MRI to measure intracranial flow is applicable to the vasculature of the eye.
The MRI protocol will be applied to control adult subjects previously examined by an ophthalmologist. Structures to be imaged will be identified on a morphological sequence. Each MRI phase contrast slice (flow MRI) will be positioned perpendicularly to the flow direction. The flow MRI data will be analysed by a dedicated image processing tool which performs the vessels segmentation. For each curve of the vessel flow evolution during the cardiac cycle is reconstructed.
Glaucomatous patients will undergo a six-month follow-up to determine if they respond to their therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flow imaging | Experimental | Other: Flow imagingGlaucoma patients and healthy subjects who will undergo ocular flow imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult participants
- Diagnosis of primary open angle glaucoma or normal-tension glaucoma
- Never received any anti glaucoma therapy
- Patients included in the group " normal pressure glaucoma " are patients where the diagnosis of optic neuropathy have been worn by the ophthalmologist with measured intraocular pressure <21 mmHg.
- Healthy controls will be examined by an ophthalmologist before inclusion
Key exclusion criteria (7 listed)
- Anyone with a classic contraindication to MRI
- Cardiovascular comorbidities or neurovascular : uncontrolled systemic hypertension , Diabetes, heart failure , carotid stenosis , ischemic stroke or transient ischemic attack.
- Already treated glaucoma
- Prescription by the ophthalmologist another treatment than prostaglandin analogue treatment.
- Other clinical forms of glaucoma : angle closure glaucoma, neovascular glaucoma, exfoliative glaucoma, secondary glaucomas, pigment dispersion glaucoma, traumatic glaucoma, congenital glaucoma
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 |
|---|---|---|
| Flow imagingAlso: Flow MRI, Cine phase-constrast magnetic resonance imaging, Cerebral blood flowParticipants will undergo morphological and then flow MRI. Flow MR images will be processed adequately to obtain quantitative values of arterial and venous flow as well as CSF flow. | Other | Flow imaging |
Primary outcome
Arterial blood flow
Time frame: Day 1
Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
3 secondary outcomes
Vascular flow curves
Time frame: Day 1
Cerebrospinal fluid (CSF) dynamic
Time frame: Day 1
Treatment response
Time frame: Day 180
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 11 Jun 2026.
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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.
Olivier Balédent, PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow imaging in people with Glaucoma, run by Centre Hospitalier Universitaire, Amiens at 2 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 7 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Arterial blood flow (time frame: Day 1). 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 11 Jun 2026.