GlaucomaENVOLNCT01621841

Analysis of Visual Pathways in Glaucoma Patients Using a 3tesla-MRI

A study testing examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy in people with Glaucoma and Fractional Anisotropy, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Glaucoma, Fractional Anisotropy
What is being tested?: examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 1 siteFrance
Study dates: Jun 2012to 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 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

for cases : Age over 40 years-old, glaucomatous lesion of the optic nerve head with cup/disc ratio, visual field loss, and minimental state superior or equal to 28/30
for healthy subjects/ matched on age and sex, no individual or familial history of glaucoma, IOP less than 21mmHG, minimental state superior or equal to 28/30

Who cannot join

Ocular hypertension, optic nerve disease, visual field loss, diabetes, Horton disease, ocular diseases, immunologic diseases, neuropsychiatric diseases, MRI contraindication (pace maker)

Trial locations and contacts

1 site in 1 country.

France1 site

Service d'ophtalmologie Hôpital Pellegrin
CHU de Bordeaux, Bordeaux, 33000

Other trials in France

About this study

Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is observed for normal tension glaucoma. Some studies have reported lesions of the optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us to analyze visual pathways and to determine the association with neurodegenerative diseases as Alzheimer.

The investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells, visual field deterioration and optic nerve cupping. Some studies have suggested that all the visual pathways could be damaged in glaucoma. Recently, a German study proved a significant reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T. Some authors have also suggested that glaucoma could share similarities with the other neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual pathways with a high level of spatial resolution.Fractional anisotropy is a tag of microstructure.

Conditions: Glaucoma, Fractional Anisotropy
Being tested: examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropyDiagnostic test
examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy

Study groups in NCT01621841
Study group	Role	What they receive
Glaucoma subjects	Experimental	Not described Receives: Diagnostic Test: examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy
heathly subjects	Placebo comparator	Not described Receives: Diagnostic Test: examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy

What is being measured

The primary outcome is the main question the study is designed to answer.

fractional anisotropy
Measured: Inclusion

Secondary outcomes (3)

volume of retrochiasmatic grey matter
Measured: Inclusion
global atrophy
Measured: inclusion
hyper intensities white matter
Measured: inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Nov 2013

First posted18 Jun 2012 (estimated)
Study startJun 2012
Primary completionJun 2013
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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01621841
Sponsor's protocol ID: CHUBX2012/01
Other IDs: 2012-A00286-37
Acronym: ENVOL
Status last verified: Dec 2013
First submitted: 11 Jun 2012
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: Yes

Publications

Tellouck L, Durieux M, Coupe P, Cougnard-Gregoire A, Tellouck J, Tourdias T, Munsch F, Garrigues A, Helmer C, Malet F, Dartigues JF, Dousset V, Delcourt C, Schweitzer C. Optic Radiations Microstructural Changes in Glaucoma and Association With Severity: A Study Using 3Tesla-Magnetic Resonance Diffusion Tensor Imaging. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6539-6547. doi: 10.1167/iovs.16-19838.
PubMed 27918827

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of Visual Pathways in Glaucoma Patients Using a 3tesla-MRI
ClinicalTrials.gov ID: NCT01621841
Acronym / sponsor ID: ENVOL / CHUBX2012/01
Conditions: Glaucoma, Fractional Anisotropy
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: University Hospital, BordeauxUniversity, hospital or other
Collaborators: Union National des Aveugles et DEficients Visuels
Study start: Jun 2012
Primary completion: Jun 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 18 Jun 2012 (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 investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Glaucoma subjects	Experimental	Diagnostic Test: examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy
heathly subjects	Placebo comparator	Diagnostic Test: examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

for cases : Age over 40 years-old, glaucomatous lesion of the optic nerve head with cup/disc ratio, visual field loss, and minimental state superior or equal to 28/30
for healthy subjects/ matched on age and sex, no individual or familial history of glaucoma, IOP less than 21mmHG, minimental state superior or equal to 28/30

Key exclusion criteria (1 listed)

Ocular hypertension, optic nerve disease, visual field loss, diabetes, Horton disease, ocular diseases, immunologic diseases, neuropsychiatric diseases, MRI contraindication (pace maker)

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
examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropyexamination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy	Diagnostic test	Glaucoma subjects, heathly subjects

Primary outcome

fractional anisotropy
Time frame: Inclusion

3 secondary outcomes

volume of retrochiasmatic grey matter
Time frame: Inclusion
global atrophy
Time frame: inclusion
hyper intensities white matter
Time frame: inclusion

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 9 Jun 2026.
Results publication: PubMed 27918827Tellouck L, Durieux M, Coupe P, Cougnard-Gregoire A, Tellouck J, Tourdias T, Munsch F, Garrigues A, Helmer C, Malet F, Dartigues JF, Dousset V, Delcourt C, Schweitzer C. Optic Radiations Microstructural Changes in Glaucoma and Association With Severity: A Study Using 3Tesla-Magnetic Resonance Diffusion Tensor Imaging. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6539-6547. doi: 10.1167/iovs.16-19838.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 1 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 9 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 1 site 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. Some participants in this study may receive a placebo. 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?

fractional anisotropy (time frame: Inclusion). 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 NCT01621841, 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 9 Jun 2026.