Magnetic Resonance Imaging of Cerebral Connectivity and Volume in Neurodegeneration and Glaucoma (EVOLUTION)

August 31, 2026 updated by: University Hospital, Bordeaux
The EVOLUTION is a 10-year extension of the ENVOL study. It seeks to compare the evolution of structural and functional connectivity (Hub Disruption Index) and cerebral volume on 3T MRI of the brain in glaucoma patients and matched controls. The study aims to examine the hypothesis that glaucomatous optic neuropathy is not limited solely to the visual pathway, but rather is associated with a broader degeneration of the central nervous system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Glaucoma is a neurodegenerative disease characterised by a progressive loss of retinal ganglion cells, typical optic neuropathy with a loss of visual field and visual function. High intraocular pressure is it's main risk factor, but the patophysiology hasn't been clearely understood, as there exist forms with normal ocular pressure (NTG - normal tension glaucoma) or mixed forms. Studies have shown that the degeneration is not limited to retinal ganglion cells only, but rather it affects the whole visual pathway including the occipital cortex. The ENVOL study has been able to show microstructural alterations of the optic radiations in glaucoma. Furthermore, glaucomatous patients have been found to be more at risk of developing other neurodegenerative diseases, namely Alzheimer's disease.

The EVOLUTION study is set to repeat 3T brain MRI in patients previously enrolled in ENVOL in order to compare brain microstructure between glaucomatous and matched healthy subjects, assess their ocular status and glaucoma progression over time, as well as compare them with orignal imagery from 10 years prior.

gression over time, as well as compare them with orignal imagery from 10 years prior.

Study subjects will undergo a typical non-invasive ophthalmic screening comprised of best-corrected visual acuity testing, slit-lamp biomicroscopy, gonioscopy, indirect opthalmoscopy, fundus photography, 30° visual field testing and optical coherence tomography of the optic nerve. They will also answer a questionnaire concerning their medical treatment, cardiovascular health and tobacco use. Next, they will undergo a 3T brain MRI comprised of a T1-weighted 3D morphological sequence, 3D FLAIR, resting state fMRI and diffusion tensor imaging.

fMRI and diffusion tensor imaging

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • having been previously included and completed the ENVOL study
  • Ability and willingness to provide informed consent
  • Having a valid health insurance in France

In glaucoma group :

  • Glaucomatous optic neuropathy, being able to be graded by the vertical C/D ratio
  • Open angle on gonioscopy in a dark-room testing according to Shaffer's classification (grade 3 or grade 4)

  • Visual field impairement (at least one of the following) :

    • 3 adjacent points with at least 5dB loss
    • one point with a loss of 10dB
    • a difference of at least 10 dB for 2 adjacent points on either side of the horizontal meridian of the nasal visual field
  • Mini Mental State Score of at least 28

In control group :

  • No personal or family history of glaucoma or ocular hypertension (IOP > 21 mmHg)
  • Open angle on gonioscopy in a dark-room testing according to Shaffer's classification (grade 3 or grade 4)
  • Intraocular pressure of ≤ 21 mmHg
  • Absence of glaucomatous neuropathy
  • Normal visual field

Exclusion Criteria:

  • Inability/unwillingness to provide informed consent
  • Other causes of ocular hypertension (trauma, uveitis)
  • Non-glaucomatous optic neuropathy (infectious, inflammatory, compressive, ischemic)
  • Unreliable visual field (>15% false positives, >33% false negatives or >20% loss of fixation)
  • Severe corneal pathology preventing access to fundus, visual field testing or altering ocular tonometry
  • Contraindications to MRI testing (pacemakers or neurosensory stimulators, cochlear implants, ferromagnetic foreign bodies, claustrophobia)
  • Patients under guardianship or other form of legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient with glaucoma
Device: MRI
MRI
Active Comparator: Patient without glaucoma
Device: MRI
MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
structural and functional connectivity matrices
Time Frame: Baseline
10-year whole brain comparison of structural and functional connectivity matrices (Hub Disruption Index) on 3T MRI in glaucoma patients and controls from the ENVOL study
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
microstructural changes
Time Frame: Baseline
Comparison of microstructural changes on diffusion MRI within the whole brain and by specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex) between the 2 groups (voxel-by-voxel analysis)
Baseline
cerebral volumes
Time Frame: Baseline
Comparison of cerebral volumes (total volume of cerebral parenchyma), and volumes of specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex) between the 2 groups
Baseline
Evolution of the above parameters
Time Frame: Baseline
Comparison of evolution of the above parameters over a 10-year period between the ENVOL study and EVOLUTION follow-up study (microstructural changes on diffusion MRI within the whole brain and by specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex), cerebral volumes (total volume of cerebral parenchyma), and volumes of specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex)).
Baseline
Demographic factors
Time Frame: Baseline
Identication of demographic that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
Baseline
Ophthalmological factors
Time Frame: Baseline
Ophthalmological factors, notably characterization of the type of glaucoma (normal pressure, high pressure) that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2024/90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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