Magnetic Resonance Imaging of Cerebral Connectivity and Volume in Neurodegeneration and Glaucoma

ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

having been previously included and completed the ENVOL study

Ability and willingness to provide informed consent

Having a valid health insurance in France

Glaucomatous optic neuropathy, being able to be graded by the vertical C/D ratio

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI

    Device

    MRI

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Patient with glaucomaExperimental treatment 1 intervention
Group B: Patient without glaucomaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

structural and functional connectivity matrices

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

Time frame
Baseline

Secondary outcomes

1

microstructural changes

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)

Time frame
Baseline
2

cerebral volumes

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

Time frame
Baseline
3

Evolution of the above parameters

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)).

Time frame
Baseline
4

Demographic factors

Identication of demographic that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above

Time frame
Baseline

Other outcomes

Sponsors and contacts

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