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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
MRI
DeviceMRI
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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)
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
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)).
Demographic factors
Identication of demographic that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
Sponsors and contacts
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