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Recruiting Not applicable

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

NCT07802769 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-08-28
Last updated
2026-09-03

Condition(s) studied

Glaucoma

Investigational drug(s) / intervention(s)

MRI

MRI: MRI

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • structural and functional connectivity matrices — 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

Trial sites (1)

FacilityCityRegionStatus
CHU Bordeaux Bordeaux France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07802769 on ClinicalTrials.gov ↗ ← All trials in France