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Recruiting NCT07802769

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

Conditions: Glaucoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University Hospital, Bordeaux

Location: CHU Bordeaux Bordeaux

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 Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07802769). StuddyBuddy aggregates publicly available trial information.