Magnetic Resonance Imaging of Cerebral Connectivity and Volume in Neurodegeneration and Glaucoma
Recruiting · NCT07802769 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
MRI
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- CHU Bordeaux - Bordeaux, France