Glaucoma and Brain Changes: How Brain Structure and Size See What Glaucoma Is Doing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EVOLUTION study is a 10-year extension that uses 3T MRI to compare brain structure and connectivity between people with glaucoma and matched healthy controls, building on previous ENVOL data. It looks for changes in cerebral volume and network connectivity (Hub Disruption Index) to understand whether glaucomatous damage extends beyond the optic pathway. Participants undergo ophthalmic exams and a non-invasive brain scan, with repeat imaging and eye assessments to track glaucoma progression. The study is observational in design, focusing on longitudinal imaging and clinical correlations. It intends to clarify whether glaucoma is associated with broader CNS degeneration beyond the visual system.

Why it matters

Who can join: the full rules

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's running

• CHU Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Cedrick Schweitzer, MD, PhD
• Email: cedric.schweitzer@chu-bordeaux.fr
• Phone: +335 56 79 55 30

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.