NCT07802769

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Aug 2026May 2027

First Submitted

Initial submission to the registry

July 1, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

July 1, 2025

Last Update Submit

August 31, 2026

Conditions

Glaucoma

Keywords

glaucomamagnetic resonance imagingneurodegenerationstructural connectomics

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (5)

  • microstructural changes

    Baseline

  • cerebral volumes

    Baseline

  • Evolution of the above parameters

    Baseline

  • Demographic factors

    Baseline

  • Ophthalmological factors

    Baseline

Study Arms (2)

Patient with glaucoma

EXPERIMENTAL

Patient with glaucoma

Device: MRI

Patient without glaucoma

ACTIVE COMPARATOR

Patient without glaucoma

Device: MRI

Interventions

MRIDEVICE

MRI

Patient with glaucomaPatient without glaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) :
  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

GlaucomaNerve Degeneration

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Cedrick Schweitzer, MD, PhD

CONTACT

+335 56 79 55 30cedric.schweitzer@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2025

First Posted

September 3, 2026

Study Start

August 28, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)