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OpenTrials
Completed

NCT Number: NCT01621841

Analysis of Visual Pathways in Glaucoma Patients Using a 3tesla-MRI

Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is observed for normal tension glaucoma. Some studies have reported lesions of the optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us to analyze visual pathways and to determine the association with neurodegenerative diseases as Alzheimer.

The investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells, visual field deterioration and optic nerve cupping. Some studies have suggested that all the visual pathways could be damaged in glaucoma. Recently, a German study proved a significant reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T. Some authors have also suggested that glaucoma could share similarities with the other neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual pathways with a high level of spatial resolution.Fractional anisotropy is a tag of microstructure.

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Key information

Conditions

Glaucoma Eye Diseases Fractional Anisotropy Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'ophtalmologie Hôpital Pellegrin

CHU de Bordeaux, Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • for cases : Age over 40 years-old, glaucomatous lesion of the optic nerve head with cup/disc ratio, visual field loss, and minimental state superior or equal to 28/30
  • for healthy subjects/ matched on age and sex, no individual or familial history of glaucoma, IOP less than 21mmHG, minimental state superior or equal to 28/30

Exclusion criteria

  • Ocular hypertension, optic nerve disease, visual field loss, diabetes, Horton disease, ocular diseases, immunologic diseases, neuropsychiatric diseases, MRI contraindication (pace maker)

Treatment and study plan

examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy

Diagnostic Test

examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), increasing spatial resolution and DTI (diffusion tensor Imaging) with fractional anisotropy

Primary outcomes

  1. fractional anisotropy

    Time frame: Inclusion

Secondary outcomes

  1. volume of retrochiasmatic grey matter

    Time frame: Inclusion

  2. global atrophy

    Time frame: inclusion

  3. hyper intensities white matter

    Time frame: inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Union National des Aveugles et DEficients Visuels

Registry information

Acronym: ENVOL

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 18, 2012
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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