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

This study has been completed.
Sponsor:
Collaborator:
Union National des Aveugles et DEficients Visuels
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01621841
First received: June 11, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition
Glaucoma
Fractional Anisotropy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • fractional anisotropy [ Time Frame: Inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • volume of retrochiasmatic grey matter [ Time Frame: Inclusion ] [ Designated as safety issue: No ]
  • global atrophy [ Time Frame: inclusion ] [ Designated as safety issue: No ]
  • hyper intensities white matter [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: June 2012
Study Completion Date: November 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma subjects
heathly subjects

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Glaucoma subjects are recruted in ophtalmologic departement

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621841

Locations
France
Service d'ophtalmologie Hôpital Pellegrin
CHU de Bordeaux, Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Union National des Aveugles et DEficients Visuels
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01621841     History of Changes
Other Study ID Numbers: CHUBX2012/01
Study First Received: June 11, 2012
Last Updated: December 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014