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

June 11, 2012
December 18, 2013
June 2012
June 2013   (final data collection date for primary outcome measure)
fractional anisotropy [ Time Frame: Inclusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01621841 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Analysis of Visual Pathways in Glaucoma Patients Using a 3tesla-MRI
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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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Glaucoma subjects are recruted in ophtalmologic departement

  • Glaucoma
  • Fractional Anisotropy
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  • Glaucoma subjects
  • heathly subjects
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
November 2013
June 2013   (final data collection date for primary outcome measure)

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)
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01621841
CHUBX2012/01
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Union National des Aveugles et DEficients Visuels
Not Provided
University Hospital, Bordeaux
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP