NCT01621841

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 9, 2026

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

June 11, 2012

Last Update Submit

June 5, 2026

Conditions

GlaucomaFractional Anisotropy

Outcome Measures

Primary Outcomes (1)

  • fractional anisotropy

    Inclusion

Secondary Outcomes (3)

  • volume of retrochiasmatic grey matter

    Inclusion

  • global atrophy

    inclusion

  • hyper intensities white matter

    inclusion

Study Arms (2)

Glaucoma subjects

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

heathly subjects

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

Interventions

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

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

Glaucoma subjectsheathly subjects

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'ophtalmologie Hôpital Pellegrin

CHU de Bordeaux, Bordeaux, 33000, France

Location

Related Publications (1)

  • Tellouck L, Durieux M, Coupe P, Cougnard-Gregoire A, Tellouck J, Tourdias T, Munsch F, Garrigues A, Helmer C, Malet F, Dartigues JF, Dousset V, Delcourt C, Schweitzer C. Optic Radiations Microstructural Changes in Glaucoma and Association With Severity: A Study Using 3Tesla-Magnetic Resonance Diffusion Tensor Imaging. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6539-6547. doi: 10.1167/iovs.16-19838.

    PMID: 27918827RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 18, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

June 9, 2026

Record last verified: 2013-12

Locations

FR(1)