Functional Brain Changes of Primary Open-angle Glaucoma Patients

Sponsor
Qing Zhou (Other)
Overall Status
Unknown status
CT.gov ID
NCT02570867
Collaborator
(none)
40
1
24
1.7

Study Details

Study Description

Brief Summary

Structural and functional brain changes of primary open-angle glaucoma patient will be examined with fMRI. POAG patients and control group were examined with 3.0T magnetic resonance imaging. The gray matter, white matter and cerebrospinal fluid volume images will be obtained and analysed.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    More and more researches showed that nerve damage in glaucoma is not limited in the optic nerve, but also involved the visual pathway, including the optic chiasm, optic beam, lateral geniculate body, optic radiation and visual cortex. Furthermore, the central nervous system changes may be earlier than visual field and the optic nerve morphology change. Tomography (OCT), laser polarimetry 0ptical (SLP), evoked potential scanning (VEP) can not accurately reflect the central nervous system changes caused by glaucoma.

    In recent years, magnetic resonance diffusion tensor imaging (DTI), blood oxygen level dependent functional magnetic resonance imaging(fMRI- BOLD) and voxel-based Morphometry(VBM) is widely used in clinical practice. The differences in the density and volume of brain tissue could be analyzed with VBM which had the advantages of comprehensive, objective and repeatable. Studies have indicated that patients with POAG can lead to a wide range of changes in the cerebral cortex which are associated with the severity of glaucoma.

    Participants in the study will be assigned to primary open-angle glaucoma (POAG) patients or healthy volunteers. Two groups will be received 3.0T functional magnetic resonance imaging(fMRI) and eye examination including visual acuity, visual field, intraocular pressure, anterior chamber angle, corneal thickness and optic nerve fiber thickness. We hope this trial will reveal the patterns and structural differences of brain function abnormalities between the POAG patents and the normal people. And the same time, the correlation between brain gray changes and visual field and retinal nerve fiber layer thickness will be analysed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Study on the Changes of Brain Function in Primary Open-angle Glaucoma Patients With fMRI
    Study Start Date :
    Jun 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    normal control group

    Normal control group: healthy volunteers will be received Functional magnetic resonance imaging(fMRI) and eye examination including visual acuity, visual field, intraocular pressure, anterior chamber angle, corneal thickness and optic nerve fiber thickness one time.

    POAG group

    POAG: The primary open angle glaucoma cases were will be received Functional magnetic resonance imaging(fMRI) and eye examination including visual acuity, visual field, intraocular pressure, anterior chamber angle, corneal thickness and optic nerve fiber thickness one time.

    Outcome Measures

    Primary Outcome Measures

    1. Changes of Brain Function [18 months]

      The gray matter, white matter and cerebrospinal fluid volume images will be obtained with 3.0T magnetic resonance imaging. The two groups will be compared by Two Sample T-Test.

    Secondary Outcome Measures

    1. Correlation between brain gray changes and retinal nerve fiber layer thickness [18 months]

      Brain grey matter volume will be measured with 3.0T magnetic resonance imaging and the optic nerve fiber layer thickness were measured with OCT. The correlation of the two will be analysed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria(POAG patients)

    1. ages of 18 and 40 years.

    2. glaucoma diagnostic criteria: a) intraocular pressure(IOP) ≥ 21mmhg; b) glaucoma specific changes of optic papilla and retinal nerve fiber layer defect;c) glaucoma specific visual field defect; d) the anterior chamber angles are open.

    3. without other eye diseases.

    4. Written informed consent.

    Inclusion Criteria(Healthy Volunteers):
    1. ages of 18 and 40 years.

    2. eye examinations of best corrected visual acuity ≥20/20.

    3. the equivalent degree of myopia < -6.00d.

    4. IOP < 21 mmHg.

    5. without other eye diseases;

    6. Written informed consent.

    Exclusion Criteria(POAG patients and Healthy Volunteers):
    1. ages over 40 years or less than 18 years.

    2. myopic degree (equivalent refraction) is greater than 6.0D.

    3. history of ocular trauma and ocular surgery.

    4. with other eye diseases: corneal diseases, cataract, diabetic retinopathy and optic nerve diseases.

    5. brain injury and other diseases of the nervous system: Alzheimer's disease, Parkinson's disease.

    6. MRI scan showed that there was a qualitative change: cerebral infarction, cerebral thrombosis, etc.

    7. install cardiac pacemakers, claustrophobic patients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Jinan University Guangzhou Guangdong China 510632

    Sponsors and Collaborators

    • Qing Zhou

    Investigators

    • Study Chair: Qing Zhou, MD, First Affiliated Hospital of Jinan University
    • Principal Investigator: Qing Zhou, MD, First Affiliated Hospital of Jinan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Qing Zhou, Vice director of Department of Ophthalmology The First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan University
    ClinicalTrials.gov Identifier:
    NCT02570867
    Other Study ID Numbers:
    • FirstJinanU
    First Posted:
    Oct 7, 2015
    Last Update Posted:
    Oct 8, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Qing Zhou, Vice director of Department of Ophthalmology The First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2015