Functional Brain Changes of Primary Open-angle Glaucoma Patients
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|ClinicalTrials.gov Identifier: NCT02570867|
Recruitment Status : Unknown
Verified October 2015 by Qing Zhou, First Affiliated Hospital of Jinan University.
Recruitment status was: Recruiting
First Posted : October 7, 2015
Last Update Posted : October 8, 2015
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Study on the Changes of Brain Function in Primary Open-angle Glaucoma Patients With fMRI|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
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: 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.
- Changes of Brain Function [ Time Frame: 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.
- Correlation between brain gray changes and retinal nerve fiber layer thickness [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570867
|Contact: Qing Zhou, MDemail@example.com|
|Contact: Xiaoyong Liu, MDfirstname.lastname@example.org|
|First Affiliated Hospital of Jinan University||Recruiting|
|Guangzhou, Guangdong, China, 510632|
|Contact: Qing Zhou, MD 86-18928903759 email@example.com|
|Contact: Xiaoyong Liu, MD 86-20-38688350 firstname.lastname@example.org|
|Principal Investigator: Qing Zhou, MD|
|Sub-Investigator: Xiaoyong Liu, MD|
|Study Chair:||Qing Zhou, MD||First Affiliated Hospital of Jinan University|
|Principal Investigator:||Qing Zhou, MD||First Affiliated Hospital of Jinan University|