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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
Sponsor:
Information provided by (Responsible Party):
Qing Zhou, First Affiliated Hospital of Jinan University

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
Glaucoma

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.


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Study Type : Observational
Estimated 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 : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
POAG group :20 cases normal control group:20 cases
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Qing Zhou, MD 86-18928903759 kerryzh@163.com
Contact: Xiaoyong Liu, MD 86-20-38688350 jndxlxy@163.com

Locations
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China, Guangdong
First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China, 510632
Contact: Qing Zhou, MD    86-18928903759    kerryzh@163.com   
Contact: Xiaoyong Liu, MD    86-20-38688350    jndxlxy@163.com   
Principal Investigator: Qing Zhou, MD         
Sub-Investigator: Xiaoyong Liu, MD         
Sponsors and Collaborators
Qing Zhou
Investigators
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Study Chair: Qing Zhou, MD First Affiliated Hospital of Jinan University
Principal Investigator: Qing Zhou, MD First Affiliated Hospital of Jinan University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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     History of Changes
Other Study ID Numbers: FirstJinanU
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by Qing Zhou, First Affiliated Hospital of Jinan University:
glaucoma
brain function
fMRI

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases