Functional Brain Changes of Primary Open-angle Glaucoma Patients

October 7, 2015 updated by: Qing Zhou

Study on the Changes of Brain Function in Primary Open-angle Glaucoma Patients With fMRI

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xiaoyong Liu, MD
  • Phone Number: 86-20-38688350
  • Email: jndxlxy@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510632
        • Recruiting
        • First Affiliated Hospital of Jinan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qing Zhou, MD
        • Sub-Investigator:
          • Xiaoyong Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

POAG group :20 cases normal control group:20 cases

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstJinanU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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