CClinicalTrials.gg
Status unknownNCT02570867Updated Oct 8, 2015

Functional Brain Changes of Primary Open-angle Glaucoma Patients

An observational study in Glaucoma, sponsored by Qing Zhou. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-08.

Sponsored by Qing Zhou · Observational

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
40
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Glaucoma

Keywords

  • glaucoma
  • brain function
  • fMRI
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 40 is below the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with Qing Zhou as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

POAG group :20 cases normal control group:20 cases

Eligibility 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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Changes of Brain Function

    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.

    Time frame: 18 months

Secondary outcomes

  1. Correlation between brain gray changes and retinal nerve fiber layer thickness

    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.

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Jinan University
    Guangzhou, Guangdong 510632, China
    • Qing Zhou, MD · Contact · kerryzh@163.com · 86-18928903759
    • Xiaoyong Liu, MD · Contact · jndxlxy@163.com · 86-20-38688350
    • Qing Zhou, MD · Principal investigator
    • Xiaoyong Liu, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30. PubMed 21453963 ↗
  • He M, Foster PJ, Ge J, Huang W, Zheng Y, Friedman DS, Lee PS, Khaw PT. Prevalence and clinical characteristics of glaucoma in adult Chinese: a population-based study in Liwan District, Guangzhou. Invest Ophthalmol Vis Sci. 2006 Jul;47(7):2782-8. doi: 10.1167/iovs.06-0051. PubMed 16799014 ↗
  • Gupta N, Yucel YH. What changes can we expect in the brain of glaucoma patients? Surv Ophthalmol. 2007 Nov;52 Suppl 2:S122-6. doi: 10.1016/j.survophthal.2007.08.006. PubMed 17998036 ↗
  • Ito Y, Shimazawa M, Chen YN, Tsuruma K, Yamashima T, Araie M, Hara H. Morphological changes in the visual pathway induced by experimental glaucoma in Japanese monkeys. Exp Eye Res. 2009 Aug;89(2):246-55. doi: 10.1016/j.exer.2009.03.013. Epub 2009 Mar 31. PubMed 19341728 ↗
  • Gupta N, Ang LC, Noel de Tilly L, Bidaisee L, Yucel YH. Human glaucoma and neural degeneration in intracranial optic nerve, lateral geniculate nucleus, and visual cortex. Br J Ophthalmol. 2006 Jun;90(6):674-8. doi: 10.1136/bjo.2005.086769. Epub 2006 Feb 7. PubMed 16464969 ↗
  • Murai H, Suzuki Y, Kiyosawa M, Tokumaru AM, Ishii K, Mochizuki M. Positive correlation between the degree of visual field defect and optic radiation damage in glaucoma patients. Jpn J Ophthalmol. 2013 May;57(3):257-62. doi: 10.1007/s10384-013-0233-0. Epub 2013 Feb 16. PubMed 23417328 ↗
  • Qing G, Zhang S, Wang B, Wang N. Functional MRI signal changes in primary visual cortex corresponding to the central normal visual field of patients with primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4627-34. doi: 10.1167/iovs.09-4834. Epub 2010 Mar 31. PubMed 20357191 ↗
  • Chen WW, Wang N, Cai S, Fang Z, Yu M, Wu Q, Tang L, Guo B, Feng Y, Jonas JB, Chen X, Liu X, Gong Q. Structural brain abnormalities in patients with primary open-angle glaucoma: a study with 3T MR imaging. Invest Ophthalmol Vis Sci. 2013 Jan 17;54(1):545-54. doi: 10.1167/iovs.12-9893. PubMed 23258150 ↗
  • Jiang MM, Zhou Q, Liu XY, Shi CZ, Chen J, Huang XH. Structural and functional brain changes in early- and mid-stage primary open-angle glaucoma using voxel-based morphometry and functional magnetic resonance imaging. Medicine (Baltimore). 2017 Mar;96(9):e6139. doi: 10.1097/MD.0000000000006139. PubMed 28248867 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02570867
Lead sponsor
Qing Zhou
Responsible party
Qing Zhou (Vice director of Department of Ophthalmology The First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan University) — Sponsor-investigator
First posted
Oct 7, 2015
Start date
Jun 2015
Primary completion
Dec 2016 (estimated)
Completion
Jun 2017 (estimated)
Last update
Oct 8, 2015

Study contacts

Qing Zhou, MD
Contact
kerryzh@163.com
86-18928903759
Xiaoyong Liu, MD
Contact
jndxlxy@163.com
86-20-38688350
Qing Zhou, MD
study chair · First Affiliated Hospital of Jinan University
Qing Zhou, MD
principal investigator · First Affiliated Hospital of Jinan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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