NCT02570867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

October 6, 2015

Last Update Submit

October 7, 2015

Conditions

Glaucoma

Keywords

glaucomabrain functionfMRI

Outcome Measures

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.

    18 months

Secondary Outcomes (1)

  • Correlation between brain gray changes and retinal nerve fiber layer thickness

    18 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

POAG group :20 cases normal control group:20 cases

You may qualify if:

  • ages of 18 and 40 years.
  • 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.
  • without other eye diseases.
  • Written informed consent.
  • ages of 18 and 40 years.
  • eye examinations of best corrected visual acuity ≥20/20.
  • the equivalent degree of myopia \< -6.00d.
  • IOP \< 21 mmHg.
  • without other eye diseases;
  • Written informed consent.

You may not qualify if:

  • ages over 40 years or less than 18 years.
  • myopic degree (equivalent refraction) is greater than 6.0D.
  • history of ocular trauma and ocular surgery.
  • with other eye diseases: corneal diseases, cataract, diabetic retinopathy and optic nerve diseases.
  • brain injury and other diseases of the nervous system: Alzheimer's disease, Parkinson's disease.
  • MRI scan showed that there was a qualitative change: cerebral infarction, cerebral thrombosis, etc.
  • install cardiac pacemakers, claustrophobic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510632, China

RECRUITING

Related Publications (9)

  • Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.

    PMID: 21453963BACKGROUND

  • 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.

    PMID: 16799014BACKGROUND

  • 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.

    PMID: 17998036BACKGROUND

  • 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.

    PMID: 19341728BACKGROUND

  • 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.

    PMID: 16464969BACKGROUND

  • 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.

    PMID: 23417328BACKGROUND

  • 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.

    PMID: 20357191BACKGROUND

  • 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.

    PMID: 23258150BACKGROUND

  • 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.

    PMID: 28248867DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Qing Zhou, MD

    First Affiliated Hospital of Jinan University

    STUDY CHAIR

  • Qing Zhou, MD

    First Affiliated Hospital of Jinan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Zhou, MD

CONTACT

86-18928903759kerryzh@163.com

Xiaoyong Liu, MD

CONTACT

86-20-38688350jndxlxy@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice director of Department of Ophthalmology The First Affiliated Hospital of Jinan University

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 7, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

CN(1)