Functional Brain Changes of Primary Open-angle Glaucoma Patients

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02570867
• Other study ID #: FirstJinanU
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 7, 2015
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2015
• Source: First Affiliated Hospital of Jinan University
• Contact: Qing Zhou, MD
• Phone: 86-18928903759
• Email: kerryzh[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Locations

Country	Name	City	State
China	First Affiliated Hospital of Jinan University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Qing Zhou

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

Gupta N, Ang LC, Noël de Tilly L, Bidaisee L, Yücel 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. Epub 2006 Feb 7. — View Citation

Gupta N, Yücel 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	18 months	No