Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT02570867
Status:
UNKNOWN
Last Update Posted:
2015-10-08
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Brain Changes of Primary Open-angle Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Brain Function', 'timeFrame': '18 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between brain gray changes and retinal nerve fiber layer thickness', 'timeFrame': '18 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'brain function', 'fMRI'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '21453963', 'type': 'BACKGROUND', 'citation': 'Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.'}, {'pmid': '16799014', 'type': 'BACKGROUND', '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. doi: 10.1167/iovs.06-0051.'}, {'pmid': '17998036', 'type': 'BACKGROUND', 'citation': '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': '19341728', 'type': 'BACKGROUND', '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.'}, {'pmid': '16464969', 'type': 'BACKGROUND', 'citation': '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': '23417328', 'type': 'BACKGROUND', '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.'}, {'pmid': '20357191', 'type': 'BACKGROUND', '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.'}, {'pmid': '23258150', 'type': 'BACKGROUND', 'citation': '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': '28248867', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'POAG group :20 cases normal control group:20 cases', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria（POAG patients）\n\n1. ages of 18 and 40 years.\n2. 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.\n3. without other eye diseases.\n4. Written informed consent.\n\nInclusion Criteria（Healthy Volunteers）:\n\n1. ages of 18 and 40 years.\n2. eye examinations of best corrected visual acuity ≥20/20.\n3. the equivalent degree of myopia \\< -6.00d.\n4. IOP \\< 21 mmHg.\n5. without other eye diseases;\n6. Written informed consent.\n\nExclusion Criteria（POAG patients and Healthy Volunteers）:\n\n1. ages over 40 years or less than 18 years.\n2. myopic degree (equivalent refraction) is greater than 6.0D.\n3. history of ocular trauma and ocular surgery.\n4. with other eye diseases: corneal diseases, cataract, diabetic retinopathy and optic nerve diseases.\n5. brain injury and other diseases of the nervous system: Alzheimer's disease, Parkinson's disease.\n6. MRI scan showed that there was a qualitative change: cerebral infarction, cerebral thrombosis, etc.\n7. install cardiac pacemakers, claustrophobic patients."}, 'identificationModule': {'nctId': 'NCT02570867', 'briefTitle': 'Functional Brain Changes of Primary Open-angle Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Jinan University'}, 'officialTitle': 'Study on the Changes of Brain Function in Primary Open-angle Glaucoma Patients With fMRI', 'orgStudyIdInfo': {'id': 'FirstJinanU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal control group', 'description': '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.'}, {'label': 'POAG group', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510632', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qing Zhou, MD', 'role': 'CONTACT', 'email': 'kerryzh@163.com', 'phone': '86-18928903759'}, {'name': 'Xiaoyong Liu, MD', 'role': 'CONTACT', 'email': 'jndxlxy@163.com', 'phone': '86-20-38688350'}, {'name': 'Qing Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaoyong Liu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qing Zhou, MD', 'role': 'CONTACT', 'email': 'kerryzh@163.com', 'phone': '86-18928903759'}, {'name': 'Xiaoyong Liu, MD', 'role': 'CONTACT', 'email': 'jndxlxy@163.com', 'phone': '86-20-38688350'}], 'overallOfficials': [{'name': 'Qing Zhou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Jinan University'}, {'name': 'Qing Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Jinan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qing Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice director of Department of Ophthalmology The First Affiliated Hospital of Jinan University', 'investigatorFullName': 'Qing Zhou', 'investigatorAffiliation': 'First Affiliated Hospital of Jinan University'}}}}