Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-01 @ 12:41 AM
Study NCT ID:
NCT01928212
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2013-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2013-08-20', 'studyFirstSubmitQcDate': '2013-08-22', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal Nerve Fiber Layer Thickness', 'timeFrame': 'Baseline', 'description': 'Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.'}]}, 'conditionsModule': {'keywords': ['retinal nerve fiber layer thickness', 'optical coherence tomography', 'Parkinson disease'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '24465663', 'type': 'DERIVED', 'citation': 'Yu JG, Feng YF, Xiang Y, Huang JH, Savini G, Parisi V, Yang WJ, Fu XA. Retinal nerve fiber layer thickness changes in Parkinson disease: a meta-analysis. PLoS One. 2014 Jan 21;9(1):e85718. doi: 10.1371/journal.pone.0085718. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': "Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PD patients and healthy subjects were included and underwent OCT examinations', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. case-control studies;\n2. patients with PD were compared with healthy controls;\n3. all subjects underwent RNFL thickness measurement by OCT;\n4. studies should provide the data of peripapillary RNFL thickness;\n5. sample size ≥10 in each group.\n\nExclusion Criteria:\n\n1. authors did not make RNFL measurements;\n2. study without healthy control group;\n3. the outcome values can not be used for meta-analysis;\n4. duplicated articles.'}, 'identificationModule': {'nctId': 'NCT01928212', 'briefTitle': 'Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis', 'orgStudyIdInfo': {'id': 'FYF20130820'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy control', 'description': 'Sex- and agematched healthy subjects', 'interventionNames': ['Device: Optical coherence tomography']}, {'label': 'Parkinson group', 'description': "Patients with Parkinson's disease", 'interventionNames': ['Device: Optical coherence tomography']}], 'interventions': [{'name': 'Optical coherence tomography', 'type': 'DEVICE', 'armGroupLabels': ['Parkinson group', 'healthy control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Yifan Feng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yifan Feng', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wenzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Eye Hospital, Wenzhou Medical College, China', 'investigatorFullName': 'Yifan Feng', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}