Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:17 PM
Study NCT ID:
NCT00553761
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2007-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERG and mfPERG in Band Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2007-11-05', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Band atrophy', 'Pattern electroretinogram', 'Chiasmal compression', 'Neural loss', 'Electrophysiological tests'], 'conditions': ['Band Atrophy']}, 'referencesModule': {'references': [{'pmid': '23052713', 'type': 'DERIVED', 'citation': 'Monteiro ML, Hokazono K, Cunha LP, Oyamada MK. Correlation between multifocal pattern electroretinography and Fourier-domain OCT in eyes with temporal hemianopia from chiasmal compression. Graefes Arch Clin Exp Ophthalmol. 2013 Mar;251(3):903-15. doi: 10.1007/s00417-012-2156-8. Epub 2012 Sep 29.'}, {'pmid': '21415059', 'type': 'DERIVED', 'citation': 'Monteiro ML, Hokazono K, Cunha LP, Oyamada MK. Multifocal pattern electroretinography for the detection of neural loss in eyes with permanent temporal hemianopia or quadrantanopia from chiasmal compression. Br J Ophthalmol. 2012 Jan;96(1):104-9. doi: 10.1136/bjo.2010.199661. Epub 2011 Mar 17.'}, {'pmid': '19264884', 'type': 'DERIVED', 'citation': 'Monteiro ML, Cunha LP, Costa-Cunha LV, Maia OO Jr, Oyamada MK. Relationship between optical coherence tomography, pattern electroretinogram and automated perimetry in eyes with temporal hemianopia from chiasmal compression. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3535-41. doi: 10.1167/iovs.08-3093. Epub 2009 Mar 5.'}, {'pmid': '18401605', 'type': 'DERIVED', 'citation': 'Cunha LP, Oyamada MK, Monteiro ML. Pattern electroretinograms for the detection of neural loss in patients with permanent temporal visual field defect from chiasmal compression. Doc Ophthalmol. 2008 Nov;117(3):223-32. doi: 10.1007/s10633-008-9126-9. Epub 2008 Apr 10.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/sites/entrez', 'label': 'Pattern Electroretinograms For the Detection of Neural Loss in Patients with Permanent Temporal Visual Field Defect from Chiasmal Compression'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the ability of pattern electroretinogram (PERG) and multifocal pattern electroretinogram (mfPERG) to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these electrophysiological tests were able to identify this such pattern. The idea is to investigate the ability of the these electrophysiological technics in detecting the neural loss from chiasmal compression and to evaluate the ability of PERG and mfPERG parameters to differentiate between eyes with band atrophy of the optic nerve and healthy eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with band atrophy from chismal compression and controls', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Visual acuity better than 20/30\n2. Refractive error less 5 spherical diopter and 3 cylinder diopter\n3. Temporal field defect\n\nExclusion Criteria:\n\n1. Presence of glaucoma and optic nerve anomalies\n2. Anormal nasal field'}, 'identificationModule': {'nctId': 'NCT00553761', 'briefTitle': 'PERG and mfPERG in Band Atrophy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Pattern Electroretinogram and Multifocal Pattern Electroretinogram For the Detection of Neural Loss in Patients With Permanent Temporal Visual Field Defect From Chiasmal Compression', 'orgStudyIdInfo': {'id': '654/06'}, 'secondaryIdInfos': [{'id': 'FAPESP 06/61549-6; 07/54142-0)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pattern electroretinogram', 'type': 'DEVICE', 'description': 'Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mário Luiz R Monteiro, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Mario Luiz Ribeiro Monteiro/University of Sao Paulo', 'oldOrganization': 'University of Sao Paulo'}}}}