Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT01316003
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2011-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2011-03-15', 'studyFirstSubmitQcDate': '2011-03-15', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microstructural analysis by Spectral domain optical coherence tomography', 'timeFrame': 'one year', 'description': 'SD-OCT images of 6 mm scans were taken using Cirrus HD-OCT (OCT 4000, Carl Zeiss Meditec, Dublin, CA) with 5 line raster (5LR) and high-definition 5 line raster (HD5LR) modes.'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'one year', 'description': 'Each subject had a routine eye examination including measuring best-corrected visual acuity (BCVA) and intraocular pressure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cone outer segment tips line', 'Optical coherence tomography'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '22018706', 'type': 'DERIVED', 'citation': 'Rii T, Itoh Y, Inoue M, Hirakata A. Foveal cone outer segment tips line and disruption artifacts in spectral-domain optical coherence tomographic images of normal eyes. Am J Ophthalmol. 2012 Mar;153(3):524-529.e1. doi: 10.1016/j.ajo.2011.08.021. Epub 2011 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the incidence and possible causes of obscured or disrupted cone outer segment tips line at fovea in spectral-domain optical coherence tomography images of normal eyes.', 'detailedDescription': 'Thirty-seven eyes of 37 individuals without eye diseases were included in this study. Optical Coherence Tomography (OCT) images were taken using Cirrus HD-OCT (Carl Zeiss Meditec) with 5 line raster and high-definition 5 line raster modes. Images with signal strength weaker than 5/10 were excluded. Distinction of COST line and the integrity of COST line, external limiting membrane, and the photoreceptor inner segment and outer segment junction at the fovea were recorded. Demographic data, refractive error of the eyes, signal strengths of the OCT images were acquired for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thirty-seven eyes of 37 individuals without eye diseases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals without eye diseases\n\nExclusion Criteria:\n\n* individuals with eye diseases'}, 'identificationModule': {'nctId': 'NCT01316003', 'briefTitle': 'Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes', 'orgStudyIdInfo': {'id': 'KyorinEye004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal subjects', 'description': 'Thirty-seven eyes of 37 individuals without eye diseases', 'interventionNames': ['Other: Optical coherence tomography']}], 'interventions': [{'name': 'Optical coherence tomography', 'type': 'OTHER', 'otherNames': ['Cirrus HD-OCT (Carl Zeiss Meditec)'], 'description': 'Optical coherence tomography', 'armGroupLabels': ['Normal subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin Eye Center', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Makoto Inoue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyorin Eye Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}