Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT03438903
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-18', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-02-18', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare repeatability between swept-source optical coherence tomography (SS-OCT) and spectral-domain OCT (SD-OCT) devices for the measurement of retinal thickness in various retinal diseases.', 'timeFrame': 'Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.', 'description': 'Comparison of Intraclass correlation coefficient (ICC) and coefficients of variability (CV) between devices'}], 'secondaryOutcomes': [{'measure': 'To compare repeatability according to the degree of macular thickness', 'timeFrame': 'Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.', 'description': 'To compare the repeatability of retinal thickness according to central macular thickness in eyes with retinal diseases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macula Abnormality']}, 'descriptionModule': {'briefSummary': 'Comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT', 'detailedDescription': 'The investigators studied the intradevice repeatability of thickness measurements for total retina, retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform (GC-IPL) layers of macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT and compared the repeatability between two devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'normal control : 36 eyes of 36 subjects\n\nretinal disease group: 78 eyes of 78 patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age-matched normal group was composed of subjects with age over at least 19 years,\n* a best-corrected visual acuity of 20/25 or higher,\n* normal fundus and intraocular pressure (IOP) \\< 21mm Hg.\n\nExclusion Criteria:\n\n* an spherical equivalent (SE) larger than ± 6 D,\n* cataract graded as more severe than grade 3 (Lens Opacities Classification System III),\n* a history of glaucoma and optic nerve diseases, or a history of vitrectomy.'}, 'identificationModule': {'nctId': 'NCT03438903', 'briefTitle': 'Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner Retinal Thickness in Various Retinal Diseases', 'orgStudyIdInfo': {'id': '2017-10-013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal group', 'description': 'Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)', 'interventionNames': ['Device: Repeat exams of OCT device']}, {'label': 'Retinal diseases group', 'description': 'Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT)', 'interventionNames': ['Device: Repeat exams of OCT device']}], 'interventions': [{'name': 'Repeat exams of OCT device', 'type': 'DEVICE', 'description': 'All 2 consecutive OCT examinations were performed by 1 experienced technician, in the order of SD-OCT and SS-OCT. The interval was 10 minutes between examinations by each OCT devices', 'armGroupLabels': ['Normal group', 'Retinal diseases group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11923', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}], 'overallOfficials': [{'name': 'Mincheol Seong, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hanyang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Yong Un shin', 'investigatorAffiliation': 'Hanyang University'}}}}