Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00744705
Status:
UNKNOWN
Last Update Posted:
2008-09-01
First Post:
2008-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-29', 'studyFirstSubmitDate': '2008-08-29', 'studyFirstSubmitQcDate': '2008-08-29', 'lastUpdatePostDateStruct': {'date': '2008-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal nerve fiber layer thickness', 'timeFrame': 'when the OCT images are taking'}], 'secondaryOutcomes': [{'measure': 'Refractive errors', 'timeFrame': 'when the OCT images are taking'}, {'measure': 'Intraocular pressure', 'timeFrame': 'when the OCT images are taking'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Retinal nerve fiber layer', 'Glaucoma', 'Myopia'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The normal range of retinal nerve fiber layer thickness might be different between Asians and Caucasians. However, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. So, the investigators want to find its normal range of in Asians.', 'detailedDescription': 'Characteristics of various ocular parameters are influenced by race. Because the retinal nerve fiber layer (RNFL) thickness is crucial in detecting early glaucomatous changes, its normal range is also important. Even though the normal range of RNFL thickness might be different according to race, the recently developed imaging device such as the Cirrus HD OCT includes only the Caucasian data. In the present study, we want to measure the RNFL thickness using the Cirrus HD OCT in normal Asian eyes and to determine its normal range in Asians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal subjects who recieved a regular medical check-up in a comprehensive medical testing center of our institute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal subjects\n* Good quality of the OCT images (signal intensity \\> 8)\n\nExclusion Criteria:\n\n* Any ocular history\n* DM'}, 'identificationModule': {'nctId': 'NCT00744705', 'briefTitle': 'Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Normative Database of the Retinal Nerve Fiber Layer Thickness Measured by the Cirrus HD OCT in Asians', 'orgStudyIdInfo': {'id': '3-2008-0076-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Normal subjects who received routine health check-up in a comprehensive medical testing center'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Gong Je Seong, MD, PhD', 'role': 'CONTACT', 'email': 'gjseong@yuhs.ac', 'phone': '82-2-2019-3441'}, {'name': 'Gong Je Seong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yongdong Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Gong Je Seong, MD, PhD', 'role': 'CONTACT', 'email': 'gjseong@yuhs.ac', 'phone': '82-2-2019-3441'}], 'overallOfficials': [{'name': 'Gong Je Seong, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gong Je Seong', 'oldOrganization': 'Yonsei University College of Medicine'}}}}