Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 12:22 AM
Study NCT ID:
NCT00772993
Status:
UNKNOWN
Last Update Posted:
2008-10-16
First Post:
2008-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma
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': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-15', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of RNFL / Full thickness retina', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glaucoma', 'myopia', 'myopia with glaucoma', 'normal control'], 'conditions': ['Glaucoma', 'Myopia']}, 'descriptionModule': {'briefSummary': 'Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'prospective consecutive recruitment from a tertialry glaucoma subspecialty practise', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open angle glaucoma\n* Myopia\n* Myopia with evidence of glaucoma\n* Normal controls\n\nExclusion Criteria:\n\n* Evidence of retinal disease\n* BCVA \\< 0.4\n* Secondary glaucoma due to intraocular inflammation\n* Lens induced glaucoma\n* Tumor induced glaucoma\n* Neovascular glaucoma'}, 'identificationModule': {'nctId': 'NCT00772993', 'briefTitle': 'Efficacy of Retinal Nerve Fiber Layer (RNFL) / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Efficacy of RNFL / Retinal Thickness Ratio by Cirrus OCT Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma', 'orgStudyIdInfo': {'id': '4-2008-0340'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Primary open angle glaucoma'}, {'label': '2', 'description': 'Normal Control'}, {'label': '3', 'description': 'Myopia with no evidence of glaucoma'}, {'label': '4', 'description': 'Myopia with evidence og glaucoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chan Yun Kim, MD,PhD', 'role': 'CONTACT', 'email': 'kangeye@hotmail.com', 'phone': '82-2-2228-3570'}, {'name': 'Chan Yun Kim, MD,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Chan Yun Kim, MD,PhD.', 'role': 'CONTACT', 'email': 'kangeye@hotmail.com', 'phone': '82-2-2228-3570'}, {'name': 'Sung Yong Kang, MD', 'role': 'CONTACT', 'email': 'kangeye@yuhs.ac', 'phone': '82-2-2228-3570'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kim Chan Yun', 'oldOrganization': 'Institute of Vision Research, Department of Ophthalmology, Yonsei University School of Medicine, Severance Hospital.'}}}}