Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-21 @ 9:50 PM
Study NCT ID:
NCT02766660
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2016-04-24', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular thickness', 'timeFrame': 'one year (between Jan 2012 and Jan 2013)', 'description': 'Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.'}, {'measure': 'Retinal nerve fiber layer thickness', 'timeFrame': 'one year (between Jan 2012 and Jan 2013)', 'description': 'Retinal nerve fiber layer thickness (micrometer) was measured by optical coherence tomography in patient and control groups.'}], 'secondaryOutcomes': [{'measure': 'Optic disc parameters', 'timeFrame': 'one year (between Jan 2012 and Jan 2013)', 'description': 'Optic disc parameters (morphologic structures) were obtained by optical coherence tomography for both groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thyroid ophthalmopathy', 'optical coherence tomography'], 'conditions': ['Thyroid Associated Ophthalmopathy']}, 'referencesModule': {'references': [{'pmid': '27493796', 'type': 'DERIVED', 'citation': 'Sayin O, Yeter V, Ariturk N. Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid-Associated Ophthalmopathy. J Ophthalmol. 2016;2016:9452687. doi: 10.1155/2016/9452687. Epub 2016 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.', 'detailedDescription': 'One hundred and thirty two eyes of 66 patients with TAO and 72 eyes of 36 healthy controls were included in the study. Proptosis level was determined by Hertel exophthalmometer. Optic disc, peripapillary retinal nerve fiber layer and macula parameters were measured by OCT. All measurements were compared between the patients and age and sex-matched healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Patient group consists the consecutive patients with thyroid associated ophthalmopathy consulted by endocrinology department.\n\nThe control group was chosen among healthy volunteers who have\n\n* no eye pathology,\n* 20/20 vision (corrected or uncorrected),\n* age and sex-matched with the patient group.\n\nExclusion Criteria:\n\nFor both groups, those who had\n\n* significant sight impairment,\n* high myopia ( \\< -5Diopters ),\n* high hyperopia ( \\> +3Diopters ),\n* optic disc anomaly,\n* vitreoretinal interface disease,\n* vascular and degenerative retinal diseases,\n* cornea or lens opacity, ocular surgery history,\n* glaucoma,\n* neurological diseases that can affect the visual field,\n* history of trauma, amblyopia,\n* diplopia,\n* keratitis,\n* history of topical or systemic steroid'}, 'identificationModule': {'nctId': 'NCT02766660', 'briefTitle': 'Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy', 'organization': {'class': 'OTHER', 'fullName': 'Neon Hospital'}, 'officialTitle': 'Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy', 'orgStudyIdInfo': {'id': '2013-379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Thyroid ophthalmopathy', 'description': 'Thyroid associated ophthalmopathy patients were measured by optical coherence tomography.', 'interventionNames': ['Device: Optical Coherence Tomography']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Control group was consisted by age and sex- macthed healthy people adn they were measured by optical coherence tomography.', 'interventionNames': ['Device: Optical Coherence Tomography']}], 'interventions': [{'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'description': 'All groups were measured by optical coherence tomography.', 'armGroupLabels': ['Control', 'Thyroid ophthalmopathy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nurşen ARITÜRK, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neon Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}