Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-31 @ 9:06 AM
Study NCT ID:
NCT00665795
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-17', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2008-04-22', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'screening indexes for dysthyroid optic neuropathy', 'timeFrame': 'indexes above 60% of orbital apex crowding were high suspected for DON'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysthyroid Optic Neuropathy', 'multidetector computed tomography', 'color doppler', 'Grave´s Orbitopathy', 'Grave´s Disease', 'morphometric analysis'], 'conditions': ['Dysthyroid Orbitopathy']}, 'referencesModule': {'references': [{'pmid': '22442048', 'type': 'DERIVED', 'citation': 'Goncalves AC, Silva LN, Gebrim EM, Monteiro ML. Quantification of orbital apex crowding for screening of dysthyroid optic neuropathy using multidetector CT. AJNR Am J Neuroradiol. 2012 Sep;33(8):1602-7. doi: 10.3174/ajnr.A3029. Epub 2012 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to study orbital structures in Graves´ Disease using multidetector computed tomography and color doppler imaging.\n\nSome changes in orbital structures detected by imaging exams could predict severity of the ocular Graves´disease. Thus the study could be useful in improve medical management of patients with Graves´ Disease.', 'detailedDescription': 'Morphometric analysis of orbital structures in Graves´ Orbitopathy using multidetector computed tomography scan and color doppler imaging:\n\nPatients with Graves´ orbitopathy are evaluated by a complete ophthalmic examination.A prospective study with Multidetector CT scan and Color Doppler of these patients are made to develop parameters capable to predict Dysthyroid Optic Neuropathy (DON).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Graves´ orbitopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Graves´Orbitopathy diagnosed based on previously reported criteria\n* Age above 20 years\n* Good cooperation for performing Visual Field test\n* Spherical refraction within ± 5 D and cylinder correction within ± 3 D\n\nExclusion Criteria:\n\n* Graves´Orbitopathy not diagnosed'}, 'identificationModule': {'nctId': 'NCT00665795', 'briefTitle': 'Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.', 'orgStudyIdInfo': {'id': '1152/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1Patients with Graves´orbitophathy.', 'description': 'Patients with Graves´orbitophathy.'}, {'label': '2 Patients with detected DON', 'description': 'Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05409 000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'General Hospital - University of Sao Paulo - School of Medicine', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mario L Monteiro, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo - School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Allan Christian Pieroni Goncalves', 'investigatorAffiliation': 'University of Sao Paulo'}}}}