Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02290704
Status:
UNKNOWN
Last Update Posted:
2017-11-28
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy and in Normal People
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-25', 'studyFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of retinal oxygen saturation in patients with GO under different managing conditions', 'timeFrame': 'before surgery ( or glucocorticoids administration), 1 week and 4 weeks after surgery ( or glucocorticoids administration)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oxygen saturation', 'retinal vessels', 'thyroid associated ophthalmopathy'], 'conditions': ["Graves' Ophthalmopathy"]}, 'referencesModule': {'references': [{'pmid': '8413459', 'type': 'BACKGROUND', 'citation': "Bahn RS, Heufelder AE. Pathogenesis of Graves' ophthalmopathy. N Engl J Med. 1993 Nov 11;329(20):1468-75. doi: 10.1056/NEJM199311113292007. No abstract available."}, {'pmid': '23838551', 'type': 'BACKGROUND', 'citation': "Alford EL, Soparkar CN. Management of the 'tight orbit' and associated visual loss. Curr Opin Otolaryngol Head Neck Surg. 2013 Aug;21(4):417-22. doi: 10.1097/MOO.0b013e32836312a1."}, {'pmid': '16704685', 'type': 'RESULT', 'citation': 'Michelson G, Scibor M. Intravascular oxygen saturation in retinal vessels in normal subjects and open-angle glaucoma subjects. Acta Ophthalmol Scand. 2006 Jun;84(3):289-95. doi: 10.1111/j.1600-0420.2005.00631.x.'}]}, 'descriptionModule': {'briefSummary': "Find if the retinal function is affected in both the nonsevere and the severe stage of Graves' ophthalmopathy (GO) by comparing the retinal oxygen saturation of GO patients with that of normal people.", 'detailedDescription': "Graves'ophthalmopathy (GO), also called thyroid-associated ophthalmopathy, is often mild and self-limiting, and probably declining in frequency, with only 3-5% of cases posing a threat to eyesight, remaining a pathogenetic enigma and a therapeutic dilemma. In its nonsevere expression, the symptoms and signs include Photophobia, Foreign body sensation, Eyelid retraction, increased intraocular pressure, Lagophthalmos, and Mild diplopia. In its severe expression, it is a disfiguring and invalidating disease with the optic nerve damaged. However, in this study, we want to find if the retinal vessels is affected in the early stage of the disease through observing the oxygen saturation of the retinal vessels and compare it with that of the normal people."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Controls- normal people; GO patients- patients with Graves' ophthalmopathy", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for GO patients:\n\n1. conforms to the diagnosis of Graves' ophthalmopathy;\n2. age \\> 18;\n3. volunteered to participate in this research, and sign the informed consent.\n\nInclusion Criteria for Control group:\n\n1. age \\> 18;\n2. diopter within + / - 3D;\n3. volunteered to participate in this research, and sign the informed consent.\n\nExclusion Criteria for GO patients:\n\n1. Fundus could not be seen clearly;\n2. pregnant and lactating women;\n3. could not tolerate the examination.\n\nExclusion Criteria for Control group:\n\n1. with severe systemic disease and cause eye lesions;\n2. have history of eye disease, ocular trauma and eye surgery impacting on visual function;\n3. pregnant and lactating women;\n4. could not tolerate the examination."}, 'identificationModule': {'nctId': 'NCT02290704', 'briefTitle': "Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy and in Normal People", 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': "Changes of Retinal Oxygen Saturation in Patients With Graves' Ophthalmopathy Under Different Managing Conditions and in Normal People", 'orgStudyIdInfo': {'id': '2013MEKY039'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'controls', 'description': 'People without eye disease'}, {'label': 'GO patients', 'description': "patients with Graves' ophthalmopathy"}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaonan Yang, Master', 'role': 'CONTACT', 'email': 'yangxn3@mail2.sysu.edu.cn', 'phone': '+8613751859797'}, {'name': 'Danping Huang, Docter', 'role': 'CONTACT', 'email': 'hdanp@mail.sysu.edu.cn', 'phone': '+8613501508328'}], 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Danping Huang', 'role': 'CONTACT', 'email': 'hdanp@mail.sysu.edu.cn', 'phone': '+8613501508328'}, {'name': 'Xiaonan Yang', 'role': 'CONTACT', 'email': 'yangxn3@mail2.sysu.edu.cn', 'phone': '+8613751859797'}], 'overallOfficials': [{'name': 'Danping Huang', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Xiaonan Yang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Siming Ai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Huasheng Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'the graduate student of Zhongshan Ophthalmic Center', 'investigatorFullName': 'Xiaonan Yang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}