Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT04919694
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Orbital Compression Surgery and Strabismus Surgery for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-06', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .", 'timeFrame': '6 weeks after surgery', 'description': "All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = \\[(raw score - 8)/16 9 100\\]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = \\[(raw score - \\*)/(2x\\*) x100\\] where \\* is the number of completed items."}, {'measure': "quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) .", 'timeFrame': '6 months', 'description': "All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = \\[(raw score - 8)/16 9 100\\]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = \\[(raw score - \\*)/(2x\\*) x100\\] where \\* is the number of completed items."}], 'secondaryOutcomes': [{'measure': 'strabismus status', 'timeFrame': '6 weeks after surgery', 'description': 'angle of deviation including up-gaze, down-gaze ,left and right-gaze'}, {'measure': 'strabismus status', 'timeFrame': '6 months after surgery', 'description': 'angle of deviation including up-gaze, down-gaze ,left and right-gaze'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Associated Ophthalmopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether combination of orbital compression surgery with strabismus surgery is better than strabismus surgery after orbital compression surgery in the treatment of moderate-to-severe thyroid associated ophthalmopathy', 'detailedDescription': 'This study will be a interventional case series. Patients with moderate-to-severe thyroid associated ophthalmopathy will be randomized to receive combination of orbital compression surgery with strabismus surgery or strabismus surgery after orbial compression surgery.Patients will be followed for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate-to-severe thyroid associate ophthalmopathy\n* CAS≤3 score\n* monocular strabismus,deviation≥20° or 35▲\n* stable thyroid function for at least 6 months, confirmed by an endocrinologist\n\nExclusion Criteria:\n\n* any previous disease in the study eye.\n* any previous systematic disease'}, 'identificationModule': {'nctId': 'NCT04919694', 'briefTitle': 'Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy', 'orgStudyIdInfo': {'id': 'yanghs20210106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combination of orbital compression and strabismus surgery', 'description': 'orbital compression and strabismus surgery are performed at the same time', 'interventionNames': ['Procedure: combination of orbital compression surgery and strabismus surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'perform strabismus surgery after orbital compression', 'description': 'Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.', 'interventionNames': ['Procedure: orbital compression']}], 'interventions': [{'name': 'combination of orbital compression surgery and strabismus surgery', 'type': 'PROCEDURE', 'description': 'combination of orbital compression surgery and strabismus surgery at the same time', 'armGroupLabels': ['combination of orbital compression and strabismus surgery']}, {'name': 'orbital compression', 'type': 'PROCEDURE', 'description': 'orbital compression', 'armGroupLabels': ['perform strabismus surgery after orbital compression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Hua sheng Yang, M.D,PHD', 'role': 'CONTACT', 'email': 'yanghs64@162.com', 'phone': '+8620-87331539'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sun Yat-sen University', 'investigatorFullName': 'Huasheng Yang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}