Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 10:42 PM
Study NCT ID:
NCT04927468
Status:
UNKNOWN
Last Update Posted:
2021-06-16
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, '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': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative deviations', 'timeFrame': '6 weeks', 'description': 'Postoperative deviations in the primary position were measured in prism diopters'}, {'measure': 'Postoperative deviations', 'timeFrame': '3 months', 'description': 'Postoperative deviations in the primary position were measured in prism diopters'}, {'measure': 'Postoperative deviations', 'timeFrame': '6 months', 'description': 'Postoperative deviations in the primary position were measured in prism diopters'}], 'secondaryOutcomes': [{'measure': 'binocular single vision', 'timeFrame': '6 weeks', 'description': 'measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.'}, {'measure': 'binocular single vision', 'timeFrame': '3 months', 'description': 'measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.'}, {'measure': 'binocular single vision', 'timeFrame': '6 months', 'description': 'measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.'}, {'measure': 'stereoacuity', 'timeFrame': '6 weeks', 'description': 'measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.'}, {'measure': 'stereoacuity', 'timeFrame': '3 months', 'description': 'measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.'}, {'measure': 'stereoacuity', 'timeFrame': '6 months', 'description': 'measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.'}, {'measure': 'ocular motility', 'timeFrame': '6 weeks', 'description': 'evaluate the ocular motility with fixed visual field examination ,scaled from -4 to +4'}, {'measure': 'ocular motility', 'timeFrame': '3 months', 'description': 'evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4'}, {'measure': 'ocular motility', 'timeFrame': '6 months', 'description': 'evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Strabismus, Mechanical', 'Graves Ophthalmopathy']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy", 'detailedDescription': "To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Grave's ophthalmopathy\n* angle of deviation more than 20°\n* clinically and biochemically euthyroid for at least 3 months;\n* a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction\n* monocular and mainly single extraocular muscle restricted motility\n\nExclusion Criteria:\n\n* Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid\n* best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes"}, 'identificationModule': {'nctId': 'NCT04927468', 'briefTitle': "Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy", 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': "The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession", 'orgStudyIdInfo': {'id': 'yanghs20210607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'supramaximal rectus recession', 'description': 'supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy', 'interventionNames': ['Procedure: supramaximal rectus recession']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal rectus recession', 'description': 'normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy', 'interventionNames': ['Procedure: normal rectus recession']}], 'interventions': [{'name': 'supramaximal rectus recession', 'type': 'PROCEDURE', 'description': 'inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus', 'armGroupLabels': ['supramaximal rectus recession']}, {'name': 'normal rectus recession', 'type': 'PROCEDURE', 'description': 'inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus', 'armGroupLabels': ['normal rectus recession']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yang Huasheng', 'role': 'CONTACT', 'email': 'yanghs64@163.com', 'phone': '+00862087331539'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Huasheng Yang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}