Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-04-18 @ 4:53 PM
Study NCT ID:
NCT02736461
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2016-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Postoperative Strabismus After Floor Fracture Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009917', 'term': 'Orbital Fractures'}, {'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strabismus happening', 'timeFrame': '6 months after orbital floor fracture repair surgery', 'description': 'Number of participants suffered from strabismus happening at 6 months after operation and their characteristics.'}]}, 'conditionsModule': {'keywords': ['Orbital fractures', 'Strabismus', 'Predicting factors', 'orbital floor fractures'], 'conditions': ['Orbital Fractures', 'Strabismus']}, 'referencesModule': {'references': [{'pmid': '25547215', 'type': 'RESULT', 'citation': 'Bartoli D, Fadda MT, Battisti A, Cassoni A, Pagnoni M, Riccardi E, Sanzi M, Valentini V. Retrospective analysis of 301 patients with orbital floor fracture. J Craniomaxillofac Surg. 2015 Mar;43(2):244-7. doi: 10.1016/j.jcms.2014.11.015. Epub 2014 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'In patients suffered from floor fractures, there are 21.9% complaining about diplopia before fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4% had similar conditions. Investigators are planned to find predicting factors to prevent such conditions from happening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.\n\nExclusion Criteria:\n\n* Prior ocular surgeries\n* Multiple facial trauma or facial bone fractures'}, 'identificationModule': {'nctId': 'NCT02736461', 'briefTitle': 'Factors Associated With Postoperative Strabismus After Floor Fracture Repair', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Factors Associated With Postoperative Strabismus After Floor Fracture Repair', 'orgStudyIdInfo': {'id': '1-104-05-124'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1- With strabismus', 'description': 'Study group with strabismus happening after floor fracture repair', 'interventionNames': ['Procedure: Floor repair surgery']}, {'label': 'Group 2- Without strabismus', 'description': 'No strabismus happening after floor fracture repair', 'interventionNames': ['Procedure: Floor repair surgery']}], 'interventions': [{'name': 'Floor repair surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Group 1- With strabismus', 'Group 2- Without strabismus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist', 'investigatorFullName': 'Ke-Hung Chien', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}