Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-30 @ 9:16 AM
Study NCT ID:
NCT03712995
Status:
COMPLETED
Last Update Posted:
2018-12-10
First Post:
2018-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014180', 'term': 'Transplantation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Retrospective review of charts of the patients enrolled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptoms of the patients', 'timeFrame': '42 months', 'description': 'Number of symptoms referred by the patient, being 0 the best result'}], 'primaryOutcomes': [{'measure': 'Eyelid retraction', 'timeFrame': '42 months', 'description': 'Upper eyelid retraction in mm'}], 'secondaryOutcomes': [{'measure': 'Retraction of the donor lower eyelid', 'timeFrame': '42 months', 'description': 'Lower eyelid retraction in mm'}, {'measure': 'Lagophthalmos', 'timeFrame': '42 months', 'description': 'Excessive aperture of the eyelids, in mm'}, {'measure': 'Lid margin stability', 'timeFrame': '42 months', 'description': 'in mm'}, {'measure': 'Eyelid status', 'timeFrame': '42 months', 'description': 'Number of complications, being 0 the best result'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cutler-Beard', 'tarsoconjunctival graft', 'upper eyelid'], 'conditions': ['Reconstructive Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid', 'detailedDescription': 'A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.\n\nFunctional, cosmetic outcomes and postoperative complications were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upper eyelid defect after tumor resection\n\nExclusion Criteria:\n\n* previous surgery'}, 'identificationModule': {'nctId': 'NCT03712995', 'briefTitle': 'Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft', 'orgStudyIdInfo': {'id': 'RUE-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cutler-Beard modified with graft', 'description': 'Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf', 'interventionNames': ["Procedure: 'Cutler-Beard modified with graft'"]}], 'interventions': [{'name': "'Cutler-Beard modified with graft'", 'type': 'PROCEDURE', 'otherNames': ['Modified Cutler-Beard technique with tarsoconjunctival graft'], 'description': 'A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.', 'armGroupLabels': ['Cutler-Beard modified with graft']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Enrique Mencía-Gutiérrez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Publication of the results in a journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}