Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT05827393
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2023-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Transplantation in Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia', 'timeFrame': 'one day', 'description': 'the change of angle of strabismus will be assessed pre and post muscle transplantation procedure , the angle of strabismus will be measured pre operative and postoperative after one day using hirschburg test measured by degree'}], 'secondaryOutcomes': [{'measure': 'assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia', 'timeFrame': 'six months', 'description': 'the stability of angle of strabismus will be assessed post muscle transplantation procedure , the angle of strabismus will be measured after six month post operative using hirschburg test measured by degree'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Strabismus, Noncomitant']}, 'descriptionModule': {'briefSummary': 'All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with esotropia or exotropia of more than 60 prism dioptre\n\nExclusion Criteria:\n\n* Muscular paralysis.\n* High myopia. .Dissociated vertical divergence. .Accommodative esotropias.\n* Large vertical deviations associated Alphabetic syndromes\n* previous surgeries in either eye'}, 'identificationModule': {'nctId': 'NCT05827393', 'briefTitle': 'Muscle Transplantation in Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Muscle Transplantation for Large Angle Horizontal Strabismus: Esotropia Versus Exotropia', 'orgStudyIdInfo': {'id': '155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': '15 patients with large angle esotropia', 'interventionNames': ['Procedure: muscle transplantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': '15 patients with large angle exotropia', 'interventionNames': ['Procedure: muscle transplantation']}], 'interventions': [{'name': 'muscle transplantation', 'type': 'PROCEDURE', 'description': 'the resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'country': 'Egypt', 'facility': 'Qena University Hospital', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer ophthalmology', 'investigatorFullName': 'doaa abody ahmed', 'investigatorAffiliation': 'South Valley University'}}}}