Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
Study NCT ID:
NCT05895695
Status:
UNKNOWN
Last Update Posted:
2023-06-08
First Post:
2023-05-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-03', 'releaseDate': '2024-10-16'}], 'estimatedResultsFirstSubmitDate': '2024-10-16'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis', 'timeFrame': '6 months', 'description': 'Comparison of surgical efficacy of levator muscle resection and plication regarding lid height as measured by MRD 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Ptosis']}, 'referencesModule': {'references': [{'pmid': '24657037', 'type': 'BACKGROUND', 'citation': 'SooHoo JR, Davies BW, Allard FD, Durairaj VD. Congenital ptosis. Surv Ophthalmol. 2014 Sep-Oct;59(5):483-92. doi: 10.1016/j.survophthal.2014.01.005. Epub 2014 Feb 5.'}, {'pmid': '26468822', 'type': 'BACKGROUND', 'citation': 'Nemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304.'}, {'pmid': '23869256', 'type': 'BACKGROUND', 'citation': 'Hwang K. Surgical anatomy of the upper eyelid relating to upper blepharoplasty or blepharoptosis surgery. Anat Cell Biol. 2013 Jun;46(2):93-100. doi: 10.5115/acb.2013.46.2.93. Epub 2013 Jun 30.'}, {'pmid': '12142765', 'type': 'BACKGROUND', 'citation': 'Baldwin HC, Manners RM. Congenital blepharoptosis: a literature review of the histology of levator palpebrae superioris muscle. Ophthalmic Plast Reconstr Surg. 2002 Jul;18(4):301-7. doi: 10.1097/01.IOP.0000021973.72318.07.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.', 'detailedDescription': 'Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.\n\nIt can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* mild to moderate simple unilateral congenital ptosis with good to fair levator function\n\nExclusion Criteria:\n\n1. severe ptosis\n2. poor levator function\n3. poor Bell's phenomenon\n4. lagophthalmos\n5. diminished corneal sensation\n6. completed congenital or acquired ptosis\n7. history of previous lid surgery"}, 'identificationModule': {'nctId': 'NCT05895695', 'briefTitle': 'Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Levator Muscle Resection for Unilateral Congenital Ptosis Repair as Compared to Levator Plication', 'orgStudyIdInfo': {'id': 'Soh-Med-23-03-01MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'evaluation of levator muscle resection on congenital ptosis', 'interventionNames': ['Procedure: levator muscle resection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'evaluation of levator muscle plication on congenital ptosis', 'interventionNames': ['Procedure: levator muscle plication']}], 'interventions': [{'name': 'levator muscle resection', 'type': 'PROCEDURE', 'description': 'resection of levator muscle in congenital unilateral ptosis', 'armGroupLabels': ['1']}, {'name': 'levator muscle plication', 'type': 'PROCEDURE', 'description': 'plication of levator muscle in congenital unilateral ptosis', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'magdy m amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Maggi h Shaker, MBBCH', 'role': 'CONTACT', 'email': 'magi_shaker@med.Sohag.edu.eg', 'phone': '01286773334'}, {'name': 'Islam a Aboellil, lecturer', 'role': 'CONTACT', 'email': 'dr.islamophth@yahoo.com', 'phone': '01006429637'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident ophthalmology department el helal hospital', 'investigatorFullName': 'Maggi Hosam Wasily', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-16', 'type': 'RELEASE'}, {'date': '2024-12-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maggi Hosam Wasily, resident ophthalmology department el helal hospital, Sohag University'}}}}