Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT04537169
Status:
UNKNOWN
Last Update Posted:
2020-09-03
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Significance of Whitnall Ligament Structure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of levator resection in relation to structure of Whitnall ligament', 'timeFrame': 'An average of 1 year', 'description': 'Relating the structure of the ligament with the degree of severity of ptosis by studying its position, shape and tightness in all cases during surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Whitnall ligament', 'congenital ptosis', 'levator resection'], 'conditions': ['Congenital Ptosis']}, 'descriptionModule': {'briefSummary': 'Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.', 'detailedDescription': "The study will be a prospective obsevational study. It will include patients (2-16 years old) who will undergo levator resection for simple congenital ptosis correction in Ophthalmology Department of Menoufia University Hospital.\n\nPatients will be divided into 3 groups, 15 patients in each. Group I for mild ptosis, Group II for moderate ptosis Group 3 for severe ptosis.\n\nExclusion criteria included any patients with previous ptosis or any eyelid surgery and patients with a non congenital ptosis.\n\nPatients included in the study well be informed about the research and the surgical maneuver which will be used with full discussion of all details regarding the postoperative follow up and the potential complications. A written consent in Arabic will then be taken from the parents of the patients\n\nPreoperative assessment will include Complete ophthalmological examination including; Margin to Reflex Distance 1 (MRD1), Vertical Fissure Height (VFH), Levator function (LF), and eyelid crease shape and position.\n\nIntraoperative assessment will include Whitnall ligament structure assessment including:\n\n* The level (the length from the insertion of the levator aponeurosis to Whitnall's ligament)\n* Shape (definite band-like, weak string, undifferentiated)\n* Tightness.\n\nPostoperative assessment will be on scheduled visits at first week, one month, 3 months and 6 months postoperatively and will include MRD1, VFH, LF, and lagophthalmos measurements\n\nResults will be documented and tabulated and statistically managed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with congenital ptosis', 'genderDescription': 'Caucasian', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Congenital ptosis\n\nExclusion Criteria:\n\n* Previous ptosis surgery\n* Non congenital ptosis'}, 'identificationModule': {'nctId': 'NCT04537169', 'briefTitle': 'Clinical Significance of Whitnall Ligament Structure', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis', 'orgStudyIdInfo': {'id': 'OPHTH2/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild congenital ptosis', 'description': 'children with mild congenital ptosis', 'interventionNames': ['Procedure: Levator resection']}, {'label': 'Moderate congenital ptosis', 'description': 'children with moderate congenital ptosis', 'interventionNames': ['Procedure: Levator resection']}, {'label': 'Severe congenital ptosis', 'description': 'children with severe congenital ptosis', 'interventionNames': ['Procedure: Levator resection']}], 'interventions': [{'name': 'Levator resection', 'type': 'PROCEDURE', 'description': 'Eyelid crease incision Dissection of the levator aponeurosis to the level of Whitnall ligament. Assessment of the structure of Whitnal ligament. Resection of a calculated part of the aponsurosis. re-attachment of the aponeurosis to the tarsus Incision closure with crease formation', 'armGroupLabels': ['Mild congenital ptosis', 'Moderate congenital ptosis', 'Severe congenital ptosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hoda M El Sobky, PhD', 'role': 'CONTACT', 'email': 'elsobky.hoda@yahoo.com', 'phone': '01210804240', 'phoneExt': '0020'}], 'facility': 'Ophthalmology Department, Menoufia University Hospital', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Sameh S Mandour, M.D.', 'role': 'CONTACT', 'email': 'dr_ssmandour@hotmail.com', 'phone': '01113139138', 'phoneExt': '0020'}, {'name': 'Mostafa M Diab, M.D.', 'role': 'CONTACT', 'email': 'mmd11@fayoum.edu.eg', 'phone': '01016737314', 'phoneExt': '0020'}], 'overallOfficials': [{'name': 'Richard C Allen', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Ophthalmology, Cullen Eye Institute,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Sameh S. Mandour', 'investigatorAffiliation': 'Menoufia University'}}}}