Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05671120
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2023-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcutaneous Levator Recession for Non-thyroid Lid Retraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-01', 'studyFirstSubmitDate': '2023-01-01', 'studyFirstSubmitQcDate': '2023-01-01', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Margin reflex distance (MRD1)', 'timeFrame': 'Baseline', 'description': 'MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position'}, {'measure': 'Margin reflex distance (MRD1)', 'timeFrame': 'at one month post operative', 'description': 'MRD1 is a commonly used parameter in the assessment of patients with blepharoptosis and is defined as the distance between the upper lid margin and the corneal reflex when the eye is in the primary position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Diseases']}, 'descriptionModule': {'briefSummary': 'This work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease\n\nExclusion Criteria:\n\n* Patients refused to participate in the study, patients with systemic diseases causing lid retraction (such as Guillain-Barré syndrome), pseudo retractions, contralateral ptosis, local skin condition (as scar adherence), medication (such as sympathomimetic drugs, lithium, and steroid), neurological conditions (such as dorsal midbrain syndrome and hydrocephalus) and thyroid related lid retraction'}, 'identificationModule': {'nctId': 'NCT05671120', 'briefTitle': 'Transcutaneous Levator Recession for Non-thyroid Lid Retraction', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Transcutaneous Levator Recession for Non-thyroid Lid Retraction', 'orgStudyIdInfo': {'id': 'levator recession'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Transcutaneous levator recession', 'interventionNames': ['Procedure: Transcutaneous levator recession']}], 'interventions': [{'name': 'Transcutaneous levator recession', 'type': 'PROCEDURE', 'description': 'recession of the upper and lower eyelid retractors can improve the upper eyelid contour if the patient has lateral flare (common in TED). The choice of procedure depends on severity of lid retraction and associated features like proptosis, status of extraocular muscles, and corneal condition', 'armGroupLabels': ['Transcutaneous levator recession']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34517', 'city': 'Damietta', 'state': 'New Damietta', 'country': 'Egypt', 'facility': 'Ehab tharwat', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ehab tharwat', 'investigatorAffiliation': 'Al-Azhar University'}}}}