Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05854420
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2023-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004774', 'term': 'Entropion'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'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': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '3 months post operative', 'description': 'The cases will be considered succeed if there is no recurrence of the entropion'}, {'measure': 'Success rate', 'timeFrame': '6 months post operative', 'description': 'The cases will be considered succeed if there is no recurrence of the entropion'}, {'measure': 'Success rate', 'timeFrame': '9 months post operative', 'description': 'The cases will be considered succeed if there is no recurrence of the entropion'}, {'measure': 'Success rate', 'timeFrame': '12 months post operative', 'description': 'The cases will be considered succeed if there is no recurrence of the entropion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Entropion']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.\n* Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included\n\nExclusion Criteria:\n\n* Patients with a follow-up period of fewer than 12 months.\n* Patients with very severe UCE and required posterior lamellar grafts.\n* Patients with etiology other than trachoma.\n* Patients with dysplastic lashes without entropion were excluded'}, 'identificationModule': {'nctId': 'NCT05854420', 'briefTitle': 'Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion', 'orgStudyIdInfo': {'id': 'Modified ALR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified anterior Lamellar Recession', 'description': 'All patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes.', 'interventionNames': ['Procedure: Modified anterior Lamellar Recession']}], 'interventions': [{'name': 'Modified anterior Lamellar Recession', 'type': 'PROCEDURE', 'description': 'ALR is one of the procedures used to treat cicatricial entropion and trichiasis. Few studies present the effect of modifications to this procedure in trachomatous entropion and trichiasis. Because trachoma is common in our country, there is a probability that the number of surgeries for TT will rise.', 'armGroupLabels': ['Modified anterior Lamellar 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'}}}}