Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT06762093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2025-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management and Outcomes of Traumatic Eyelid Injuries in Assiut University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014945', 'term': 'Wound Healing'}], 'ancestors': [{'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2025-01-01', 'studyFirstSubmitQcDate': '2025-01-01', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of traumatic eyelid injuries', 'timeFrame': '2 year', 'description': 'To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Eyelid Injuries']}, 'descriptionModule': {'briefSummary': 'this study aim To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.\n\nTo describe the clinical characteristics of traumatic eyelid injuries, including the etiology, location, and extent of injury.\n\nTo evaluate the management approaches utilized for traumatic eyelid injuries, including surgical repair, medical therapy, and other treatments.\n\nTo assess the outcomes of traumatic eyelid injuries, including functional outcomes, cosmetic results, and complication rates', 'detailedDescription': "Vision is the most cared-for function of the human body, and the eyelids are provided to cover the eye for protection. Eyelids are not only protective curtains in front of the eyes but also contribute to the shape and beauty of the face. They are complex structures designed to protect the globe from various external trauma . Eyelids help to keep the corneas moist, protect against injury and excessive light, and regulate the amount of light reaching the retina. They are essential for the distribution and drainage of tears .\n\nTraumatic eyelid injuries are a common occurrence and can range in severity from minor lacerations to more complex injuries involving the eyelid structures. These injuries can significantly impact a patient's visual function and cosmetic appearance. Understanding the epidemiology, clinical presentation, management approaches, and outcomes of traumatic eyelid injuries is important for optimizing patient care.\n\nEyelid injuries are an important subtype of facial trauma, which necessitates the ophthalmologist being competent and fully informed . Lacerated wounds of the eyelids are common features of ocular trauma and often occur in isolation without any associated intraocular injuries . Eyelid lacerations can be treated using different techniques depending on their depth, width, injury mechanism, and accompanying injuries. They can be repaired with primary closure, skin flap, or skin graft. Small defects limited to the skin of the eyelids can be repaired by direct closure .\n\nEyelid trauma may often appear trivial but can have profound effects on injury-associated morbidity. Recovery of full eyelid function and maintenance of the lacrimal apparatus are important considerations when approaching lid trauma \\[. Proper information and education can help individuals to avoid eye injuries and their substantial burden ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments\n\nExclusion Criteria:\n\n* Patients presented with eyelid injuries who are:\n* Presented late\n* Presented after a previous intervention\n* Known to have co-existing eyelid pathology (as tumors, infections, congenital abnormalities)\n* Patients with incomplete medical records or loss to follow-up'}, 'identificationModule': {'nctId': 'NCT06762093', 'briefTitle': 'Management and Outcomes of Traumatic Eyelid Injuries in Assiut University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Management and Outcomes of Traumatic Eyelid Injuries in Assiut University Hospital', 'orgStudyIdInfo': {'id': 'Traumatic Eyelid Injuries MO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'traumatic eyelid injuries', 'description': '* Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments.\n* Traumatic eyelid injuries can include, but are not limited to:\n\n * Contusions\n * Lacerations\n * Avulsions\n * Eyelid margin defects\n * Eyelid margin involvement\n * Eyelid crease disruption\n * Eyelid tissue loss', 'interventionNames': ['Procedure: surgical repaire']}], 'interventions': [{'name': 'surgical repaire', 'type': 'PROCEDURE', 'otherNames': ['Surgical Repair'], 'description': '* Primary closure of lacerations\n* Eyelid margin repair\n* Eyelid crease reconstruction\n* Eyelid transposition flaps or grafts\n* Tarsorrhaphy', 'armGroupLabels': ['traumatic eyelid injuries']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mahmoud Ismail Moussa, residant doctor', 'role': 'CONTACT', 'email': 'Mahmoud.16285235@med.aun.edu.eg', 'phone': '+201009847524'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Residant doctor at Assiut university hospital', 'investigatorFullName': 'Mahmoud Ismail Moussa Abdellateef', 'investigatorAffiliation': 'Assiut University'}}}}