Viewing Study NCT05538260


Ignite Creation Date: 2025-12-25 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 4:05 AM
Study NCT ID: NCT05538260
Status: UNKNOWN
Last Update Posted: 2022-09-13
First Post: 2022-09-08
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Pediatric Ocular Trauma in Minia Governate
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 103}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiology of trauma', 'timeFrame': '2 years', 'description': 'incidence of trauma'}, {'measure': 'Visual outcome', 'timeFrame': '6 months', 'description': 'Visual acuity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Ocular Trauma']}, 'descriptionModule': {'briefSummary': 'The most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. The epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and creative activities and type of registration and recording of data. About half a million people in the world are blind as a result of eye injuries. About 30-40% of monocular blindness is due to ocular trauma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age below 16 years\n\nExclusion Criteria:\n\n* Age above 16 years Previous ocular surgery'}, 'identificationModule': {'nctId': 'NCT05538260', 'briefTitle': 'Pediatric Ocular Trauma in Minia Governate', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Epidemiology and Visual Outcome of Pediatric Ocular Trauma', 'orgStudyIdInfo': {'id': 'MiniaU PED'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Repair of ocular trauma in children below 16 years old', 'type': 'PROCEDURE', 'description': 'Diagnosis and repair of pediatric ocular trauma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'state': 'Minya Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hosny A Zein', 'role': 'CONTACT', 'email': 'hosnyzein@yahoo.com', 'phone': '01014145780'}], 'facility': 'Minia University Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Hosny A Zein, MD', 'role': 'CONTACT', 'email': 'hosnyzein@yahoo.com', 'phone': '01014145780', 'phoneExt': '02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'Hosny Ahmed Zein', 'investigatorAffiliation': 'Minia University'}}}}