Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-05 @ 4:33 AM
Study NCT ID:
NCT03178760
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2017-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010211', 'term': 'Papilledema'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2017-06-04', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of optic nerve sheath diameter', 'timeFrame': '1-3 minute', 'description': 'mm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optic nerve sheath diameter', 'average optic nerve sheath diameter for healthy children'], 'conditions': ['Optic Papilla Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.', 'detailedDescription': 'The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .\n\n1. Age\n2. Gender\n3. Length (cm)\n4. Weight (kg)\n5. Waist Circumference (cm)\n6. Body Mass Index'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients without cerebral edema applied the emergency care unit.', 'genderDescription': 'Measurements will be classified with gender.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Children without cerebral edema.\n\nExclusion Criteria:\n\n• Children with cerebral edema.'}, 'identificationModule': {'nctId': 'NCT03178760', 'briefTitle': 'Determination of Normal Measures of Optic Nerve Sheath Diameter in Children', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Determination of Normal Measures of Optic Nerve Sheath Diameter in Children', 'orgStudyIdInfo': {'id': 'AU-70904504/393-19.06.2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for;\n\n1. Age\n2. Gender\n3. Weight\n4. Length\n5. Waist Circumference\n6. Body mass index'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'Ozlem Tolu Kendir', 'investigatorAffiliation': 'Cukurova University'}}}}