Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-03 @ 12:39 AM
Study NCT ID:
NCT03344432
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Intraocular Pressure With Intracranial Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2017-11-12', 'studyFirstSubmitQcDate': '2017-11-12', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure smaller than 20 mmHg', 'timeFrame': 'Immediately', 'description': 'Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure equal or more than 20 mmHg', 'timeFrame': 'Immediately', 'description': 'Intraocular pressure equal or more than 20 mmHg with Intracranial pressure equal or more than 20 mmHg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intraocular Pressure', 'Intracranial Pressure Increase', 'Trauma, Brain', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).\n\nObjective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.', 'detailedDescription': "Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).\n\nObjective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.\n\nMaterial and methods. Correlation and diagnostic test design study. Inclusion criteria: children with TBIs admitted to the emergency room and indication of catheter for ICP measurement.\n\nExclusion criteria: injury or ophthalmic disease, glaucoma, encephalic death. Intraocular pressure was measured with electronic tonometer in both eyes prior to placement of the catheter for ICP measurement.\n\nCorrelation was estimated with Spearman's Rho. The utility values of the diagnostic test were obtained from an Receiver Operating Characteristic curve."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children of 2 at 15 years old with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points), in pediatric emergency room, with indication by the neurosurgeon to place a invasive catheter for intracranial pressure measurement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points),\n2. who have been admitted to the pediatric emergency room\n3. and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement.\n\nExclusion Criteria:\n\n1. Ocular trauma,\n2. brain death,\n3. know eye disease,\n4. refusal of parents or guardians to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03344432', 'acronym': 'IOPICPTBI', 'briefTitle': 'Correlation Intraocular Pressure With Intracranial Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury', 'orgStudyIdInfo': {'id': 'HCG/CI-0693/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With intraocular pressure high', 'description': 'Intracranial pressure equal or more than 20 mmHg', 'interventionNames': ['Diagnostic Test: with intraocular pressure high', 'Diagnostic Test: without intraocular pressure high']}, {'label': 'Without intraocular pressure high', 'description': 'Intracranial pressure smaller than 20 mmHg', 'interventionNames': ['Diagnostic Test: with intraocular pressure high', 'Diagnostic Test: without intraocular pressure high']}], 'interventions': [{'name': 'with intraocular pressure high', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.', 'armGroupLabels': ['With intraocular pressure high', 'Without intraocular pressure high']}, {'name': 'without intraocular pressure high', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.', 'armGroupLabels': ['With intraocular pressure high', 'Without intraocular pressure high']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Karla Isis Aviles-Martinez, PhD', 'role': 'CONTACT', 'email': 'draisispediatra@yahoo.com.mx', 'phone': '39424400'}, {'name': 'Juan Luis Soto-Mancilla, Master', 'role': 'CONTACT', 'phone': '39424400'}], 'facility': 'Hospital Civil Fray Antonio Alcalde', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'centralContacts': [{'name': 'Karla Isis I Aviles-Martinez, PhD', 'role': 'CONTACT', 'email': 'draisispediatra@yahoo.com.mx', 'phone': '39424400', 'phoneExt': '48052'}, {'name': 'Adriana López-Enríquez, MD', 'role': 'CONTACT', 'email': 'aleurg2@hotmail.com', 'phone': '39424400', 'phoneExt': '48051'}], 'overallOfficials': [{'name': 'Karla Isis I Aviles Martinez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Civil Fray Antonio Alcalde'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dra. Karla Isis Avilés-Martínez', 'investigatorFullName': 'KARLA ISIS AVILES MARTINEZ', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}