Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02665858
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2016-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-24', 'studyFirstSubmitDate': '2016-01-24', 'studyFirstSubmitQcDate': '2016-01-24', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of RNFLT/TRT Thickness', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pediatric Idiopathic Intracranial Hypertension']}, 'descriptionModule': {'briefSummary': 'Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH.\n\nIn this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with suspected IIH\n\nExclusion Criteria:\n\n* Retinal disease\n* High refractive error\n* Unable to undergo OCT imaging'}, 'identificationModule': {'nctId': 'NCT02665858', 'briefTitle': 'OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0035-15-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IIH Patients', 'description': 'Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging', 'interventionNames': ['Other: OCT Imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging', 'interventionNames': ['Other: OCT Imaging']}], 'interventions': [{'name': 'OCT Imaging', 'type': 'OTHER', 'armGroupLabels': ['Control Group', 'IIH Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Yuval Cohen, MD, PhD', 'role': 'CONTACT', 'email': 'dr.yuvalcohen@gmail.com'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Yuval Cohen, MD, PhD', 'role': 'CONTACT', 'email': 'dr.yuvalcohen@gmail.com', 'phone': '972-586904951'}], 'overallOfficials': [{'name': 'Yuval Cohen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}