Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04603118
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2020-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients
Sponsor:
Organization:
Raw JSON
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The control group consisted of 22 individuals who applied with other complaints than headaches. ONSD was measured from both eyes before and after the LP. After pre-LP measurements were taken, opening and closing cerebrospinal fluid pressure was measured. In the control group, ONSD was measured with optic USG.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2020-10-03', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between intracranial pressure change and optic nerve sheath diameter', 'timeFrame': 'Baseline to 10-15 minutes after lumbar puncture', 'description': 'Before and after lumbar puncture, optic nerve sheath diameter measured with optic ultrasonography. The correlation of these measurements with cerebrospinal fluid opening and closing pressures was investigated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic intracranial hypertension', 'Optic nerve sheath diameter measurement', 'Increased intracranial pressure', 'Lumbar puncture'], 'conditions': ['Pseudotumor Cerebri']}, 'referencesModule': {'references': [{'pmid': '9534686', 'type': 'BACKGROUND', 'citation': 'Soler D, Cox T, Bullock P, Calver DM, Robinson RO. Diagnosis and management of benign intracranial hypertension. Arch Dis Child. 1998 Jan;78(1):89-94. doi: 10.1136/adc.78.1.89. No abstract available.'}, {'pmid': '3364156', 'type': 'BACKGROUND', 'citation': 'Sorensen PS, Krogsaa B, Gjerris F. Clinical course and prognosis of pseudotumor cerebri. A prospective study of 24 patients. Acta Neurol Scand. 1988 Feb;77(2):164-72. doi: 10.1111/j.1600-0404.1988.tb05888.x.'}, {'pmid': '1998880', 'type': 'BACKGROUND', 'citation': 'Wall M, George D. Idiopathic intracranial hypertension. A prospective study of 50 patients. Brain. 1991 Feb;114 ( Pt 1A):155-80.'}, {'pmid': '1992368', 'type': 'BACKGROUND', 'citation': 'Giuseffi V, Wall M, Siegel PZ, Rojas PB. Symptoms and disease associations in idiopathic intracranial hypertension (pseudotumor cerebri): a case-control study. Neurology. 1991 Feb;41(2 ( Pt 1)):239-44. doi: 10.1212/wnl.41.2_part_1.239.'}, {'pmid': '3395261', 'type': 'BACKGROUND', 'citation': 'Durcan FJ, Corbett JJ, Wall M. The incidence of pseudotumor cerebri. Population studies in Iowa and Louisiana. Arch Neurol. 1988 Aug;45(8):875-7. doi: 10.1001/archneur.1988.00520320065016.'}, {'pmid': '19930211', 'type': 'BACKGROUND', 'citation': 'Dhungana S, Sharrack B, Woodroofe N. Idiopathic intracranial hypertension. Acta Neurol Scand. 2010 Feb;121(2):71-82. doi: 10.1111/j.1600-0404.2009.01172.x. Epub 2009 Nov 23.'}, {'pmid': '8309269', 'type': 'BACKGROUND', 'citation': 'Radhakrishnan K, Ahlskog JE, Garrity JA, Kurland LT. Idiopathic intracranial hypertension. Mayo Clin Proc. 1994 Feb;69(2):169-80. doi: 10.1016/s0025-6196(12)61045-3.'}, {'pmid': '21680652', 'type': 'BACKGROUND', 'citation': 'Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16.'}, {'pmid': '19037972', 'type': 'BACKGROUND', 'citation': 'Brazis PW. Clinical review: the surgical treatment of idiopathic pseudotumour cerebri (idiopathic intracranial hypertension). Cephalalgia. 2008 Dec;28(12):1361-73. doi: 10.1111/j.1468-2982.2008.01778.x.'}, {'pmid': '10980304', 'type': 'BACKGROUND', 'citation': 'Levine DN. Ventricular size in pseudotumor cerebri and the theory of impaired CSF absorption. J Neurol Sci. 2000 Aug 15;177(2):85-94. doi: 10.1016/s0022-510x(00)00348-8.'}, {'pmid': '18923135', 'type': 'BACKGROUND', 'citation': 'Bruce BB, Kedar S, Van Stavern GP, Monaghan D, Acierno MD, Braswell RA, Preechawat P, Corbett JJ, Newman NJ, Biousse V. Idiopathic intracranial hypertension in men. Neurology. 2009 Jan 27;72(4):304-9. doi: 10.1212/01.wnl.0000333254.84120.f5. Epub 2008 Oct 15.'}, {'pmid': '20818852', 'type': 'BACKGROUND', 'citation': 'Avery RA, Shah SS, Licht DJ, Seiden JA, Huh JW, Boswinkel J, Ruppe MD, Chew A, Mistry RD, Liu GT. Reference range for cerebrospinal fluid opening pressure in children. N Engl J Med. 2010 Aug 26;363(9):891-3. doi: 10.1056/NEJMc1004957. No abstract available.'}, {'pmid': '26453995', 'type': 'BACKGROUND', 'citation': 'Hayreh SS. Pathogenesis of optic disc edema in raised intracranial pressure. Prog Retin Eye Res. 2016 Jan;50:108-44. doi: 10.1016/j.preteyeres.2015.10.001.'}, {'pmid': '71138', 'type': 'BACKGROUND', 'citation': 'Hayreh SS. Optic disc edema in raised intracranial pressure. V. Pathogenesis. Arch Ophthalmol. 1977 Sep;95(9):1553-65. doi: 10.1001/archopht.1977.04450090075006.'}, {'pmid': '11158909', 'type': 'BACKGROUND', 'citation': 'Suzuki H, Takanashi J, Kobayashi K, Nagasawa K, Tashima K, Kohno Y. MR imaging of idiopathic intracranial hypertension. AJNR Am J Neuroradiol. 2001 Jan;22(1):196-9.'}, {'pmid': '9754178', 'type': 'BACKGROUND', 'citation': 'Brodsky MC, Vaphiades M. Magnetic resonance imaging in pseudotumor cerebri. Ophthalmology. 1998 Sep;105(9):1686-93. doi: 10.1016/S0161-6420(98)99039-X.'}, {'pmid': '17384377', 'type': 'RESULT', 'citation': 'Girisgin AS, Kalkan E, Kocak S, Cander B, Gul M, Semiz M. The role of optic nerve ultrasonography in the diagnosis of elevated intracranial pressure. Emerg Med J. 2007 Apr;24(4):251-4. doi: 10.1136/emj.2006.040931.'}, {'pmid': '19167786', 'type': 'RESULT', 'citation': 'Le A, Hoehn ME, Smith ME, Spentzas T, Schlappy D, Pershad J. Bedside sonographic measurement of optic nerve sheath diameter as a predictor of increased intracranial pressure in children. Ann Emerg Med. 2009 Jun;53(6):785-91. doi: 10.1016/j.annemergmed.2008.11.025. Epub 2009 Jan 23.'}, {'pmid': '18495051', 'type': 'RESULT', 'citation': 'Geeraerts T, Duranteau J, Benhamou D. Ocular sonography in patients with raised intracranial pressure: the papilloedema revisited. Crit Care. 2008;12(3):150. doi: 10.1186/cc6893. Epub 2008 May 16.'}, {'pmid': '18477382', 'type': 'RESULT', 'citation': 'Soldatos T, Karakitsos D, Chatzimichail K, Papathanasiou M, Gouliamos A, Karabinis A. Optic nerve sonography in the diagnostic evaluation of adult brain injury. Crit Care. 2008;12(3):R67. doi: 10.1186/cc6897. Epub 2008 May 13.'}, {'pmid': '16997419', 'type': 'RESULT', 'citation': 'Tayal VS, Neulander M, Norton HJ, Foster T, Saunders T, Blaivas M. Emergency department sonographic measurement of optic nerve sheath diameter to detect findings of increased intracranial pressure in adult head injury patients. Ann Emerg Med. 2007 Apr;49(4):508-14. doi: 10.1016/j.annemergmed.2006.06.040. Epub 2006 Sep 25.'}, {'pmid': '12670853', 'type': 'RESULT', 'citation': 'Blaivas M, Theodoro D, Sierzenski PR. Elevated intracranial pressure detected by bedside emergency ultrasonography of the optic nerve sheath. Acad Emerg Med. 2003 Apr;10(4):376-81. doi: 10.1111/j.1553-2712.2003.tb01352.x.'}, {'pmid': '21769456', 'type': 'RESULT', 'citation': 'Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.'}, {'pmid': '18275454', 'type': 'RESULT', 'citation': 'Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.'}, {'pmid': '22258019', 'type': 'RESULT', 'citation': 'Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.'}, {'pmid': '22944553', 'type': 'RESULT', 'citation': 'Amini A, Kariman H, Arhami Dolatabadi A, Hatamabadi HR, Derakhshanfar H, Mansouri B, Safari S, Eqtesadi R. Use of the sonographic diameter of optic nerve sheath to estimate intracranial pressure. Am J Emerg Med. 2013 Jan;31(1):236-9. doi: 10.1016/j.ajem.2012.06.025. Epub 2012 Aug 31.'}, {'pmid': '21523461', 'type': 'RESULT', 'citation': 'Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.'}, {'pmid': '21505900', 'type': 'RESULT', 'citation': 'Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.'}, {'pmid': '22204998', 'type': 'RESULT', 'citation': 'Roque PJ, Wu TS, Barth L, Drachman D, Khor KN, Lovecchio F, Stapczynski S. Optic nerve ultrasound for the detection of elevated intracranial pressure in the hypertensive patient. Am J Emerg Med. 2012 Oct;30(8):1357-63. doi: 10.1016/j.ajem.2011.09.025. Epub 2011 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'Idiopathic intracranial hypertensionis a type of increased intracranial pressure. Diagnosis is made by lumbar puncture, which is an invasive technique. The relationship between ICP and optic nerve sheath diameters (ONSD) were examined in our study. Thus, it was investigated whether the optic nerve sheath diameter could be used in the diagnosis of IIH. In the present study, it was found that ONSD measurement by optic USG significantly reflects increased ICP and decreasing pressure via LP is rapidly reflects to ONSD measurement. And it is suggested that ONSD measurements by optic USG, a non-invasive method, can be used in the diagnosis and follow-up of IIH patients.', 'detailedDescription': 'Backgrounds: Idiopathic intracranial hypertension (IIH); symptoms include headaches, blurred vision and papilledema which may lead to permanent visual loss. Definitive diagnosis of IIH usually requires the measurement of intracranial pressure (ICP) via lumbar puncture (LP) which is an invasive technique. In our study, the relationship between ICP and optic nerve sheath diameters (ONSD) were examined. Thus it was investigated whether optic nerve ultrasonography (USG) is a useful tool instead of LP for the diagnosis of IIH.\n\nMethods: A total of 25 patients who applied to the neurology clinics of Ankara Numune Training and Research Hospital between May 2014 and December 2015 and were diagnosed with IIH were included in the study. The control group consisted of 22 individuals who applied with other complaints than headaches. ONSD was measured from both eyes before and after the LP. After pre-LP measurements were taken, opening and closing CSF (cerebrospinal fluid) pressure was measured. In the control group, ONSD was measured with optic USG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of idiopathic intracranial hypertension\n* Adults aged 17-65\n\nExclusion Criteria:\n\n* In cranial imaging, if pathology such as tumor, sinus vein thrombosis is detected\n* People for whom lumbar puncture is contraindicated or cannot be performed'}, 'identificationModule': {'nctId': 'NCT04603118', 'briefTitle': 'Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Comparison of Optic Nerve Sheath Diameters Measured by Optic Ultrasonography Before and After Lumbar Puncture in Idiopathic Intracranial Hypertension Patients', 'orgStudyIdInfo': {'id': 'DIA-SONSD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'The patients with Idiopathic intracranial hypertension (IIH)', 'description': '33 patients who applied to the neurology clinic with the pre-diagnosis of IIH were performed lumbar puncture. 25 of them diagnosed with IIH. Optic nerve sheath diameter was measured by optic ultrasonography from both eyes before and after the LP.', 'interventionNames': ['Procedure: Optic ultrasonography', 'Procedure: Lumbar puncture']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'In the control group, optic nerve sheath diameter was measured from both eyes by optic ultrasonography.', 'interventionNames': ['Procedure: Optic ultrasonography']}], 'interventions': [{'name': 'Optic ultrasonography', 'type': 'PROCEDURE', 'armGroupLabels': ['Control group', 'The patients with Idiopathic intracranial hypertension (IIH)']}, {'name': 'Lumbar puncture', 'type': 'PROCEDURE', 'armGroupLabels': ['The patients with Idiopathic intracranial hypertension (IIH)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Numune Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Oğuzhan Kurşun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data is available for one year after publication', 'ipdSharing': 'YES', 'description': 'For a reasonable purpose, data can be given to appropriate people if desired.', 'accessCriteria': 'The reason and purpose of the request is clearly explained and the appropriate persons can access it via e-mail.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'Zehra Bozdoğan Şenel', 'investigatorAffiliation': 'Ege University'}}}}