Clinical trial NCT04603118: Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients
Official title: Comparison of Optic Nerve Sheath Diameters Measured by Optic Ultrasonography Before and After Lumbar Puncture in Idiopathic Intracranial Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pseudotumor Cerebri
Keywords: Idiopathic intracranial hypertension
Optic nerve sheath diameter measurement
Increased intracranial pressure
Lumbar puncture
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 47
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who applied to the neurology clinics 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 cerebrospinal fluid pressure was measured. In the control group, ONSD was measured with optic USG.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Methods: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic intracranial hypertension
* Adults aged 17-65

Exclusion Criteria:

* In cranial imaging, if pathology such as tumor, sinus vein thrombosis is detected
* People for whom lumbar puncture is contraindicated or cannot be performed

Primary outcomes:
measure: Correlation between intracranial pressure change and optic nerve sheath diameter
timeFrame: Baseline to 10-15 minutes after lumbar puncture
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Numune Training and Research Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Oğuzhan Kurşun
role: PRINCIPAL_INVESTIGATOR
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