Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

Pseudotumor Cerebri Clinical Trial

Official title:

Comparison of Optic Nerve Sheath Diameters Measured by Optic Ultrasonography Before and After Lumbar Puncture in Idiopathic Intracranial Hypertension Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603118
• Other study ID #: DIA-SONSD
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: April 1, 2016

Study information

• Verified date: October 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 1, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

Procedure:
• Optic ultrasonography

• Lumbar puncture

Locations

Country	Name	City	State
Turkey	Ankara Numune Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between intracranial pressure change and optic nerve sheath diameter	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.	Baseline to 10-15 minutes after lumbar puncture