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OpenTrials
Completed

NCT Number: NCT04603118

Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

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.

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Key information

Conditions

Pseudotumor Cerebri Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Numune Training and Research Hospital

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optic ultrasonography

Procedure

Lumbar Puncture

Procedure

Primary outcomes

  1. Correlation between intracranial pressure change and optic nerve sheath diameter

    Time frame: Baseline to 10-15 minutes after lumbar puncture

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2020
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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