Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

October 22, 2020 updated by: Zehra Bozdoğan Şenel, Ege University

Comparison of Optic Nerve Sheath Diameters Measured by Optic Ultrasonography Before and After Lumbar Puncture 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Ankara Numune Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: The patients with Idiopathic intracranial hypertension (IIH)
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.
Procedure: Lumbar puncture
Procedure: Optic ultrasonography
Other: Control group
In the control group, optic nerve sheath diameter was measured from both eyes by optic ultrasonography.
Procedure: Optic ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 10-15 minutes after lumbar puncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Oğuzhan Kurşun, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIA-SONSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

For a reasonable purpose, data can be given to appropriate people if desired.

IPD Sharing Time Frame

Data is available for one year after publication

IPD Sharing Access Criteria

The reason and purpose of the request is clearly explained and the appropriate persons can access it via e-mail.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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