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Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

Primary Purpose

Pseudotumor Cerebri

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Optic ultrasonography
Lumbar puncture
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pseudotumor Cerebri focused on measuring Idiopathic intracranial hypertension, Optic nerve sheath diameter measurement, Increased intracranial pressure, Lumbar puncture

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara Numune Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

The patients with Idiopathic intracranial hypertension (IIH)

Control group

Arm 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.

In the control group, optic nerve sheath diameter was measured from both eyes by optic ultrasonography.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2020
Last Updated
October 22, 2020
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04603118
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudotumor Cerebri
Keywords
Idiopathic intracranial hypertension, Optic nerve sheath diameter measurement, Increased intracranial pressure, Lumbar puncture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The patients with Idiopathic intracranial hypertension (IIH)
Arm Type
Other
Arm 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.
Arm Title
Control group
Arm Type
Other
Arm Description
In the control group, optic nerve sheath diameter was measured from both eyes by optic ultrasonography.
Intervention Type
Procedure
Intervention Name(s)
Optic ultrasonography
Intervention Type
Procedure
Intervention Name(s)
Lumbar puncture
Primary Outcome Measure Information:
Title
Correlation between intracranial pressure change and optic nerve sheath diameter
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.
Time Frame
Baseline to 10-15 minutes after lumbar puncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oğuzhan Kurşun
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Numune Training and Research Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

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