Determination of Normal Measures of Optic Nerve Sheath Di... | NCT03178760

Studies
Determination of Normal Measures of Optic Nerve Sheath Diameter in Children

NCT03178760

Sponsor

Cukurova University

Status

Completed

Last Update Posted

Feb 13, 2025Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Optic Papilla Edema

Interventions

Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2020Actual

Primary Completion Date

Jul 15, 2024Actual

Completion Date

Nov 15, 2024Actual

First Submitted Date

Jun 4, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .

Age
Gender
Length (cm)
Weight (kg)
Waist Circumference (cm)
Body Mass Index

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.	Diagnostic Test	Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for; Age Gender Weight Length Waist Circumference Body mass index

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of optic nerve sheath diameter	mm	1-3 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Children without cerebral edema.

Exclusion Criteria:

• Children with cerebral edema.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Measurements will be classified with gender.

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

all patients without cerebral edema applied the emergency care unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akdeniz University		Antalya			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010211	Papilledema

Ancestor Terms

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided