Measurement of the Optic Nerve Sheath Diameter

NCT ID: NCT05548335

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-31

Brief Summary

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This study is a prospective assessment of the accuracy of ocular ultrasound as a tool to measure the diameter of the optic nerve sheath and the eyeball transverse diameter in healthy adult patients presenting to the Emergency Department and have confirmatory imaging of the optic nerve as part of their clinical care.

Detailed Description

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This will be a prospective evaluation of accuracy of microconvex and linear transducers for ultrasound measurements of the ONSD and the ETD. Study population will be adult patients that present to Cleveland Clinic Akron General Emergency Department between July 1, 2022 and July 31 April 1, 2023. Patients will be identified on the Emergency Medicine Department tracking board. Patients, once identified as meeting inclusion criteria will be asked to participate in this study and full written consent will be required. All participants will have identical procedures and there will be no groups.

Conditions

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Optic Nerve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

There are no groups. All subjects will have the same inclusion criteria and will have the same intervention.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking. All subjects have same intervention.

Study Groups

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Ocular Ultrasound

This arm includes all patients enrolled who will have an ocular ultrasound with two different probes for a total of four ultrasounds.

Group Type OTHER

Ocular Ultrasound

Intervention Type PROCEDURE

1\. Patients presenting to the emergency department and have a normal head and/or ocular computed tomography scan will be considered for inclusion in this study. Study staff will discuss the study with the patient and obtain consent. At that point, operator will perform ocular ultrasound. Procedure will start with either the linear or microconvex probe. A single-use sterile gel packet will be used to apply gel to one closed eyelid. The probe will be placed with minimal pressure on the eye. A transverse measurement of the ONSD will be taken. In this same view the maximal transverse diameter of the eyeball will also be measured. Images of the eye with ONSD and ETD measurements will be captured. Repeat until three measurements have been obtained resulting in an average ONSD and ETD for that eye. Repeat for other eye. Switch probe and repeat on both eyes.

Interventions

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Ocular Ultrasound

1\. Patients presenting to the emergency department and have a normal head and/or ocular computed tomography scan will be considered for inclusion in this study. Study staff will discuss the study with the patient and obtain consent. At that point, operator will perform ocular ultrasound. Procedure will start with either the linear or microconvex probe. A single-use sterile gel packet will be used to apply gel to one closed eyelid. The probe will be placed with minimal pressure on the eye. A transverse measurement of the ONSD will be taken. In this same view the maximal transverse diameter of the eyeball will also be measured. Images of the eye with ONSD and ETD measurements will be captured. Repeat until three measurements have been obtained resulting in an average ONSD and ETD for that eye. Repeat for other eye. Switch probe and repeat on both eyes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older, and;
* Present to Cleveland Clinic Akron General's ED (Main)
* Have CT head and/or ocular ordered as a part of clinical care that is read as normal or no acute disease (confirmatory imaging), and;
* Agree to and provide written consent for participation.

Exclusion Criteria

* Acute ocular pathology
* Abnormal brain and/or ocular CT
* History of increased intracranial pressure or optic nerve disease
* Not medically stable
* Pregnant or incarcerated
* Unable to consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cleveland Clinic Akron General

OTHER

Sponsor Role lead

Responsible Party

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Joshua Jacquet

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Jacquet, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Akron General

Locations

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Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joshua Jacquet, MD

Role: CONTACT

330-344-6000

Jessica Krizo, PhD

Role: CONTACT

330-344-6316

Facility Contacts

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Jessica Krizo

Role: primary

330-344-6316

Other Identifiers

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21036

Identifier Type: -

Identifier Source: org_study_id

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