Measurement of the Optic Nerve Sheath Diameter

NCT05548335 | Unknown

• 1 other identifier: 21036
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optic Nerve

Keywords

ocular ultrasound; optic nerve sheath diameter; ETD

Outcome Measures

Primary Outcomes (1)

• The Primary objective is to determine the accuracy of the microconvex ultrasound transducer as compared to the linear ultrasound transducer for ultrasound measurement of the optic nerve sheath diameter compared to CT measurements.

  The patient will be enrolled and be involved with the study for 15-20 minutes. At this time the research procedures will be done.

  through study duration, one year is anticipated.

Secondary Outcomes (3)

• To determine the level of intra- and inter-rater variability for ultrasound measurement of the optic nerve sheath diameter between the two transducer types.

  through study duration, one year is anticipated.

• To determine the accuracy of the microconvex ultrasound transducer as compared to the linear ultrasound transducer for ultrasound measurement of the eyeball transverse diameter compared to CT measurements.

  through study duration, one year is anticipated.

• To determine the accuracy of the microconvex ultrasound transducer as compared to the linear ultrasound transducer for ultrasound measurement of the ONSD/ETD compared to CT measurements.

  through study duration, one year is anticipated.

Study Arms (1)

Ocular Ultrasound

OTHER

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

Procedure: Ocular Ultrasound

Interventions

Ocular Ultrasound 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.

Ocular Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cleveland Clinic Akron General: lead

Study Sites (1)

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

RECRUITING

Study Officials

• Joshua Jacquet, MD

  Cleveland Clinic Akron General

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Jacquet, MD

CONTACT

330-344-6000; jacquej3@ccf.org

Jessica Krizo, PhD

CONTACT

330-344-6316; krizoj@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking. All subjects have same intervention.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: There are no groups. All subjects will have the same inclusion criteria and will have the same intervention.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)