Measurement of the Optic Nerve Sheath Diameter

Microconvex Probe Versus Linear Probe for Measurement of the Optic Nerve Sheath Diameter

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.

Study Overview

• Status: Recruiting
• Conditions: Optic Nerve
• Intervention / Treatment: Procedure: Ocular Ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Jacquet, MD; Phone Number: 330-344-6000; Email: jacquej3@ccf.org
• Study Contact Backup: Name: Jessica Krizo, PhD; Phone Number: 330-344-6316; Email: krizoj@ccf.org

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44307
      • Recruiting
      • Cleveland Clinic Akron General
      • Contact: Jessica Krizo; Phone Number: 330-344-6316

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Ocular Ultrasound; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the level of intra- and inter-rater variability for ultrasound measurement of the optic nerve sheath diameter between the two transducer types.	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.
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.	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.
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.	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.

Collaborators and Investigators

• Sponsor: Cleveland Clinic Akron General
• Investigators: Principal Investigator: Joshua Jacquet, MD, Cleveland Clinic Akron General

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: ocular ultrasound; ETD; optic nerve sheath diameter
• Other Study ID Numbers: 21036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No