Measurement of the Optic Nerve Sheath Diameter

Optic Nerve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548335
• Other study ID #: 21036
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Cleveland Clinic Akron General
• Contact: Joshua Jacquet, MD
• Phone: 330-344-6000
• Email: jacquej3[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Optic Nerve

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Akron General	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic Akron General

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.