Clinical trial NCT05548335: Measurement of the Optic Nerve Sheath Diameter
Official title: Microconvex Probe Versus Linear Probe for Measurement of the Optic Nerve Sheath Diameter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Optic Nerve
Keywords: ocular ultrasound
optic nerve sheath diameter
ETD
Lead sponsor: Cleveland Clinic Akron General
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There are no groups. All subjects will have the same inclusion criteria and will have the same intervention.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: through study duration, one year is anticipated.
Secondary outcomes:
measure: To determine the level of intra- and inter-rater variability for ultrasound measurement of the optic nerve sheath diameter between the two transducer types.
timeFrame: through study duration, one year is anticipated.
measure: 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.
timeFrame: through study duration, one year is anticipated.
measure: 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.
timeFrame: through study duration, one year is anticipated.
Other outcomes:
Locations:
city: Akron
country: United States
facility: Cleveland Clinic Akron General
state: Ohio
Study officials:
affiliation: Cleveland Clinic Akron General
name: Joshua Jacquet, MD
role: PRINCIPAL_INVESTIGATOR
References: