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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Jacquet, MD | Contact | 330-344-6000 | jacquej3@ccf.org | |
| Jessica Krizo, PhD | Contact | 330-344-6316 | krizoj@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Jacquet, MD | Cleveland Clinic Akron General | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Akron General | Recruiting | Akron | Ohio | 44307 | United States |
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There are no groups. All subjects will have the same inclusion criteria and will have the same intervention.
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No masking. All subjects have same intervention.
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|
| 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. |