Recruiting

Observational Study

Sponsor:

Cleveland Clinic Akron General

Code:

NCT05548335

Conditions

Optic Nerve

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ocular Ultrasound

Study Details

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

Study ID

NCT05548335

Start date

Oct 1, 2022

Status verified date

Aug, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome 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. [ Time Frame: through study duration, one year is anticipated. ]

Central Contacts and Locations

Central contacts

Joshua Jacquet, MD

330-344-6000jacquej3@ccf.org

Jessica Krizo, PhD

330-344-6316krizoj@ccf.org

Locations

Cleveland Clinic Akron General

Recruiting

Akron, Ohio, United States, 44307

Contacts

Jessica Krizo

330-344-6316

More Information

Sponsor

Cleveland Clinic Akron General

Last update posted

Aug 8, 2023

Last verified

Aug, 2023

Keywords

  • ocular ultrasound
  • optic nerve sheath diameter
  • ETD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cleveland Clinic Akron General on 2023-08-08.