Ocular Ultrasound for Optic Nerve Assessment

Overseen By Jessica Krizo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Akron General Medical Center

Disqualifiers: Acute ocular pathology, Abnormal CT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 15-20 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ocular ultrasound, a non-invasive imaging technique, can accurately measure parts of the eye, such as the optic nerve sheath, in healthy adults visiting the emergency department. It focuses on individuals with normal CT scans of their heads or eyes as part of their care. Participants will undergo an ocular ultrasound using different probes to gather detailed images. This trial suits those visiting the Cleveland Clinic Akron General's Emergency Department for routine care without acute eye problems. As an unphased study, it offers participants the opportunity to contribute to advancing non-invasive diagnostic techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ocular ultrasound is safe for optic nerve assessment?

Research has shown that using ultrasound on the eye safely and effectively checks the optic nerve. This non-invasive method does not involve surgery or entering the body, making it a low-risk option.

Studies have found that measuring the size of the optic nerve's covering with ultrasound is well-tolerated by patients. No reports of side effects or problems have emerged from using this method.

Overall, ocular ultrasound is recognized as a safe tool for assessing conditions related to the optic nerve, especially in emergencies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ocular ultrasound for optic nerve assessment because this technique provides a non-invasive and quick way to gather crucial information about the optic nerve. Unlike traditional methods that might involve more invasive procedures or radiation exposure, ocular ultrasound uses sound waves to create images, making it safer and more comfortable for patients. This method could potentially offer real-time insights, allowing for faster decision-making in clinical settings. The use of two different probes to perform four ultrasounds enhances the accuracy and detail of the assessment, giving doctors a comprehensive view of the optic nerve's condition.

What evidence suggests that ocular ultrasound is effective for optic nerve assessment?

Research has shown that using an ultrasound on the eye effectively measures the size of the optic nerve sheath, aiding in the detection of increased skull pressure. This non-invasive method, which requires no surgery, can be performed quickly at the bedside. Studies indicate that even individuals with basic training can perform these measurements accurately. Specifically, it reliably predicts high skull pressure, crucial for diagnosing conditions like optic nerve swelling. This makes eye ultrasound a promising tool for emergency and critical care settings. Participants in this trial will undergo ocular ultrasound using two different probes, totaling four ultrasounds. ^{1 4 6 7 8}

Who Is on the Research Team?

Joshua Jacquet, MD

Principal Investigator

Cleveland Clinic Akron General

Are You a Good Fit for This Trial?

This trial is for adults over 18 who visit the Cleveland Clinic Akron General's ED, need a CT scan of their head or eyes as part of normal care, and can give written consent. It's not for pregnant or incarcerated individuals, those with eye diseases, abnormal brain/eye CTs, unstable health conditions, or past issues with high pressure in the brain.

Inclusion Criteria

Agree to and provide written consent for participation

My recent head or eye scans show no signs of acute illness.

Present to Cleveland Clinic Akron General's ED (Main)

Exclusion Criteria

Not medically stable

Abnormal brain and/or ocular CT

Pregnant or incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ocular ultrasound with two different probes for a total of four ultrasounds

15-20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Ocular Ultrasound

Trial Overview The study is testing how well ocular ultrasound works to measure optic nerve sheath diameter in healthy patients. Participants will have this non-invasive test alongside standard imaging procedures during their emergency department visit.

How Is the Trial Designed?

Group I: Ocular Ultrasound Experimental Treatment 1 Intervention

This arm includes all patients enrolled who will have an ocular ultrasound with two different probes for a total of four ultrasounds.

Who Is Running the Clinical Trial?

Akron General Medical Center

Lead Sponsor

Trials

7

Recruited

280+

Cleveland Clinic Akron General

Lead Sponsor

Trials

8

Recruited

480+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554479/

Optic Nerve Sheath Ultrasound - StatPearls - NCBI Bookshelf Point of care optic nerve sheath ultrasound (ONSUS) is a bedside practice that can be used to evaluate for increased intracranial pressure.

2. theultrasoundjournal.springeropen.com theultrasoundjournal.springeropen.com/articles/10.1186/s13089-025-00431-7

Efficacy of a theoretical-practical course for the ultrasound ... This study evaluates the ability of medical and nursing students, Intensive Care Unit (ICU) nurses, and ICU residents to perform ONSD measurements after a ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1539213/full

Ultrasound-based measurement of optic nerve sheath to ... This study explores the ability of different measurement modalities to predict ICP elevation, aiming to provide a superior non-invasive ICP monitoring ...

4. nature.com nature.com/articles/s41526-024-00347-x

Quantitative ultrasound image assessment of the optic ... This longitudinal study aims to quantify the axial plane of the optic nerve subarachnoid space area (ONSSA), which is filled with cerebrospinal fluid (CSF) and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2688115224010695

Novice emergency physician ultrasonography of optic ... This study aims to assess sensitivity and specificity of emergency physician‐performed ocular ultrasound for diagnosis of papilledema compared to ophthalmology ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433128/

Ocular Ultrasound in the Diagnosis of Optic Neuropathies The aim of this review is to analyze the role of ocular ultrasound in the precise and targeted diagnosis of optic neuropathies.

7. journals.lww.com journals.lww.com/ccejournal/fulltext/2021/11000/ultrasound_of_optic_nerve_sheath_diameter_and.16.aspx

Ultrasound of Optic Nerve Sheath Diameter and Stroke... Elevations in optic nerve sheath diameter were associated with increased inhospital mortality and poor functional outcome at 6 months.

8. theultrasoundjournal.springeropen.com theultrasoundjournal.springeropen.com/articles/10.1186/s13089-023-00331-8

Evaluation of commercially available point-of-care ... Ultrasound of the optic nerve sheath has the potential to be a convenient, non-invasive, point-of-injury or triage measure for elevated ...