Optic NerveNCT05548335
Measurement of the Optic Nerve Sheath Diameter
A study testing Ocular Ultrasound in people with Optic Nerve, run by Cleveland Clinic Akron General at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve
- What is being tested?
- Ocular Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microconvex Probe Versus Linear Probe for Measurement of the Optic Nerve Sheath Diameter
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.
Read the 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.
- Conditions
- Optic Nerve
- Being tested
- Ocular Ultrasound
- Keywords
- ocular ultrasound, optic nerve sheath diameter, ETD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular UltrasoundProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ocular Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study duration, one year is anticipated.
Secondary outcomes (3)
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.
Measured: 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 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.
Measured: 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.
Measured: through study duration, one year is anticipated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Why it stopped: quality assurance of measurement technique not adequate for research standards
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NerveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There are no groups. All subjects will have the same inclusion criteria and will have the same intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Akron General
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Jacquet, Cleveland Clinic Akron General
- Investigators
- Joshua Jacquet, MD, Principal investigator, Cleveland Clinic Akron General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548335
- Sponsor's protocol ID
- 21036
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microconvex Probe Versus Linear Probe for Measurement of the Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT05548335
- Acronym / sponsor ID
- 21036
- Conditions
- Optic Nerve
- Keywords
- ocular ultrasound, optic nerve sheath diameter, ETD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: quality assurance of measurement technique not adequate for research standards
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cleveland Clinic Akron GeneralUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are no groups. All subjects will have the same inclusion criteria and will have the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Ocular Ultrasound | Other | Procedure: Ocular UltrasoundThis arm includes all patients enrolled who will have an ocular ultrasound with two different probes for a total of four ultrasounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Acute ocular pathology
- Abnormal brain and/or ocular CT
- History of increased intracranial pressure or optic nerve disease
- Not medically stable
- Pregnant or incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular Ultrasound1. 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. | Procedure or surgery | Ocular Ultrasound |
Primary outcome
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.
The patient will be enrolled and be involved with the study for 15-20 minutes. At this time the research procedures will be done.
3 secondary outcomes
To determine the level of intra- and inter-rater variability for ultrasound measurement of the optic nerve sheath diameter between the two transducer types.
Time frame: 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 eyeball transverse diameter compared to CT measurements.
Time frame: 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.
Time frame: through study duration, one year is anticipated.
Results and safety
The study was stopped early (reason given: quality assurance of measurement technique not adequate for research standards). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Jacquet, MD principal investigator
Cleveland Clinic Akron General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular Ultrasound in people with Optic Nerve, run by Cleveland Clinic Akron General at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: quality assurance of measurement technique not adequate for research standards). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.