Cerebrovascular Accident (Stroke)NCT07818408
Value of Optic Nerve Sheath Diameter in Differentiating Ischemic From Hemorrhagic Stroke
An observational study of Cerebrovascular Accident (Stroke), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
We aimed to examine bedside ONSD values measured by ocular ultrasonography in patients presenting to the ED with stroke, and to determine a diagnostic cut-off value for differentiating ischemic from hemorrhagic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident (Stroke)
- What is being tested?
- Bedside Ocular Ultrasonography (ONSD Measurement)
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 years and older) who presented to the adult emergency department of a tertiary training and research hospital with symptoms of acute stroke. To be included in this population, patients must have a confirmed diagnosis of cerebrovascular disease (either ischemic or hemorrhagic stroke) verified by radiological neuroimaging (CT or MRI). The population strictly excludes intubated patients and individuals with a history or imaging evidence of pre-existing conditions that could independently raise intracranial pressure or cause cerebral edema, such as intracranial masses, aneurysms, metastases, hydrocephalus, or optic neuritis.
Who may be able to join
- Patients older than 18 years presenting to the ED with stroke.
- Patients diagnosed with cerebrovascular disease (CVD) by radiological imaging (CT/MRI).
Who cannot join
- Patients who are intubated. Patients unwilling to participate.
- History or imaging findings of mass, aneurysm, metastasis, hydrocephalus, sarcoidosis, ventriculoperitoneal shunt, or optic neuritis.
- Any condition leading to cerebral edema or affecting ONSD by independently raising intracranial pressure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Emergency Medicine Department
Ankara
About this study
Official title: Diagnostic Value of Bedside Ultrasonographic Optic Nerve Sheath Diameter Measurement in Differentiating Ischemic From Hemorrhagic Stroke in the Emergency Department
We aimed to examine bedside ONSD values measured by ocular ultrasonography in patients presenting to the ED with stroke, and to determine a diagnostic cut-off value for differentiating ischemic from hemorrhagic stroke.
Read the detailed description
This study was conducted prospectively and observationally in the adult emergency department of a tertiary training and research hospital. Patients older than 18 years who presented to the ED with stroke on the investigator's shift days, who were not followed up or treated by the investigator, and who were diagnosed with cerebrovascular disease (CVD) by radiological imaging (CT/MRI) were included in the study. Patients who were intubated, those who were unwilling to participate, and those in whom mass, aneurysm, metastasis, hydrocephalus, sarcoidosis, ventriculoperitoneal shunt, optic neuritis, or any cause that could lead to cerebral edema or affect the ONSD by raising ICP was identified in their history or on imaging were excluded.
- Conditions
- Cerebrovascular Accident (Stroke)
- Being tested
- Bedside Ocular Ultrasonography (ONSD Measurement)
- Keywords
- optic nerve sheath diameter, stroke, ultrasonography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside Ocular Ultrasonography (ONSD Measurement)Diagnostic test
Measurement of the optic nerve sheath diameter using a high-frequency (4-10 MHz) linear probe at 3 mm posterior to the papilla, immediately after the CT/MRI procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Hemorrhagic Stroke Patients Receives: Diagnostic Test: Bedside Ocular Ultrasonography (ONSD Measurement) | |
| Group 2 | Ischemic Stroke Patients Receives: Diagnostic Test: Bedside Ocular Ultrasonography (ONSD Measurement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut-off Value of Optic Nerve Sheath Diameter (ONSD)
Determination of the optimal ONSD cut-off value (in millimeters) to effectively differentiate between ischemic and hemorrhagic stroke subtypes.
Measured: Evaluated immediately following the initial imaging procedure (CT/MRI) in the emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Apr 2021
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular Accident (Stroke)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Yildirim, MD, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818408
- Sponsor's protocol ID
- ASH3
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu D, Li Z, Zhang X, Zhao L, Jia J, Sun F, Wang Y, Ma D, Wei W. Assessment of intracranial pressure with ultrasonographic retrobulbar optic nerve sheath diameter measurement. BMC Neurol. 2017 Sep 29;17(1):188. doi: 10.1186/s12883-017-0964-5.
PubMed 28962603Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.
PubMed 25034476
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Bedside Ultrasonographic Optic Nerve Sheath Diameter Measurement in Differentiating Ischemic From Hemorrhagic Stroke in the Emergency Department
- ClinicalTrials.gov ID
- NCT07818408
- Acronym / sponsor ID
- ASH3
- Conditions
- Cerebrovascular Accident (Stroke)
- Keywords
- optic nerve sheath diameter, stroke, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Sep 2026 (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.
We aimed to examine bedside ONSD values measured by ocular ultrasonography in patients presenting to the ED with stroke, and to determine a diagnostic cut-off value for differentiating ischemic from hemorrhagic stroke.
Detailed description
This study was conducted prospectively and observationally in the adult emergency department of a tertiary training and research hospital. Patients older than 18 years who presented to the ED with stroke on the investigator's shift days, who were not followed up or treated by the investigator, and who were diagnosed with cerebrovascular disease (CVD) by radiological imaging (CT/MRI) were included in the study. Patients who were intubated, those who were unwilling to participate, and those in whom mass, aneurysm, metastasis, hydrocephalus, sarcoidosis, ventriculoperitoneal shunt, optic neuritis, or any cause that could lead to cerebral edema or affect the ONSD by raising ICP was identified in their history or on imaging were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Bedside Ocular Ultrasonography (ONSD Measurement)Hemorrhagic Stroke Patients |
| Group 2 | – | Diagnostic Test: Bedside Ocular Ultrasonography (ONSD Measurement)Ischemic Stroke Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older) who presented to the adult emergency department of a tertiary training and research hospital with symptoms of acute stroke. To be included in this population, patients must have a confirmed diagnosis of cerebrovascular disease (either ischemic or hemorrhagic stroke) verified by radiological neuroimaging (CT or MRI). The population strictly excludes intubated patients and individuals with a history or imaging evidence of pre-existing conditions that could independently raise intracranial pressure or cause cerebral edema, such as intracranial masses, aneurysms, metastases, hydrocephalus, or optic neuritis.
Key inclusion criteria (2 listed)
- Patients older than 18 years presenting to the ED with stroke.
- Patients diagnosed with cerebrovascular disease (CVD) by radiological imaging (CT/MRI).
Key exclusion criteria (3 listed)
- Patients who are intubated. Patients unwilling to participate.
- History or imaging findings of mass, aneurysm, metastasis, hydrocephalus, sarcoidosis, ventriculoperitoneal shunt, or optic neuritis.
- Any condition leading to cerebral edema or affecting ONSD by independently raising intracranial pressure.
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 |
|---|---|---|
| Bedside Ocular Ultrasonography (ONSD Measurement)Measurement of the optic nerve sheath diameter using a high-frequency (4-10 MHz) linear probe at 3 mm posterior to the papilla, immediately after the CT/MRI procedure. | Diagnostic test | Group 1, Group 2 |
Primary outcome
Cut-off Value of Optic Nerve Sheath Diameter (ONSD)
Time frame: Evaluated immediately following the initial imaging procedure (CT/MRI) in the emergency department.
Determination of the optimal ONSD cut-off value (in millimeters) to effectively differentiate between ischemic and hemorrhagic stroke subtypes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 28962603Liu D, Li Z, Zhang X, Zhao L, Jia J, Sun F, Wang Y, Ma D, Wei W. Assessment of intracranial pressure with ultrasonographic retrobulbar optic nerve sheath diameter measurement. BMC Neurol. 2017 Sep 29;17(1):188. doi: 10.1186/s12883-017-0964-5.
- Background: PubMed 25034476Sekhon MS, Griesdale DE, Robba C, McGlashan N, Needham E, Walland K, Shook AC, Smielewski P, Czosnyka M, Gupta AK, Menon DK. Optic nerve sheath diameter on computed tomography is correlated with simultaneously measured intracranial pressure in patients with severe traumatic brain injury. Intensive Care Med. 2014 Sep;40(9):1267-74. doi: 10.1007/s00134-014-3392-7. Epub 2014 Jul 18.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident (Stroke), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 14 Sep 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cut-off Value of Optic Nerve Sheath Diameter (ONSD) (time frame: Evaluated immediately following the initial imaging procedure (CT/MRI) in the emergency department.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818408, which also lists 2 linked publications.
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 14 Sep 2026.