Normal Diameter of Optic NerveNCT04600570
Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers
An observational study of Normal Diameter of Optic Nerve, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Diameter of Optic Nerve
- What is being tested?
- ultrasound
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Oct 2020to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal volunteers
Who may be able to join
- adult volunteer aged more than 20 years
Who cannot join
- aged less than 20 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Emergency Medicine, National Taiwan University Hospital
Taipei
About this study
Official title: Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers and Its Associating Factors
The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.
Read the detailed description
Ultrasound measurement of optic nerve sheath diameter (ONSD) had been considered as a non-invasive way to distinguish the presence of elevated intracranial pressure (ICP). Besides detecting elevated ICP in various neurological diseases, ONSD can also be applied to cardiac arrest survivors as one of the prognostic factors. It is a simple, quick, repeatable technique without the need of contrast medians. In order to make precise interpretations, the database of the normal distribution of ONSD and its associated factors in healthy volunteers is necessary. The majority of previous reports are from Western countries, and limited reports of ONSD in the Asian population have high variability.
Therefore, collecting local data of ONSD in Taiwan is important. In this study, the investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. The investigators planed to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.
- Conditions
- Normal Diameter of Optic Nerve
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
ultrasound measurement for optic nerve outer diameter
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve outer diameter
optic nerve outer diameter
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start16 Oct 2020
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Diameter of Optic NerveStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Ching Lien, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600570
- Sponsor's protocol ID
- 202008032RINC
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers and Its Associating Factors
- ClinicalTrials.gov ID
- NCT04600570
- Acronym / sponsor ID
- 202008032RINC
- Conditions
- Normal Diameter of Optic Nerve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 23 Oct 2020 (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.
The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.
Detailed description
Ultrasound measurement of optic nerve sheath diameter (ONSD) had been considered as a non-invasive way to distinguish the presence of elevated intracranial pressure (ICP). Besides detecting elevated ICP in various neurological diseases, ONSD can also be applied to cardiac arrest survivors as one of the prognostic factors. It is a simple, quick, repeatable technique without the need of contrast medians. In order to make precise interpretations, the database of the normal distribution of ONSD and its associated factors in healthy volunteers is necessary. The majority of previous reports are from Western countries, and limited reports of ONSD in the Asian population have high variability.
Therefore, collecting local data of ONSD in Taiwan is important. In this study, the investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. The investigators planed to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal volunteers
Key inclusion criteria (1 listed)
- adult volunteer aged more than 20 years
Key exclusion criteria (1 listed)
- aged less than 20 years
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 |
|---|---|---|
| ultrasoundultrasound measurement for optic nerve outer diameter | Other | – |
Primary outcome
optic nerve outer diameter
Time frame: 60 days
optic nerve outer diameter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
Related trials for Normal Diameter of Optic Nerve
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis
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.
Wan-Ching Lien principal investigator
NTUH
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 Normal Diameter of Optic Nerve, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Jul 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ching Lien (+886-23123456 ext. 65637, wanchinglien@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve outer diameter (time frame: 60 days). 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 20 Jul 2026.