Optic Nerve Sheath DiameterONSDNCT03131245
Optic Nerve Sheath Diameter in Craniosynostosis
An observational study of Optic Nerve Sheath Diameter, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Changes of optic nerve sheath diameter after position changes Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Optic Nerve Sheath Diameter
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2017to 31 Jul 2018
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children for correction of craniosyostosis
Who may be able to join
- craniosynostosis
Who cannot join
- infection on eye area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Optic Nerve Sheath Diameter in Modified Prone Position in Craniosynostosis Children
Changes of optic nerve sheath diameter after position changes
Read the detailed description
Changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis
- Conditions
- Optic Nerve Sheath Diameter
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter
optic nerve sheath diameter measure with ultrasound
Measured: 10 minutes after prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start23 Jun 2017
- Primary completion17 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath DiameterStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131245
- Sponsor's protocol ID
- H1703-147-840
- Acronym
- ONSD
- Status last verified
- Oct 2018
- First submitted
- 19 Apr 2017
- Last updated
- 15 Oct 2018
- 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 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Optic Nerve Sheath Diameter in Modified Prone Position in Craniosynostosis Children
- ClinicalTrials.gov ID
- NCT03131245
- Acronym / sponsor ID
- ONSD / H1703-147-840
- Conditions
- Optic Nerve Sheath Diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 27 Apr 2017 (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.
Changes of optic nerve sheath diameter after position changes
Detailed description
Changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children for correction of craniosyostosis
Key inclusion criteria (1 listed)
- craniosynostosis
Key exclusion criteria (1 listed)
- infection on eye area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
optic nerve sheath diameter
Time frame: 10 minutes after prone position
optic nerve sheath diameter measure with ultrasound
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 15 Oct 2018.
- 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.
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 Optic Nerve Sheath Diameter, run by Seoul National University Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 15 Oct 2018. 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 South Korea. 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?
optic nerve sheath diameter (time frame: 10 minutes after prone position). 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 15 Oct 2018.