Optic Papilla EdemaNCT03178760
Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
An observational study of Optic Papilla Edema, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Optic Papilla Edema
- What is being tested?
- Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 15 Nov 2024
- 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 4 to 18 years
- All sexes
- Child, Adult
Study population: all patients without cerebral edema applied the emergency care unit.
Who may be able to join
- Children without cerebral edema.
Who cannot join
- Children with cerebral edema.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.
Read the detailed description
The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .
- Age
- Gender
- Length (cm)
- Weight (kg)
- Waist Circumference (cm)
- Body Mass Index
- Conditions
- Optic Papilla Edema
- Being tested
- Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.
- Keywords
- Optic nerve sheath diameter, average optic nerve sheath diameter for healthy children
- Medical subject headings
- Papilledema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.Diagnostic test
Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for;
- Age
- Gender
- Weight
- Length
- Waist Circumference
- Body mass index
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of optic nerve sheath diameter
mm
Measured: 1-3 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start15 Jun 2020
- Primary completion15 Jul 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Papilla EdemaStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Tolu Kendir, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178760
- Sponsor's protocol ID
- AU-70904504/393-19.06.2020
- Status last verified
- Feb 2025
- First submitted
- 4 Jun 2017
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
- ClinicalTrials.gov ID
- NCT03178760
- Acronym / sponsor ID
- AU-70904504/393-19.06.2020
- Conditions
- Optic Papilla Edema
- Keywords
- Optic nerve sheath diameter, average optic nerve sheath diameter for healthy children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 7 Jun 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.
The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.
Detailed description
The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .
- Age
- Gender
- Length (cm)
- Weight (kg)
- Waist Circumference (cm)
- Body Mass Index
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- all patients without cerebral edema applied the emergency care unit.
Key inclusion criteria (1 listed)
- Children without cerebral edema.
Key exclusion criteria (1 listed)
- Children with cerebral edema.
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 |
|---|---|---|
| Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for; 1. Age 2. Gender 3. Weight 4. Length 5. Waist Circumference 6. Body mass index | Diagnostic test | – |
Primary outcome
Measurement of optic nerve sheath diameter
Time frame: 1-3 minute
mm
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 13 Feb 2025.
- 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 Optic Papilla Edema, run by Cukurova University 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 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 13 Feb 2025. 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?
Measurement of optic nerve sheath diameter (time frame: 1-3 minute). 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 13 Feb 2025.