Optic Nerve Sheath DiameterNCT06209034
Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery
A study testing Optic nerve sheath measurement in people with Optic Nerve Sheath Diameter and Intracranial Pressure Increase, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results. Laparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Optic Nerve Sheath Diameter, Intracranial Pressure Increase
- What is being tested?
- Optic nerve sheath measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 15 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 aged patients
- American Society of Anesthesiologists Classification (ASA) I-II-III patients
- Patients undergoing laparoscopic surgery
Who cannot join
- American Society of Anesthesiologists Classification (ASA) IV-V patients
- Those with known ophthalmic disease
- Those with a history of ophthalmic surgery
- Those with any known neurological disorder
- History of intracranial hypertension
- Patients who will undergo open abdominal surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kocaeli University
Kocaeli
Sevim Cesur
Kocaeli
About this study
Official title: Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery
Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results.
Laparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (ICP).
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment.Ultrasonographic assessment of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive measurement of intracranial pressure.
Read the detailed description
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment. Previous studies have demonstrated that ultrasonographic measurement of ONSD correlates with the degree of ICP and can detect intracranial hypertension in a variety of clinical settings.
It was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe.
Ultrasonographically, in each measurement, the optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. ONSD will be measured bilaterally 3 mm behind the papilla. It will be evaluated by transverse measurement for each optic nerve.
- Being tested
- Optic nerve sheath measurement
- Keywords
- Ultrasonography, Optic nerve sheath diameter, Laparoscopic surgery
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath measurementOther
ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve.
| Study group | Role | What they receive |
|---|---|---|
| Optic nerve sheath measurement | Other | Optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes in each ultrasonographic measurement. ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve. Receives: Other: Optic nerve sheath measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of optic nerve sheath diameter
Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start30 Dec 2023
- Primary completion31 Jul 2024
- Study completion15 Sep 2024
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.
- 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
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Cesur, Kocaeli University
- Investigators
- Sevim Cesur, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209034
- Sponsor's protocol ID
- KÜ GOKAEK-2023/19.12
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2024
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06209034
- Acronym / sponsor ID
- KÜ GOKAEK-2023/19.12
- Keywords
- Ultrasonography, Optic nerve sheath diameter, Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 17 Jan 2024 (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.
Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results.
Laparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (ICP).
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment.Ultrasonographic assessment of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive measurement of intracranial pressure.
Detailed description
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment. Previous studies have demonstrated that ultrasonographic measurement of ONSD correlates with the degree of ICP and can detect intracranial hypertension in a variety of clinical settings.
It was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe.
Ultrasonographically, in each measurement, the optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. ONSD will be measured bilaterally 3 mm behind the papilla. It will be evaluated by transverse measurement for each optic nerve.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optic nerve sheath measurement | Other | Other: Optic nerve sheath measurementOptic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes in each ultrasonographic measurement. ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 aged patients
- American Society of Anesthesiologists Classification (ASA) I-II-III patients
- Patients undergoing laparoscopic surgery
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists Classification (ASA) IV-V patients
- Those with known ophthalmic disease
- Those with a history of ophthalmic surgery
- Those with any known neurological disorder
- History of intracranial hypertension
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 |
|---|---|---|
| Optic nerve sheath measurementONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve. | Other | Optic nerve sheath measurement |
Primary outcome
Evaluation of optic nerve sheath diameter
Time frame: During the operation
Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery
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 18 Mar 2026.
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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.
Sevim Cesur study director
Kocaeli University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic nerve sheath measurement in people with Optic Nerve Sheath Diameter and Intracranial Pressure Increase, run by Kocaeli University at 2 sites 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 3 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluation of optic nerve sheath diameter (time frame: During the operation). 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 18 Mar 2026.