Multiple SclerosisNCT06533930
Evaluation of the Relationship Between Optic Nerve Diameter and Optic Nerve Sheath Diameter Measured by Transorbital Sonography With Clinical, Radiological, and Electrophysiological Parameters in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to evaluate the reliability of optic nerve diameter (OND) and optic nerve sheath diameter (ONSD) measurements made with transorbital sonography (TOS) and magnetic resonance imaging (MRI) in patient groups that may progress with subclinical optic atrophy over time, such as those with… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Transorbital Sonography, Orbita Magnetic Resonance Imaging and Visual Evoked Potentials
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Apr 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients having been diagnosed with MS and healthy volunteers.
Who may be able to join
- Being between the ages of 18-65
- Having been diagnosed with Multiple Sclerosis
- Undergoing disease-modifying therapy (DMT) for more than 6 months
- EDSS score ≤ 7
Who cannot join
- Patients whose Multiple Sclerosis diagnosis is uncertain
- Having ocular pathology that may affect optic nerve measurements (e.g., glaucoma, high myopia, history of ocular surgery)
- Having major systemic diseases that may affect optic nerve measurements (e.g., diabetes mellitus, hypertension)
- EDSS score > 7
- Having experienced a clinical relapse or optic neuritis within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University, Faculty of Medicine
Kütahya, Kütahya, 43100
About this study
The primary aim of this study is to evaluate the reliability of optic nerve diameter (OND) and optic nerve sheath diameter (ONSD) measurements made with transorbital sonography (TOS) and magnetic resonance imaging (MRI) in patient groups that may progress with subclinical optic atrophy over time, such as those with multiple sclerosis (MS). The secondary aims of this study are to compare the relationship of TOS with visual evoked potentials (VEP) and optical coherence tomography (OCT) parameters used in the assessment of the afferent visual pathway in MS and its clinical subtypes and to evaluate the potential of TOS as a diagnostic and monitoring tool for detecting optic nerve atrophy, subclinical axonal loss, and clinical disability in MS.
Read the detailed description
The study included 102 patients with MS-81 with relapsing-remitting MS (RRMS), 19 with secondary progressive MS (SPMS), and 2 with primary progressive MS (PPMS)-as well as 34 healthy controls, all selected according to the inclusion and exclusion criteria. Demographic data for all participants, and clinical characteristics of the MS patient group, were recorded. Expanded Disability Status Scale (EDSS) measurements were performed for the patients. Then, TOS, orbital MRI, VEP and OCT examinations were applied to the individuals in the patient group on the same day for each eye. Measurements recorded included OND and ONSD by TOS and MRI, P100 latency and amplitude by VEP, and peripapillary retinal nerve fiber layer (pRNFL) thickness by OCT. In the healthy control group, OND and ONSD were measured using only transorbital TOS to establish normal measurement ranges.
- Conditions
- Multiple Sclerosis
- Being tested
- Transorbital Sonography, Orbita Magnetic Resonance Imaging, Visual Evoked Potentials, Optical Coherence Tomography
- Keywords
- Multiple Sclerosis, Transorbital Sonography, Optic Nerve Sheath Diameter, Optic Nerve Diameter, Magnetic Resonance Imaging, Visual Evoked Potentials, Optical Coherence Tomography
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transorbital SonographyOther
Also called TOS
OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.
Orbita Magnetic Resonance ImagingOther
Also called MRI
OND and ONSD of participants in the MS patient group were measured by orbita MRI.
Visual Evoked PotentialsOther
Also called VEP
P100 amplitude and P100 latency values of participants in the MS patient group were measured by VEP.
Optical Coherence TomographyOther
Also called OCT
pRNFL thickness of participants in the MS patient group were measured by OCT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | (MS Patients) Receives: Other: Transorbital Sonography; Other: Orbita Magnetic Resonance Imaging; Other: Visual Evoked Potentials; Other: Optical Coherence Tomography | |
| Healthy Controls (HC) | Healthy Controls (HC) Receives: Other: Transorbital Sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transorbital Sonography
OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.
Measured: 2 minutes
Orbita Magnetic Resonance Imaging
OND and ONSD of participants in the MS patient group were measured by orbita MRI.
Measured: 30 minutes
Secondary outcomes (3)
Visual Evoked Potentials
Visual Evoked Potentials
Measured: 20 minutes
Optical Coherence Tomography
pRNFL thickness of participants in the MS patient group were measured by OCT.
Measured: 15 minutes
Expanded Disability Status Scale
Disability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Çetiner, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533930
- Sponsor's protocol ID
- 2023/11-27
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2024
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Optic Nerve Diameter and Optic Nerve Sheath Diameter Measured by Transorbital Sonography With Clinical, Radiological, and Electrophysiological Parameters in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06533930
- Acronym / sponsor ID
- 2023/11-27
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Transorbital Sonography, Optic Nerve Sheath Diameter, Optic Nerve Diameter, Magnetic Resonance Imaging, Visual Evoked Potentials, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 1 Aug 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.
The primary aim of this study is to evaluate the reliability of optic nerve diameter (OND) and optic nerve sheath diameter (ONSD) measurements made with transorbital sonography (TOS) and magnetic resonance imaging (MRI) in patient groups that may progress with subclinical optic atrophy over time, such as those with multiple sclerosis (MS). The secondary aims of this study are to compare the relationship of TOS with visual evoked potentials (VEP) and optical coherence tomography (OCT) parameters used in the assessment of the afferent visual pathway in MS and its clinical subtypes and to evaluate the potential of TOS as a diagnostic and monitoring tool for detecting optic nerve atrophy, subclinical axonal loss, and clinical disability in MS.
Detailed description
The study included 102 patients with MS-81 with relapsing-remitting MS (RRMS), 19 with secondary progressive MS (SPMS), and 2 with primary progressive MS (PPMS)-as well as 34 healthy controls, all selected according to the inclusion and exclusion criteria. Demographic data for all participants, and clinical characteristics of the MS patient group, were recorded. Expanded Disability Status Scale (EDSS) measurements were performed for the patients. Then, TOS, orbital MRI, VEP and OCT examinations were applied to the individuals in the patient group on the same day for each eye. Measurements recorded included OND and ONSD by TOS and MRI, P100 latency and amplitude by VEP, and peripapillary retinal nerve fiber layer (pRNFL) thickness by OCT. In the healthy control group, OND and ONSD were measured using only transorbital TOS to establish normal measurement ranges.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | Other: Transorbital Sonography, Other: Orbita Magnetic Resonance Imaging, Other: Visual Evoked Potentials, Other: Optical Coherence Tomography(MS Patients) |
| Healthy Controls (HC) | – | Other: Transorbital SonographyHealthy Controls (HC) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients having been diagnosed with MS and healthy volunteers.
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
- Having been diagnosed with Multiple Sclerosis
- Undergoing disease-modifying therapy (DMT) for more than 6 months
- EDSS score ≤ 7
Key exclusion criteria (5 listed)
- Patients whose Multiple Sclerosis diagnosis is uncertain
- Having ocular pathology that may affect optic nerve measurements (e.g., glaucoma, high myopia, history of ocular surgery)
- Having major systemic diseases that may affect optic nerve measurements (e.g., diabetes mellitus, hypertension)
- EDSS score > 7
- Having experienced a clinical relapse or optic neuritis within the last 6 months.
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 |
|---|---|---|
| Transorbital SonographyAlso: TOSOND and ONSD of participants in the MS patient group and healthy control group were measured by TOS. | Other | Healthy Controls (HC), Patients with Multiple Sclerosis |
| Orbita Magnetic Resonance ImagingAlso: MRIOND and ONSD of participants in the MS patient group were measured by orbita MRI. | Other | Patients with Multiple Sclerosis |
| Visual Evoked PotentialsAlso: VEPP100 amplitude and P100 latency values of participants in the MS patient group were measured by VEP. | Other | Patients with Multiple Sclerosis |
| Optical Coherence TomographyAlso: OCTpRNFL thickness of participants in the MS patient group were measured by OCT. | Other | Patients with Multiple Sclerosis |
Primary outcome
Transorbital Sonography
Time frame: 2 minutes
OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.
Orbita Magnetic Resonance Imaging
Time frame: 30 minutes
OND and ONSD of participants in the MS patient group were measured by orbita MRI.
3 secondary outcomes
Visual Evoked Potentials
Time frame: 20 minutes
Optical Coherence Tomography
Time frame: 15 minutes
Expanded Disability Status Scale
Time frame: 30 minutes
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 29 Aug 2025.
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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 Multiple Sclerosis, run by Kutahya Health Sciences 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 4 inclusion and 5 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 29 Aug 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?
Transorbital Sonography (time frame: 2 minutes). The study lists 2 primary outcomes in all. 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 29 Aug 2025.