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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06533930
Enrollment
136
Registered
2024-08-01
Start date
2023-10-01
Completion date
2024-04-01
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Transorbital Sonography, Optic Nerve Sheath Diameter, Optic Nerve Diameter, Magnetic Resonance Imaging, Visual Evoked Potentials, Optical Coherence Tomography

Brief 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 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.

Interventions

OTHERTransorbital Sonography

OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.

OTHEROrbita Magnetic Resonance Imaging

OND and ONSD of participants in the MS patient group were measured by orbita MRI.

OTHERVisual Evoked Potentials

P100 amplitude and P100 latency values of participants in the MS patient group were measured by VEP.

OTHEROptical Coherence Tomography

pRNFL thickness of participants in the MS patient group were measured by OCT.

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Transorbital Sonography2 minutesOND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.
Orbita Magnetic Resonance Imaging30 minutesOND and ONSD of participants in the MS patient group were measured by orbita MRI.

Secondary

MeasureTime frameDescription
Visual Evoked Potentials20 minutesVisual Evoked Potentials
Optical Coherence Tomography15 minutespRNFL thickness of participants in the MS patient group were measured by OCT.
Expanded Disability Status Scale30 minutesDisability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026