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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Transorbital Sonography; Other: Orbita Magnetic Resonance Imaging; Other: Visual Evoked Potentials; Other: Optical Coherence Tomography

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 Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kütahya
    • Kütahya, Kütahya, Turkey (Türkiye), 43100
      • Kutahya Health Sciences University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients having been diagnosed with MS and healthy volunteers.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls (HC)	Other: Transorbital Sonography; OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.; Other Names: TOS
Patients with Multiple Sclerosis; (MS Patients)	Other: Transorbital Sonography; OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.; Other Names: TOS; Other: Orbita Magnetic Resonance Imaging; OND and ONSD of participants in the MS patient group were measured by orbita MRI.; Other Names: MRI; Other: Visual Evoked Potentials; P100 amplitude and P100 latency values of participants in the MS patient group were measured by VEP.; Other Names: VEP; Other: Optical Coherence Tomography; pRNFL thickness of participants in the MS patient group were measured by OCT.; Other Names: OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transorbital Sonography	OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.	2 minutes
Orbita Magnetic Resonance Imaging	OND and ONSD of participants in the MS patient group were measured by orbita MRI.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Evoked Potentials	Visual Evoked Potentials	20 minutes
Optical Coherence Tomography	pRNFL thickness of participants in the MS patient group were measured by OCT.	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.	30 minutes

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Magnetic Resonance Imaging; Optical Coherence Tomography; Optic Nerve Sheath Diameter; Visual Evoked Potentials; Transorbital Sonography; Optic Nerve Diameter
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena; Tomography; Diagnostic Imaging; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Tomography, Optical; Optical Imaging; Nervous System Physiological Phenomena; Ocular Physiological Phenomena; Tomography, Optical Coherence; Evoked Potentials, Visual
• Other Study ID Numbers: 2023/11-27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No