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

NCT06533930 | Completed

• 1 other identifier: 2023/11-27
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Visual Evoked Potentials

  20 minutes

• Optical Coherence Tomography

  15 minutes

• Expanded Disability Status Scale

  30 minutes

Study Arms (2)

Patients with Multiple Sclerosis

(MS Patients)

Other: Transorbital Sonography; Other: Orbita Magnetic Resonance Imaging; Other: Visual Evoked Potentials; Other: Optical Coherence Tomography

Healthy Controls (HC)

Healthy Controls (HC)

Other: Transorbital Sonography

Interventions

Transorbital Sonography OTHER

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

Also known as: TOS

Healthy Controls (HC); Patients with Multiple Sclerosis

Orbita Magnetic Resonance Imaging OTHER

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

Also known as: MRI

Patients with Multiple Sclerosis

Visual Evoked Potentials OTHER

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

Also known as: VEP

Patients with Multiple Sclerosis

Optical Coherence Tomography OTHER

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

Also known as: OCT

Patients with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients having been diagnosed with MS and healthy volunteers.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University, Faculty of Medicine

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Evoked Potentials, Visual; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

TU (1)