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Completed

NCT Number: NCT06533930

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kutahya Health Sciences University, Faculty of Medicine

Kütahya, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transorbital Sonography

Other

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

Other names: TOS

Orbita Magnetic Resonance Imaging

Other

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

Other names: MRI

Visual Evoked Potentials

Other

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

Other names: VEP

optical coherence tomography

Other

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

Other names: OCT

Primary outcomes

  1. Transorbital Sonography

    Time frame: 2 minutes

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

  2. Orbita Magnetic Resonance Imaging

    Time frame: 30 minutes

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

Secondary outcomes

  1. Visual Evoked Potentials

    Time frame: 20 minutes

    Visual Evoked Potentials

  2. Optical Coherence Tomography

    Time frame: 15 minutes

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

  3. Expanded Disability Status Scale

    Time frame: 30 minutes

    Disability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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