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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 136 (actual)
• Sponsor: Kutahya Health Sciences University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Transorbital Sonography	OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.
OTHER	Orbita Magnetic Resonance Imaging	OND and ONSD of participants in the MS patient group were measured by orbita MRI.
OTHER	Visual Evoked Potentials	P100 amplitude and P100 latency values of participants in the MS patient group were measured by VEP.
OTHER	Optical Coherence Tomography	pRNFL thickness of participants in the MS patient group were measured by OCT.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-08-01
• Last updated: 2025-08-29

Locations

1 site across 1 country: Turkey (Türkiye)