Evaluation of the Relationship Between OND and ONSD Measured by TOS With Clinical, Radiological, and Electrophysiological Parameters in MS Patients
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Transorbital SonographyOther: Orbita Magnetic Resonance ImagingOther: Visual Evoked PotentialsOther: Optical Coherence Tomography
- Registration Number
- NCT06533930
- Lead Sponsor
- Kutahya Health Sciences University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MS Optical Coherence Tomography (patients with multiple sclerosis) MS Visual Evoked Potentials (patients with multiple sclerosis) MS Transorbital Sonography (patients with multiple sclerosis) Control Transorbital Sonography (healthy volunteers) MS Orbita Magnetic Resonance Imaging (patients with multiple sclerosis)
- Primary Outcome Measures
Name Time Method Transorbital Sonography 2 minutes OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS.
Orbita Magnetic Resonance Imaging 30 minutes OND and ONSD of participants in the MS patient group were measured by orbita MRI.
- Secondary Outcome Measures
Name Time Method Visual Evoked Potentials 20 minutes Visual Evoked Potentials
Expanded Disability Status Scale 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.
Optical Coherence Tomography 15 minutes pRNFL thickness of participants in the MS patient group were measured by OCT.
Trial Locations
- Locations (1)
Kutahya Health Sciences University, Faculty of Medicine
🇹🇷Kütahya, Turkey