Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533930
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Evaluation of the Relationship Between OND and ONSD Measured by TOS With Clinical Radiological and Electrophysiological Parameters in MS Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None