Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis

NCT05706220 · tracked via the Priya Life Science Spain tracker

Sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Phase

Observational

Started

2022-06-13

Last updated

2025-05-16

Condition(s) studied

Multiple SclerosisClinically Isolated SyndromeRelapsing Remitting Multiple SclerosisProgressive Multiple Sclerosis

Investigational drug(s) / intervention(s)

Eye trackingMicroperimetryOptical coherence tomography (OCT)Visual processing speed test

Eye tracking: Eye tracker will be used to evaluate eye movements

Microperimetry: Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test

Optical coherence tomography (OCT): Macular Cube 512x128 or 200x200 scan. OCT will be used to analysis of retinal nerve fiber layer, ganglion cell complex and ganglion-cell/inner plexiform layer

Visual processing speed test: Visual processing speed test will be used for assessing subject visual stimulus search and reach times. Thirty-two different everyday visual stimuli divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities.

Study summary

This project aims to analyze ocular motility problems, visual processing speed and microperimetry, and their relationship with consolidated retinal structural biomarkers (optical coherence tomography, OCT) in patients with Multiple Sclerosis w/w reading complaints comparing with healthy subjects.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Diagnosis of Multiple Sclerosis * Best distant corrected visual acuity equal or greater than 0.7 (decimal scale). Glasses or soft contact lenses users. * Best close corrected visual acuity equal to or greater than 20/30 (Snellen scale).Glasses or soft contact lenses users. Exclusion Criteria: * Patients with a history of acute optic neuritis (ON) and/or who experienced an episode of ON \<6 months prior to the study, to avoid potential interference of papilledema with accurate peripapillary RNFL thickness measurements. * Patients with other retinal and optic nerve diseases, advanced cataracts according to the international Lens Opacities Classification System III (LOCS III) (opacities greater than C2N2) * Patients with other ophthalmological diseases that could affect central visual acuity * Subjects with high refractive error (+ - 6 diopters). * Subjects with other demyelinating disorders (neuromyelitis optica or acute disseminated encephalomyelitis).

Primary outcome measure(s)

Eye Tracking Data — 24 Hours
Characteristics of eye movements recorded with the eye tracker system during reading tests
Values for Visual Processing Speed (VPS) — 24 Hours
VPS will be assessing subject visual stimulus search reaction time (S-RT) and reach reaction time (R-RT), measured in seconds. Thirty-two different everyday visual stimuli were divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities (10º, 20º y 30º)
Retinal sensitivity assessed by microperimetry — 24 Hours
Sensitivity and fixation analysis with microperimetry
Values for OCT neuroretinal and peripapillary parameters — 24 Hours
OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans

Trial sites (1)

Facility	City	Region	Status
IOBA - Universidad de Valladolid	Valladolid	Valladolid

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Other trials for the same condition

Home-Based Exergame Rehabilitation for Upper Limb Function in People With Multiple Sclerosis Starting soon

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting

Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS) Active, not recruiting

Mixed Reality for Upper Limb Rehabilitation in People With Multiple Sclerosis (VIRTUALDOMUS) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05706220 on ClinicalTrials.gov ↗ ← All trials in Spain