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

• Conditions: Clinically Isolated Syndrome; Progressive Multiple Sclerosis; Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis

• Registration Number: NCT05706220
• Lead Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Brief 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.

Detailed Description

Anamnesis, ophthalmological medical history including difficulties in reading with appropriate glasses.

The following protocol will be applied:

* Comprehensive eye examination

* Stereopsis

* Primary gaze position

* Cover test: far and near

* Vergence and version eye movements

* Presence of nystagmus

* Far and near best corrected visual acuity, with updated refraction

-.Pupillary light reflex

* Biomicroscopy of the anterior pole

* Intraocular pressure

* Recording of eye movements during two standardized tests: International Reading Speed Texts test (IReST®) and Developmental Eye Movement Test (DEM™) with Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software.

* Visual processing speed

* Microperimetry

* Optical coherence tomography

* Eye fundus

* Patients with a history of clinical optic neuritis will additionally undergo contrast sensitivity tests, the Farnsworth® test (Farnsworth test 28 Hue x 100) and normal monocular perimetry using the standard Swedish Interactive Thresholding Algorithm (SITA-central 24-2) perimeter test. Humphrey® (Humphrey visual field analyser) and other tests at the discretion of the investigator.

Study Timeline

• Study Start: 2022-06-13
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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
Eye Tracking Data	24 Hours	Characteristics of eye movements recorded with the eye tracker system during reading tests
Retinal sensitivity assessed by microperimetry	24 Hours	Sensitivity and fixation analysis with microperimetry

Secondary Outcome Measures

Name	Time	Method
Saccades recorded with the eye tracker system	24 Hours	number of saccades, duration in milliseconds
Fixation assessment with microperimetry	24 Hours	Fixation assessment: P1, P2 fixation points (indexes P1 and P2)
Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry	24 Hours	BCEA assessment: areas BCEA 63, BCEA 95
Analysis of the macular integrity (MI) with microperimetry	24 Hours	MI assessment: macular integrity index
Ganglion Cell Layer measurement (GCL: Macular OCT)	24 Hours	Optical Coherence Tomography (OCT) will be used to assess the GCL of patients with multiple sclerosis
Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)	24 Hours	Optical Coherence Tomography (OCT) will be used to assess the GCIPL of patients with multiple sclerosis
Fixations recorded with the eye tracker system	24 Hours	number of fixations, duration in milliseconds
Preferred Retinal Locus (PRL) analysis with microperimetry	24 Hours	PRL assessment: Low-PRL, PRL High
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)	24 Hours	Optical Coherence Tomography (OCT) will be used to assess the RNFL of patients with multiple sclerosis

Trial Locations

Locations (1)

IOBA - Universidad de Valladolid; 🇪🇸 Valladolid, Spain