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Enrolling by Invitation

NCT Number: NCT05706220

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Central Nervous System Diseases Chronic Disease Clinically Isolated Syndrome Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Eye Diseases Immune System Diseases Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Progressive Multiple Sclerosis Relapsing Remitting Multiple Sclerosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IOBA - Universidad de Valladolid

Valladolid, 47011, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

eye tracking

Diagnostic Test

Eye tracker will be used to evaluate eye movements

Other names: Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software

Microperimetry

Diagnostic Test

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

Other names: Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)

Optical coherence tomography (OCT)

Diagnostic Test

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

Other names: Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA

Visual processing speed test

Diagnostic 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.

Primary outcomes

  1. Eye Tracking Data

    Time frame: 24 Hours

    Characteristics of eye movements recorded with the eye tracker system during reading tests

  2. Values for Visual Processing Speed (VPS)

    Time frame: 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)

  3. Retinal sensitivity assessed by microperimetry

    Time frame: 24 Hours

    Sensitivity and fixation analysis with microperimetry

  4. Values for OCT neuroretinal and peripapillary parameters

    Time frame: 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

Secondary outcomes

  1. Fixations recorded with the eye tracker system

    Time frame: 24 Hours

    number of fixations, duration in milliseconds

  2. Saccades recorded with the eye tracker system

    Time frame: 24 Hours

    number of saccades, duration in milliseconds

  3. Fixation assessment with microperimetry

    Time frame: 24 Hours

    Fixation assessment: P1, P2 fixation points (indexes P1 and P2)

  4. Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry

    Time frame: 24 Hours

    BCEA assessment: areas BCEA 63, BCEA 95

  5. Preferred Retinal Locus (PRL) analysis with microperimetry

    Time frame: 24 Hours

    PRL assessment: Low-PRL, PRL High

  6. Analysis of the macular integrity (MI) with microperimetry

    Time frame: 24 Hours

    MI assessment: macular integrity index

  7. Ganglion Cell Layer measurement (GCL: Macular OCT)

    Time frame: 24 Hours

    Optical Coherence Tomography (OCT) will be used to assess the GCL of patients with multiple sclerosis

  8. Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)

    Time frame: 24 Hours

    Optical Coherence Tomography (OCT) will be used to assess the RNFL of patients with multiple sclerosis

  9. Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)

    Time frame: 24 Hours

    Optical Coherence Tomography (OCT) will be used to assess the GCIPL of patients with multiple sclerosis

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Fundación Eugenio Rodríguez Pascual
  • Hospital del Rio Hortega

Registry information

Official study title

Visual Processing Speed and Objective Analysis of Supranuclear Ocular Movements Control in Multiple Sclerosis Patients and Its Relationship With OCT and Reading Difficulties

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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