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Enrolling by invitationNCT05706220Updated May 16, 2025

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

An observational study in Multiple Sclerosis, Clinically Isolated Syndrome and Relapsing Remitting Multiple Sclerosis, sponsored by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Primary conditionMultiple Sclerosis, Relapsing-RemittingRegistry: Multiple SclerosisReclassifiedWhy we changed it
Registry
Multiple Sclerosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Sclerosis, Relapsing-Remitting
Why
  1. The study's listed conditions name Multiple Sclerosis, Relapsing-Remitting, a narrower term within Multiple Sclerosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the 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.
02

Conditions studied

  • Multiple Sclerosis
  • Clinically Isolated Syndrome
  • Relapsing Remitting Multiple Sclerosis
  • Progressive Multiple Sclerosis

Keywords

  • ocular motility disorders
  • eye movement
  • eye tracking
  • microperimetry
  • fixational eye movements
  • visual processing speed
  • optical coherence tomography
03

In context

Multiple Sclerosis, Relapsing-Remitting Reclassified

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Compared within Multiple Sclerosis, Relapsing-Remitting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Multiple Sclerosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Control group (healthy volonteers) and patients with Multiple Sclerosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control group

    * Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy) * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Optical coherence tomography

    Diagnostic Test: Eye tracking · Diagnostic Test: Microperimetry · Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Visual processing speed test

  • Clinically Isolated Syndrome Patients

    * Ophthalmologic examination * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Optical coherence tomography * Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest)

    Diagnostic Test: Eye tracking · Diagnostic Test: Microperimetry · Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Visual processing speed test

  • Relapsing-remitting Multiple Sclerosis Patients

    * Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy) * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Optical coherence tomography * Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest)

    Diagnostic Test: Eye tracking · Diagnostic Test: Microperimetry · Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Visual processing speed test

  • Primary Progressive Multiple Sclerosis Patients

    * Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy) * Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software * Visual processing speed * Microperimetry * Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest) * Optical coherence tomography

    Diagnostic Test: Eye tracking · Diagnostic Test: Microperimetry · Diagnostic Test: Optical coherence tomography (OCT) · Diagnostic Test: Visual processing speed test

Interventions

  • Diagnostic testEye tracking

    Eye tracker will be used to evaluate eye movements

    Also known as: Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software

  • Diagnostic testMicroperimetry

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

    Also known as: Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)

  • Diagnostic testOptical 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

    Also known as: Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA

  • Diagnostic testVisual 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.

06

What researchers measure

Primary outcomes

  1. Eye Tracking Data

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

    Time frame: 24 Hours

  2. Values for Visual Processing Speed (VPS)

    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)

    Time frame: 24 Hours

  3. Retinal sensitivity assessed by microperimetry

    Sensitivity and fixation analysis with microperimetry

    Time frame: 24 Hours

  4. Values for OCT neuroretinal and peripapillary parameters

    OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans

    Time frame: 24 Hours

Secondary outcomes

  1. Fixations recorded with the eye tracker system

    number of fixations, duration in milliseconds

    Time frame: 24 Hours

  2. Saccades recorded with the eye tracker system

    number of saccades, duration in milliseconds

    Time frame: 24 Hours

  3. Fixation assessment with microperimetry

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

    Time frame: 24 Hours

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

    BCEA assessment: areas BCEA 63, BCEA 95

    Time frame: 24 Hours

  5. Preferred Retinal Locus (PRL) analysis with microperimetry

    PRL assessment: Low-PRL, PRL High

    Time frame: 24 Hours

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

    MI assessment: macular integrity index

    Time frame: 24 Hours

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

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

    Time frame: 24 Hours

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

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

    Time frame: 24 Hours

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

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

    Time frame: 24 Hours

07

Study locations

1 site
  • IOBA - Universidad de Valladolid
    Valladolid, 47011, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2022 (actual). Primary completion is estimated for Dec 2025, 42 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2022
First posted
Jan 31, 2023
StartActual
Jun 13, 2022
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
May 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05706220
Lead sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
Fundación Eugenio Rodríguez Pascual, Hospital del Rio Hortega
Responsible party
Sponsor
First posted
Jan 31, 2023
Start date
Jun 13, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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