NCT05706220

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

November 28, 2022

Last Update Submit

May 14, 2025

Conditions

Multiple SclerosisClinically Isolated SyndromeRelapsing Remitting Multiple SclerosisProgressive Multiple Sclerosis

Keywords

ocular motility disorderseye movementeye trackingmicroperimetryfixational eye movementsvisual processing speedoptical coherence tomography

Outcome Measures

Primary Outcomes (4)

  • Eye Tracking Data

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

    24 Hours

  • 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)

    24 Hours

  • Retinal sensitivity assessed by microperimetry

    Sensitivity and fixation analysis with microperimetry

    24 Hours

  • 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

    24 Hours

Secondary Outcomes (9)

  • Fixations recorded with the eye tracker system

    24 Hours

  • Saccades recorded with the eye tracker system

    24 Hours

  • Fixation assessment with microperimetry

    24 Hours

  • Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry

    24 Hours

  • Preferred Retinal Locus (PRL) analysis with microperimetry

    24 Hours

  • +4 more secondary outcomes

Study Arms (4)

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 trackingDiagnostic Test: MicroperimetryDiagnostic 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 trackingDiagnostic Test: MicroperimetryDiagnostic 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 trackingDiagnostic Test: MicroperimetryDiagnostic 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 trackingDiagnostic Test: MicroperimetryDiagnostic Test: Optical coherence tomography (OCT)Diagnostic Test: Visual processing speed test

Interventions

Eye trackingDIAGNOSTIC_TEST

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
Clinically Isolated Syndrome PatientsControl groupPrimary Progressive Multiple Sclerosis PatientsRelapsing-remitting Multiple Sclerosis Patients
MicroperimetryDIAGNOSTIC_TEST

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

Also known as: Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)
Clinically Isolated Syndrome PatientsControl groupPrimary Progressive Multiple Sclerosis PatientsRelapsing-remitting Multiple Sclerosis Patients
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

Also known as: Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA
Clinically Isolated Syndrome PatientsControl groupPrimary Progressive Multiple Sclerosis PatientsRelapsing-remitting Multiple Sclerosis Patients
Visual processing speed testDIAGNOSTIC_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.

Clinically Isolated Syndrome PatientsControl groupPrimary Progressive Multiple Sclerosis PatientsRelapsing-remitting Multiple Sclerosis Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Control group (healthy volonteers) and patients with Multiple Sclerosis

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IOBA - Universidad de Valladolid

Valladolid, Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic ProgressiveOcular Motility Disorders

Interventions

Eye-Tracking TechnologyTomography, Optical Coherence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesCranial Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Eye Movement MeasurementsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisTomography, OpticalOptical ImagingDiagnostic ImagingTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

January 31, 2023

Study Start

June 13, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

ES(1)