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

January 20, 2023 updated by: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47011
        • IOBA - Universidad de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Control group (healthy volonteers) and patients with Multiple Sclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Diagnostic test: Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test
Other Names:
  • Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)
Diagnostic 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
Other Names:
  • Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA
Diagnostic test: 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.
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
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
Diagnostic test: Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test
Other Names:
  • Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)
Diagnostic 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
Other Names:
  • Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA
Diagnostic test: 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.
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
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
Diagnostic test: Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test
Other Names:
  • Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)
Diagnostic 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
Other Names:
  • Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA
Diagnostic test: 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.
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
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
Diagnostic test: Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test
Other Names:
  • Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)
Diagnostic 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
Other Names:
  • Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fixations recorded with the eye tracker system
Time Frame: 24 Hours
number of fixations, duration in milliseconds
24 Hours
Saccades recorded with the eye tracker system
Time Frame: 24 Hours
number of saccades, duration in milliseconds
24 Hours
Fixation assessment with microperimetry
Time Frame: 24 Hours
Fixation assessment: P1, P2 fixation points (indexes P1 and P2)
24 Hours
Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry
Time Frame: 24 Hours
BCEA assessment: areas BCEA 63, BCEA 95
24 Hours
Preferred Retinal Locus (PRL) analysis with microperimetry
Time Frame: 24 Hours
PRL assessment: Low-PRL, PRL High
24 Hours
Analysis of the macular integrity (MI) with microperimetry
Time Frame: 24 Hours
MI assessment: macular integrity index
24 Hours
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
24 Hours
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
24 Hours
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
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Hospital del Río Hortega
Fundación Eugenio Rodríguez Pascual

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 13, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

January 20, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-PI045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Progressive Multiple Sclerosis

Clinical Trials on Eye tracking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe