Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
NCT ID: NCT05706220
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
120 participants
OBSERVATIONAL
2022-06-13
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
Eye tracking
Eye tracker will be used to evaluate eye movements
Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation 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
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)
Eye tracking
Eye tracker will be used to evaluate eye movements
Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation 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
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)
Eye tracking
Eye tracker will be used to evaluate eye movements
Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation 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
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
Eye tracking
Eye tracker will be used to evaluate eye movements
Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation 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
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.
Interventions
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Eye tracking
Eye tracker will be used to evaluate eye movements
Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation 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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
80 Years
ALL
Yes
Sponsors
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Fundación Eugenio Rodríguez Pascual
UNKNOWN
Hospital del Rio Hortega
OTHER
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
OTHER
Responsible Party
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Locations
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IOBA - Universidad de Valladolid
Valladolid, Valladolid, Spain
Countries
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Other Identifiers
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22-PI045
Identifier Type: -
Identifier Source: org_study_id
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