Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eye tracking, Microperimetry, Optical coherence tomography (OCT), Visual processing speed test.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Visual Processing Speed and Objective Analysis of Supranuclear Ocular Movements Control in Multiple Sclerosis Patients and Its Relationship With OCT and Reading Difficulties
Overview
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.
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.
Interventions
- Diagnostic test Eye tracking
Eye tracker will be used to evaluate eye movements - Diagnostic test Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test - 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 - 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 outcome measures
- Eye Tracking Data [Time frame: 24 Hours]
- Values for Visual Processing Speed (VPS) [Time frame: 24 Hours]
- Retinal sensitivity assessed by microperimetry [Time frame: 24 Hours]
- Values for OCT neuroretinal and peripapillary parameters [Time frame: 24 Hours]
Secondary outcome measures (9)
- Fixations recorded with the eye tracker system [Time frame: 24 Hours]
- Saccades recorded with the eye tracker system [Time frame: 24 Hours]
- Fixation assessment with microperimetry [Time frame: 24 Hours]
- Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry [Time frame: 24 Hours]
- Preferred Retinal Locus (PRL) analysis with microperimetry [Time frame: 24 Hours]
- Analysis of the macular integrity (MI) with microperimetry [Time frame: 24 Hours]
- Ganglion Cell Layer measurement (GCL: Macular OCT) [Time frame: 24 Hours]
- Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT) [Time frame: 24 Hours]
- Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL) [Time frame: 24 Hours]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- IOBA - Universidad de Valladolid — Valladolid
Identifiers
NCT: NCT05706220 · 22-PI045