Clinical trial NCT05706220: Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: 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
Lead sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Sponsor class: OTHER
Collaborators: name: Fundación Eugenio Rodríguez Pascual
name: Hospital del Rio Hortega
First posted: 2023-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Control group (healthy volonteers) and patients with Multiple Sclerosis

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.

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.

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).

Primary outcomes:
measure: Eye Tracking Data
timeFrame: 24 Hours
measure: Values for Visual Processing Speed (VPS)
timeFrame: 24 Hours
measure: Retinal sensitivity assessed by microperimetry
timeFrame: 24 Hours
measure: Values for OCT neuroretinal and peripapillary parameters
timeFrame: 24 Hours
Secondary outcomes:
measure: Fixations recorded with the eye tracker system
timeFrame: 24 Hours
measure: Saccades recorded with the eye tracker system
timeFrame: 24 Hours
measure: Fixation assessment with microperimetry
timeFrame: 24 Hours
measure: Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry
timeFrame: 24 Hours
measure: Preferred Retinal Locus (PRL) analysis with microperimetry
timeFrame: 24 Hours
measure: Analysis of the macular integrity (MI) with microperimetry
timeFrame: 24 Hours
measure: Ganglion Cell Layer measurement (GCL: Macular OCT)
timeFrame: 24 Hours
measure: Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
timeFrame: 24 Hours
measure: Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: IOBA - Universidad de Valladolid
Study officials:
References: