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

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

Status: Invitation-only

Conditions: Multiple Sclerosis; Progressive Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Diagnostic Test: Microperimetry; Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Eye tracking; Diagnostic Test: Visual processing speed test

Study type: Observational

Funder types: Other

Identifiers

NCT05706220

22-PI045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

120 participants in 4 patient groups

Control group

Description:

* 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

Treatment:

Diagnostic Test: Visual processing speed test

Diagnostic Test: Eye tracking

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Microperimetry

Clinically Isolated Syndrome Patients

Description:

* 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)

Treatment:

Diagnostic Test: Visual processing speed test

Diagnostic Test: Eye tracking

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Microperimetry

Relapsing-remitting Multiple Sclerosis Patients

Description:

* 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)

Treatment:

Diagnostic Test: Visual processing speed test

Diagnostic Test: Eye tracking

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Microperimetry

Primary Progressive Multiple Sclerosis Patients

Description:

* 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

Treatment:

Diagnostic Test: Visual processing speed test

Diagnostic Test: Eye tracking

Diagnostic Test: Optical coherence tomography (OCT)

Diagnostic Test: Microperimetry