NCT05706220

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis
• Clinically Isolated Syndrome
• Relapsing Remitting Multiple Sclerosis
• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-01-31
• Last updated: 2025-05-16

Locations

1 site across 1 country: Spain