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Clinical Trials/NCT05706220
NCT05706220
Enrolling By Invitation
Not Applicable

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

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 site in 1 country120 target enrollmentJune 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Enrollment
120
Locations
1
Primary Endpoint
Values for Visual Processing Speed (VPS)
Status
Enrolling By Invitation
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2022
End Date
December 31, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

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

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).

Outcomes

Primary Outcomes

Values for Visual Processing Speed (VPS)

Time Frame: 24 Hours

VPS will be assessing subject visual stimulus search reaction time (S-RT) and reach reaction time (R-RT), measured in seconds. Thirty-two different everyday visual stimuli were divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities (10º, 20º y 30º)

Values for OCT neuroretinal and peripapillary parameters

Time Frame: 24 Hours

OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans

Eye Tracking Data

Time Frame: 24 Hours

Characteristics of eye movements recorded with the eye tracker system during reading tests

Retinal sensitivity assessed by microperimetry

Time Frame: 24 Hours

Sensitivity and fixation analysis with microperimetry

Secondary Outcomes

  • Saccades recorded with the eye tracker system(24 Hours)
  • Fixation assessment with microperimetry(24 Hours)
  • Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry(24 Hours)
  • Analysis of the macular integrity (MI) with microperimetry(24 Hours)
  • Ganglion Cell Layer measurement (GCL: Macular OCT)(24 Hours)
  • Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)(24 Hours)
  • Fixations recorded with the eye tracker system(24 Hours)
  • Preferred Retinal Locus (PRL) analysis with microperimetry(24 Hours)
  • Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)(24 Hours)

Study Sites (1)

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