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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05706220
• Other study ID #: 22-PI045
• Status: Enrolling by invitation
• Start date: June 13, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Progressive Multiple Sclerosis
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Eye tracking
Eye tracker will be used to evaluate eye movements
• Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation 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
• 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.

Locations

Country	Name	City	State
Spain	IOBA - Universidad de Valladolid	Valladolid

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA	Fundación Eugenio Rodríguez Pascual, Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye Tracking Data	Characteristics of eye movements recorded with the eye tracker system during reading tests	24 Hours
Primary	Values for Visual Processing Speed (VPS)	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)	24 Hours
Primary	Retinal sensitivity assessed by microperimetry	Sensitivity and fixation analysis with microperimetry	24 Hours
Primary	Values for OCT neuroretinal and peripapillary parameters	OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans	24 Hours
Secondary	Fixations recorded with the eye tracker system	number of fixations, duration in milliseconds	24 Hours
Secondary	Saccades recorded with the eye tracker system	number of saccades, duration in milliseconds	24 Hours
Secondary	Fixation assessment with microperimetry	Fixation assessment: P1, P2 fixation points (indexes P1 and P2)	24 Hours
Secondary	Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry	BCEA assessment: areas BCEA 63, BCEA 95	24 Hours
Secondary	Preferred Retinal Locus (PRL) analysis with microperimetry	PRL assessment: Low-PRL, PRL High	24 Hours
Secondary	Analysis of the macular integrity (MI) with microperimetry	MI assessment: macular integrity index	24 Hours
Secondary	Ganglion Cell Layer measurement (GCL: Macular OCT)	Optical Coherence Tomography (OCT) will be used to assess the GCL of patients with multiple sclerosis	24 Hours
Secondary	Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)	Optical Coherence Tomography (OCT) will be used to assess the RNFL of patients with multiple sclerosis	24 Hours
Secondary	Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)	Optical Coherence Tomography (OCT) will be used to assess the GCIPL of patients with multiple sclerosis	24 Hours