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
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.
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). |
Country | Name | City | State |
---|---|---|---|
Spain | IOBA - Universidad de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA | Fundación Eugenio Rodríguez Pascual, Hospital del Río Hortega |
Spain,
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 |
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