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| Name | Class |
|---|---|
| Fundación Eugenio Rodríguez Pascual | UNKNOWN |
| Hospital del Rio Hortega | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group |
|
| |
| Clinically Isolated Syndrome Patients |
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| Relapsing-remitting Multiple Sclerosis Patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye tracking | Diagnostic Test | Eye tracker will be used to evaluate eye movements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eye Tracking Data | Characteristics of eye movements recorded with the eye tracker system during reading tests | 24 Hours |
| 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 |
| Retinal sensitivity assessed by microperimetry | Sensitivity and fixation analysis with microperimetry | 24 Hours |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fixations recorded with the eye tracker system | number of fixations, duration in milliseconds | 24 Hours |
| Saccades recorded with the eye tracker system | number of saccades, duration in milliseconds |
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Inclusion Criteria:
Exclusion Criteria:
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Control group (healthy volonteers) and patients with Multiple Sclerosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOBA - Universidad de Valladolid | Valladolid | Valladolid | 47011 | Spain |
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| Primary Progressive Multiple Sclerosis Patients |
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| Microperimetry | Diagnostic Test | Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test |
|
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| Optical coherence tomography (OCT) | Diagnostic Test | 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 | Diagnostic 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. |
|
| 24 Hours |
| Fixation assessment with microperimetry | Fixation assessment: P1, P2 fixation points (indexes P1 and P2) | 24 Hours |
| Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry | BCEA assessment: areas BCEA 63, BCEA 95 | 24 Hours |
| Preferred Retinal Locus (PRL) analysis with microperimetry | PRL assessment: Low-PRL, PRL High | 24 Hours |
| Analysis of the macular integrity (MI) with microperimetry | MI assessment: macular integrity index | 24 Hours |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000084542 | Eye-Tracking Technology |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D053483 | Eye Movement Measurements |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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