Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05706220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-16
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084542', 'term': 'Eye-Tracking Technology'}, {'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D053483', 'term': 'Eye Movement Measurements'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye Tracking Data', 'timeFrame': '24 Hours', 'description': 'Characteristics of eye movements recorded with the eye tracker system during reading tests'}, {'measure': 'Values for Visual Processing Speed (VPS)', 'timeFrame': '24 Hours', 'description': '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)'}, {'measure': 'Retinal sensitivity assessed by microperimetry', 'timeFrame': '24 Hours', 'description': 'Sensitivity and fixation analysis with microperimetry'}, {'measure': 'Values for OCT neuroretinal and peripapillary parameters', 'timeFrame': '24 Hours', 'description': 'OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans'}], 'secondaryOutcomes': [{'measure': 'Fixations recorded with the eye tracker system', 'timeFrame': '24 Hours', 'description': 'number of fixations, duration in milliseconds'}, {'measure': 'Saccades recorded with the eye tracker system', 'timeFrame': '24 Hours', 'description': 'number of saccades, duration in milliseconds'}, {'measure': 'Fixation assessment with microperimetry', 'timeFrame': '24 Hours', 'description': 'Fixation assessment: P1, P2 fixation points (indexes P1 and P2)'}, {'measure': 'Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry', 'timeFrame': '24 Hours', 'description': 'BCEA assessment: areas BCEA 63, BCEA 95'}, {'measure': 'Preferred Retinal Locus (PRL) analysis with microperimetry', 'timeFrame': '24 Hours', 'description': 'PRL assessment: Low-PRL, PRL High'}, {'measure': 'Analysis of the macular integrity (MI) with microperimetry', 'timeFrame': '24 Hours', 'description': 'MI assessment: macular integrity index'}, {'measure': 'Ganglion Cell Layer measurement (GCL: Macular OCT)', 'timeFrame': '24 Hours', 'description': 'Optical Coherence Tomography (OCT) will be used to assess the GCL of patients with multiple sclerosis'}, {'measure': 'Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)', 'timeFrame': '24 Hours', 'description': 'Optical Coherence Tomography (OCT) will be used to assess the RNFL of patients with multiple sclerosis'}, {'measure': 'Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)', 'timeFrame': '24 Hours', 'description': 'Optical Coherence Tomography (OCT) will be used to assess the GCIPL of patients with multiple sclerosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ocular motility disorders', 'eye movement', 'eye tracking', 'microperimetry', 'fixational eye movements', 'visual processing speed', 'optical coherence tomography'], 'conditions': ['Multiple Sclerosis', 'Clinically Isolated Syndrome', 'Relapsing Remitting Multiple Sclerosis', 'Progressive Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Anamnesis, ophthalmological medical history including difficulties in reading with appropriate glasses.\n\nThe following protocol will be applied:\n\n* Comprehensive eye examination\n* Stereopsis\n* Primary gaze position\n* Cover test: far and near\n* Vergence and version eye movements\n* Presence of nystagmus\n* Far and near best corrected visual acuity, with updated refraction\n\n -.Pupillary light reflex\n* Biomicroscopy of the anterior pole\n* Intraocular pressure\n* 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.\n* Visual processing speed\n* Microperimetry\n* Optical coherence tomography\n* Eye fundus\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Control group (healthy volonteers) and patients with Multiple Sclerosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis\n* Best distant corrected visual acuity equal or greater than 0.7 (decimal scale). Glasses or soft contact lenses users.\n* Best close corrected visual acuity equal to or greater than 20/30 (Snellen scale).Glasses or soft contact lenses users.\n\nExclusion Criteria:\n\n* 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.\n* 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)\n* Patients with other ophthalmological diseases that could affect central visual acuity\n* Subjects with high refractive error (+ - 6 diopters).\n* Subjects with other demyelinating disorders (neuromyelitis optica or acute disseminated encephalomyelitis).'}, 'identificationModule': {'nctId': 'NCT05706220', 'briefTitle': 'Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA'}, 'officialTitle': 'Visual Processing Speed and Objective Analysis of Supranuclear Ocular Movements Control in Multiple Sclerosis Patients and Its Relationship With OCT and Reading Difficulties', 'orgStudyIdInfo': {'id': '22-PI045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': '* Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy)\n* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software\n* Visual processing speed\n* Microperimetry\n* Optical coherence tomography', 'interventionNames': ['Diagnostic Test: Eye tracking', 'Diagnostic Test: Microperimetry', 'Diagnostic Test: Optical coherence tomography (OCT)', 'Diagnostic Test: Visual processing speed test']}, {'label': 'Clinically Isolated Syndrome Patients', 'description': '* Ophthalmologic examination\n* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software\n* Visual processing speed\n* Microperimetry\n* Optical coherence tomography\n* Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest)', 'interventionNames': ['Diagnostic Test: Eye tracking', 'Diagnostic Test: Microperimetry', 'Diagnostic Test: Optical coherence tomography (OCT)', 'Diagnostic Test: Visual processing speed test']}, {'label': 'Relapsing-remitting Multiple Sclerosis Patients', 'description': '* Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy)\n* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software\n* Visual processing speed\n* Microperimetry\n* Optical coherence tomography\n* Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest)', 'interventionNames': ['Diagnostic Test: Eye tracking', 'Diagnostic Test: Microperimetry', 'Diagnostic Test: Optical coherence tomography (OCT)', 'Diagnostic Test: Visual processing speed test']}, {'label': 'Primary Progressive Multiple Sclerosis Patients', 'description': '* Ophthalmologic examination (best-corrected visual acuity, cover and uncover tests, slit-lamp biomicroscopy, funduscopy)\n* Eye movement recording with the Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software\n* Visual processing speed\n* Microperimetry\n* Patients with a history of optic neuritis will undergo additional tests at the discretion of the researcher (e.g. visual field, FarnsworthTest)\n* Optical coherence tomography', 'interventionNames': ['Diagnostic Test: Eye tracking', 'Diagnostic Test: Microperimetry', 'Diagnostic Test: Optical coherence tomography (OCT)', 'Diagnostic Test: Visual processing speed test']}], 'interventions': [{'name': 'Eye tracking', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Tobii™ Pro Nano hardware package eye-tracking system and Tobii™ Pro Lab - full edition software'], 'description': 'Eye tracker will be used to evaluate eye movements', 'armGroupLabels': ['Clinically Isolated Syndrome Patients', 'Control group', 'Primary Progressive Multiple Sclerosis Patients', 'Relapsing-remitting Multiple Sclerosis Patients']}, {'name': 'Microperimetry', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Macular Integrity Assessment (MAIA™, Centervue, Padova, Italy)'], 'description': 'Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test', 'armGroupLabels': ['Clinically Isolated Syndrome Patients', 'Control group', 'Primary Progressive Multiple Sclerosis Patients', 'Relapsing-remitting Multiple Sclerosis Patients']}, {'name': 'Optical coherence tomography (OCT)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Cirrus High definition (HD) - OCT 5000® ,Carl Zeiss Meditec, Dublin,California, USA'], 'description': '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', 'armGroupLabels': ['Clinically Isolated Syndrome Patients', 'Control group', 'Primary Progressive Multiple Sclerosis Patients', 'Relapsing-remitting Multiple Sclerosis Patients']}, {'name': 'Visual processing speed test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Visual processing speed test will be used for assessing subject visual stimulus search and reach times.\n\nThirty-two different everyday visual stimuli divided in four complexity groups that were presented along 8 radial visual field positions at three different eccentricities.', 'armGroupLabels': ['Clinically Isolated Syndrome Patients', 'Control group', 'Primary Progressive Multiple Sclerosis Patients', 'Relapsing-remitting Multiple Sclerosis Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47011', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'IOBA - Universidad de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Eugenio Rodríguez Pascual', 'class': 'UNKNOWN'}, {'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}