Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Eye tracking, Microperimetry, Optical coherence tomography (OCT), Visual processing speed test.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Visual Processing Speed and Objective Analysis of Supranuclear Ocular Movements Control in Multiple Sclerosis Patients and Its Relationship With OCT and Reading Difficulties
Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест Eye tracking
Eye tracker will be used to evaluate eye movements - Диагностический тест Microperimetry
Perimetric examination with Expert Exam strategy Microperimetry be used for fixation test - Диагностический тест 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 - Диагностический тест 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.
Первичные конечные точки
- Eye Tracking Data [Срок оценки: 24 Hours]
- Values for Visual Processing Speed (VPS) [Срок оценки: 24 Hours]
- Retinal sensitivity assessed by microperimetry [Срок оценки: 24 Hours]
- Values for OCT neuroretinal and peripapillary parameters [Срок оценки: 24 Hours]
Вторичные конечные точки (9)
- Fixations recorded with the eye tracker system [Срок оценки: 24 Hours]
- Saccades recorded with the eye tracker system [Срок оценки: 24 Hours]
- Fixation assessment with microperimetry [Срок оценки: 24 Hours]
- Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry [Срок оценки: 24 Hours]
- Preferred Retinal Locus (PRL) analysis with microperimetry [Срок оценки: 24 Hours]
- Analysis of the macular integrity (MI) with microperimetry [Срок оценки: 24 Hours]
- Ganglion Cell Layer measurement (GCL: Macular OCT) [Срок оценки: 24 Hours]
- Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT) [Срок оценки: 24 Hours]
- Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL) [Срок оценки: 24 Hours]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Испания · 1 центр
- IOBA - Universidad de Valladolid — Valladolid
Идентификаторы
NCT: NCT05706220 · 22-PI045