Visual Processing Speed and Objective Analysis of Supranuclear Ocular Movements Control in Multiple Sclerosis Patients and Its Relationship With OCT and Reading Difficulties
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Values for Visual Processing Speed (VPS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Values for Visual Processing Speed (VPS)
时间窗: 24 Hours
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)
Values for OCT neuroretinal and peripapillary parameters
时间窗: 24 Hours
OCT assessment will be by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans
Eye Tracking Data
时间窗: 24 Hours
Characteristics of eye movements recorded with the eye tracker system during reading tests
Retinal sensitivity assessed by microperimetry
时间窗: 24 Hours
Sensitivity and fixation analysis with microperimetry
次要结局
- Saccades recorded with the eye tracker system(24 Hours)
- Fixation assessment with microperimetry(24 Hours)
- Bivariate Contour Ellipse Area (BCEA) analysis with microperimetry(24 Hours)
- Analysis of the macular integrity (MI) with microperimetry(24 Hours)
- Ganglion Cell Layer measurement (GCL: Macular OCT)(24 Hours)
- Macular ganglion cell-inner plexiform layer thickness measurement (GCIPL)(24 Hours)
- Fixations recorded with the eye tracker system(24 Hours)
- Preferred Retinal Locus (PRL) analysis with microperimetry(24 Hours)
- Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)(24 Hours)