Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia
研究概览
简要总结
The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up the patient with optic coherence tomography, a fast, non-invasive and comfortable method
详细描述
All patients will be asked about their data and their general medical history, and will be underwent on one hand, a complete neurological examination including the degree of neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r) or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a complete ophthalmological examination too, including the patient's graduation, pupillary and ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell 28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see possible anatomical alterations in both macula and optic nerve. The follow-up of these explorations will be repeated in all cases at 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 18 years.
- •Best corrected visual acuity more than 0.4 (20/50 Snellen = 0.4 logMAR = 65 ETDRS letters).
- •Refractive defect less than 5 diopters of spherical equivalent and / or cylinder less than 2 diopters.
- •Transparent optical media: Opacity of crystalline <1 according to Lens Opacities Classification System (LOCS) III.
- •Open anterior chamber angle assessed by gonioscopy with Goldmann lens (grade> III).
- •Availability and collaboration to carry out the tests of the exploratory protocol.
- •Acceptance of informed consent.
排除标准
- •Previous intraocular surgeries of less than 6 months of evolution. Patients with refractive surgery using the LASIK or LASEK technique will not be excluded.
- •Physical or mental difficulties to perform reliable and reproducible perimeters.
- •Pathology and / or ocular malformations, angular or optic nerve anomalies.
- •Any retinopathy or maculopathy.
- •Intraocular pressure (IOP)> 21 mmHg.
- •Signal-to-noise ratio in OCT less than 5/
- •Failure to meet any inclusion criteria.
- •Mental retardation or any other limitation in obtaining informed consent.
结局指标
主要结局
early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia
时间窗: change from baseline to 6 month
macular, ganglion cell layer and retinal nerve fiber layer thickness measure
次要结局
未报告次要终点
研究者
Jose Luis Urcelay Segura
Head Of ophthalmology
Hospital General Universitario Gregorio Marañon