Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03285204
• Other study ID #: ELA-AF-OCT-2014-01
• Status: Recruiting
• Start date: July 2015
• Est. completion date: February 2020

Study information

• Verified date: April 2018
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Pilar Rojas, MD
• Phone: +34616042758
• Email: pilar.rojas.lozano[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 5/10.

• Failure to meet any inclusion criteria.

• Mental retardation or any other limitation in obtaining informed consent.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Friedreich Ataxia
• Motor Neuron Disease
• Sclerosis
• Vision Disorders
• Vision, Low

Locations

Country	Name	City	State
Spain	Pilar Rojas Lozano	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Jose Luis Urcelay Segura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia	macular, ganglion cell layer and retinal nerve fiber layer thickness measure	change from baseline to 6 month