Study Purpose:
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 methodStudy Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jose L Urcelay, PhD, HGU Gregorio Marañón
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Pilar Rojas, MD / email hidden; JavaScript is required / +34616042758
Full Study Summary:
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.
Study Sponsor:
Jose Luis Urcelay Segura
Estimated Enrollment:
90
Estimated Study Start Date:
07 / 01 / 2015
Estimated Study Completion Date:
02 / 01 / 2020
Posting Last Modified Date:
02 / 26 / 2019
Date Study Added to neals.org:
09 / 15 / 2017
Minimum Age:
18 Years
Maximum Age:
N/A
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.
Pilar Rojas Lozano | Recruiting
Pilar Rojas Lozano / +34616042758 / email hidden; JavaScript is required
Madrid 28010
Spain