Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia
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ClinicalTrials.gov Identifier: NCT03285204 |
Recruitment Status : Unknown
Verified April 2018 by Jose Luis Urcelay Segura, Hospital General Universitario Gregorio Marañon.
Recruitment status was: Recruiting
First Posted : September 15, 2017
Last Update Posted : February 26, 2019
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Condition or disease |
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Amyotrophic Lateral Sclerosis |
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia |
Actual Study Start Date : | July 2015 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | February 2020 |

Group/Cohort |
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ALS patients |
Friedreich Ataxia patients |
Healthy control |
- early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia [ Time Frame: change from baseline to 6 month ]macular, ganglion cell layer and retinal nerve fiber layer thickness measure

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285204
Contact: Pilar Rojas, MD | +34616042758 | pilar.rojas.lozano@gmail.com |
Spain | |
Pilar Rojas Lozano | Recruiting |
Madrid, Spain, 28010 | |
Contact: Pilar Rojas Lozano +34616042758 pilar.rojas.lozano@gmail.com |
Principal Investigator: | Jose L Urcelay, PhD | HGU Gregorio Marañón |
Responsible Party: | Jose Luis Urcelay Segura, Head Of ophthalmology, Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT03285204 |
Other Study ID Numbers: |
ELA-AF-OCT-2014-01 |
First Posted: | September 15, 2017 Key Record Dates |
Last Update Posted: | February 26, 2019 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
optical coherence tomography amyotrophic lateral sclerosis |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Vision Disorders Vision, Low Friedreich Ataxia Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases |
TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Neurologic Manifestations Sensation Disorders Eye Diseases Spinocerebellar Degenerations Cerebellar Diseases Brain Diseases Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mitochondrial Diseases |