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

February 25, 2019 updated by: Jose Luis Urcelay Segura
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

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Amyotrophic lateral sclerosis patients Friedreich's ataxia patients Healthy volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ALS patients
Friedreich Ataxia patients
Healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Luis Urcelay Segura

Investigators

  • Principal Investigator: Jose L Urcelay, PhD, Hgu Gregorio Maranon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELA-AF-OCT-2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe