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Status unknownNCT03285204Updated Feb 26, 2019

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

An observational study in Amyotrophic Lateral Sclerosis, sponsored by Jose Luis Urcelay Segura. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Jose Luis Urcelay Segura · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • optical coherence tomography
  • amyotrophic lateral sclerosis
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Amyotrophic lateral sclerosis patients Friedreich's ataxia patients Healthy volunteers

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • ALS patients
  • Friedreich Ataxia patients
  • Healthy control
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What researchers measure

Primary outcomes

  1. early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia

    macular, ganglion cell layer and retinal nerve fiber layer thickness measure

    Time frame: change from baseline to 6 month

06

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03285204
Lead sponsor
Jose Luis Urcelay Segura
Responsible party
Jose Luis Urcelay Segura (Head Of ophthalmology, Hospital General Universitario Gregorio Marañon) — Sponsor-investigator
First posted
Sep 15, 2017
Start date
Jul 2015
Primary completion
Jan 2020 (estimated)
Completion
Feb 2020 (estimated)
Last update
Feb 26, 2019

Study contacts

Pilar Rojas, MD
Contact
pilar.rojas.lozano@gmail.com
+34616042758
Jose L Urcelay, PhD
principal investigator · HGU Gregorio Marañón

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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