UnknownNot Applicable

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

Spain90 participantsStarted 2015-07

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia

Timeframe: change from baseline to 6 month

Trial details

NCT IDNCT03285204

SponsorJose Luis Urcelay Segura

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01

Contact for this trial

Pilar Rojas, MD

+34616042758 pilar.rojas.lozano@gmail.com

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.