Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedr… (NCT03285204) | Clinical Trial Compass
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.
1This study is looking at the relationship between neurological disability and visual impairment in ALS — can you explain what kinds of vision-related tests or measurements this trial would involve, and whether any of them would be uncomfortable or burdensome for me given my current symptoms?
2Since this trial is listed as 'Phase NA,' it sounds like it's an observational study rather than a treatment trial — does that mean participating wouldn't change my actual ALS care in any way, and what would I actually gain from being involved?
3The study is trying to find early biomarkers for ALS using visual measurements — would any data collected from me during this study be shared back with you or my care team in a way that could be useful for tracking my condition?
4The recruitment status for this trial is listed as 'unknown,' so can you help me find out whether it is still actively enrolling patients and, if not, whether there are similar observational studies I could consider instead?
5Given that this is a biomarker study and not a treatment trial, would you recommend I prioritize looking into treatment-focused trials for ALS first, or is there a reason participating in observational research like this might still make sense for my situation right now?
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
1
early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia