Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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Amyotrophic Lateral Sclerosis (ALS) is an adult-onset, devastating, neurodegenerative disease characterized by the loss of cortical, brain stem, and spinal motor neurons. Visual evoked potentials studies in patients with ALS suggest visual pathway involvement. Optic coherence tomography (OCT) is a non-invasive cross-sectional imaging modality measuring the optical reflections in biological tissues. The main objective of this observational cohort study is to explore the correlation between changes on OCT retinal parameters and and clinical disability as measured by the ALS Functional Rating Scale (ALS-FRS-r) in patients with ALS at baseline, 3 and 6 months. A secondary objective is to explore the correlation between changes in retinal OCT parameters and pulmonary function tests (FVC and FEV1) in this cohort of patients with ALS. A parallel cohort of healthy age and sex matched subjects will participate as controls to obtain reference values of their retinal layers' thickness at baseline, 3 and 6 months.

Official Title
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Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Diagnostic Test: Optic coherence tomography
* Diagnostic Test: Pulmonary function test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ALS according to the El Escorial criteria. Age 18 years to 80 years old Disease duration less than 36 months Patients logistically able to attend and be evaluated at baseline, 3 and 6 months Exclusion Criteria: Patients with diabetes mellitus Patients with glaucoma, refractive errors of ± 6 diopters or more, or other ophthalmologic disorders such as media opacities that could interfere with retinal OCT assessment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Observational study of a cohort of patients with amyotrophic lateral sclerosis compared to a parallel cohort of healthy age and sex matched subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Amyotrophic lateral sclerosis<br>Patients diagnosed with amyotrophic lateral sclerosis | Diagnostic Test: Optic coherence tomography<br>* Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.<br>Diagnostic Test: Pulmonary function test<br>* Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.<br>|
| Other: Control<br>Parallel cohort of healthy age and sex matched subjects | Diagnostic Test: Optic coherence tomography<br>* Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.<br>Diagnostic Test: Pulmonary function test<br>* Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal layer thickness parameters over 3 and 6 months in ALS patients | Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls | Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls in micrometers | 6 month | 
| Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS | Correlation between changes in retinal layers thickness in micrometers and ALS-FRS scores in ALS patients over 3 and 6 month | 6 month | 
| Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months | Correlation between changes in retinal layers thickness parameters in micrometers and changes in FEV1 in liters and FVC in liters on pulmonary function testing in patients with ALS over 3 and 6 month | 6 month |