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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
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
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 6 month
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