Clinical trial NCT03377868: Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
Official title: Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in retinal layer thickness parameters over 3 and 6 months in ALS patients
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls
timeFrame: 6 month
measure: Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS
timeFrame: 6 month
measure: Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
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