Study Purpose:
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 Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Diagnostic Test
Intervention Name:
Optic coherence tomography, Pulmonary function test
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Achraf Makki, MD / email hidden; JavaScript is required / +9611350000
Study Sponsor:
American University of Beirut Medical Center
Estimated Enrollment:
30
Estimated Study Start Date:
01 / 03 / 2018
Estimated Study Completion Date:
09 / 28 / 2018
Posting Last Modified Date:
12 / 19 / 2017
Date Study Added to neals.org:
12 / 19 / 2017
Minimum Age:
N/A
Maximum Age:
N/A
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