Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: Optic coherence tomography; Diagnostic Test: Pulmonary function test

• Registration Number: NCT03377868
• Lead Sponsor: American University of Beirut Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-16
• Last Update Submitted: 2017-12-16
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19
• Study Start: 2018-01-03
• Primary Completion: 2018-07-28
• Study Completion: 2018-09-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Amyotrophic lateral sclerosis	Pulmonary function test	Patients diagnosed with amyotrophic lateral sclerosis
Control	Optic coherence tomography	Parallel cohort of healthy age and sex matched subjects
Patients with Amyotrophic lateral sclerosis	Optic coherence tomography	Patients diagnosed with amyotrophic lateral sclerosis
Control	Pulmonary function test	Parallel cohort of healthy age and sex matched subjects

Primary Outcome Measures

Name	Time	Method
Change in retinal layer thickness parameters over 3 and 6 months in ALS patients	6 months	Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls	6 month	Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls in micrometers
Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS	6 month	Correlation between changes in retinal layers thickness in micrometers and ALS-FRS scores in ALS patients over 3 and 6 month
Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months	6 month	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