NCT03377868

Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Optic coherence tomography	Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
DIAGNOSTIC_TEST	Pulmonary function test	Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.

Timeline

• Start date: 2018-01-03
• Primary completion: 2018-07-28
• Completion: 2018-09-28
• First posted: 2017-12-19
• Last updated: 2017-12-19