Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optic coherence tomography
Pulmonary function test
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with Amyotrophic lateral sclerosis
Control
Arm Description
Patients diagnosed with amyotrophic lateral sclerosis
Parallel cohort of healthy age and sex matched subjects
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT03377868
First Posted
December 6, 2017
Last Updated
December 16, 2017
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03377868
Brief Title
Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
Official Title
Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2018 (Anticipated)
Primary Completion Date
July 28, 2018 (Anticipated)
Study Completion Date
September 28, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Amyotrophic lateral sclerosis
Arm Type
Other
Arm Description
Patients diagnosed with amyotrophic lateral sclerosis
Arm Title
Control
Arm Type
Other
Arm Description
Parallel cohort of healthy age and sex matched subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
Optic coherence tomography
Intervention Description
Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulmonary function test
Intervention Description
Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
Primary Outcome Measure Information:
Title
Change in retinal layer thickness parameters over 3 and 6 months in ALS patients
Description
Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls
Description
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
Title
Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS
Description
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
Title
Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Achraf Makki, MD
Phone
+9611350000
Ext
7359
Email
am132@aub.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Elia Malek, MD
Email
em26@aub.edu.lb
12. IPD Sharing Statement
Citations:
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Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
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