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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
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 6, 2017
    Last Updated
    December 16, 2017
    Sponsor
    American University of Beirut Medical Center
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    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

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    Citation
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    Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

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