Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis

December 16, 2017 updated by: Achraf Makki, American University of Beirut Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with Amyotrophic lateral sclerosis
Patients diagnosed with amyotrophic lateral sclerosis
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.
Other: Control
Parallel cohort of healthy age and sex matched subjects
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in retinal layer thickness parameters over 3 and 6 months in ALS patients
Time Frame: 6 months
Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 3, 2018

Primary Completion (Anticipated)

July 28, 2018

Study Completion (Anticipated)

September 28, 2018

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 16, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 16, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM.AS.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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