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Study to Assess OCT: RNFL and GCL in MS Patients

Sponsor
Tampa Bay Uveitis Center, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT03313843
Collaborator
(none)
73
Enrollment
2
Locations
38.6
Actual Duration (Months)
36.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. The same system will be used consistently for the duration of the study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypothesis: Multiple sclerosis results in axonal degeneration which can be assessed objectively and non-invasively by serial OCT measurements of the RNFL and GCL.

    This will be a prospective cross-sectional, non-interventional study; total recruitment will be 200 subjects. Recruitment will be stratified to enroll at least 50 subjects currently taking Lemtrada and 50 subjects with a documented diagnosis of ON. The study will enroll subjects primarily from practices in the Tampa Bay Area and adjacent counties. It is a planned non-interventional study; subjects will be followed by their neurologist and the study ophthalmologist and will receive standard of care. All subjects will have the ophthalmological examination and diagnostic measures, by the Principal Investigator, Dr. Grace Levy-Clarke, at Tampa Bay Uveitis Center.

    Study Duration: The study duration will be 24 months, with an interim analysis at 50% recruitment status.

    There are two primary aims of this longitudinal observational study:

    1. To determine whether atrophy within specific retinal layers over time is associated with clinical neurological progression of MS

    2. To determine whether an ON history affects the relationship described in aim # 1

    Eye Exam: Subject will have an eye exam, including:

    Visual Acuity Testing Color Vision Testing Automated perimetry/Peripheral Vision Testing Completing the National Eye Institute Visual Functioning Questionnaire (NEI/VFQ) Slit Lamp Examination Measurement of Intraocular Pressure (IOP) Dilated Fundus Examination (Ophthalmoscopy) Fundus Photography Optical Coherence Tomography: RNFL and Macular OCT

    Neurologic Assessments: Must be performed no more than 60 days prior to screening/assessment Day 0 Ophthalmic Assessments

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    73 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Cross Sectional Study To Assess The Clinical Utility of Optical Coherence Tomography to Measure Axonal Degeneration of the Optic Nerve, in a Cohort of 200 Subjects Meeting the Diagnostics Criteria of Multiple Sclerosis
    Actual Study Start Date :
    Feb 9, 2018
    Actual Primary Completion Date :
    Dec 17, 2020
    Actual Study Completion Date :
    Apr 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT) [Assessed at Baseline then 6, 12, 18 and 24-month time points]

      Optical Coherence Tomography (OCT) will be used to assess change in RNFL of patients with multiple sclerosis

    Secondary Outcome Measures

    1. Ganglion Cell Layer measurement (GCL: Macular OCT) [Assessed at Baseline then 6, 12, 18 and 24 - month time points]

      Optical Coherence Tomography (OCT) will be used to assess change in GCL of patients with multiple sclerosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 or older

    • Pregnant women will be excluded by self declaration

    • Male or female

    • A diagnosis of MS, that meets the 2010 Revised McDonald Diagnostic Criteria

    • A visual acuity of 20/400 or better in at least one eye

    Exclusion Criteria:

    • Any ocular disease than prevents assessment of the optic nerve and macula by OCT

    • Advance glaucoma with optic nerve damage

    • Any optic neuropathy not diagnosed as ON associated with MS

    • A diagnosis of Macular Degeneration

    • Any previous ocular trauma

    • Any medical history of a cerebrovascular accident

    • Any planned ocular or systemic elective surgery during study duration

    • Any contraindication to a comprehensive dilated ophthalmic examination

    • Inability to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampa Bay Uveitis Center New Port Richey Florida United States 34655
    2 Tampa Bay Uveitis Center Tampa Florida United States 33618

    Sponsors and Collaborators

    • Tampa Bay Uveitis Center, LLC

    Investigators

    • Principal Investigator: Grace Levy-Clarke, M.D., Tampa Bay Uveitis Center, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tampa Bay Uveitis Center, LLC
    ClinicalTrials.gov Identifier:
    NCT03313843
    Other Study ID Numbers:
    • TBUC10022017
    First Posted:
    Oct 18, 2017
    Last Update Posted:
    Jun 2, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tampa Bay Uveitis Center, LLC
    Optical Coherence Tomography
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jun 2, 2021