An observational study in Multiple Sclerosis, sponsored by Tampa Bay Uveitis Center, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Tampa Bay Uveitis Center, LLC · Observational
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.
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:
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
The study population will include patients meeting the diagnostic criteria of multiple sclerosis. Patients will be 18 years or older and pregnant women will be excluded. male and fmale patients will be recruited.
Exclusion Criteria:
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
Optical Coherence Tomography (OCT) will be used to assess change in RNFL of patients with multiple sclerosis
Time frame: Assessed at Baseline then 6, 12, 18 and 24-month time points
Ganglion Cell Layer measurement (GCL: Macular OCT)
Optical Coherence Tomography (OCT) will be used to assess change in GCL of patients with multiple sclerosis
Time frame: Assessed at Baseline then 6, 12, 18 and 24 - month time points
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Tampa Bay Uveitis Center, LLC