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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at Baseline then 6, 12, 18 and 24-month time points |
| Measure | Description | Time Frame |
|---|---|---|
| Ganglion Cell Layer measurement (GCL: Macular OCT) | Optical Coherence Tomography (OCT) will be used to assess change in GCL of patients with multiple sclerosis | Assessed at Baseline then 6, 12, 18 and 24 - month time points |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Grace Levy-Clarke, M.D. | Tampa Bay Uveitis Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa Bay Uveitis Center | New Port Richey | Florida | 34655 | United States | ||
| Tampa Bay Uveitis Center |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Tampa |
| Florida |
| 33618 |
| United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |