Study to Assess OCT: RNFL and GCL in MS Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• United States
  • Florida
    • New Port Richey, Florida, United States, 34655
      • Tampa Bay Uveitis Center
    • Tampa, Florida, United States, 33618
      • Tampa Bay Uveitis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 30, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: TBUC10022017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No