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CompletedNCT03313843Updated Jun 2, 2021

Study to Assess OCT: RNFL and GCL in MS Patients

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
73
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Optical Coherence Tomography
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
73 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

06

Study locations

2 sites
  • Tampa Bay Uveitis Center
    New Port Richey, Florida 34655, United States
  • Tampa Bay Uveitis Center
    Tampa, Florida 33618, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03313843
Lead sponsor
Tampa Bay Uveitis Center, LLC
Responsible party
Sponsor
First posted
Oct 18, 2017
Start date
Feb 9, 2018
Primary completion
Dec 17, 2020
Completion
Apr 30, 2021
Last update
Jun 2, 2021

Study contacts

Grace Levy-Clarke, M.D.
principal investigator · Tampa Bay Uveitis Center, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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