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
1 other identifier
observational
73
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedStudy Start
First participant enrolled
February 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJune 2, 2021
May 1, 2021
2.9 years
October 9, 2017
May 30, 2021
Conditions
Keywords
Outcome Measures
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
Assessed at Baseline then 6, 12, 18 and 24-month time points
Secondary Outcomes (1)
Ganglion Cell Layer measurement (GCL: Macular OCT)
Assessed at Baseline then 6, 12, 18 and 24 - month time points
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tampa Bay Uveitis Center
New Port Richey, Florida, 34655, United States
Tampa Bay Uveitis Center
Tampa, Florida, 33618, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grace Levy-Clarke, M.D.
Tampa Bay Uveitis Center, LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2017
First Posted
October 18, 2017
Study Start
February 9, 2018
Primary Completion
December 17, 2020
Study Completion
April 30, 2021
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share