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Kimberly M. Winges, Jack S. Werner, Danielle J. Harvey, Peter A. Calabresi, Laura J. Balcer, Kim E. Cello, Laurel A. Nelson, John L. Keltner; Comparison of Retinal Nerve Fiber Layer Thickness and Macular Thickness/Volume Among Patients with Relapsing-Remitting Multiple Sclerosis: Baseline Data from a Phase 3 Trial of Fingolimod. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5308.
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To document the prevalence of retinal nerve fiber layer thinning in association with macular thinning/volume loss in the relapsing-remitting multiple sclerosis (RRMS) population, and to determine if these associations are significant in corresponding quadrants at baseline.
In compliance with the Declaration of Helsinki, baseline data from a large American phase 3 trial of Fingolimod was used to collect RNFL and macular data for 900 RRMS patients, representing 1800 eyes screened by the UC Davis OCT Reading Center. RNFL and macular thickness/volume were measured and stratified by Stratus OCT algorithms (Carl Zeiss Meditec Inc, Dublin, CA). Results were categorized as "reduced" (less than 1% or 1-5% or normal) or "not reduced" (within limits of or greater than 99% of normal). Macular thickness/volume was compared to RNFL thickness by cross-tabulation. Chi-square tests or Fisher’s exact tests were used to determine statistical significance of any associations, separating right and left eyes.
349 (38.8%) patients demonstrated reduced (<5%) average RNFL thickness (RNFLT) in at least one eye, while 551 (61.2%) were not reduced. 245 (27.2%) patients showed reduced (<5%) total macular volume (TMV) in at least one eye, while 655 (72.8%) were at or above normal. 488 (54.2%) patients had no significant reduction of RNFLT or TMV in either eye. 182 (20.2%) patients demonstrated reduced TMV and RNFLT in at least one eye. 42.8% eyes with reduced RNFLT had reduced TMV. Interestingly, 8.7% eyes without reduction in RNFLT demonstrated reduced TMV. Associations between all anatomically corresponding macula and RNFL quadrant thicknesses were significant (p<0.001).
RNFL and macular thinning/volume loss are linked significantly and anatomically in the RRMS baseline patient population. Documenting the prevalence and distribution of these structural abnormalities suggests new retinal areas to probe for functional vision changes in MS.
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