Objective: To evaluate concurrent and predictive validity for low-contrast le tter acuity (L-CLA) testing as a candidate visual component for the multiple Sc lerosis Functional Composite (mSFC). methods: L-CLA testing...
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Objective: To evaluate concurrent and predictive validity for low-contrast le tter acuity (L-CLA) testing as a candidate visual component for the multiple Sc lerosis Functional Composite (mSFC). methods: L-CLA testing was conducted in tw o mS patient cohorts. In the mSFC Validation Study, 137 participants from a Phas e III trial of inteferon beta-1a (Avonex) for relapsing-remitting mS were foll owed. A second cohort included 65 patients with secondary progressive mS who par ticipated in a substudy of the International mS Secondary Progressive Avonex Con trolled Trial (ImPACT). The total number of letters read correctly at four contr ast levels (100, 5, 1.25, and 0.6%) was correlated with Expanded Disability Sta tus Scale (EDSS), mSFC, Sickness Impact Profile, multiple Sclerosis Quality of L ife Inventory, and brain parenchymal fraction (BPF), as determined by mRI. Resul ts: Low-and high-contrast letter acuity scores correlated with BPF at follow- up in the mSFC Validation Study (5%: r=0.40, p mSFC (5%: r=0.47, p mPACT Substudy, change in L-CLA scores from baseline to year 1 predicted s ubsequent change in the EDSS from year 1 to 2 at the 5%(p=0.0142) and the 1.25 %(p=0.0038) contrast levels, after adjusting for change in mSFC scores from bas eline to year 1. Conclusions: Low-contrast letter acuity (L-CLA) scores demons trate concurrent and predictive validity in patients with relapsing-remitting a nd secondary progressive multiple sclerosis (mS). L-CLA testing provides additi onal information relevant to the mS disease process that is not entirely capture d by the multiple Sclerosis Functional Composite.
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