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From the Division of Neuro-Ophthalmology, Departments of Neurology (Drs. Balcer, Nano–Schiavi, Pfohl, Mills, Markowitz, Jacobs, and Galetta) and Ophthalmology (Drs. Balcer, Ying, Galetta, and Maguire), University of Pennsylvania School of Medicine, Philadelphia; Center for Research Methodology and Biometrics (Drs. Baier and Cutter), AMC Cancer Research Center, Lakewood, CO; Mellen Center for Multiple Sclerosis Treatment and Research (Dr. Cohen), Department of Neurology, Cleveland Clinic Foundation, OH; Biogen, Inc. (Drs. Kooijmans and Sandrock), Cambridge, MA; Department of Neurology (Dr. Bowen), University of Washington Medical Center, Seattle; Department of Neurology (Dr. Ford), University of New Mexico Health Science Center, Albuquerque; Department of Neurology (Dr. Heidenreich), Medizinische Hochschule, Hannover, Germany; and MS Center at Shepherd Center (Dr. Stuart), Atlanta, GA.
Address correspondence and reprint requests to Dr. L.J. Balcer, Department of Neurology, 3 East Gates, 3400 Spruce St., Philadelphia, PA 19104; e-mail: lbalcer{at}mail.med.upenn.edu
Background: Visual dysfunction is one of the most common causes of disability in multiple sclerosis (MS). The Multiple Sclerosis Functional Composite (MSFC), a new clinical trial outcome measure, does not currently include a test of visual function.
Objective: To examine contrast letter acuity as a candidate visual function test for the MSFC.
Methods: Binocular contrast letter acuity testing (Sloan charts) was performed in a subgroup of participants from the International Multiple Sclerosis Secondary Progressive Avonex Controlled Trial (IMPACT Substudy) and in MS patients and disease-free control subjects from a cross-sectional study of visual outcome measures (Multiple Sclerosis Vision Prospective cohort [MVP cohort]). High-contrast visual acuity was measured in both studies; MVP cohort participants underwent additional binocular testing for contrast sensitivity (Pelli–Robson chart), color vision (D-15 desaturated test), and visual field (Esterman test, Humphrey Field Analyzer II).
Results: Contrast letter acuity (Sloan charts, p < 0.0001, receiver operating characteristic curve analysis) and contrast sensitivity (Pelli–Robson chart, p = 0.003) best distinguished MS patients from disease-free control subjects in the MVP cohort. Correlations of Sloan chart scores with MSFC and Expanded Disability Statue Scale (EDSS) scores in both studies were significant and moderate in magnitude, demonstrating that Sloan chart scores reflect visual and neurologic dysfunction not entirely captured by the EDSS or MSFC.
Conclusions: Among clinical measures, contrast letter acuity (Sloan charts) and contrast sensitivity (Pelli–Robson chart) demonstrate the greatest capacity to identify binocular visual dysfunction in MS. Sloan chart testing also captures unique aspects of neurologic dysfunction not captured by current EDSS or MSFC components, making it a strong candidate visual function test for the MSFC.
Received April 23, 2003. Accepted in final form July 31, 2003.
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