Validity of low-contrast letter acuity as a visual performance outcome measure for multiple sclerosis

Author:

Balcer Laura J1,Raynowska Jenelle1,Nolan Rachel1,Galetta Steven L1,Kapoor Raju2,Benedict Ralph3,Phillips Glenn4,LaRocca Nicholas5,Hudson Lynn6,Rudick Richard4,

Affiliation:

1. Department of Neurology, New York University School of Medicine, New York, NY, USA

2. National Hospital for Neurology and Neurosurgery, London, UK

3. Department of Neurology, University at Buffalo, Buffalo, NY, USA

4. Biogen, Cambridge, MA, USA

5. National Multiple Sclerosis Society, New York, NY, USA

6. Critical Path Institute, Tucson, AZ, USA

Abstract

Low-contrast letter acuity (LCLA) has emerged as the leading outcome measure to assess visual disability in multiple sclerosis (MS) research. As visual dysfunction is one of the most common manifestations of MS, sensitive visual outcome measures are important in examining the effect of treatment. Low-contrast acuity captures visual loss not seen in high-contrast visual acuity (HCVA) measurements. These issues are addressed by the MS Outcome Assessments Consortium (MSOAC), including representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. MSOAC goals are acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are clinically meaningful. This review shows that MS and disease-free controls have similar median HCVA, while MS patients have significantly lower LCLA. Deficits in LCLA and vision-specific quality of life are found many years after an episode of acute optic neuritis, even when HCVA has recovered. Studies reveal correlations between LCLA and the Expanded Disability Status Score (EDSS), Multiple Sclerosis Functional Composite (MSFC), retinal nerve fiber layer (RNFL) and ganglion cell layer plus inner plexiform layer (GCL + IPL) thickness on optical coherence tomography (OCT), brain magnetic resonance imaging (MRI), visual evoked potential (VEP), electroretinogram (ERG), pupillary function, and King-Devick testing. This review also concludes that a 7-point change in LCLA is clinically meaningful. The overall goal of this review is to describe and characterize the LCLA metric for research and clinical use among persons with MS.

Publisher

SAGE Publications

Subject

Clinical Neurology,Neurology

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