VA Low Vision Intervention Trial (LOVIT) II

Edward Hines Jr Va Hospital, Hines IL

Investigators

Abstract

Abstract VA estimates that there are more than 1 million visually impaired veterans over the age of 45 in the U.S. (157,000 with legal blindness and 1,026,000 with low vision not severe enough to be classified as legally blind).Visual impairments often limit a person's ability to function in everyday life, hindering performance of simple every day tasks and increasing risks of injury, a decline of general health, lower self esteem or depression. Rehabilitation programs have the potential to restore independence for such people and improve their quality of life. In January, 2007 VA Secretary Nicholson announced a $40 million dollar plus program to establish a comprehensive nationwide rehabilitation system called the Continuum of Care for Visually Impaired Veterans designed to enhance inpatient services provided by the VA blind rehabilitation centers and expand outpatient low vision and blind rehabilitation services. Outcomes research is needed to evaluate the effectiveness of the new Continuum of Care service delivery models. The proposed single-masked, multicenter, randomized, controlled trial conducted at 5 VA sites will determine if the Interdisciplinary Team Model of low vision service delivery (services provided by optometrist and low vision therapist including: low vision examination, low vision therapy to improve use of remaining vision and low vision devices, structured homework to practice use of low vision devices and provision of low vision devices) is more effective in improving visual reading ability for 330 veterans with macular diseases and best corrected distance visual acuity of 20/50-20/100 than the Basic Low Vision Service (optometrist alone providing low vision examination and provision of low vision devices with demonstration of their use and maintenance). Effectiveness will be measured with the Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48), a valid and reliable instrument that is administered by telephone to measure changes in patients' self-reported difficulty reading and performing other daily living activities before and after rehabilitation. Primary analysis will compare the mean changes in VA LV VFQ-48 visual reading ability scores between treatment and control groups using a t-test for independent groups. Secondary analysis will compare the mean changes in other visual ability measures (mobility, visual information processing, visual motor skills and overall visual ability) in the treatment and control groups using t-tests for independent groups with correction for multiple statistical comparisons. Costs and consequences of the two programs will be compared. Multiple linear regressions will be used to determine if changes in visual ability can be predicted by measures of visual impairment, life state, age or functional status.