VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision.

PURPOSE To compare the effectiveness of low vision rehabilitation (LVR) and basic low vision (LV) in a single masked multicentre randomised controlled trial (RCT). METHODS Three hundred and thirty patients eligible for US. Veterans Affairs (VA) healthcare services with primary eye diagnosis (better-seeing eye) of macular disease and best-corrected distance visual acuity of 0.40-1.00 logMAR (6/15 to 6/60 or 20/50 to 20/200 Snellen) are being enrolled at seven VA facilities. All participants receive an optometric LV examination; and they are eligible to receive the same LV devices that are provided without charge. In LVR, a LV therapist dispenses devices and provides 2 or 3 (1½ to 2½ h) therapy sessions with assigned homework to teach effective use of remaining vision and LV devices. Contact time with the therapist depends upon the devices prescribed and the patient's progress in learning the skills that are taught. In basic LV, devices are dispensed by the optometrist without LV therapy. Contact time for dispensing is one hour or less depending on LV devices prescribed. The primary outcome measure is a comparison of the changes in visual reading ability (estimated from patients' difficulty ratings of reading items on the VA LV VFQ-48 questionnaire) between the treatment and control arms from pre-intervention baseline to 4 months (2 months after completion of treatment). Secondary outcome measures are changes in overall visual ability, visual ability domain scores calculated from subsets of items (mobility, visual information processing and visual motor skills), Short Form-36, and Minnesota Low Vision Reading Test scores. Cost-effectiveness analysis will be conducted using VA LV VFQ-48 scores and QALYS computed from EuroQol scores. RESULTS A total of 137 patients representing 41.5% of the study target of 330 patients were randomised from October 2010 to March 2012. Among those 137 patients, mean age was 80.2 (S.D. ± 9.9) years at enrollment; 97.1% of the patients were males; 94.2% were white. Mean best corrected VA was 0.65 (S.D. ± 0.3) logMAR (approximately Snellen 6/27 or 20/90) at baseline. CONCLUSIONS LOVIT II is the first multicentre RCT comparing the effectiveness and cost-effectiveness of LVR and basic LV for patients with macular diseases and near normal or moderate levels of visual impairment.