To evaluate the effectiveness of a lowvision rehabilitation program.Methods: A multicenter randomized clinical trial was conducted from November 2004 to November 2006 with a 4-month follow-up. A total of 126 patients were included, 98% of whom were white and male. The patients were referred from eye or low-vision clinics and blind rehabilitation centers with a visual acuity in the better-seeing eye worse than 20/100 and better than 20/500 and were eligible for Veterans Affairs (VA) services. Telephone interviews of patients were conducted in their homes before and after participation in an outpatient low-vision program at a VA medical care facility or a (waiting list) control group. The interviewer administering questionnaires by telephone was masked to patients' assignments. Interventions included low-vision examination, counseling, and prescription and provision of low-vision devices and 6 weekly sessions provided by a low-vision therapist to teach use of assistive devices and adaptive strategies to perform daily living tasks independently.Main Outcome Measure: Change in patients' visual reading ability estimated from participant responses to the Veterans Affairs Low-Vision Visual Functioning Questionnaire (LV VFQ-48) reading items completed at baseline compared with 4 months after enrollment for the treatment and control groups. The secondary outcomes were changes in other visual ability domains (mobility, visual information processing, visual motor skills) and overall vi-sual ability from baseline to 4 months estimated from VA LV VFQ-48 difficulty ratings for subsets of items.Results: The treatment group demonstrated significant improvement in all aspects of visual function compared with the control group. The difference in mean changes was 2.43 logits (95% confidence interval [CI], 2.07-2.77; P Ͻ.001; effect size, 2.51) for visual reading ability; 0.84 logit (95% CI, 0.58-1.10; P Ͻ .001; effect size, 1.14) for mobility; 1.38 logits (95% CI, 1.15-1.62; PϽ.001; effect size, 2.03) for visual information processing; 1.51 logits (95% CI, 1.22-1.80; P Ͻ .001; effect size, 1.82) for visual motor skills; and 1.63 logits (95% CI, 1.40-1.86; P Ͻ .001; effect size, 2.51) for overall visual function. Conclusion:The program effectively provided lowvision rehabilitation for patients with macular diseases.Applications to Clinical Practice: At least 10 hours of low-vision therapy, including a home visit and assigned homework to encourage practice, is justified for patients with moderate and severe vision loss from macular diseases. Because the waiting-list control patients demonstrated a decline in functional ability, low-vision services should be offered as early as possible.

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The challenges of conducting clinical trials in a rehabilitation setting and use of a waiting list (deferred treatment) control group extend beyond LOVIT. The design and methods of LOVIT may be applicable to other trials of rehabilitation services and to outcomes for which reliable and valid measurement tools must be developed.

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.