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Clinical Trials |

Outcomes of the Veterans Affairs Low Vision Intervention Trial (LOVIT)

Joan A. Stelmack, OD, MPH; X. Charlene Tang, MD, PhD; Domenic J. Reda, PhD; Stephen Rinne, MA; Rickilyn M. Mancil, MA; Robert W. Massof, PhD ; LOVIT Study Group
Arch Ophthalmol. 2008;126(5):608-617. doi:10.1001/archopht.126.5.608.
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Objective  To evaluate the effectiveness of a low-vision 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 visual 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 < .001; effect size, 2.51) for visual reading ability; 0.84 logit (95% CI, 0.58-1.10; P < .001; effect size, 1.14) for mobility; 1.38 logits (95% CI, 1.15-1.62; P < .001; effect size, 2.03) for visual information processing; 1.51 logits (95% CI, 1.22-1.80; P < .001; effect size, 1.82) for visual motor skills; and 1.63 logits (95% CI, 1.40-1.86; P < .001; effect size, 2.51) for overall visual function.

Conclusion  The program effectively provided low-vision 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.

Trial Registration  clinicaltrials.gov Identifier: NCT00223756

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Figure 1.

The flow diagram describes the flow of participants through each stage of the Veterans Affairs Low Vision Intervention Trial.

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Figure 2.

Differences in mean changes in reading ability (A), mobility (B), visual information processing (C), visual motor skills (D), and overall visual ability (E) for all patients and within subgroups of patients defined by age, baseline distance visual acuity, and presence or absence of visual fluctuations. The data points represent differences in mean 4-month changes between the treatment and control groups. All patients: n=126; age ≤ 80 y: n=61; age > 80 y: n=65; distance VA ≤ 20/250: n=66; distance VA > 20/250: n=60; no vision fluctuation: n=96; vision fluctuation: n=30. VA indicates visual acuity.

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