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Clinical Trials, Vol. 4, No. 6, 650-660 (2007)
DOI: 10.1177/1740774507085274

The Veterans Affairs Low Vision Intervention Trial (LOVIT): Design and Methodology

Joan A Stelmack

Blind Rehabilitation Center, Edward E. Hines Jr. Veterans Affairs Hospital, Hines, IL, USA, Illinois College of Optometry, Chicago, IL, USA, Department of Ophthalmology and Visual Science, University of Illinois at Chicago, School of Medicine, Chicago, IL, USA, Joan.Stelmack{at}med.va.gov

X. Charlene Tang

Veterans Affairs Cooperative Studies Program Coordinating Center, Edward Hines Jr. Veterans Affairs Hospital, Hines, IL, USA

Domenic J. Reda

Veterans Affairs Cooperative Studies Program Coordinating Center, Edward Hines Jr. Veterans Affairs Hospital, Hines, IL, USA

D'Anna Moran

Blind Rehabilitation Center, Edward E. Hines Jr. Veterans Affairs Hospital, Hines, IL, USA

Stephen Rinne

Blind Rehabilitation Center, Edward E. Hines Jr. Veterans Affairs Hospital, Hines, IL, USA

Rickilyn M. Mancil

Vision Rehabilitation Research Laboratory, W. G. Hefner VA Medical Center, Salisbury, North Carolina, USA

Roger Cummings

Vision Rehabilitation Research Laboratory, W. G. Hefner VA Medical Center, Salisbury, North Carolina, USA

Gary Mancil

Vision Rehabilitation Research Laboratory, W. G. Hefner VA Medical Center, Salisbury, North Carolina, USA

Kevin Stroupe

Veterans Affairs Cooperative Studies Program Coordinating Center, Edward Hines Jr. Veterans Affairs Hospital, Hines, IL, USA

Nancy Ellis

Veterans Affairs Cooperative Studies Program Coordinating Center, Edward Hines Jr. Veterans Affairs Hospital, Hines, IL, USA

Robert W. Massof

Johns Hopkins Wilmer Eye Institute, Baltimore MD, USA

Background Visual impairment is a major public health problem. Vision rehabilitation programs have the potential to restore independence and improve quality of life for persons with permanent vision loss, and few have been evaluated in randomized controlled trials.

Purpose The Veterans Affairs (VA) Low Vision Intervention Trial is a multicenter randomized clinical trial to evaluate the effectiveness of a new outpatient low vision rehabilitation program.

Methods 126 patients with moderate and severe vision loss due to macular diseases are randomized to low vision treatment in an outpatient setting or a usual care control group at two VA facilities in Hines, Illinois, and Salisbury, North Carolina. The primary outcome is the change in visual reading ability from baseline to four months measured with the Veterans Affairs Low Vision Visual Functioning Questionnaire-48 (VA LV VFQ-48). Secondary outcomes compare the mean change in visual ability measured with the VA LV VFQ-48 (overall ability, mobility, visual information processing, visual motor skills) for the treatment and control groups. Costs and cost effectiveness of outpatient treatment are evaluated.

Results The low vision rehabilitation setting, use of a waiting list control group to address ethical issues, development of the treatment protocol, development of a vision function questionnaire for patients to self-report the difficulty they experience performing daily activities, and the use of Rasch analysis to develop and estimate this outcome measure are described.

Limitations If the new low vision rehabilitation program is proven effective, studies will be needed to determine which of the multiple aspects of the intervention are necessary and sufficient.

Conclusions 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. Clinical Trials 2007; 4: 650—660. http://ctj.sagepub.com

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 Arch OphthalmolHome page
J. A. Stelmack, X. C. Tang, D. J. Reda, S. Rinne, R. M. Mancil, R. W. Massof, and for the LOVIT Study Group
Outcomes of the Veterans Affairs Low Vision Intervention Trial (LOVIT)
Arch Ophthalmol, May 1, 2008; 126(5): 608 - 617.
[Abstract] [Full Text] [PDF]

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