title: Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): A Randomized Clinical Trial.
abstract: OBJECTIVE
  Randomized clinical trials are needed to compare effectiveness and cost-effectiveness of different low-vision (LV) programs.
  
  
  OBJECTIVE
  To determine the value of adding LV rehabilitation with a therapist compared with LV services without intervention.
  
  
  METHODS
  A randomized clinical trial was conducted from September 27, 2010, to July 31, 2014, of 323 veterans with macular diseases and best-corrected distance visual acuity (BCDVAbetter-eye) of 20/50 to 20/200. Masked interviewers administered questionnaires by telephone before and after LV treatment. Using an intention-to-treat design, participants were randomized to receive LV devices with no therapy or LV devices with a rehabilitation therapist providing instruction and homework on the use of LV devices, eccentric viewing, and environmental modification. Visual ability was measured in dimensionless log odds units (logits) (0.14-logit change in visual ability corresponds to ability change expected from a 1-line change in visual acuity).
  
  
  METHODS
  Low-vision devices without therapy and LV devices with therapy.
  
  
  METHODS
  Comparison of changes (baseline to 4 months) in overall visual ability and in 4 functional domains (reading, visual information, visual motor, and mobility) estimated from responses to the Veterans Affairs Low Vision Visual Functioning Questionnaire (higher scores indicates more ability or less difficulty in performing activities), and comparison of MNREAD changes (baseline to end of treatment) in maximum reading speed, critical print size, and reading acuity (higher number indicates lower visual acuity).
  
  
  RESULTS
  Of the 323 participants, 314 were male (97.2%); mean (SD) age, 80 (10.5) years. Basic LV was effective in improving visual ability. However, the LV rehabilitation group improved more in all visual function domains except mobility. Differences were 0.34-logit reading (95% CI, 0.0005 to 0.69; P = .05), 0.27-logit visual information (95% CI, 0.01 to 0.53; P = .04), 0.37-logit visual motor (95% CI, 0.08 to 0.66; P = .01), and 0.27-logit overall (95% CI, 0.06 to 0.49; P = .01). For MNREAD measures, there was more improvement in reading acuity (difference, -0.11 logMAR, 95% CI, -0.15 to -0.07; P < .001) and maximum reading speed (mean increase of 21.0 words/min; 95% CI, 6.4 to 35.5; P = .005), but not critical print size for the LV rehabilitation group (-0.06 logMAR; 95% CI, -0.12 to 0.002; P = .06). In stratified analyses, the LV rehabilitation group with BCDVAbetter-eye worse than 20/63 to 20/200 improved more in visual ability (reading, visual motor, and overall). Differences were 0.56-logit reading ability (95% CI, 0.08-1.04; P = .02), 0.40-logit visual motor (95% CI, 0.03-0.78; P = .04), 0.34-logit overall (95% CI, 0.06-0.62; P = .02). There was no significant difference between treatment groups for those with BCDVAbetter-eye of 20/50 to 20/63.
  
  
  CONCLUSIONS
  Both basic LV alone and combined with LV rehabilitation were effective, but the added LV rehabilitation increased the effect only for patients with BCDVAbetter-eye worse than 20/63 to 20/200. Basic LV services may be sufficient for most LV patients with mild visual impairment.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00958360.
authors.affiliation: Blind Rehabilitation Center, Edward Hines Jr Veterans Affairs Hospital, Hines, Illinois2Department of Ophthalmology and Visual Science, University of Illinois at Chicago School of Medicine, Chicago3Illinois College of Optometry, Chicago.
authors.forename: Joan A
authors.initials: JA
authors.lastname: Stelmack
authors.affiliation: Veterans Affairs Cooperative Studies Program Coordinating Center, Edward Hines Jr. Veterans Affairs Hospital, Hines, Illinois.
authors.forename: X Charlene
authors.initials: XC
authors.lastname: Tang
authors.affiliation: Veterans Affairs Cooperative Studies Program Coordinating Center, Edward Hines Jr. Veterans Affairs Hospital, Hines, Illinois.
authors.forename: Yongliang
authors.initials: Y
authors.lastname: Wei
authors.affiliation: Surgical Service, Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.
authors.forename: Denise Thomas
authors.initials: DT
authors.lastname: Wilcox
authors.affiliation: Rehabilitation Medicine Service, Dayton Veterans Affairs Medical Center, Dayton, Ohio.
authors.forename: Timothy
authors.initials: T
authors.lastname: Morand
authors.affiliation: Surgical Service, William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.
authors.forename: Karen
authors.initials: K
authors.lastname: Brahm
authors.affiliation: Blind Rehabilitation Center, Edward Hines Jr Veterans Affairs Hospital, Hines, Illinois2Department of Ophthalmology and Visual Science, University of Illinois at Chicago School of Medicine, Chicago.
authors.forename: Scott
authors.initials: S
authors.lastname: Sayers
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Massof