JAMA Ophthalmology Journal Club Slides: Outcomes of the Veterans Affairs Low Vision Intervention Trial II Stelmack JA, Tang XC, Wei Y, et al; LOVIT II Study Group. Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): a randomized clinical trial. JAMA Ophthalmol. Published online December 15, 2016. doi:10.1001/jamaophthalmol.2016.4742

Introduction Importance: Randomized clinical trials are needed to compare the effectiveness and cost-effectiveness of different low-vision (LV) programs, guide policy, and identify individuals who benefit most from different services. Objective: To determine if providing LV devices with LV rehabilitation (including therapy and homework on the use of LV devices, eccentric viewing, and environmental modification) is more effective for patients with macular diseases and best-corrected distance visual acuity better seeing eye (BCDVAbetter-eye) of 20/50 to 20/200 than providing basic LV services (LV devices without homework or therapy).

Methods Design, Setting, and Participants: 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 Main Outcomes and Measures: 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). Limitations: The LOVIT studies were conducted in the Veterans Affairs system where veterans are eligible for LV services and provided LV devices without charge. The primary weakness is that study results cannot be generalized to the US private sector where Medicare covers LV therapy prescribed by physicians and provided by occupational therapy, but does not cover the cost of LV devices.

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..

Results A comparison of the mean changes in primary and secondary outcomes was made in logits from baseline to 4 months between the treatment groups. A 0.14-logit change in visual ability corresponds to the ability change expected from a 1-line change in visual acuity. Compared with those in the LV group who received basic services, patients in the LV rehabilitation group who received basic LV services plus LV rehabilitation reported greater improvement in visual ability (reading, visual information processing, visual motor skills, and overall). Within groups, improvement was found in all functional domains and overall visual ability in the LV rehabilitation group and for all functional domains and overall visual ability except mobility in the basic LV group. The outcomes comparisons between the treatment groups were not altered after adjusting for all covariates (n = 272).

Results A subgroup analyses was based on the preplanned stratification by BCDVAbetter-eye. Patients with BCDVAbetter-eye worse than 20/63 to 20/200 assigned to the LV rehabilitation group who received basic LV plus LV rehabilitation experienced more improvement in visual ability (reading, visual motor, and overall) than those assigned to basic LV services. There was no difference in outcomes between treatment groups for patients with BCDVAbetter-eye 20/50 to 20/63. Compared with patients with worse visual acuity, those with better BCDVAbetter-eye received fewer anti-VEGF injections in the year before the study (35 [26.5%] vs 78 [40.8%]; P = .005); they had fewer central or juxtafixational scotomas (48 [44.9%] vs 125 [74.0%]; P < .001), higher contrast sensitivity (1.2 [0.8%] vs 1.0 [0.7%]; P = .04), and better MNREAD reading performance measures (reading acuity, 0.65 logMAR vs 1.03 logMAR; P < .001; maximum reading speed, 142.6 vs 94.8 words/min; P < .001; critical print size, 1.09 logMAR vs 1.31 logMAR; P = .03). In addition, patients with better BCDVAbetter-eye were prescribed fewer desktop electronic magnifiers (20 [15.2%] vs 87 [45.5%]; P < .001) or portable video magnifiers (28 [21.2%] vs 68 [35.6%]; P = .004).

Results Mean Changes in MNREAD Measures for All Patients

Comment This trial demonstrated that both basic LV services and basic LV services plus LV rehabilitation provided for veterans with macular diseases, most of whom were white, male, and covered by Medicare, had improved visual ability (reading, visual information processing, visual motor skills, and overall) at 4-month follow-up. Basic LV services plus LV rehabilitation also improved mobility. In preplanned stratified analyses, visual ability (reading, visual motor skills, and overall) improved more in the LV rehabilitation group than in the basic LV services group for patients with BCDVAbetter-eye worse than 20/63 to 20/200; there were no differences between treatment groups for those with BCDVAbetter-eye 20/50 to 20/63. There were differences in the number of anti-VEGF injections received in the year before the study, contrast sensitivity, presence of central or juxtafixational scotomas, and LV devices prescribed between the stratified groups. These results led us to conclude that patients with mild LV (20/50 to 20/63) benefit from basic LV services except for mobility but gain no additional benefit from LV rehabilitation, whereas patients with moderate LV (worse than 20/63 to 20/200), also with the exception of mobility, benefit from basic LV services but gain even greater benefit with the addition of LV rehabilitation.

Conflict of Interest Disclosures Contact Information If you have questions, please contact the corresponding author: Joan Stelmack, OD, MPH, Blind Rehabilitation Center, Edward Hines Jr. Veterans Affairs Hospital (Mail Stop 124), 5000 S Fifth Ave, Hines, IL 60141 (joan.stelmack@va.gov). Funding/Support Funding for this research was provided by Department of Veterans Affairs Rehabilitation Research and Development grant C6958R. Funding for the low-vision devices prescribed and dispensed to veteran participants was provided by the Department of Veterans Affairs Prosthetics Service. Conflict of Interest Disclosures None reported.