IMPORTANCE Binocular amblyopia treatment using contrast-rebalanced stimuli showed promise in laboratory studies and requires clinical trial investigation in a home-based setting.OBJECTIVE To compare the effectiveness of a binocular video game with a placebo video game for improving visual functions in older children and adults. DESIGN, SETTING, AND PARTICIPANTSThe Binocular Treatment of Amblyopia Using Videogames clinical trial was a multicenter, double-masked, randomized clinical trial. Between March 2014 and June 2016, 115 participants 7 years and older with unilateral amblyopia (amblyopic eye visual acuity, 0.30-1.00 logMAR; Snellen equivalent, 20/40-20/200) due to anisometropia, strabismus, or both were recruited. Eligible participants were allocated with equal chance to receive either the active or the placebo video game, with minimization stratified by age group (child, age 7 to 12 years; teenager, age 13 to 17 years; and adult, 18 years and older).INTERVENTIONS Falling-blocks video games played at home on an iPod Touch for 1 hour per day for 6 weeks. The active video game had game elements split between eyes with a dichoptic contrast offset (mean [SD] initial fellow eye contrast, 0.23 [0.14]). The placebo video game presented identical images to both eyes. MAIN OUTCOMES AND MEASURESChange in amblyopic eye visual acuity at 6 weeks. Secondary outcomes included compliance, stereoacuity, and interocular suppression. Participants and clinicians who measured outcomes were masked to treatment allocation. RESULTSOf the 115 included participants, 65 (56.5%) were male and 83 (72.2%) were white, and the mean (SD) age at randomization was 21.5 (13.6) years. There were 89 participants (77.4%) who had prior occlusion. The mean (SD) amblyopic eye visual acuity improved 0.06 (0.12) logMAR from baseline in the active group (n = 56) and 0.07 (0.10) logMAR in the placebo group (n = 59). The mean treatment difference between groups, adjusted for baseline visual acuity and age group, was −0.02 logMAR (95% CI, −0.06 to 0.02; P = .25). Compliance with more than 25% of prescribed game play was achieved by 36 participants (64%) in the active group and by 49 (83%) in the placebo group. At 6 weeks, 36 participants (64%) in the active group achieved fellow eye contrast greater than 0.9 in the binocular video game. No group differences were observed for any secondary outcomes. Adverse effects included 3 reports of transient asthenopia. CONCLUSIONS AND RELEVANCEThe specific home-based binocular falling-blocks video game used in this clinical trial did not improve visual outcomes more than the placebo video game despite increases in fellow eye contrast during game play. More engaging video games with considerations for compliance may improve effectiveness.

Improvements from optical treatment resulted in one-fifth of participants becoming ineligible for the main clinical trial. Studies investigating additional amblyopia therapies must include an appropriate optical treatment only phase and/or parallel treatment group regardless of patient age. Optical treatment of amblyopia in adult patients warrants further investigation.

Aniseikonia is a difference in the perceived size or shape of images between eyes, and can arise from a variety of physiological, neurological, retinal, and optical causes. Aniseikonia is associated with anisometropia, as both anisometropia itself and the optical correction for anisometropia can cause aniseikonia. Image size differences above one to three per cent can be clinically symptomatic. Common symptoms include asthenopia, headache and diplopia in vertical gaze. Size differences of three and more impair binocular visual functions such as binocular summation and stereopsis. Above five per cent of aniseikonia, binocular inhibition or suppression tend to occur to prevent diplopia and confusion. Aniseikonia can be measured using a range of techniques and can be corrected or reduced by prescribing contact lenses or specially designed spectacle lenses. Subjective testing of aniseikonia is the only way to accurately measure the overall perceived amount of aniseikonia. However, currently it is not routinely assessed in most clinical settings. At least two-thirds of patients with amblyopia have anisometropia, thus we may expect aniseikonia to be common in patients with anisometropic amblyopia. However, aniseikonia may not be experienced by the patient under normal binocular viewing conditions if the image from the amblyopic eye is of poor quality or is too strongly suppressed for image size differences to be recognised. This lack of binocular simultaneous perception in amblyopia may also prevent the measurement of aniseikonia, as most common techniques require direct comparisons of images seen by each eye. Current guidelines for the treatment of amblyopia advocate full correction of anisometropia to equalise image clarity, but do not address aniseikonia. Significant image size differences between eyes may lead to suppression and abnormal binocular adaptations. It is possible that correcting anisometropia and aniseikonia simultaneously, particularly at the initial diagnosis of anisometropia, would reduce the need to develop suppression and improve treatment outcomes for anisometropic amblyopia.

BackgroundAdequate fruit and vegetable (F&V) intake is important for disease prevention. Yet, most Americans, especially low-income and racial/ethnic minorities, do not eat adequate amounts. These disparities are partly attributable to food environments in low-income neighborhoods where residents often have limited access to affordable, healthful food and easy access to inexpensive, unhealthful foods. Increasing access to affordable healthful food in underserved neighborhoods through mobile markets is a promising, year-round strategy for improving dietary behaviors and reducing F&V intake disparities. However, to date, there have been no randomized controlled trials studying their effectiveness. The objective of the ‘Live Well, Viva Bien’ (LWVB) cluster randomized controlled trial is to evaluate the efficacy of a multicomponent mobile market intervention at increasing F&V intake among residents of subsidized housing complexes.Methods/DesignOne housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. The intervention group received bimonthly, discount, mobile, fresh F&V markets in conjunction with a nutrition education intervention (two F&V campaigns, newsletters, DVDs and cooking demonstrations) for 12 months. The control group received physical activity and stress reduction interventions. Outcome measures include F&V intake (measured by two validated F&V screeners at baseline, six-month and twelve-months) along with potential psychosocial mediating variables. Extensive quantitative and qualitative process evaluation was also conducted throughout the study.DiscussionModifying neighborhood food environments in ways that increase access to affordable, healthful food is a promising strategy for improving dietary behaviors among low-income, racial and ethnic minority groups at increased risk for obesity and other food-related chronic diseases. Discount, mobile F&V markets address all the major barriers to eating more F&V (high cost, poor quality, limited access and limited time to shop and cook) and provide a year-round solution to limited access to healthful food in low-income neighborhoods. LWVB is the first randomized controlled trial evaluating the effectiveness of mobile markets at increasing F&V intake. If proven efficacious at increasing F&V consumption, LWVB could be disseminated widely to neighborhoods that have low access to fresh F&V.Trials registrationClinicatrials.gov registration number: NCT02669472 First Received: January 19, 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3141-7) contains supplementary material, which is available to authorized users.