Significance
This pilot randomized trial, the first to evaluate a specific base-in relieving prism treatment strategy for childhood intermittent exotropia, did not support proceeding to a full-scale clinical trial. Defining and measuring prism adaptation in children with intermittent exotropia is challenging and needs further study.
Purpose
Determine whether to proceed to a full-scale trial of relieving base-in prism spectacles versus refractive correction alone for children with intermittent exotropia.
Methods
Children 3- to <13-years-old with distance intermittent exotropia control score of ≥2 points on the Intermittent Exotropia Office Control Scale1 (0 = phoria to 5 = constant), ≥1 episode of spontaneous exotropia,16–35∆ by prism-and-alternate-cover test, who did not fully prism adapt on a 30-minute in-office prism-adaptation test were randomized to base-in relieving prism (40% of the larger of distance and near exodeviations) or non-prism spectacles for 8 weeks. A priori criteria to conduct a full-scale trial were defined for the adjusted treatment group difference in mean distance control: “proceed” (≥ 0.75 points favoring prism), “uncertain” (> 0 to <0.75 points favoring prism), or “do not proceed" (≥ 0 points favoring non-prism).
Results
57 children (mean age 6.6 ± 2.2 years; mean baseline distance control 3.5 points) received prism (N = 28) or non-prism (N = 29) spectacles. At 8-weeks, mean control was 3.6 and 3.3 points in prism (N = 25) and non-prism (N = 25) groups, respectively; adjusted difference 0.3 points (95% confidence interval -0.5 to 1.1) favoring non-prism (meeting our a priori “do not proceed” criterion).
Conclusions
Base-in prism spectacles, equal to 40% of the larger of the exodeviations at distance or near, worn for 8 weeks by 3- to 12-year-old children with intermittent exotropia did not yield better distance control than refractive correction alone, with the confidence interval indicating a favorable effect of 0.75 points or larger is unlikely. There was insufficient evidence to warrant a full-scale randomized trial.