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Home-Based Therapy for Symptomatic Convergence Insufficiency in Children: A Randomized Clinical Trial

Pediatric Eye Disease Investigator Group

doi: 10.1097/OPX.0000000000000975
Feature Article - Public Access

Purpose: To compare the effectiveness of home-based (HB) computer vergence/accommodative therapy (HB-C) to HB near target push-up therapy (HB-PU) and to HB placebo treatment (HB-P) among children aged 9 to <18 years with symptomatic convergence insufficiency (CI).

Methods: In this multicenter randomized clinical trial, participants were randomly assigned to computer therapy, near target push-ups, or placebo. All therapy was prescribed for 5 days per week at home. A successful outcome at 12 weeks was based on meeting predetermined composite criteria for the CI Symptom Survey, near point of convergence, and positive fusional vergence at near.

Results: A total of 204 participants were randomly assigned to HB-C (n = 75), HB-PU (n = 85), or HB-P (n = 44). At 12 weeks, 16 of 69 (23%, 95% CI: 14–35%) in the HB-C group, 15 of 69 (22%, 95% CI: 13–33%) in the HB-PU group, and 5 of 31 (16%, 95% CI: 5–34%) in the HB-P group were classified as having a successful outcome. The difference in the percentage of participants with a successful outcome in the HB-C group compared with the HB-PU group was −4% (two-sided 97.5% CI: −19 to +11%; p = 0.56) and with the HB-P group was +5% (two-sided 97.5% CI: −12 to +22%; p = 0.52), adjusted for baseline levels of the composite outcome components.

Conclusions: The majority of participants with symptomatic CI did not have a successful outcome at 12 weeks. Some participants treated with placebo were successful. With recruitment reaching only 34% of that originally planned and differential loss to follow-up among groups, estimates of success are not precise and comparisons across groups are difficult to interpret.

The Writing Committee and a list of the members of the Pediatric Eye Disease Investigator Group appear in the Acknowledgments.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.optvissci.com).

Mitchell M. Scheiman, Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647. e-mail: pedig@jaeb.org

© 2016 American Academy of Optometry