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

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01515943.

Figure 1

Visit Completion by Treatment Group. *Numbers enclosed in parentheses indicate the number of participants who completed the examination within the analysis window. Visits completed outside of the predefined analysis windows were considered missed and excluded from the analyses. ^§Participant was withdrawn from the study against protocol immediately after randomization due to ineligibility.