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.
RCT Entities:
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.
Authors: Mitchell Scheiman; G Lynn Mitchell; Susan Cotter; Marjean Taylor Kulp; Jeffrey Cooper; Michael Rouse; Eric Borsting; Richard London; Janice Wensveen Journal: Optom Vis Sci Date: 2005-07 Impact factor: 1.973
Authors: M W Rouse; E Borsting; L Hyman; M Hussein; S A Cotter; M Flynn; M Scheiman; M Gallaway; P N De Land Journal: Optom Vis Sci Date: 1999-09 Impact factor: 1.973
Authors: Mitchell Scheiman; G Lynn Mitchell; Susan Cotter; Jeffrey Cooper; Marjean Kulp; Michael Rouse; Eric Borsting; Richard London; Janice Wensveen Journal: Arch Ophthalmol Date: 2005-01
Authors: Eric J Borsting; Michael W Rouse; G Lynn Mitchell; Mitchell Scheiman; Susan A Cotter; Jeffrey Cooper; Marjean Taylor Kulp; Richard London Journal: Optom Vis Sci Date: 2003-12 Impact factor: 1.973
Authors: Ingryd J Lorenzana; David A Leske; Sarah R Hatt; Trevano W Dean; Erin C Jenewein; Linda R Dagi; Casey J Beal; Yi Pang; Dashaini V Retnasothie; Christina A Esposito; S A Erzurum; Amy E Aldrich; Eric R Crouch; Zhuokai Li; Raymond T Kraker; Jonathan M Holmes; Susan A Cotter Journal: Optom Vis Sci Date: 2022-08-02 Impact factor: 2.106
Authors: Mitchell M Scheiman; Tara L Alvarez; Susan A Cotter; Marjean T Kulp; Loraine T Sinnott; Maureen D Plaumann; Jasleen Jhajj Journal: Optom Vis Sci Date: 2021-01-01 Impact factor: 2.106