PURPOSE: The Convergence Insufficiency Treatment Trial (CITT) Investigator Group conducted a preliminary study assessing the effectiveness of home-based push-up therapy and office-based vision therapy/orthoptics for the treatment of convergence insufficiency (CI). The CITT group developed a placebo therapy program that was designed to simulate real vision therapy/orthoptics. The purpose of this paper is to evaluate the effectiveness of this placebo therapy program in maintaining masking of subjects randomized to the office-based treatment arms (real or placebo). METHODS:Subjects (ages 9 to 30 years) were enrolled, stratified into two groups by age, and then randomly assigned to one of three treatment groups: pencil push-up therapy, office-based vision therapy/orthoptics, or office-based placebo vision therapy/orthoptics. At the end of treatment, subjects in the two office-based therapy groups (placebo and real) were asked: (1) which treatment do you think you received? and (2) how sure are you about your answer? RESULTS: Ninety-five percent of subjects assigned to real therapy and 83% assigned to placebo therapy thought they were in the real therapy group. Of the subjects who thought they received real therapy, 90% assigned to real therapy and 89% assigned to placebo therapy were "somewhat sure," "pretty sure," or "very sure" of their answer. Those assigned to real therapy had more responses in the "very sure" category. CONCLUSION: The CITT placebo therapy program was effective in maintaining subject masking in this multicenter clinical trial.
RCT Entities:
PURPOSE: The Convergence Insufficiency Treatment Trial (CITT) Investigator Group conducted a preliminary study assessing the effectiveness of home-based push-up therapy and office-based vision therapy/orthoptics for the treatment of convergence insufficiency (CI). The CITT group developed a placebo therapy program that was designed to simulate real vision therapy/orthoptics. The purpose of this paper is to evaluate the effectiveness of this placebo therapy program in maintaining masking of subjects randomized to the office-based treatment arms (real or placebo). METHODS: Subjects (ages 9 to 30 years) were enrolled, stratified into two groups by age, and then randomly assigned to one of three treatment groups: pencil push-up therapy, office-based vision therapy/orthoptics, or office-based placebo vision therapy/orthoptics. At the end of treatment, subjects in the two office-based therapy groups (placebo and real) were asked: (1) which treatment do you think you received? and (2) how sure are you about your answer? RESULTS: Ninety-five percent of subjects assigned to real therapy and 83% assigned to placebo therapy thought they were in the real therapy group. Of the subjects who thought they received real therapy, 90% assigned to real therapy and 89% assigned to placebo therapy were "somewhat sure," "pretty sure," or "very sure" of their answer. Those assigned to real therapy had more responses in the "very sure" category. CONCLUSION: The CITT placebo therapy program was effective in maintaining subject masking in this multicenter clinical trial.
Authors: Mitchell Scheiman; Susan Cotter; Marjean Taylor Kulp; G Lynn Mitchell; Jeffrey Cooper; Michael Gallaway; Kristine B Hopkins; Mary Bartuccio; Ida Chung Journal: Optom Vis Sci Date: 2011-11 Impact factor: 1.973
Authors: Mitchell Scheiman; G Lynn Mitchell; Susan A Cotter; Marjean Kulp; Christopher Chase; Eric Borsting; Eugene Arnold; Carolyn Denton; Richard Hertle Journal: Vis Dev Rehabil Date: 2015-10
Authors: Mitchell Scheiman; Michael Rouse; Marjean Taylor Kulp; Susan Cotter; Richard Hertle; G Lynn Mitchell Journal: Optom Vis Sci Date: 2009-05 Impact factor: 1.973
Authors: Marjean Kulp; G Lynn Mitchell; Eric Borsting; Mitchell Scheiman; Susan Cotter; Michael Rouse; Susanna Tamkins; Brian G Mohney; Andrew Toole; Kathleen Reuter Journal: Invest Ophthalmol Vis Sci Date: 2009-01-17 Impact factor: 4.799