April 2009
Volume 50, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2009
Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy
Author Affiliations & Notes
  • M. T. Kulp
    College of Optometry, Ohio State University, Columbus, Ohio
  • G. L. Mitchell
    College of Optometry, Ohio State University, Columbus, Ohio
  • E. Borsting
    College of Optometry, Southern California, Fullerton, California
  • M. Scheiman
    Pennsylvania College of Optometry, Salus University, Philadelphia, Pennsylvania
  • S. Cotter
    College of Optometry, Southern California, Fullerton, California
  • M. Rouse
    College of Optometry, Southern California, Fullerton, California
  • S. Tamkins
    Bascom Palmer Eye Institute, Miami, Florida
  • B. G. Mohney
    Mayo Clinic, Rochester, Minnesota
  • A. Toole
    College of Optometry, Ohio State University, Columbus, Ohio
  • CITT Study Group
    College of Optometry, Ohio State University, Columbus, Ohio
  • Footnotes
    Commercial Relationships  M.T. Kulp, None; G.L. Mitchell, None; E. Borsting, None; M. Scheiman, None; S. Cotter, None; M. Rouse, None; S. Tamkins, None; B.G. Mohney, None; A. Toole, None.
  • Footnotes
    Support  U10EY014713, U10EY014659, U10EY014716, U10EY014715, U10EY014709, U10EY014710, U10EY014676, U10EY014706, and U10EY014712 from the National Eye Institute
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 1997. doi:
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      M. T. Kulp, G. L. Mitchell, E. Borsting, M. Scheiman, S. Cotter, M. Rouse, S. Tamkins, B. G. Mohney, A. Toole, CITT Study Group; Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1997.

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Abstract

Purpose: : To determine if demographic variables affected masking of subjects in the Convergence Insufficiency Treatment Trial (CITT) and whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment. We also evaluated the effectiveness of the CITT placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms.

Methods: : Patients (n=221, ages 9 to 17 years) were randomized to one of 4 treatment groups; 2 of which were office-based and masked to treatment (n=114). The placebo therapy program was designed to appear like real vergence/accommodative therapy, without stimulating vergence, accommodation, or fine saccades (beyond levels of daily visual activities). After treatment, patients in the office-based groups were asked if they thought they received real or placebo therapy and how confident they were in their answer.

Results: : Ninety-three percent of patients assigned to real therapy and 85% assigned to placebo therapy thought they were in the real therapy group (p=0.17). No significant differences were found between the two groups in adherence (p≥0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, gender, race or ethnicity (p > 0.30 for all comparisons). No association was found between patients’ perception of group assignment and symptoms or signs at outcome (p≥0.38 for all comparisons).

Conclusions: : The CITT placebo therapy program was effective in maintaining patient masking in this study and, therefore, may potentially be used in future clinical trials using vergence/accommodative therapy. Masking was not affected by demographic variables. Perception of group assignment was not related to symptoms or signs at outcome.

Clinical Trial: : www.clinicaltrials.gov NCT00338611

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • vergence • binocular vision/stereopsis 
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