Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy

Marjean Kulp, G. Lynn Mitchell, Eric Borsting, Mitchell Scheiman, Susan Cotter, Michael Rouse, Susanna Tamkins, Brian G. Mohney, Andrew Toole, Kathleen Reuter

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

PURPOSE. To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the officebased treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment.METHODS. Patients (n=221, ages, 9-17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n=114). The placebo therapy program was designed to appear to be 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 whether they thought they had received real or placebo therapy and how confident they were in their answers. 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 to the therapy (P≥0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, 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 have potential for use 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 (ClinicalTrials.gov number, NCT00338611).

Original languageEnglish (US)
Pages (from-to)2560-2566
Number of pages7
JournalInvestigative Ophthalmology and Visual Science
Volume50
Issue number6
DOIs
StatePublished - 2009

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Placebos
Clinical Trials
Therapeutics
Ocular Motility Disorders
Signs and Symptoms
Demography
Saccades
Group Psychotherapy

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience
  • Medicine(all)

Cite this

Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy. / Kulp, Marjean; Mitchell, G. Lynn; Borsting, Eric; Scheiman, Mitchell; Cotter, Susan; Rouse, Michael; Tamkins, Susanna; Mohney, Brian G.; Toole, Andrew; Reuter, Kathleen.

In: Investigative Ophthalmology and Visual Science, Vol. 50, No. 6, 2009, p. 2560-2566.

Research output: Contribution to journalArticle

Kulp, M, Mitchell, GL, Borsting, E, Scheiman, M, Cotter, S, Rouse, M, Tamkins, S, Mohney, BG, Toole, A & Reuter, K 2009, 'Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy', Investigative Ophthalmology and Visual Science, vol. 50, no. 6, pp. 2560-2566. https://doi.org/10.1167/iovs.08-2693
Kulp, Marjean ; Mitchell, G. Lynn ; Borsting, Eric ; Scheiman, Mitchell ; Cotter, Susan ; Rouse, Michael ; Tamkins, Susanna ; Mohney, Brian G. ; Toole, Andrew ; Reuter, Kathleen. / Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy. In: Investigative Ophthalmology and Visual Science. 2009 ; Vol. 50, No. 6. pp. 2560-2566.
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T1 - Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy

AU - Kulp, Marjean

AU - Mitchell, G. Lynn

AU - Borsting, Eric

AU - Scheiman, Mitchell

AU - Cotter, Susan

AU - Rouse, Michael

AU - Tamkins, Susanna

AU - Mohney, Brian G.

AU - Toole, Andrew

AU - Reuter, Kathleen

PY - 2009

Y1 - 2009

N2 - PURPOSE. To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the officebased treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment.METHODS. Patients (n=221, ages, 9-17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n=114). The placebo therapy program was designed to appear to be 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 whether they thought they had received real or placebo therapy and how confident they were in their answers. 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 to the therapy (P≥0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, 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 have potential for use 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 (ClinicalTrials.gov number, NCT00338611).

AB - PURPOSE. To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the officebased treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment.METHODS. Patients (n=221, ages, 9-17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n=114). The placebo therapy program was designed to appear to be 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 whether they thought they had received real or placebo therapy and how confident they were in their answers. 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 to the therapy (P≥0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, 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 have potential for use 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 (ClinicalTrials.gov number, NCT00338611).

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