Dataset Information

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

ABSTRACT:

Purpose

To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based 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 >or= 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 >or= 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).

SUBMITTER: Kulp M

PROVIDER: S-EPMC2759605 | biostudies-literature | 2009 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Kulp Marjean M Mitchell G Lynn GL Borsting Eric E Scheiman Mitchell M Cotter Susan S Rouse Michael M Tamkins Susanna S Mohney Brian G BG Toole Andrew A Reuter Kathleen K

Investigative ophthalmology & visual science 20090117 6

<h4>Purpose</h4>To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based 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.<h4>Methods</h4>Patients (n = 221, ages, 9-17 years) were randomized to one of four treatment groups, two of wh ...[more]

PMID: 19151384

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Project description:PurposeTo determine the effectiveness of office-based vergence/accommodative therapy for improving accommodative amplitude and accommodative facility in children with symptomatic convergence insufficiency and accommodative dysfunction.MethodsWe report changes in accommodative function following therapy among participants in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial with decreased accommodative amplitude (115 participants in vergence/accommodative therapy; 65 in placebo therapy) or decreased accommodative facility (71 participants in vergence/accommodative therapy; 37 in placebo therapy) at baseline. The primary analysis compared mean change in amplitude and facility between the vergence/accommodative and placebo therapy groups using analyses of variance models after 4, 8, 12 and 16 weeks of treatment. The proportions of participants with normal amplitude and facility at each time point were calculated. The average rate of change in amplitude and facility from baseline to week 4, and from weeks 4 to 16, were determined in the vergence/accommodative therapy group.ResultsFrom baseline to 16 weeks, the mean improvement in amplitude was 8.6 dioptres (D) and 5.2 D in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 3.5 D, 95% confidence interval (CI): 1.5 to 5.5 D; p = 0.01). The mean improvement in facility was 13.5 cycles per minute (cpm) and 7.6 cpm in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 5.8 cpm, 95% CI: 3.8 to 7.9 cpm; p < 0.0001). Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy. In the vergence/accommodative therapy group, amplitude increased at an average rate of 1.5 D per week during the first 4 weeks (p < 0.0001), then slowed to 0.2 D per week (p = 0.002) from weeks 4 to 16. Similarly, facility increased at an average rate of 1.5 cpm per week during the first 4 weeks (p < 0.0001), then slowed to 0.6 cpm per week from weeks 4 to 16 (p < 0.0001).ConclusionOffice-based vergence/accommodative therapy is effective for improving accommodative function in children with symptomatic convergence insufficiency and coexisting accommodative dysfunction.

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Dataset Information

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

Purpose

Methods

Results

Conclusions

Publications

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

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