Journal article
Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy
Investigative ophthalmology & visual science, v 50(6), pp 2560-2566
01 Jun 2009
PMID: 19151384
Featured in Collection : UN Sustainable Development Goals @ Drexel
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 >= 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). (Invest Ophthalmol Vis Sci. 2009; 50: 2560-2566) DOI:10.1167/iovs.08-2693
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Details
- Title
- Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy
- Creators
- Marjean Kulp - The Ohio State UniversityG. Lynn Mitchell - The Ohio State UniversityEric Borsting - Marshall B. Ketchum UniversityMitchell Scheiman - Salus UniversitySusan Cotter - Marshall B. Ketchum UniversityMichael Rouse - Marshall B. Ketchum UniversitySusanna Tamkins - University of MiamiBrian G. Mohney - Mayo ClinicAndrew Toole - The Ohio State UniversityKathleen Reuter - The Ohio State UniversityCITT Study Grp
- Publication Details
- Investigative ophthalmology & visual science, v 50(6), pp 2560-2566
- Publisher
- Assoc Research Vision Ophthalmology Inc
- Number of pages
- 7
- Grant note
- U10EY014659 / NATIONAL EYE INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Eye Institute (NEI) U10EY014713; U10EY014659; U10EY014716; U10EY014715; U10EY014709; U10EY014710; U10EY014676; U10EY014706; U10EY014712 / National Eye Institute; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Eye Institute (NEI)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pennsylvania College of Optometry (PCO)
- Web of Science ID
- WOS:000266403800003
- Scopus ID
- 2-s2.0-66849085978
- Other Identifier
- 991021900610304721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Ophthalmology