Convergence Insufficiency Clinical Trial
Official title:
A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled, single-masked, clinical trial designed to compare the benefits of two commonly used treatment approaches for patients with convergence insufficiency (CI)
Considerable controversy exists regarding the best treatment for convergence insufficiency
(CI), a common condition that often interferes with the ability to perform near work. The
two most widely used treatments have significant differences in costs and in practitioner
perceived utility. Pencil push-up therapy (PPT) is a simple, low-cost treatment in which
patients are prescribed a single procedure to perform at home with only periodic follow-up.
Office-based vision therapy (OBVT) is a more comprehensive, time-consuming, complex, and
costly treatment in which patients are scheduled for weekly in-office therapy visits and are
often prescribed a specific sequence of therapeutic procedures to perform at home. It is
important to consider whether either, neither, or both treatments are effective.
The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked-examiner,
multi-center clinical trial in which patients are randomized to one of these two treatment
approaches. The primary goal is to answer the following question:
After 12 weeks of treatment, is one therapy more effective than the other in improving CI
signs and symptoms? We will test the null hypothesis that there is no difference in the
distribution of outcomes between the two populations.
The primary outcome measure will be a classification of each patient as a “success,”
“improvement,” or “failure.” This classification will be based on the level of improvement
in both the signs (near point of convergence and positive fusional vergence) and symptoms of
CI.
Additional questions relate to longer term effects:
1. Are the patients who were classified as “success” or “improvement” at twelve weeks the
same at the one-year follow-up for each treatment group?
2. Are there differences in the distributions of changes in near point of convergence,
positive fusional vergence, or accommodative amplitudes, between the two treatment
groups, at twelve weeks and at one-year of follow up?
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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