Convergence Insufficiency Clinical Trial
Official title:
Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)
CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention
Following the success of the NEI-funded Convergence Insufficiency Treatment Trials (CITT),
the next logical and important research issue is to determine if the successful treatment of
symptomatic convergence insufficiency (CI) (i.e., improvement of symptoms and ophthalmic
signs) impacts function (reading and attention).
It is well documented that children with symptomatic CI report significantly more symptoms
when reading and doing close work (e.g., blurred vision, headaches, double vision, loss of
concentration, frequent loss of place, trouble remembering what was read), manifest more
academic-impairing behaviors (e.g., difficulty finishing assignments), and score worse on
parent ratings of attention compared to children with normal binocular vision. Because
reduction of symptoms and adverse academic behaviors are established outcomes of successful
treatment of CI, we propose to test the hypothesis that resolution of these symptoms and
behaviors leads to improved reading performance and attention. Previous studies have found
improvements in reading comprehension reading speed and accuracy after successful treatment
of CI. In a recent pilot study, investigators also found significant improvement in reading
comprehension and attention after 16 weeks of successful treatment of symptomatic CI with
office-based vergence/accommodative therapy; however, there was no control group. To
definitively determine whether the successful treatment of symptomatic CI positively impacts
reading and attention requires a placebo-controlled randomized clinical trial.
Objective: We propose a multicenter, placebo-controlled, randomized clinical trial (RCT) of
324 children ages 9 to <14 years (Grades 3-8) with symptomatic CI. [we will restrict
recruitment to children who do not have significant single word reading deficits.]
Participants will be randomized to 16 weeks of treatment with either [a] office-based
vergence/accommodative therapy with home reinforcement (OBVAT) or [b] office-based placebo
therapy with home reinforcement (OBPT). Outcomes (reading and attention) will be assessed
after 16 weeks of treatment. In addition, we will test the long-term effects on outcomes at 1
year after treatment completion. All analyses will test the null hypothesis of no difference
in outcomes between the two treatment groups.
Specific Aim 1 - Reading Performance: To compare reading comprehension outcomes for children
with symptomatic CI who receive 16 weeks of OBVAT and OBPT treatment. The primary outcome
measure of reading performance is the Wechsler Individual Achievement test (WIAT-III) reading
comprehension subtest score. In secondary analyses, we will examine the effects of the
treatment on word reading, pseudoword decoding, oral reading fluency, and listening
comprehension. We also will examine the correlation of changes in CI symptoms and ophthalmic
signs with reading outcomes. Analysis of the 1-year follow-up data will be used to determine
if any gains in reading performance observed after 16 weeks of treatment are sustained.
Specific Aim 2 - Attention: To investigate the effect of treatment on teacher- and
parent-rated measures of attention for children with symptomatic CI who receive 16 weeks of
OBVAT and OBPT intervention. The primary outcome measure of attention is the score on the
Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN). In secondary
analyses, we will examine the effects of treatment on a second parent-rated attention scale
called the SNAP. We also will examine the correlation of changes in CI-symptoms and
ophthalmic signs with attention outcomes. Analysis of the 1-year follow-up data will be used
to determine if any gains in attention observed after 16 weeks of treatment are maintained.
Scientific and Clinical Impact: The relationship between the treatment of symptomatic CI and
its effect on reading and attention in children is unknown. The results of the proposed study
will contribute to a better understanding of these relationships and help to resolve
controversy surrounding this issue. The results will have important implications for
educators, psychologists, eye professionals, and other health care providers who care for
children with reading and attention problems and guide hypothesis development for future
scientific investigations on evidence-based relationships between visual disorders and other
developmental disorders in children.
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