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The convergence insufficiency treatment trial: design, methods, and baseline data.

ABSTRACT: This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients.We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) office-based vergence/accommodative therapy with home reinforcement, 4) office-based placebo therapy. Outcome data on the Convergence Insufficiency Symptom Survey (CISS) score (primary outcome), near point of convergence (NPC), and positive fusional vergence were collected after 12 weeks of active treatment and again at 6 and 12 months posttreatment.The CITT enrolled 221 children with symptomatic CI with a mean age of 12.0 years (SD = +2.3). The clinical profile of the cohort at baseline was 9Delta exophoria at near (+/- 4.4) and 2Delta exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/- 7.5), and near positive fusional vergence break = 13 Delta (+/- 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05).Hallmark features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a placebo treatment arm, masked outcome examinations, and the CISS score outcome measure. The baseline data reported herein define the clinical profile of those enrolled into the CITT.

SUBMITTER: Convergence Insufficiency Treatment Trial (CITT) Study Group

PROVIDER: S-EPMC2782898 | biostudies-other | 2008 Jan-Feb

REPOSITORIES: biostudies-other

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The convergence insufficiency treatment trial: design, methods, and baseline data.

Ophthalmic epidemiology 20080101 1

<h4>Objective</h4>This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients.<h4>Methods</h4>We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer verg ...[more]

PMID: 18300086

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Project description:SignificanceThese data confirm the effectiveness of office-based vergence/accommodative therapy for improving convergence in children with symptomatic convergence insufficiency. They also highlight the importance of using a primary outcome measure that is as objective as possible rather than relying solely on self-reported symptoms for studies of binocular vision in children.PurposeThe purpose of this study was to report changes in clinical signs and symptoms of convergence insufficiency (secondary outcome measures) from a multicenter clinical trial (Convergence Insufficiency Treatment Trial-Attention & Reading Trial [CITT-ART]) evaluating the effectiveness of vergence/accommodative therapy for improving reading and attention in children with symptomatic convergence insufficiency.MethodsThree hundred eleven children aged 9 to 14 years with symptomatic convergence insufficiency were randomly assigned to 16 weeks of office-based vergence/accommodative therapy or to placebo therapy. Improvements in (1) near point of convergence (NPC), (2) positive fusional vergence (PFV), and (3) self-reported symptoms (Convergence Insufficiency Symptom Survey [CISS] score) were compared after 16 weeks of treatment.ResultsMean NPC improved 10.4 cm in the vergence/accommodative and 6.2 cm in the placebo therapy group (mean difference of -4.2 cm [95% confidence interval {CI}, -5.2 to -3.2 cm; P < .001]); mean PFV increased 23.2 and 8.8Δ in the vergence/accommodative and placebo therapy groups, respectively (mean difference of 14.4Δ [95% CI, 12.1 to 16.8Δ; P < .001]). The mean CISS score improved 11.8 and 10.4 points in the vergence/accommodative and placebo therapy groups, respectively (mean difference of 1.5 points [95% CI, -3.8 to +0.8 points; P = .21]).ConclusionsOur results demonstrate that office-based vergence/accommodative therapy is effective for improving the NPC and PFV in children with symptomatic convergence insufficiency. However, given that both treatment groups had a similar reduction in self-reported symptoms, it may not be prudent to use the CISS alone as a measure of successful treatment.

Project description:To determine whether treatment of symptomatic convergence insufficiency (CI) has an effect on Academic Behavior Survey (ABS) scores.The ABS is a six-item survey developed by the Convergence Insufficiency Treatment Trial Group that quantifies the frequency of adverse school behaviors and parental concern about school performance on an ordinal scale from 0 (never) to 4 (always) with total scores ranging from 0 to 24. The ABS was administered at baseline and after 12 weeks of treatment to the parents of 218 children aged 9 to 17 years with symptomatic CI, who were enrolled in the Convergence Insufficiency Treatment Trial and randomized into (1) home-based pencil push-ups; (2) home-based computer vergence/accommodative therapy and pencil push-ups; (3) office-based vergence/accommodative therapy with home reinforcement; and (4) office-based placebo therapy with home reinforcement. Participants were classified as successful (n = 42), improved (n = 60), or non-responder (n = 116) at the completion of 12 weeks of treatment using a composite measure of the symptom score, nearpoint of convergence, and positive fusional vergence. Analysis of covariance methods were used to compare the mean change in ABS between response to treatment groups while controlling for the ABS score at baseline.The mean ABS score for the entire group at baseline was 12.85 (SD = 6.3). The mean ABS score decreased (improved) in those categorized as successful, improved, and non-responder by 4.0, 2.9, and 1.3 points, respectively. The improvement in the ABS score was significantly related to treatment outcome (p < 0.0001), with the ABS score being significantly lower (better) for children who were successful or improved after treatment as compared to children who were non-responders (p = 0.002 and 0.043, respectively).A successful or improved outcome after CI treatment was associated with a reduction in the frequency of adverse academic behaviors and parental concern associated with reading and school work as reported by parents.

Project description:PurposeTo investigate symptom patterns and evaluate the relationship between patient characteristics and symptom severity before and after treatment for symptomatic children with convergence insufficiency (CI).MethodsIn a randomized clinical trial, the convergence insufficiency symptom survey was administered pre- and posttreatment to 221 children aged 9 to <18 years with symptomatic CI. Frequency of symptom type was determined at baseline, mean change in performance-related vs. eye-related symptoms for treatment responders was compared, and the relationship between patient characteristics and symptom severity at baseline for the entire cohort and after treatment for those who responded to treatment was determined.ResultsAt baseline, the score for performance-related symptoms was greater than that for eye-related symptoms (mean response of 2.3 vs. 1.8, p < 0.001) regardless of age, sex, race/ethnicity, or presence of parent-reported Attention Deficit Hyperactivity Disorder (ADHD). Symptom severity increased with age for both the overall and eye-related subscale scores (p = 0.048, p = 0.022, respectively). Children with parent-reported ADHD were more symptomatic (p = 0.005) than those without parent-reported ADHD because of a higher performance-related score (p < 0.001). A significant and equal improvement (p < 0.01) for the performance- and eye-related symptoms was found in treatment responders. Girls had significantly lower performance-related symptoms than boys (p = 0.014), and black children reported less eye-related symptoms than white children (p = 0.022). Children without parent-reported ADHD had significantly less symptoms overall and less eye-related symptoms than children with parent-reported ADHD (p = 0.019, p = 0.011, respectively).ConclusionsBecause of a high frequency of both performance- and eye-related symptoms, clinicians should perform a targeted history that addresses both types of symptoms to help identify children with symptomatic CI. Future study regarding the relationship of CI and symptoms and their potential influence on ADHD, reading performance, and attention is warranted.

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The convergence insufficiency treatment trial: design, methods, and baseline data.

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The convergence insufficiency treatment trial: design, methods, and baseline data.

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