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Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART): Design and Methods.

ABSTRACT: OBJECTIVE:To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). METHODS:CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. CONCLUSION:The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

SUBMITTER: CITT-ART Investigator Group

PROVIDER: S-EPMC4772970 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART): Design and Methods.

Scheiman Mitchell M Mitchell G Lynn GL Cotter Susan A SA Kulp Marjean M Chase Christopher C Borsting Eric E Arnold Eugene E Denton Carolyn C Hertle Richard R

Vision development and rehabilitation 20151001 3

<h4>Objective</h4>To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI).<h4>Methods</h4>CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are ra ...[more]

PMID: 26942226

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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:SignificanceThe results of this study suggest that clinicians providing vergence/accommodative therapy for convergence insufficiency in children should not suggest that such treatment will lead to improvements in attention when compared with placebo treatment.PurposeThis study aimed to compare the effects of 16 weeks of vergence/accommodative therapy and placebo therapy on changes in attention for children in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial.MethodsThree hundred ten children 9 to 14 years old with convergence insufficiency were assigned to receive treatment with office-based vergence/accommodative therapy or placebo therapy. Attention tests were administered at baseline and after 16 weeks of treatment. The primary measure of attention was the Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN) scale. Other measures included the Swanson, Nolan, and Pelham checklist; the Homework Problems Checklist; and the d2 Test of Attention. Within and between-group differences are reported using Cohen d effect sizes.ResultsFor the SWAN, there was no significant difference between the groups for the inattention scale parental report (d = 0.036; 95% confidence interval, -0.21 to 0.28) or for the hyperactivity impulsivity scale parental report (d = -0.003; 95% confidence interval, -0.24 to 0.24). Similar results were found for teacher reports and the secondary measures (d estimates from -0.97 to +0.10). There were, however, large within-group changes with d ≥ 1 in both treatment groups for the SWAN, the Homework Problems Checklist, and the d2 Test of Attention.ConclusionsThese results suggest that vergence/accommodative therapy is no better than placebo therapy in improving attention. Large improvements in inattention, completing homework, and selective and sustained attention were found in each group. However, these improvements cannot be attributed to improvements in vergence and accommodation and are likely due to nonspecific effects of an intensive therapy regimen.

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.

Project description:PurposeTo determine whether coexisting accommodative dysfunction in children with symptomatic convergence insufficiency (CI) impacts presenting clinical convergence measures, symptoms and treatment success for CI.MethodsSecondary data analyses of monocular accommodative amplitude (AA; push-up method), monocular accommodative facility (AF; ±2.00 D lens flippers) and symptoms (CI Symptom Survey [CISS]) in children with symptomatic CI from the Convergence Insufficiency Treatment Trial (N = 218) and CITT-Attention and Reading Trial (N = 302) were conducted. Decreased AA was defined as more than 2D below the minimum expected amplitude for age (15 - ¼ age); those with AA < 5 D were excluded. Decreased AF was defined as <6 cycles per minute. Mean near point of convergence (NPC), near positive fusional vergence (PFV) and symptoms (CISS) were compared between those with and without accommodative dysfunction using analysis of variance and independent samples t-testing. Logistic regression was used to compare the effect of baseline accommodative function on treatment success [defined using a composite of improvements in: (1) clinical convergence measures and symptoms (NPC, PFV and CISS scores) or (2) solely convergence measures (NPC and PFV)].ResultsAccommodative dysfunction was common in children with symptomatic CI (55% had decreased AA; 34% had decreased AF). NPC was significantly worse in those with decreased AA (mean difference = 6.1 cm; p < 0.001). Mean baseline CISS scores were slightly worse in children with coexisting accommodative dysfunction (decreased AA or AF) (30.2 points) than those with normal accommodation (26.9 points) (mean difference = 3.3 points; p < 0.001). Neither baseline accommodative function (p ≥ 0.12 for all) nor interaction of baseline accommodative function and treatment (p ≥ 0.50) were related to treatment success based on the two composite outcomes.ConclusionsA coexisting accommodative dysfunction in children with symptomatic CI is associated with worse NPC, but it does not impact the severity of symptoms in a clinically meaningful way. Concurrent accommodative dysfunction does not impact treatment response for CI.

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Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART): Design and Methods.

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Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART): Design and Methods.

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