Randomized clinical trial of treatments for symptomatic convergence insufficiency in children.
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ABSTRACT:
SUBMITTER: Convergence Insufficiency Treatment Trial Study Group
PROVIDER: S-EPMC2779032 | biostudies-literature | 2008 Oct
REPOSITORIES: biostudies-literature
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Randomized clinical trial of treatments for symptomatic convergence insufficiency in children.
Archives of ophthalmology (Chicago, Ill. : 1960) 20081001 10
<h4>Objective</h4>To compare home-based pencil push-ups (HBPP), home-based computer vergence/accommodative therapy and pencil push-ups (HBCVAT+), office-based vergence/accommodative therapy with home reinforcement (OBVAT), and office-based placebo therapy with home reinforcement (OBPT) as treatments for symptomatic convergence insufficiency.<h4>Methods</h4>In a randomized clinical trial, 221 children aged 9 to 17 years with symptomatic convergence insufficiency were assigned to 1 of 4 treatments ...[more]
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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.
| S-EPMC6855327 | biostudies-literature
Project description:PurposeTo compare the effectiveness of home-based (HB) computer vergence/accommodative therapy (HB-C) to HB near target push-up therapy (HB-PU) and to HB placebo treatment (HB-P) among children aged 9 to <18 years with symptomatic convergence insufficiency (CI).MethodsIn this multicenter randomized clinical trial, participants were randomly assigned to computer therapy, near target push-ups, or placebo. All therapy was prescribed for 5 days per week at home. A successful outcome at 12 weeks was based on meeting predetermined composite criteria for the CI Symptom Survey, near point of convergence, and positive fusional vergence at near.ResultsA total of 204 participants were randomly assigned to HB-C (n = 75), HB-PU (n = 85), or HB-P (n = 44). At 12 weeks, 16 of 69 (23%, 95% CI: 14-35%) in the HB-C group, 15 of 69 (22%, 95% CI: 13-33%) in the HB-PU group, and 5 of 31 (16%, 95% CI: 5-34%) in the HB-P group were classified as having a successful outcome. The difference in the percentage of participants with a successful outcome in the HB-C group compared with the HB-PU group was -4% (two-sided 97.5% CI: -19 to +11%; p = 0.56) and with the HB-P group was +5% (two-sided 97.5% CI: -12 to +22%; p = 0.52), adjusted for baseline levels of the composite outcome components.ConclusionsThe majority of participants with symptomatic CI did not have a successful outcome at 12 weeks. Some participants treated with placebo were successful. With recruitment reaching only 34% of that originally planned and differential loss to follow-up among groups, estimates of success are not precise and comparisons across groups are difficult to interpret.
| S-EPMC5118058 | biostudies-literature
Project description:PurposeTo assess the long-term stability of improvements in symptoms and signs in 9- to 17-year-old children enrolled in the Convergence Insufficiency Treatment Trial who were asymptomatic after treatment for convergence insufficiency.MethodsSeventy-nine patients who were asymptomatic after a 12-week therapy program for convergence insufficiency were followed for 1 year [33/60 in office-based vergence/accommodative therapy (OBVAT), 18/54 in home-based pencil push-ups (HBPP), 12/57 in home-based computer vergence/accommodative therapy and pencil push-ups (HBCVAT+), and 16/54 in office-based placebo therapy (OBPT)]. Symptoms and clinical signs were measured 6 months and 1 year after completion of the 12-week therapy program. The primary outcome measure was the mean change on the Convergence Insufficiency Symptom Survey (CISS). Secondary outcome measures were near point of convergence, positive fusional vergence at near, and proportions of patients who remained asymptomatic or who were classified as successful or improved based on a composite measure of CISS, near point of convergence, and positive fusional vergence.ResultsOne-year follow-up visit completion rate was 89% with no significant differences between groups (p = 0.26). There were no significant changes in the CISS in any treatment group during the 1-year follow-up. The percentage who remained asymptomatic in each group was 84.4% (27/32) for OBVAT, 66.7% (10/15) for HBPP, 80% (8/10) for HBCVAT+, and 76.9% (10/13) for OBPT. The percentage who remained either successful or improved 1-year posttreatment was 87.5% (28/32) for OBVAT, 66.6% (10/15) for HBPP, 80% (8/10) for HBCVAT+, and 69.3% (9/13) for OBPT.ConclusionsMost children aged 9 to 17 years who were asymptomatic after a 12-week treatment program of OBVAT for convergence insufficiency maintained their improvements in symptoms and signs for at least 1 year after discontinuing treatment. Although the sample sizes for the home-based and placebo groups were small, our data suggest that a similar outcome can be expected for children who were asymptomatic after treatment with HBPP or HBCVAT+.
| S-EPMC2780441 | biostudies-literature
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.
| S-EPMC10544663 | biostudies-literature
Project description:SignificanceThe results of this study suggest that clinicians providing vergence/accommodative therapy for the treatment of childhood convergence insufficiency should not suggest that such treatment, on average, will lead to improvements on standardized assessments of reading performance after 16 weeks of treatment.PurposeThe purpose of this study was to determine the effect of office-based vergence/accommodative therapy on reading performance in 9- to 14-year-old children with symptomatic convergence insufficiency.MethodsIn a multicenter clinical trial, 310 children 9 to 14 years old with symptomatic convergence insufficiency were randomized in a 2:1 ratio to 16 weeks of office-based vergence/accommodative therapy or office-based placebo therapy, respectively. The primary outcome was change in reading comprehension as measured by the reading comprehension subtest of the Wechsler Individual Achievement Test, Third Edition (WIAT-III) at the 16-week outcome. Secondary reading outcomes of word identification, reading fluency, listening comprehension, comprehension of extended text, and reading comprehension were also evaluated.ResultsThe adjusted mean improvement in WIAT-III reading comprehension was 3.7 (95% confidence interval [CI], 2.6 to 4.7) standard score points in the vergence/accommodative therapy group and 3.8 (95% CI, 2.4 to 5.2) points in the placebo therapy group, with an adjusted mean group difference of -0.12 (95% CI, -1.89 to 1.66) points that was not statistically significant. No statistically significant treatment group differences were found for any of the secondary reading outcome measures.ConclusionsFor children aged 9 to 14 years with symptomatic convergence insufficiency, office-based vergence/accommodative therapy was no more effective than office-based placebo therapy for improving reading performance on standardized reading tests after 16 weeks of treatment.
| S-EPMC6855328 | biostudies-literature
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.
| S-EPMC8639028 | biostudies-literature
Project description:PurposeTo evaluate the kinetics of change in symptoms and signs of convergence insufficiency (CI) during 12 weeks of treatment with commonly prescribed vision therapy/orthoptic treatment regimens.MethodsIn a randomized clinical trial, 221 children aged 9 to 17 years with symptomatic CI were assigned to home-based pencil push-ups (HBPP), home-based computer vergence/accommodative therapy and pencil push-ups (HBCVAT+), office-based vergence/accommodative therapy with home reinforcement (OBVAT), or office-based placebo therapy with home reinforcement (OBPT). Symptoms and signs were measured after 4, 8, and 12 weeks of treatment. The outcome measures were the mean CI Symptom Survey (CISS), near point of convergence (NPC), positive fusional vergence (PFV), and proportions of patients who were classified as successful or improved based on a composite measure of CISS, NPC, and PFV.ResultsOnly the OBVAT group showed significant improvements in symptoms between each visit (p < 0.001). Between weeks 8 and 12, all groups showed a significant improvement in symptoms. Between-group differences were apparent by week 8 (p = 0.037) with the fewest symptoms in the OBVAT group. For each group, the greatest improvements in NPC and PFV were achieved during the first 4 weeks. Differences between groups became apparent by week 4 (p < 0.001), with the greatest improvements in NPC and PFV in the OBVAT group. Only the OBVAT group continued to show significant improvements in PFV at weeks 8 and 12. The percentage of patients classified as "successful" or "improved" based on our composite measure increased in all groups at each visit.ConclusionsThe rate of improvement is more rapid for clinical signs (NPC and PFV) than for symptoms in children undergoing treatment for CI. OBVAT results in a more rapid improvement in symptoms, NPC and PFV, and a greater percentage of patients reaching pre-determined criteria of success when compared with HBPP, HBCVAT+, or OBPT.
| S-EPMC2916019 | biostudies-literature
Project description:SignificanceDeficits of disparity divergence found with objective eye movement recordings may not be apparent with standard clinical measures of negative fusional vergence (NFV) in children with symptomatic convergence insufficiency.PurposeThis study aimed to determine whether NFV is normal in untreated children with symptomatic convergence insufficiency and whether NFV improves after vergence/accommodative therapy.MethodsThis secondary analysis of NFV measures before and after office-based vergence/accommodative therapy reports changes in (1) objective eye movement recording responses to 4° disparity divergence step stimuli from 12 children with symptomatic convergence insufficiency compared with 10 children with normal binocular vision (NBV) and (2) clinical NFV measures in 580 children successfully treated in three Convergence Insufficiency Treatment Trial studies.ResultsAt baseline, the Convergence Insufficiency Treatment Trial cohort's mean NFV break (14.6 ± 4.8Δ) and recovery (10.6 ± 4.2Δ) values were significantly greater (P < .001) than normative values. The post-therapy mean improvements for blur, break, and recovery of 5.2, 7.2, and 1.3Δ, respectively, were statistically significant (P < .0001). Mean pre-therapy responses to 4° disparity divergence step stimuli were worse in the convergence insufficiency group compared with the NBV group for peak velocity (P < .001), time to peak velocity (P = .01), and response amplitude (P < .001). After therapy, the convergence insufficiency group showed statistically significant improvements in mean peak velocity (11.63°/s; 95% confidence interval [CI], 6.6 to 16.62°/s), time to peak velocity (-0.12 seconds; 95% CI, -0.19 to -0.05 seconds), and response amplitude (1.47°; 95% CI, 0.83 to 2.11°), with measures no longer statistically different from the NBV cohort (P > .05).ConclusionsDespite clinical NFV measurements that seem greater than normal, children with symptomatic convergence insufficiency may have deficient NFV when measured with objective eye movement recordings. Both objective and clinical measures of NFV can be improved with vergence/accommodative therapy.
| S-EPMC7789288 | biostudies-literature
Project description:PurposeTo evaluate the time course of improvements in clinical convergence measures for children with symptomatic convergence insufficiency treated with office-based vergence/accommodative therapy.MethodsWe evaluated convergence measures from 205, 9- to 14-year-old children with symptomatic convergence insufficiency randomised to office-based vergence/accommodative therapy in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART). Near-point of convergence (NPC) and near-positive fusional vergence (PFV) were measured at baseline and after 4, 8, 12 and 16 weeks of therapy; mean change in NPC and PFV between these time points were compared using repeated measures analysis of variance. Rates of change in NPC and PFV from: (1) baseline to 4 weeks and (2) 4-16 weeks were calculated. For each time point, the proportion of participants to first meet the normal criterion for NPC (<6 cm), PFV blur (break if no blur; >15Δ and >2 times the exodeviation) and convergence composite (NPC and PFV both normal) were calculated.ResultsThe greatest change in NPC and PFV (7.6 cm and 12.7 Δ) and the fastest rate of improvement in NPC and PFV (1.9 cm/week and 3.2 Δ/week, respectively) were both found during the first 4 weeks of therapy, with both slowing over the subsequent 12 weeks. After 12 weeks of therapy, the NPC, PFV and convergence composite were normal in 93.2%, 91.7% and 87.8% of participants, respectively, and normalised with another 4 weeks of therapy in 4.4%, 2.0% and 4.4% of participants, respectively.ConclusionAlthough the greatest improvements in NPC and PFV occurred in the first 4 weeks of therapy, most participants had weekly improvements over the subsequent 12 weeks of treatment. While most children with convergence insufficiency obtained normal convergence following 12 weeks of therapy, an additional 4 weeks of vergence/accommodative therapy may be beneficial for some participants.
| S-EPMC9798873 | biostudies-literature
Project description:SignificanceThese data confirm the effectiveness of office-based vergence/accommodative therapy for improving the near point of convergence and positive fusional vergence in young adults with symptomatic convergence insufficiency within a double-masked longitudinal randomized clinical trial.PurposeThis study aimed to report changes in clinical signs and symptoms of convergence insufficiency from a randomized clinical trial evaluating the effectiveness of office-based vergence/accommodative therapy for young adults with symptomatic convergence insufficiency.MethodsIn this double-masked, randomized clinical trial, convergence insufficiency patients (n = 50; average age, 21 ± 3 years; range, 18 to 32 years) were randomized to either office-based vergence/accommodative therapy or office-based placebo therapy. Improvements in (1) near point of convergence, (2) positive fusional vergence, and (3) self-reported symptoms (Convergence Insufficiency Symptom Survey [CISS] score) were evaluated after twelve 1-hour sessions of treatment within the office comparing the results from the vergence/accommodative therapy and the placebo therapy groups.ResultsThe mean near point of convergence improved by 6.0 and 3.1 cm in the vergence/accommodative and placebo therapy groups, respectively (mean difference of -2.9 cm; 95% confidence interval [CI], -4.6 to -1.0 cm; P < .01). The mean positive fusional vergence increased by 17.3 and 7.4Δ in the vergence/accommodative and placebo therapy groups, respectively (mean difference of 9.9Δ; 95% CI, 4.9 to 16.0Δ; P < .001). The mean CISS score improved by 12.4 and 10.1 points in the vergence/accommodative and placebo therapy groups, respectively (mean difference of 2.3 points; 95% CI, -8.3 to +4.6 points; P = .56).ConclusionsOur results demonstrate that office-based vergence/accommodative therapy is effective for improving the near point of convergence and positive fusional vergence in young adults with symptomatic convergence insufficiency. However, given that both treatment groups had a similar reduction in self-reported symptoms, we recommend that the CISS be revised if it is to be used as an outcome measure in future studies of convergence insufficiency.
| S-EPMC7744390 | biostudies-literature