Rachel Coulter

Randomized clinical trial of treatments for symptomatic convergence insufficiency in children

OBJECTIVE 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. METHODS In a randomized clinical trial, 221 children aged 9 to 17 years with symptomatic convergence insufficiency were assigned to 1 of 4 treatments. MAIN OUTCOME MEASURES Convergence Insufficiency Symptom Survey score after 12 weeks of treatment. Secondary outcomes were near point of convergence and positive fusional vergence at near. RESULTS After 12 weeks of treatment, the OBVAT groups mean Convergence Insufficiency Symptom Survey score (15.1) was statistically significantly lower than those of 21.3, 24.7, and 21.9 in the HBCVAT+, HBPP, and OBPT groups, respectively (P < .001). The OBVAT group also demonstrated a significantly improved near point of convergence and positive fusional vergence at near compared with the other groups (P <or= .005 for all comparisons). A successful or improved outcome was found in 73%, 43%, 33%, and 35% of patients in the OBVAT, HBPP, HBCVAT+, and OBPT groups, respectively. CONCLUSIONS Twelve weeks of OBVAT results in a significantly greater improvement in symptoms and clinical measures of near point of convergence and positive fusional vergence and a greater percentage of patients reaching the predetermined criteria of success compared with HBPP, HBCVAT+, and OBPT. Application to Clinical Practice Office-based vergence accommodative therapy is an effective treatment for children with symptomatic convergence insufficiency. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00338611.

The convergence insufficiency treatment trial: Design, methods, and baseline data

Objective: 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. Methods: 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. Results: 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 9Δ exophoria at near (+/− 4.4) and 2Δ exophoria (+/−2.8) at distance, CISS score = 30 (+/−9.0), NPC = 14 cm (+/− 7.5), and near positive fusional vergence break = 13 Δ (+/− 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05).Conclusion: 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.

Validity of the convergence insufficiency symptom survey: a confirmatory study.

Purpose. The objectives of the present study were to evaluate whether investigator bias influenced the Convergence Insufficiency Symptom Survey (CISS) scores of children with normal binocular vision (NBV) in our original validation study, reevaluate the usefulness of the cutoff score of 16, and reexamine the validity of the CISS. Methods. Six clinical sites participating in the Convergence Insufficiency Treatment Trial (CITT) enrolled 46 children 9 to <18 years with NBV. Examiners masked to the child’s binocular vision status administered the CISS. The mean CISS score was compared with that from the children with NBV in the original, unmasked CISS study and also to that of the 221 symptomatic convergence insufficiency (CI) children enrolled in the CITT. Results. The mean (±standard deviation) CISS score for 46 subjects with NBV was 10.4 (±8.1). This was comparable with our prior unmasked NBV study (mean = 8.1 (±6.2); p = 0.11) but was significantly different from that of the CITT CI group (mean = 29.8 ± 9.0; p < 0.001). Eighty-three percent of these NBV subjects scored <16 on the CISS, which is not statistically different from the 87.5% found in the original unmasked study (p = 0.49). Conclusions. Examiner bias did not affect the CISS scores for subjects with NBV in our prior study. The CISS continues to be a valid instrument for quantifying symptoms in 9 to <18-year-old children. These results also confirm the validity of a cut-point of ≥16 in distinguishing children with symptomatic CI from those with NBV.

Vision Therapy/Orthoptics for Symptomatic Convergence Insufficiency in Children: Treatment Kinetics

Purpose. To 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. Methods. In 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. Results. Only 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. Conclusions. The 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.

The presumed influence of attention on accuracy in the developmental eye movement (DEM) test.

Background The developmental eye movement (DEM) test is a clinical test used widely to evaluate ocular motility function (accuracy and speed) in school-age children. Purpose The purpose of this study was to investigate, retrospectively, the change in accuracy over time while performing the DEM horizontal reading task in children. Methods The charts from children who had performed the DEM test during a routine eye examination in a pediatric optometry service were reviewed. The study included 22 patients (6 to 11 years old, 12 boys, 10 girls) who had a routine eye examination that was precepted by one of the authors (R.C.) during the period of 1995 to 1999. Patients were divided into two categories: 1) those with abnormal DEM test results and 2) a control group consisting of those with normal DEM test results. Chart review was done consecutively within each category. Collected data included patient age, gender, refractive error, and DEM test results. For analysis, the horizontal task of the DEM was divided into two halves (I and II), Part I always preceded part II, and data was sorted as the number of errors per part. Results More errors in accuracy occurred in part II than in part I (Wilcoxon signed rank test, p ≤ 0.01) of the horizontal DEM test in the group of subjects with an abnormal DEM test. No differences in the number of errors in parts I and II of the horizontal task of the DEM were found in the control group. Conclusions Findings showed that when excessive errors in accuracy occurred, the number of errors increased over time. If the errors were caused by an oculomotor dysfunction found in the DEM, errors should be equally distributed throughout the text. If errors were caused by fatigue, a difference in parts I and II should have occurred in both the test and the control group. These findings suggest that attention may influence accuracy over time in those patients that do poorly on the DEM test.

Eye examination testability in children with autism and in typical peers.

Purpose To compare testability of vision and eye tests in an examination protocol of 9- to 17-year-old patients with autism spectrum disorder (ASD) to typically developing (TD) peers. Methods In a prospective pilot study, 61 children and adolescents (34 with ASD and 27 who were TD) aged 9 to 17 years completed an eye examination protocol including tests of visual acuity, refraction, convergence (eye teaming), stereoacuity (depth perception), ocular motility, and ocular health. Patients who required new refractive correction were retested after wearing their updated spectacle prescription for 1 month. The specialized protocol incorporated visual, sensory, and communication supports. A psychologist determined group status/eligibility using DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria by review of previous evaluations and parent responses on the Social Communication Questionnaire. Before the examination, parents provided information regarding patients’ sex, race, ethnicity, and, for ASD patients, verbal communication level (nonverbal, uses short words, verbal). Parents indicated whether the patient wore a refractive correction, whether the patient had ever had an eye examination, and the age at the last examination. Chi-square tests compared testability results for TD and ASD groups. Results Typically developing and ASD groups did not differ by age (p = 0.54), sex (p = 0.53), or ethnicity (p = 0.22). Testability was high on most tests (TD, 100%; ASD, 88 to 100%), except for intraocular pressure (IOP), which was reduced for both the ASD (71%) and the TD (89%) patients. Among ASD patients, IOP testability varied greatly with verbal communication level (p < 0.001). Although IOP measurements were completed on all verbal patients, only 37.5% of nonverbal and 44.4% of ASD patients who used short words were successful. Conclusions Patients with ASD can complete most vision and eye tests within an examination protocol. Testability of IOPs is reduced, particularly for nonverbal patients and patients who use short words to communicate.

A study of pre-school vision screening tests' testability, validity and duration: do group differences matter?

Vision screening was performed on 268 pre-school children: 170 from a private pre-school, 33 from a Caribbean-American parochial pre-school and 65 pre-school children from a clinic serving indigent Spanish farm-workers. Using a multi-station format, a stereoacuity test and two visual acuity tests were performed during a single screening session. The time it took to complete a test was recorded. To pass the screening, children were required to pass one visual acuity test and the stereoacuity test. Children who could not complete the protocol were retested at a later date. Children who failed the screening and every fourth child who passed the screening were referred for a full eye examination. The parents and teachers were masked to the results of the screening as well as the optometrists who performed the eye examination. Sensitivity, specificity and accuracy scores were 100%, 79% and 80%, respectively. Three-year-old children completed the Lea Symbol Chart more often than the HOTV. No differences in time required to complete a visual acuity test were found. The Lea Symbol chart is more likely to be completed by young children. Testability changes significantly with age rather than with the instrument when socio-ethnic factors are held constant. Differences among groups and the sensitivity of the screening are discussed.

Pediatric use of topical ophthalmic drugs

BACKGROUND Changes in the policies of the Food and Drug Administration (FDA) have resulted in a rapid increase in the number of drugs now labeled for pediatric use. In topical ophthalmic drugs, there are pharmaceuticals approved for use in children in the treatment of allergy, inflammation, and bacterial and viral infection. Clinicians should anticipate that this trend will continue into the future. OVERVIEW This article reviews the history of FDA oversight of drugs used to treat children. Recent shifts in policies and approach are emphasized. Pediatric issues associated with ophthalmic drug use are discussed, including important differences regarding dosage, instillation, distribution, systemic toxicity, and metabolism. A summary of topical ophthalmic drugs approved for pediatric use, including age considerations, is provided. CONCLUSIONS Clinicians should be aware of the increasing number of topical ophthalmic drugs that are approved for pediatric use. Social, regulatory, and economic factors suggest this trend will continue. When prescribing these drugs for use in children, clinicians should remember to refer to details of labeling for Pediatric Use, including the age of the child for whom the drug is approved.

The Presumed Influence of Attention on Accuracy in the Developmental Eye Movement (DEM) Test: Authors’ Response

BACKGROUND The developmental eye movement (DEM) test is a clinical test used widely to evaluate ocular motility function (accuracy and speed) in school-age children. PURPOSE The purpose of this study was to investigate, retrospectively, the change in accuracy over time while performing the DEM horizontal reading task in children. METHODS The charts from children who had performed the DEM test during a routine eye examination in a pediatric optometry service were reviewed. The study included 22 patients (6 to 11 years old, 12 boys, 10 girls) who had a routine eye examination that was precepted by one of the authors (R.C.) during the period of 1995 to 1999. Patients were divided into two categories: 1) those with abnormal DEM test results and 2) a control group consisting of those with normal DEM test results. Chart review was done consecutively within each category. Collected data included patient age, gender, refractive error, and DEM test results. For analysis, the horizontal task of the DEM was divided into two halves (I and II), Part I always preceded part II, and data was sorted as the number of errors per part. RESULTS More errors in accuracy occurred in part II than in part I (Wilcoxon signed rank test, p < or = 0.01) of the horizontal DEM test in the group of subjects with an abnormal DEM test. No differences in the number of errors in parts I and II of the horizontal task of the DEM were found in the control group. CONCLUSIONS Findings showed that when excessive errors in accuracy occurred, the number of errors increased over time. If the errors were caused by an oculomotor dysfunction found in the DEM, errors should be equally distributed throughout the text. If errors were caused by fatigue, a difference in parts I and II should have occurred in both the test and the control group. These findings suggest that attention may influence accuracy over time in those patients that do poorly on the DEM test.