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 cut-off 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 - <18 years with NBV. Examiners masked to the child’s binocular vision status administered the CISS. The mean CISS score was compared to that from the children with NBV in the original, unmasked CISS study and also to that of the 221 symptomatic CI children enrolled in the CITT. Results The mean (±SD) CISS score for 46 subjects with NBV was 10.4 (±8.1). This was comparable to that from 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 less than 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 and these results confirm the validity of a cut-point of ≥ 16 in distinguishing children with symptomatic CI from those with NBV.
Purpose To compare visual performance between emmetropic and uncorrected moderately hyperopic preschool age children without strabismus or amblyopia. Design Cross-sectional study. Methods Setting Multicenter, institutional. Patient or Study Population Children aged 4 or 5 years. Intervention or Observation Procedures Visual functions were classified as normal or reduced for each child based on the 95% confidence interval for emmetropes. Hyperopic (≥3.0 diopters [D] to ≤6.0D in the most hyperopic meridian; astigmatism≤1.50D; anisometropia≤1.0D) and emmetropic status were determined by cycloplegic autorefraction. Main Outcome Measures Uncorrected monocular distance and binocular near visual acuity (VA); accommodative response; and near random dot stereoacuity. Results Mean (±SD) LogMAR distance VA among 248 emmetropes was better than among 244 hyperopes for the better (0.05±0.10 vs. 0.14±0.11, p<.001) and worse eyes (0.10±0.11 vs. 0.19±0.10, p<.001). Mean binocular LogMAR near VA was better in emmetropes than hyperopes (0.13±0.11 vs. 0.21±0.11, p<.001). Mean accommodative response for emmetropes was lower than for hyperopes for both Monocular Estimation Method (1.03±0.51D vs. 2.03±1.03D, p<0.001) and Grand Seiko (0.46±0.45D vs. 0.99±1.0D, p<0.001). Median near stereoacuity was better in emmetropes than hyperopes (40 sec arc vs.120 sec arc, p<0.001). The average number of reduced visual functions was lower in emmetropic than in hyperopic children (.19 vs.1.0 p<0.001). Conclusions VA, accommodative response, and stereoacuity were significantly reduced in moderate uncorrected hyperopic preschool children compared to emmetropes. Higher hyperopes (≥4 to ≤6D) were at greatest risk, although more than half of children with lower magnitudes (≥3 to <4D) demonstrated one or more reductions in function.
Purpose To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment. Methods Patients (n = 221, ages, 9–17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n = 114). The placebo therapy program was designed to appear to be real vergence/accommodative therapy, without stimulating vergence, accommodation, or fine saccades (beyond levels of daily visual activities). After treatment, patients in the office-based groups were asked whether they thought they had received real or placebo therapy and how confident they were in their answers. Results Ninety-three percent of patients assigned to real therapy and 85% assigned to placebo therapy thought they were in the real therapy group (P = 0.17). No significant differences were found between the two groups in adherence to the therapy (P ≥ 0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, race, or ethnicity (P > 0.30 for all comparisons). No association was found between patients' perception of group assignment and symptoms or signs at outcome (P ≥ 0.38 for all comparisons). Conclusions The CITT placebo therapy program was effective in maintaining patient masking in this study and therefore may have potential for use in future clinical trials using vergence/accommodative therapy. Masking was not affected by demographic variables. Perception of group assignment was not related to symptoms or signs at outcome (ClinicalTrials.gov number, NCT00338611).
NPC break performed best in identifying children with CI.
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