We recently discovered that 10 (3.2%) participants in the CITT-ART should not have been enrolled because they did not meet the eligibility criterion for positive fusional convergence. However, the blur values (used to characterise within- and between-group changes in fusional vergence) of ineligible participants (mean = 13.0 Δ) were similar to those of eligible participants (mean = 11.4 Δ) and there was no meaningful effect on published results thus far. We are gratified that a sensitivity analysis excluding these 10 participants showed the study results to be essentially the same. (1) Tables 2 and 3 below (table numbers correspond to the table numbers in the published paper) show the minimal impact of excluding the 10 participants, including no changes in the status of statistical significance (Table 3). Changes in effect size are not meaningful.
Table 2.
Type of Accommodative Dysfunction | Office-based Vergence/ Accommodative n (%) | Office-based Placebo n (%) | Overall n (%) | |||
---|---|---|---|---|---|---|
Published | After exclusions | Published | After exclusion | Published | After exclusions | |
Decreased Amplitude * | 104 (52.5%) | 102 (53.1%) | 63 (60.6%) | 61 (61%) | 167 (55.3%) | 163 (55.8%) |
Decreased Facility ** | 67 (33.8%) | 64 (33.3%) | 37 (35.6%) | 34 (34%) | 104 (34.4%) | 98 (33.6%) |
Either Decreased Amplitude or Facility | 130 (65.7%) | 126 (65.6%) | 72 (69.2%) | 68 (68%) | 202 (66.9%) | 194 (66.4%) |
more than 2D below the minimum expected amplitude for age (15 - ¼ age)
less than 6 cycles per minute
Table 3.
Accommodative Measure | Decreased Accommodative Function** | Age-normal Accommodative Function | Difference Between Means (95% CI) | P Value* | Cohen’s d | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Mean (SD) | N | Mean (SD) | |||||||||
Near point of convergence (cm) | ||||||||||||
Amplitude | Published | 286 | 17 (8.2) | 234 | 10.9 (5.8) | 6.1 (4.9, 7.4) | <.001 | 0.85 | ||||
After exclusions | 282 | 17.1 (8.2) | 228 | 11 (5.8) | 6.1 (4.8, 7.4) | <.001 | 0.84 | |||||
Facility | Published | 205 | 15.2 (8.3) | 315 | 13.7 (7.4) | 1.5 (0.2, 2.9) | 0.03 | 0.2 | ||||
After exclusions | 199 | 15.3 (8.4) | 311 | 13.7 (7.4) | 1.6 (0.2, 3) | 0.03 | 0.21 | |||||
Positive fusional vergence (Δ) | ||||||||||||
Amplitude | Published | 286 | 10.5 (4) | 234 | 12.1 (4) | −1.6 (−2.3, −0.9) | <.001 | 0.4 | ||||
After exclusions | 282 | 10.5 (4) | 228 | 12.1 (4.1) | −1.6 (−2.3, −0.9) | <.001 | 0.39 | |||||
Facility | Published | 205 | 10.7 (4) | 315 | 11.6 (4) | −0.9 (−1.6, −0.2) | 0.02 | 0.21 | ||||
After exclusions | 199 | 10.7 (4.1) | 311 | 11.6 (4) | −0.9 (−1.6, −0.2) | 0.01 | 0.22 | |||||
CISS Score | ||||||||||||
Amplitude | Published | 286 | 30.9 (8.9) | 234 | 27.9 (8.2) | 3 (1.5, 4.4) | <.001 | 0.34 | ||||
After exclusions | 282 | 30.9 (8.9) | 228 | 27.8 (8.3) | 3.1 (1.6, 4.6) | <.001 | 0.36 | |||||
Facility | Published | 205 | 30.9 (8.8) | 315 | 28.7 (8.5) | 2.2 (0.7, 3.7) | 0.006 | 0.25 | ||||
After exclusions | 199 | 30.8 (8.8) | 311 | 28.7 (8.6) | 2.1 (0.6, 3.7) | 0.007 | 0.25 |
The p values are for independent samples t tests of mean differences.
Decreased accommodative amplitude was more than 2D below the minimum expected amplitude for age (15 - ¼ age); Decreased accommodative facility was less than 6 cycles per minute
References
- 1.Kulp MT, Sinnott LT, Cotter SA, Borsting E, Toole AJ, Chen AM, et al. Does coexisting accommodative dysfunction impact clinical convergence measures, symptoms and treatment success for symptomatic convergence insufficiency in children? Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians. 2022;42(1):59–70. [DOI] [PMC free article] [PubMed] [Google Scholar]