Table 3. Refractive Error Change Between Baseline and 12 Months.
| Measure | Completing 12 mo, No. (%) | Change in spherical equivalent refractive error from baseline to 12 mo, mean (SD) Da,b | >1 D of spherical equivalent myopic change from baseline to 12 mo, No. (%) | >1 D of spherical equivalent myopic change from baseline to 12 mo in overminus vs nonoverminus groups, risk ratio (95% CI)c | ||
|---|---|---|---|---|---|---|
| Overminus | Nonoverminus | Overminus | Nonoverminus | |||
| No. | 189 | 169 | 189 | 169 | ||
| Overall by cycloplegic refraction | 358 (100) | −0.42 (0.69) | −0.04 (0.46) | 33 (17) | 2 (1) | 14.8 (4.0 to 182.6) |
| Baseline spherical equivalent refractive errord | ||||||
| Myopia | ||||||
| No. | 43 | 44 | 43 | 44 | ||
| −0.50 to −6.00 D | 87 (100) | −1.07 (0.76) | −0.16 (0.57) | 22 (51) | 1 (2) | 22.5 (4.1 to 667.6) |
| Emmetropia | ||||||
| No. | 60 | 48 | 60 | 48 | ||
| −0.375 to 0.375 D | 108 (100) | −0.30 (0.64) | −0.01 (0.41) | 8 (13) | 1 (2) | 6.4 (1.0 to 164.9) |
| Hyperopia | ||||||
| No. | 84 | 77 | 84 | 77 | ||
| 0.50 to 1.00 D | 161 (100) | −0.18 (0.44) | 0.00 (0.41) | 3 (4) | 0 | NAe |
| Overall | ||||||
| No. | 65 | 61 | 65 | 61 | ||
| By cycloplegic autorefractionf | 126 (100) | −0.45 (0.69) | −0.05 (0.66) | 12 (18) | 3 (5) | 3.8 (1.1 to 28.3) |
Abbreviations: D, diopters; NA, not applicable.
Overall treatment group difference of 12-month refractive error (overminus − nonoverminus) equal to −0.37 D (95% CI, −0.49 to −0.26 D). The difference is obtained from an analysis of covariance model adjusted for baseline spherical equivalent refractive error in the most myopic eye and age. P < .001 for treatment group difference. Three children were excluded from analysis owing to visits out of the analysis window.
Refractive error in most myopic eye at baseline.
Exact risk ratio and CIs were obtained from a Farrington-Manning score test and reflect the relative probability of a participant in the overminus group having more than 1.00 D of myopic change at 12 months compared with a participant in the nonoverminus group.
Subgroups do not include 2 ineligible participants who had a refractive error greater than 1.00 D at baseline (1 with 1.125 D, and 1 with 1.25 D).
Among participants who were in the hyperopic group at baseline, 3 participants in the overminus group and 0 participants in the nonoverminus group had myopic shift of more than 1.00 D at 12 months. A risk ratio could not be calculated owing to the denominator of 0.
Overall treatment group difference of 12-month refractive error from cycloplegic autorefraction (overminus − nonoverminus) equal to −0.39 D (95% CI, −0.64 to −0.15 D). Difference obtained from an analysis of covariance model adjusted for baseline refractive error in the most myopic eye and age. P value not reported. One participant with autorefraction was excluded from analysis because the visit was outside the analysis window.