Table 2. Efficacy Measures (Modified Intention-to-Treat Set).
End point | Placebo (n = 144) | Atropine, 0.01% (n = 133) | Atropine, 0.02% (n = 212) |
---|---|---|---|
Responder analysis: <0.50 D myopia progression at month 36 | |||
No. of eyes | 252 | 200 | 366 |
No. (%) of responder eyes | 44 (17.5) | 57 (28.5) | 81 (22.1) |
Odds ratio for low-dose atropine/placebo (95% CI) | NA | 4.54 (1.15 to 17.96) | 1.77 (0.50 to 6.26) |
P value | NA | .03 | .37 |
Cycloplegic refraction: mean change from baseline in SER | |||
Baseline | |||
No. of eyes | 282 | 266 | 424 |
Mean SER (SD), D | −2.45 (1.13) | −2.41 (1.17) | −2.42 (1.17) |
Median (IQR) | −2.38 (1.66) | −2.20 (1.53) | −2.26 (1.57) |
Month 36 | |||
No. of eyes | 252 | 200 | 366 |
Mean SER (SD), D | −3.72 (1.42) | −3.41 (1.49) | −3.61 (1.53) |
Median (IQR) | −3.73 (2.05) | −3.28 (2.02) | −3.51 (2.10) |
Least squares mean change (95% CI) from baseline at month 36, D | −1.28 (−1.37 to −1.19) | −1.04 (−1.14 to −0.94) | −1.18 (−1.26 to −1.10) |
Least squares mean difference (95% CI) between low-dose atropine and placebo, D | NA | 0.24 (0.11 to 0.37) | 0.10 (−0.02 to 0.22) |
P value | NA | <.001 | .10 |
Biometric measure: mean change from baseline in axial length | |||
Baseline | |||
No. of eyes | 281 | 266 | 419 |
Mean axial length (SD), mm | 24.33 (0.84) | 24.37 (0.81) | 24.30 (0.87) |
Median (IQR) | 24.40 (1.20) | 24.39(1.09) | 24.29 (1.14) |
Month 36 | |||
No. of eyes | 252 | 200 | 366 |
Mean axial length (SD), mm | 25.09 (0.88) | 25.12 (0.87) | 25.01 (0.98) |
Median (IQR) | 25.13 (1.29) | 25.09 (1.27) | 25.01 (1.26) |
Least squares mean change (95% CI) from baseline at month 36, mm | 0.81 (0.76 to 0.85) | 0.68 (0.63 to 0.72) | 0.73 (0.69 to 0.76) |
Least squares mean difference (95% CI) between low-dose atropine and placebo, mm | NA | −0.13 (−0.19 to −0.07) | −0.08 (−0.13 to −0.02) |
P value | NA | <.001 | .005 |
Abbreviations: D, diopter; NA, not applicable; SER, spherical equivalent refractive error.