Table 1

Linear mixed model mean effect estimates of ophthalmic parameters after 2 years of treatment during the washout period

Group
time point		Placebo0.1% loading dose0.01%
Axial length, mm
 Baseline24.60 (24.42; 24.78)
 30 mo25.26 (25.04; 25.47)−0.07 (−0.18; 0.04)−0.09 (−0.20; 0.018)
 30-mo adjusted-p   0.82 0.76
 36 mo25.33 (25.11; 25.56)−0.06 (−0.18; 0.07)−0.09 (−0.21; 0.04)
 36-mo adjusted-p   0.86 0.78
Spherical equivalent refraction, diopters
 Baseline−2.99 (−3.26; −2.71)
 30 mo−4.27 (−4.64; −3.91)0.03 (−0.20; 0.27)0.07 (−0.17; 0.30)
 30-mo adjusted-p   0.94 0.86
 36 mo−4.43 (−4.83; −4.03)−0.02 (−0.30; 0.26)0.17 (−0.11; 0.45)
 36-mo adjusted-p   0.94 0.82
Intraocular pressure, mm Hg
 Baseline16.2 (15.5; 16.9)
 30 mo17.7 (16.7; 18.6)0.3 (−0.8; 1.4)0.3 (−0.8; 1.4)
 30-mo adjusted-p   0.86 0.86
 36 mo17.8 (16.8; 18.8)−0.9 (−2.0; 0.2)−0.9 (−2.0; 0.2)
 36-mo adjusted-p   0.76 0.76
Distance BCVA, LogMAR
 Baseline−0.12 (−0.13; −0.10)
 30 mo−0.11 (−0.13; −0.09)−0.01 (−0.03; 0.02)−0.01 (−0.03; 0.02)
 30-mo adjusted-p   0.86 0.86
 36 mo−0.11 (−0.13; −0.09)−0.01 (−0.03; 0.01)−0.02 (−0.04; 0.00)
 36-mo adjusted-p   0.86 0.76
Near BCVA, LogMAR
 Baseline−0.08 (−0.09; −0.06)
 30 mo−0.08 (−0.10; −0.05)−0.01 (−0.03; 0.02)0.01 (−0.02; 0.04)
 30-mo adjusted-p   0.86 0.86
 36 mo−0.08 (−0.10; −0.05)0.00 (−0.03; 0.02)0.00 (−0.03; 0.02)
 36-mo adjusted-p   0.94 0.94
Accommodation amplitude, diopters
 Baseline16.4 (15.6; 17.2)
 30 mo17.2 (16.1; 18.2)0.3 (−0.8; 1.5)−0.4 (−1.5; 0.8)
 30-mo adjusted-p   0.86 0.86
 36 mo16.3 (15.3; 17.3)0.0 (−1.2; 1.0)0.0 (−1.1; 1.1)
 36-mo adjusted-p   0.94 0.99
Mesopic pupil diameter, mm
 Baseline4.47 (4.25; 4.69)
 30 mo4.41 (4.17; 4.64)0.00 (−0.26; 0.25)−0.02 (−0.27; 0.23)
 30-mo adjusted-p   0.99 0.94
 36 mo4.37 (4.10; 4.64)−0.11 (−0.41; 0.20)−0.04 (−0.35; 0.27)
 36-mo adjusted-p   0.86 0.94
Photopic pupil diameter, mm
 Baseline2.97 (2.81; 3.12)
 30 mo2.79 (2.68; 2.91)0.06 (−0.07; 0.19)−0.01 (−0.14; 0.12)
 36-mo adjusted-p   0.86 0.94
 36-mo2.80 (2.59; 3.02)0.07 (−0.19; 0.32)0.05 (−0.20; 0.31)
 36-mo adjusted-p   0.86 0.88

  • Effect estimates presented as total for the placebo group and differences from the placebo group for the intervention groups (0.1% loading dose and 0.01% groups).

  • Adjusted significance levels are reported for the visits during the washout period (30 and 36 months) after adjusting for the false discovery rate.

  • 0.1% loading dose, participants who received a 0.1% loading dose the first 6 months of intervention and then 0.01% for the remaining 18 months of intervention; 0.01%, participants who received 0.01% for the full 2 years of the intervention; placebo, participants who received placebo during the 2 years of active intervention.

  • mo, months; SER, spherical equivalent refraction.