Table 2. Spherical Equivalent Refractive Error (SER) and Axial Length by Treatment Groupa,b.
| Variable | Baseline | 12-mo Visit | 24-mo Visit | 30-mo Visitc | ||||
|---|---|---|---|---|---|---|---|---|
| Atropine (n = 125) | Placebo (n = 62) | Atropine (n = 93) | Placebo (n = 49) | Atropine (n = 119) | Placebo (n = 58) | Atropine (n = 118) | Placebo (n = 57) | |
| Mean right and left eye SER, No. (%), D | ||||||||
| <−6.00 | 0 | 0 | 1 (1) | 1 (2) | 7 (6) | 1 (2) | 11 (9) | 3 (5) |
| −6.00 to <−5.00 | 5 (4) | 1 (2) | 9 (10) | 1 (2) | 11 (9) | 5 (9) | 10 (8) | 3 (5) |
| −5.00 to <−4.00 | 17 (14) | 5 (8) | 17 (18) | 9 (18) | 26 (22) | 14 (24) | 26 (22) | 15 (26) |
| −4.00 to <−3.00 | 27 (22) | 19 (31) | 18 (19) | 13 (27) | 31 (26) | 17 (29) | 35 (30) | 19 (33) |
| −3.00 to <−2.00 | 37 (30) | 22 (35) | 30 (32) | 18 (37) | 26 (22) | 17 (29) | 19 (16) | 13 (23) |
| −2.00 to <−1.00 | 39 (31) | 15 (24) | 18 (19) | 7 (14) | 17 (14) | 4 (7) | 16 (14) | 4 (7) |
| −1.00 to <0.00 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 1 (1) | 0 |
| Mean (SD) | −2.83 (1.17) | −2.83 (0.97) | −3.22 (1.27) | −3.22 (1.05) | −3.64 (1.46) | −3.54 (1.08) | −3.81 (1.56) | −3.69 (1.16) |
| Median | −2.60 | −2.81 | −2.94 | −3.00 | −3.52 | −3.51 | −3.66 | −3.65 |
| Change of mean right and left eye SER from baseline (outcome − baseline), No. (%), D | ||||||||
| ≤−3.50 | NA | NA | 0 | 0 | 0 | 0 | 1 (1) | 0 |
| >−3.50 to −3.00 | 0 | 0 | 1 (1) | 0 | 2 (2) | 1 (2) | ||
| >−3.00 to −2.50 | 0 | 0 | 1 (1) | 0 | 5 (4) | 0 | ||
| >−2.50 to −2.00 | 0 | 0 | 5 (4) | 2 (3) | 5 (4) | 3 (5) | ||
| >−2.00 to −1.50 | 1 (1) | 1 (2) | 8 (7) | 7 (12) | 8 (7) | 6 (11) | ||
| >−1.50 to −1.00 | 5 (5) | 2 (4) | 19 (16) | 9 (16) | 22 (19) | 11 (19) | ||
| >−1.00 to −0.50 | 22 (24) | 17 (35) | 37 (31) | 18 (31) | 35 (30) | 20 (35) | ||
| >−0.50 to 0.00 | 57 (61) | 27 (55) | 46 (39) | 18 (31) | 36 (31) | 13 (23) | ||
| >0 | 8 (9) | 2 (4) | 2 (2) | 4 (7) | 4 (3) | 3 (5) | ||
| Mean (SD) | −0.39 (0.36) | −0.45 (0.35) | −0.78 (0.64) | −0.74 (0.60) | −0.94 (0.77) | −0.88 (0.71) | ||
| Median | −0.31 | −0.40 | −0.58 | −0.63 | −0.72 | −0.77 | ||
| Adjusted treatment group difference of mean change in SER from baseline at 24 and 30 mo (atropine – placebo) (95% CI), Dd | NA | NA | NA | NA | −0.02 (−0.19 to 0.15)e | −0.04 (−0.25 to 0.17)f | ||
| Participants with ≥0.5 D progression in myopia from baseline, No. (%) | NA | NA | 35 (38) | 20 (41) | 78 (66) | 37 (64) | 83 (70) | 41 (72) |
| Participants with ≥1 D progression in myopia from baseline, No. (%) | NA | NA | 6 (6) | 3 (6) | 34 (29) | 18 (31) | 44 (37) | 21 (37) |
| Participants with ≥2 D progression in myopia from baseline, No. (%) | NA | NA | 0 | 0 | 7 (6) | 2 (3) | 14 (12) | 4 (7) |
| Mean right and left eye axial length, No. (%), mmg | ||||||||
| 22.0 to <23.0 | 5 (4) | 3 (5) | 1 (1) | 1 (2) | 1 (1) | 0 (0) | 0 (0) | 0 (0) |
| 23.0 to <24.0 | 33 (26) | 12 (19) | 23 (25) | 9 (18) | 18 (15) | 8 (14) | 18 (15) | 7 (12) |
| 24.0 to <25.0 | 51 (41) | 30 (48) | 36 (40) | 22 (45) | 50 (42) | 25 (43) | 44 (37) | 23 (40) |
| 25.0 to <26.0 | 33 (26) | 15 (24) | 26 (29) | 14 (29) | 37 (31) | 21 (36) | 40 (34) | 20 (35) |
| 26.0 to <27.0 | 3 (2) | 2 (3) | 5 (5) | 2 (4) | 12 (10) | 3 (5) | 15 (13) | 6 (11) |
| 27.0 to <28.0 | 0 | 0 | 0 | 1 (2) | 1 (1) | 1 (2) | 1 (1) | 1 (2) |
| Mean (SD) | 24.4 (0.8) | 24.4 (0.8) | 24.7 (0.8) | 24.7 (0.8) | 24.9 (0.9) | 24.9 (0.8) | 24.9 (0.9) | 24.9 (0.8) |
| Median | 24.4 | 24.3 | 24.6 | 24.6 | 24.8 | 24.7 | 24.9 | 24.8 |
| Change of mean right and left eye axial length from baseline (outcome – baseline), mmg | ||||||||
| <0 | NA | NA | 4 (4) | 1 (2) | 1 (1) | 0 | 0 | 0 |
| 0 to <0.25 | 54 (59) | 25 (51) | 41 (34) | 19 (33) | 30 (25) | 15 (26) | ||
| 0.25 to <0.50 | 28 (31) | 20 (41) | 39 (33) | 18 (31) | 37 (31) | 18 (32) | ||
| 0.50 to <0.75 | 4 (4) | 2 (4) | 22 (18) | 14 (24) | 31 (26) | 11 (19) | ||
| 0.75 to <1.00 | 1 (1) | 1 (2) | 8 (7) | 5 (9) | 6 (5) | 8 (14) | ||
| 1.00 to <1.25 | 0 | 0 | 7 (6) | 2 (3) | 10 (8) | 4 (7) | ||
| 1.25 to <1.50 | 0 | 0 | 0 | 0 | 1 (1) | 1 (2) | ||
| ≥1.50 | 0 | 0 | 1 (1) | 0 | 3 (3) | 0 (0) | ||
| Mean (SD) | 0.22 (0.17) | 0.25 (0.16) | 0.42 (0.29) | 0.41 (0.27) | 0.51 (0.35) | 0.49 (0.32) | ||
| Median | 0.20 | 0.23 | 0.38 | 0.36 | 0.44 | 0.45 | ||
| Adjusted treatment group difference of mean change in axial length from baseline at 24 and 30 mo (atropine – placebo) (95% CI), mmh,i | NA | NA | NA | NA | −0.002 (−0.106 to 0.102)j | 0.009 (−0.115 to 0.134)k | ||
Abbreviations: D, diopter; NA, not applicable.
All percentages in this table are column percentages (of total number of participants randomly assigned to the treatment group who completed the specified visit).
In-person follow-up at the 12-month visit was reduced due to the COVID-19 public health emergency. Virtual visits were conducted when semiannual visits could not be completed in person but excluded cycloplegic autorefraction. Study eye drops were delivered to all participants.
Study treatment was discontinued at the 24-month visit; 30-month visit was without treatment.
The adjusted treatment group difference of mean change in SER from baseline adjusted for baseline SER, age, iris color (brown vs nonbrown), and race (East Asian vs non–East Asian participants), to account for potential residual confounding.
The adjusted mean change in SER from baseline at 24 months was −0.82 D vs −0.80 D in the atropine and placebo groups, respectively.
The adjusted mean change in SER from baseline at 30 months was −0.97 D vs −0.93 D in the atropine and placebo groups, respectively.
The total number of participants in the atropine group with axial length measurement at 12 months was 91.
The adjusted treatment group difference of mean change in axial length from baseline adjusted for baseline axial length, age, iris color (brown vs nonbrown), and race (East Asian vs non–East Asian participants), to account for potential residual confounding.
The CIs were adjusted to control the overall false discovery rate for the multiple secondary outcomes at 5%.
The adjusted mean change in axial length from baseline at 24 months was 0.44 mm vs 0.45 mm in the atropine and placebo groups, respectively.
The adjusted mean change in axial length from baseline at 30 months was 0.53 mm vs 0.52 mm in the atropine and placebo groups, respectively.