Table 3.
Treatment Groups | |||
---|---|---|---|
Placebo | Low-Dose (0.01% Atropine) |
Loading Dose (0.1% to 0.01% Atropine) |
|
At 3-month visit | |||
N | 32 | 32 | 33 |
Total | 6 (18.8) | 8 (25.0) | 22 (66.7) *** |
Mydriasis | 0 | 0 | 11 (33.3) ** |
Photophobia | 0 | 3 (9.4) | 16 (48.5) *** |
Blurred near vision | 0 | 0 | 18 (54.5) *** |
Discomfort during administration | 2 (6.3) | 2 (6.3) | 3 (9.1) |
Other adverse reactions or events | 4 (12.5) | 5 (15.6) | 3 (9.1) |
Serious adverse reactions | 0 | 0 | 0 |
At 6-month visit | |||
N | 31 | 32 | 33 |
Total | 4 (12.9) | 1 (3.1) | 15 (45.5) * |
Mydriasis | 0 | 0 | 7 (21.2) * |
Photophobia | 0 | 0 | 11 (33.3) ** |
Blurred near vision | 0 | 1 (3.1) | 12 (36.4) *** |
Discomfort during administration | 2 (6.5) | 1 (3.1) | 2 (6.1) |
Other adverse reactions or events | 3 (9.7) | 0 | 2 (6.1) |
Serious adverse reactions | 0 | 0 | 0 |
Notes: Distribution of adverse reactions and events. Data are presented as the number of participants with percentages in parenthesis. Total refers to the number of participants with one or more adverse events. Investigators performed the distinction between adverse reactions and events. A further detailed reporting of adverse reactions and events was not possible due to the intention of maintaining masking. p values were adjusted with the false discovery rate (FDR) method and referred to as adj-P. Footnotes: *, adj-P < 0.05; **, adj-P < 0.01; ***, adj-P < 0.001. Abbreviations: FDR = false discovery rate; N = number of participants.