Discussion
myopia
ADVERSE EVENTS, MYOPIA
We investigated the effect and safety of 0.01% and 0.1% loading dose atropine eye drops in reducing myopia progression in Danish children following twelve months treatment. We found a small effect on myopia progression, which was non-significant following multiple comparisons adjustment. We found a moderate frequency of adverse events, primarily in participants receiving 0.1% loading dose, followed by a low frequency of adverse events after dose-switching to 0.01%. Mesopic and photopic pupil diameter was significantly increased in both intervention groups compared to placebo, indicating that the eye drops had been used.We observed a dose-dependent effect on AL and SER progression which was greater in the 0.1% loading dose group than the 0.01% group, during the initial six-month loading dose phase. We found a non-significant effect on AL progression in our 0.01% group after twelve months of treatment similar in size to that found in the LAMP study (− 0.07 mm and − 0.05 mm, respectively) [A rebound effect has been reported after atropine cessation which speculatively may be reduced by dose-tapering rather than complete cessation of atropine eye drops [Approximately half of participants in the 0.1% loading dose group experienced pupil-related side effects during the loading dose phase (i.e., the initial six months in this group). The LAMP study speculated that less iris pigmentation might result in an increased occurrence of pupil-related side effects [A strength of this study was the double-masked, placebo-controlled, randomized clinical trial-setup and low drop-out rate. Also, we retained a placebo group receiving vehicle in contrast to for example the ATOM2 study [