Myopia Control Efficacy of Grid Dimension Multiregion Spectacle Lenses: A One‐Year Randomized Double‐Masked Controlled Trial

Purpose To evaluate the effectiveness and safety of grid dimension multiregion (GDM) spectacle lenses in myopia control and compare the myopia control effects between GDM and highly aspherical lenslets (HAL) spectacle lenses. Methods A total of 150 children aged 6–13 years were enrolled at the Hangzhou Campus of Eye Hospital of Wenzhou Medical University between December 2022 and July 2023 and randomly assigned to the GDM and HAL groups. Cycloplegic autorefraction (spherical equivalent refraction [SER]) and axial length (AL) were measured at baseline and 6‐month intervals until one year follow‐up. Results 131 participants completed the study and were included in the final analysis. At the six‐month follow‐up, the changes in SER and AL were 0.06 ± 0.37 D and 0.01 ± 0.11 mm in the GDM group and −0.06 ± 0.31 D and 0.04 ± 0.11 mm in the HAL group, respectively. The GDM group showed a statistically significant difference in SER changes compared to the HAL group ( p = 0.042). No statistically significant difference in AL was observed between the groups ( p = 0.266). At the one‐year follow‐up, the changes in SER were −0.17 ± 0.40 D in the GDM group and −0.19 ± 0.36 D in the HAL group. The changes in AL were 0.07 ± 0.17 mm in the GDM group and 0.11 ± 0.15 mm in the HAL group. No statistically significant differences in SER or AL were observed between the GDM and HAL groups ( p = 0.980 and p = 0.131, respectively). After adjustment using generalized estimating equations, a significant difference in AL change was observed between the GDM and HAL groups ( p = 0.048). In terms of subjective visual quality, there was no statistical difference in the total scores between the GDM and HAL groups ( p = 0.436). No adverse events were reported in any group. Conclusions Both GDM and HAL lenses effectively controlled myopia progression over 1 year, with GDM showing slightly superior efficacy in limiting axial elongation. Trial Registration : Chinese Clinical Trial Registry: ChiCTR2200066890