April 15, 2022
By Dwight Akerman, OD, MBA, FAAO, FBCLA, FIACLE
This randomized clinical trial aimed to evaluate whether Essilor Stellest spectacle lenses with aspherical lenslets still slow myopia progression over two years and whether the level of lenslet asphericity would affect myopia control efficacy in a dose-dependent manner.
This double-masked randomized clinical trial was conducted between July 2018 and October 2020 at the Eye Hospital of Wenzhou Medical University in Wenzhou, China. Children aged 8 to 13 years with a cycloplegic spherical equivalent refraction (SER) of -0.75D to -4.75D and astigmatism with less than -1.50D were recruited and randomized into either single vision (SV), highly aspherical lenslet (HAL), or slightly aspherical lenslet (SAL) spectacle lenses. After two years, 157 children completed the study. Myopia progressed to 0.66D/0.34mm in the HAL group, 1.04D/0.51mm in the SAL group, and 1.46D/0.69mm in the SV group.
The key outcomes of the study include:
- Higher lenslet asphericity led to higher myopia control efficacy, so HAL lenses were more effective at slowing down myopia progression than SAL lenses.
- HAL lenses showed high myopia control efficacy and slowed down myopia progression by 0.80D (55%) and axial elongation by 0.35mm (51%), on average, compared to single-vision spectacle lenses (SVL).
- Two-year results demonstrated that wearing time matters in myopia control and highlighted its significant impact on myopia control efficacy outcomes. Hence myopia control efficacy increased in children who wore HAL lenses full time (≥12 hours/day) every day, to 0.99D (67%) slowdown in myopia progression and 0.41mm (60%) axial length efficacy on average when compared to SVL.
The researchers concluded that HAL and SAL reduced the rate of myopia progression and axial elongation throughout two years, with higher efficacy for HAL. Longer wearing hours improved myopia control efficacy for HAL, reinforcing that all-day wear of myopia control interventions should be encouraged.
Abstract
Spectacle Lenses With Aspherical Lenslets for Myopia Control vs. Single-Vision Spectacle Lenses: A Randomized Clinical Trial
Jinhua Bao, Yingying Huang, Xue Li, Adeline Yang, Fengchao Zhou Junqian Wu, Chu Wang, Yuhao Li, Ee Woon Lim, Daniel P. Spiegel, Björn Drobe, Hao Chen
Importance: Reducing myopia progression can reduce the risk of associated ocular pathologies.
Objective: To evaluate whether spectacle lenses with higher lenslet asphericity have a higher myopia control efficacy throughout 2 years.
Design, setting, and participants: This double-masked randomized clinical trial was conducted between July 2018 and October 2020 at the Eye Hospital of Wenzhou Medical University in Wenzhou, China. Children aged 8 to 13 years with a cycloplegic spherical equivalent refraction (SER) of -0.75 D to -4.75 D and astigmatism with less than -1.50 D were recruited. A data and safety monitoring committee reviewed findings from a planned interim analysis in 2019.
Interventions: Participants were randomly assigned in a 1:1:1 ratio to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL).
Main outcome and measures: Two-year changes in SER and axial length and their differences between groups.
Results: Of 157 participants who completed each visit (mean [SD] age, 10.4 [1.2] years), 54 were analyzed in the HAL group, 53 in the SAL group, and 50 in the SVL group. Mean (SE) 2-year myopia progression in the SVL group was 1.46 (0.09) D. Compared with SVL, the mean (SE) change in SER was less for HAL (by 0.80 [0.11] D) and SAL (by 0.42 [0.11] D; P ≤ .001). The mean (SE) increase in axial length was 0.69 (0.04) mm for SVL. Compared with SVL, the increase in axial length was slowed by a mean (SE) of 0.35 (0.05) mm for HAL and 0.18 (0.05) mm for SAL (P ≤ .001). Compared with SVL, for children who wore HAL at least 12 hours every day, the mean (SE) change in SER was slowed by 0.99 (0.12) D, and the increase in axial length slowed by 0.41 (0.05) mm.
Conclusions and relevance: In this study, HAL and SAL reduced the rate of myopia progression and axial elongation throughout 2 years, with higher efficacy for HAL. Longer wearing hours resulted in better myopia control efficacy for HAL.
Bao, J., Huang, Y., Li, X., Yang, A., Zhou, F., Wu, J., … & Chen, H. (2022). Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA ophthalmology.
DOI: 10.1001/jamaophthalmol.2022.0401
