The results from the first-year interim analysis showed that spectacle lenses with highly aspherical lenslets (HAL) and spectacle lenses with slightly aspherical lenslets (SAL) were effective in slowing myopia progression. 13 This study evaluates novel spectacle lenses with aspherical lenslets and explores the effect of lenslet asphericity on myopia control efficacy. 7 - 9 Furthermore, several studies have shown a positive dose-response relationship between the efficacy of optical interventions and parameters such as addition power in multifocal soft contact lenses 10 and spectacle lenses 11, 12 and in the wearing time of multifocal soft contact lenses. Peripheral visual signals have been found to dominate central refractive development, 6 and the effect of peripheral myopic retinal defocus was found to provide myopia control signals.
3 - 5 The common features of these myopia optical interventions are to provide central correction for distance vision and correct peripheral retinal defocus or induce peripheral myopic retinal defocus simultaneously. 2 Increasing evidence suggests that specifically designed optical interventions such as spectacle lenses, soft contact lenses, and orthokeratology slow myopia progression in children. 1 Myopia control interventions have been used for many years to reduce the severity of myopia and decrease the risk of associated ocular pathologies. The projected 2050 prevalence rates of myopia and high myopia are alarming.
#Clinical trial of beyond contact lenses registration#
Trial Registration Chinese Clinical Trial Registry Identifier: ChiCTR1800017683 Longer wearing hours resulted in better myopia control efficacy for HAL. 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 increase in axial length slowed by 0.41 (0.05) mm.Ĭonclusions 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. Compared with SVL, 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). The mean (SE) increase in axial length was 0.69 (0.04) mm for SVL. Compared with SVL, the mean (SE) change in SER was less for HAL (by 0.80 D) and SAL (by 0.42 D P ≤ .001). Mean (SE) 2-year myopia progression in the SVL group was 1.46 (0.09) D. Results Of 157 participants who completed each visit (mean age, 10.4 years), 54 were analyzed in the HAL group, 53 in the SAL group, and 50 in the SVL group.
Main Outcome and Measures Two-year changes in SER and axial length and their differences between groups. 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). A data and safety monitoring committee reviewed findings from a planned interim analysis in 2019. 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. Objective To evaluate whether spectacle lenses with higher lenslet asphericity have a higher myopia control efficacy throughout 2 years.ĭesign, 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. Importance Reducing myopia progression can reduce the risk of associated ocular pathologies.
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