This randomized clinical trial aimed to evaluate whether spectacle lenses with aspherical lenslets slow myopia progression over 2 years and whether the level of lenslet asphericity affects myopia control efficacy in a dose-dependent manner.
ObjectiveSpectacle lenses with highly aspherical lenslets (HAL) and slightly aspherical lenslets (SAL) showed effective myopia control. This study was to investigate their effects on macular choroidal thickness (ChT) in myopic children.MethodsExploratory analysis from a 2-year, double-masked, randomised trial. 170 children aged 8–13 years with myopia between −0.75D and −4.75D, astigmatism of 1.50D or less, and anisometropia of 1.00D or less were recruited. Participants were randomly assigned in a 1:1:1 ratio to receive HAL, SAL or single vision spectacle lenses (SVL). The subfoveal, parafoveal and perifoveal ChT were evaluated every 6 months.Results154 participants completed all examinations. The ChT showed significant changes over time in all three groups in all regions (all p<0.05). The ChTs continuously decreased in the SVL group (ranging from −20.75 (SD 22.34) μm to −12.18 (22.57) μm after 2 years in different regions). Compared with the SVL group, ChT in the SAL group decreased less (ranging from −16.49 (21.27) μm to −5.29 (18.15) μm). In the HAL group, ChT increased in the first year and then decreased in the second year (ranging from −0.30 (27.54) μm to 8.92 (23.97) μm after two years). The perifoveal ChT decreased less than the parafoveal ChT, and the superior region decreased the least.ConclusionsThe ChT of the macula decreased after 2 years of myopia progression with SVL. Wearing spectacle lenses with aspherical lenslets reduced or abolished the ChT thinning and HAL had a more pronounced effect.Trial registration numberChiCTR1800017683.
Objectives To investigate the short- and long-term effects of myopia control spectacle lenses with highly aspherical lenslets (HAL) and slightly aspherical lenslets (SAL) on visual function and visual quality using data obtained from a randomized controlled clinical trial. Methods This was a prospective, randomized, controlled, and double-blinded study; 170 myopic children aged 8–13 years were randomly assigned to the HAL, SAL, or single-vision spectacle lenses (SVL) groups. Distance and near visual acuity (VA) at high (100%) and low (10%) contrast in photopic and scotopic conditions, near phoria, stereoacuity, and accommodative lag, microfluctuations (AMFs), amplitude (AA) were measured after wearing lenses for 10 min, 6 months, and 12 months. Results In total, 161 subjects completed all follow-up in 12 months and were included in the analysis. After 10 min of wearing, the HAL and SAL groups had lower scotopic and low-contrast VA than the SVL group (decreased 0.03–0.08 logMAR and 0.01–0.04 logMAR in different VAs in the HAL and SAL groups, respectively, all P < 0.05). The reduction in VA was recovered at 12 months as the HAL and SAL groups exhibited significant VA improvements, and the VA was not different among the three groups (all P > 0.05). The HAL and SAL groups had significantly larger AMFs than the SVL group (HAL vs. SAL vs. SVL: 0.21 ± 0.08 D vs. 0.16 ± 0.05 D vs. 0.15 ± 0.06 D at baseline, 0.19 ± 0.07 D vs. 0.17 ± 0.05 D vs. 0.13 ± 0.07 D at 12 months, all P < 0.05). There were no significant differences in accommodative lag, AA, or phoria between the groups (all P > 0.05). The HAL and SAL groups had reduced stereoacuity compared to the SVL group at baseline (70’ vs. 60’ vs. 50’, P = 0.005), but no difference was observed at 12 months (70’ vs. 70’ vs. 70’, P = 0.11). Conclusions HAL and SAL have no significant influence on accommodation and phoria except had larger AMF than SVL. Scotopic VA and low-contrast VA are reduced with short-term HAL and SAL use but recovered to be at same level with the SVL after 1 year of use. Trial registration Chinese Clinical Trial Registry: ChiCTR1800017683. Registered on 9 August 2018. http://www.chictr.org.cn/showproj.aspx?proj=29789
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