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Myopia Control Efficacy of Spectacle Lenses with Dual-Index Aspherical Lenslets: A 1-Year Randomized Clinical Trial
DOI:10.1016/j.xops.2025.100766.png)
Abstract
En 中文
Objective: To examine the myopia control efficacy, in terms of axial elongation, of a new myopia control spectacle lenses with Dual-Index Aspherical Lenslets (DIAL) embedded within the lens, compared with single-vision spectacle Design: A prospective, randomized, double-masked clinical trial. Participants: Eighty children aged 8 to 13 years with myopia (spherical equivalent refraction [SER] between -0.75 Intervention: Participants were randomized to either the DIAL or SVL spectacle lenses group (1:1 ratio). Main Outcome Measures: Axial length (AL), noncycloplegic subjective refraction, and best-corrected visual acuity (BCVA) were measured at baseline and 6-month intervals. Questionnaires on adaptation and compliance were administered during all visits. Results: A total of 76 (N - 38 in each group) participants (mean [standard deviation] age, 10.8 [1.6] years) completed the 1-year visit. Mean (+/- standard error) 1-year AL change in the DIAL and SVL groups was 0.04 +/- 0.02 and 0.22 +/- 0.04 mm, respectively. A mean difference of -0.18 mm (95% confidence interval [CI], -0.26 to -0.10 mm; P < 0.001) was found. Mean 1-year SER change in the DIAL and SVL groups was -0.13 +/- 0.06 and -0.39 +/- 0.08 D, respectively, with a mean difference of 0.26 D (95% CI, 0.06-0.46 D; P - 0.01). Compared with SVL, younger children (8 to <11 years) and older children (11-13 years) in the DIAL group had significantly less axial elongation (-0.29 mm less for younger children and -0.09 mm less for older children), with greater myopia control effect of DIAL spectacle lenses among the younger group than among the older group (P - 0.004 for interaction). No significant differences between the lens groups were found for distance BCVA (P - 0.36). All participants adapted within 3 to 4 days regardless of lens group. No significant differences in mean daily wearing time were seen between the DIAL and SVL groups (P - 0.53). Conclusions: Dual-Index Aspherical Lenslets spectacle lenses showed good myopia control efficacy, in terms of axial elongation, compared with SVL, among children aged 8 to 13 years in Singapore. (c) 2025 by the American Academy of Ophthalmology.
Keywords:
Aspherical lenslets
Myopia control spectacle lenses
Optical intervention
Randomized trial
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