双折射率非晶状体眼镜控制近视效果：1年随机临床试验

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2025-03-14 DOI:10.1016/j.xops.2025.100766

Yee Ling Wong PhD , Andrew Tan BBus , Ee Woon Lim , Hua Ren Chua , Liang Shen PhD , Matthieu Guillot MSc , Björn Drobe PhD

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引用次数: 0

摘要

目的观察新型双折射率非晶状体（DIAL）控制近视镜片与单视力控制近视镜片（SVLs）在1年内的控制近视效果。设计一项前瞻性、随机、双盲临床试验。研究招募了80名8 - 13岁近视儿童（球面等效屈光度[SER]在- 0.75 - - 4.75屈光度[D]之间）。参与者被随机分为DIAL或SVL眼镜组（比例为1:1）。主要观察指标轴长（AL）、非睫状体麻痹性主观屈光和最佳矫正视力（BCVA）分别在基线和6个月的间隔进行测量。在所有访问期间都进行了关于适应和遵守的问卷调查。结果共76名参与者（N = 38，每组）完成了为期1年的随访，平均[标准差]年龄为10.8[1.6]岁。DIAL组和SVL组的平均（±标准误差）1年AL变化分别为0.04±0.02和0.22±0.04 mm。平均差为- 0.18 mm(95%置信区间[CI]， - 0.26至- 0.10 mm；P & lt;0.001)。DIAL组和SVL组1年平均SER变化分别为- 0.13±0.06 D和- 0.39±0.08 D，平均差异为0.26 D (95% CI, 0.06 - 0.46 D；P = 0.01)。与SVL相比，DIAL组年龄较小的儿童（8 ~ 11岁）和年龄较大的儿童（11 ~ 13岁）的轴向伸长率显著降低（年龄较小的儿童轴向伸长率降低- 0.29 mm，年龄较大的儿童轴向伸长率降低- 0.09 mm），且DIAL镜片控制近视的效果在年龄较小的儿童组优于年龄较大的儿童组（交互作用P = 0.004）。晶状体组间BCVA距离无显著差异（P = 0.36）。所有受试者均在3 ~ 4天内适应，不考虑镜片组。DIAL组和SVL组的平均每日佩戴时间无显著差异（P = 0.53）。结论在新加坡8 ~ 13岁儿童中，双指数非球面镜片与SVL相比，在轴向伸长率方面具有良好的控制近视效果。财务披露专有或商业披露可在本文末尾的脚注和披露中找到。

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Myopia Control Efficacy of Spectacle Lenses with Dual-Index Aspherical Lenslets: A 1-Year Randomized Clinical Trial

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 lenses (SVLs) over a 1-year period.

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 and −4.75 diopters [D]) were recruited.

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.