Ophthalmology · 2025
Myopia Control Efficacy of Asymmetric Multipoint Defocus Technique Spectacle Lenses: One-Year Double-Masked Randomized Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Wang Mengyi, Ma Runting, Kuang Longhao, Chen Xiaoqin, Vincent Stephen J, Tan Hongmei, Lai Zhipeng, Xu Shengsong, Hu Yin, Han Mengya, Chen Qiwen, Wang Zixin, Li Lihua, Yang Xiao
Аннотация
PURPOSE: To evaluate the 12-month myopia control efficacy of an asymmetric multipoint defocus technique (AMDT) spectacle lens.
DESIGN: Double-masked randomized controlled trial.
PARTICIPANTS: One hundred forty participants completed all visits (mean age, 10.6 ± 1.5 years; 50% female), with spherical equivalent refraction (SER) between -5.00 and -0.75 diopters (D), astigmatism of 1.50 D or less, and anisometropia of 1.50 D or less.
METHODS: One hundred forty-four children 8 to 13 years of age with myopia of -0.75 D to -5.00 D recruited from 2 ophthalmic centers were randomized (1:1) to wear AMDT spectacle lenses or single-vision lenses (SVLs). Cycloplegic SER and axial length (AL) were measured at the baseline, 6-month, and 12-month visits. Adaptation and visual performance questionnaires were administered during the intervention.
MAIN OUTCOME MEASURES: The SER change after 1 year was the primary outcome, and the changes in AL, visual performance, and ocular parameters after 1 year were defined as secondary outcomes.
RESULTS: After 12 months, the SVL group (n = 69) exhibited mean changes in SER and AL of -0.50 ± 0.06 D and 0.32 ± 0.02 mm, respectively, compared with -0.16 ± 0.06 D and 0.17 ± 0.02 mm (both P < 0.001) in the AMDT group (n = 71). Compared with the SVL group, participants in the AMDT group showed significantly less myopia progression by 0.39 D in SER (74%) and 0.17 mm in AL (51%) after adjustment for baseline age, baseline SER and AL, and ophthalmic center. The correlation between younger age and more rapid AL elongation was more pronounced in the SVL group (r = -0.68; P < 0.001) compared with the AMDT group (r = -0.37; P = 0.002). Thirty participants (42%) in the AMDT group displayed no SER progression after 1 year. No serious adverse events or persistent visual discomfort were observed.
CONCLUSIONS: Compared with SVLs, AMDT spectacle lenses significantly reduced SER and AL progression over 1 year, with a favorable safety profile and visual performance. The correlation between age and myopia progression was diminished after AMDT participants intervention, but not for SVLs.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
DESIGN: Double-masked randomized controlled trial.
PARTICIPANTS: One hundred forty participants completed all visits (mean age, 10.6 ± 1.5 years; 50% female), with spherical equivalent refraction (SER) between -5.00 and -0.75 diopters (D), astigmatism of 1.50 D or less, and anisometropia of 1.50 D or less.
METHODS: One hundred forty-four children 8 to 13 years of age with myopia of -0.75 D to -5.00 D recruited from 2 ophthalmic centers were randomized (1:1) to wear AMDT spectacle lenses or single-vision lenses (SVLs). Cycloplegic SER and axial length (AL) were measured at the baseline, 6-month, and 12-month visits. Adaptation and visual performance questionnaires were administered during the intervention.
MAIN OUTCOME MEASURES: The SER change after 1 year was the primary outcome, and the changes in AL, visual performance, and ocular parameters after 1 year were defined as secondary outcomes.
RESULTS: After 12 months, the SVL group (n = 69) exhibited mean changes in SER and AL of -0.50 ± 0.06 D and 0.32 ± 0.02 mm, respectively, compared with -0.16 ± 0.06 D and 0.17 ± 0.02 mm (both P < 0.001) in the AMDT group (n = 71). Compared with the SVL group, participants in the AMDT group showed significantly less myopia progression by 0.39 D in SER (74%) and 0.17 mm in AL (51%) after adjustment for baseline age, baseline SER and AL, and ophthalmic center. The correlation between younger age and more rapid AL elongation was more pronounced in the SVL group (r = -0.68; P < 0.001) compared with the AMDT group (r = -0.37; P = 0.002). Thirty participants (42%) in the AMDT group displayed no SER progression after 1 year. No serious adverse events or persistent visual discomfort were observed.
CONCLUSIONS: Compared with SVLs, AMDT spectacle lenses significantly reduced SER and AL progression over 1 year, with a favorable safety profile and visual performance. The correlation between age and myopia progression was diminished after AMDT participants intervention, but not for SVLs.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.