Myopia Control Efficacy of Asymmetric Multipoint Defocus Technique Spectacle Lenses: One-Year Double-Masked Randomized Controlled Trial.

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.