Myopia control efficacy of annular microstructure defocus spectacle lenses: a 1-year multicenter study.

PURPOSE: To evaluate the efficacy of annular microstructure defocus (AMD) spectacle lenses in controlling myopia progression in children and adolescents.

METHODS

This 1-year prospective, multicenter, non-randomized, controlled, single-blind (blind evaluator) trial was carried out in Chinese children and adolescents aged 6 ~ 18 years, with myopia between − 0.50D and − 10.00D and astigmatism ≤ 4.00D. Subjects were assigned in a 2:1 ratio to wear AMD spectacle lenses (n = 1,952) or wear single-vision (SV) spectacle lenses (n = 1,109) based on the choices of the subjects/parents. One-year changes in cycloplegic spherical equivalent refraction (SER) by autorefraction and axial length (AL) were used to evaluate the myopia control efficacy of AMD spectacle lenses.

RESULTS

A total of 1,367 subjects (875 in the AMD group and 492 in the SV group) completed cycloplegic SER measurement at the 12-month follow-up visit. 1,791 subjects (1,194 in the AMD group and 597 in the SV group) completed AL measurement at the 12-month follow-up visit. After propensity score matching (PSM), the average change in cycloplegic SER for the subjects in the AMD group was significantly less than that in the SV group (-0.30 ± 0.24D vs. -0.79 ± 0.34D, P<0.001), and the average change in AL for the subjects in the AMD group was significantly slower than that in the SV group (0.18 ± 0.12 mm vs. 0.39 ± 0.17 mm, P<0.001), too. The efficacy of AMD spectacle lenses in controlling myopia progression and slowing axial elongation was 62.0% and 53.8%, respectively. Significant interaction effects were observed between age and treatment group (ΔSER: β = -0.037, ΔAL: β = 0.010, both P < 0.05),and between baseline SER and treatment group (ΔSER: β = 0.063, ΔAL: β = -0.020, both P < 0.05).These results indicated that the efficacy of AMD spectacle lenses in slowing myopia progression and axial elongation diminished with increasing age and baseline SER.

CONCLUSIONS

The study confirmed the myopia control efficacy of AMD spectacle lenses based on changes in cycloplegic SER or AL over 1 year. Younger subjects with lower levels of myopia benefited more from wearing AMD spectacle lenses. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2200066085. Registered 23 November 2022, http://www.chictr.org.cn/.