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/.