One-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression

Purpose : To report the 1-year efficacy of Myofix Defocus spectacles, designed to control the progression of myopia in childhood. Methods: A total of 47 myopic children aged 7 to 15 years were enrolled. Cycloplegic objective refraction (spherical equivalent refraction, SE) and axial length (AL) were measured at baseline, 6 months and 12 months. Linear regression models were used to identify risk factors of 12-month changes in SE and AL. For comparison, two virtual control groups of American children were included. Tolerance was assessed through a questionnaire at each follow-up visit. Results: Of the initial cohort, 11 participants were lost to follow-up after 6 months due to reasons unrelated to lens design (77.1% retention rate). Over 12 months, the mean SE change in all eyes was -0.21±0.30 D, and AL change was 0.19±0.13mm. Progression was significantly different in participants who reported good compared to poor compliance (p<0.001). At the 12-month follow-up, participants with good compliance had a mean SE progression of -0.12±0.25D and a mean AL change of 0.17±0.11 mm. In virtual controls, the mean annual SE progression was -0.47±0.36 diopters, and AL change was 0.26±0.17 mm. In compliant participants, Myofix Defocus lens demonstrated a 75% reduction in SE and 37% reduction in AL compared to virtual controls. Conclusion: After 1 year, Myofix Defocus spectacles slowed myopia progression in children, demonstrating comparable efficacy to other defocus-incorporated spectacle designs. Greater compliance resulted in better treatment effect. Further long-term studies are warranted to confirm these findings.