Ophthalmol Ther. 2025 Nov 12. doi: 10.1007/s40123-025-01270-4. Online ahead of print.
ABSTRACT
INTRODUCTION: To report the 1-year efficacy of Myofix Defocus spectacles, designed to control the progression of myopia in childhood.
METHODS: A total of 47 children with myopia aged 7-15 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 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 ± 0.13 mm. 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 ± 0.25 D and a mean AL change of 0.17 ± 0.11 mm. In virtual controls, the mean annual SE progression was – 0.47 ± 0.36 D, and AL change was 0.26 ± 0.17 mm (both p < 0.001). In compliant participants, Myofix Defocus lens demonstrated a 75% reduction in SE and 37% reduction in AL compared to virtual controls.
CONCLUSIONS: 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.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT07092072. Registered retrospectively on July 29, 2025.
PMID:41222872 | DOI:10.1007/s40123-025-01270-4
