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

Rafael Iribarren,Abel Szeps,Carlos Kotlik,Martín de Tomas,Gabriel Martín,Jos Rozema,Carla Lanca

Published 2025 in Ophthalmology and Therapy

ABSTRACT

To report the 1-year efficacy of Myofix Defocus spectacles, designed to control the progression of myopia in childhood. 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. 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. 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. ClinicalTrials.gov identifier: NCT07092072. Registered retrospectively on July 29, 2025.

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