Work

Twelve-Month Efficacy and Visual Tolerability of MyoPi Spectacle Lenses in Childhood Myopia

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Objective: To evaluate the 12-month efficacy, safety, and visual tolerability of MyoPi continuous free-form defocus spectacle lenses compared with conventional single-vision spectacle lenses (SVLs) in children with myopia. Design: Prospective, multicenter, randomized, single-masked, parallel-group clinical trial. Participants: A total of 116 eligible children were randomized 1:1 to MyoPi or SVLs. Eligible participants were 8 to 13 years of age with bilateral cycloplegic spherical equivalent refraction (SER) from -0.75 to -5.00 diopters (D). Methods: Participants were randomized 1:1 to MyoPi or single-vision spectacle lenses and were followed at baseline, week 1, month 3, month 6, and month 12. Intervention: Children wore their assigned spectacles during routine daytime activities and were followed for 12 months. Main Outcome Measures: The primary efficacy outcome was change in axial length from baseline to month 12. The key refractive outcome was change in cycloplegic SER from baseline to month 12. Safety and visual-performance questionnaire findings were assessed as supportive clinical outcomes. Results: < 0.001). Adverse events occurred in 29.8% and 24.6% of participants, respectively; no serious adverse events, unexpected events, or device deficiencies were recorded. Conclusions: In children with myopia, MyoPi continuous free-form defocus spectacle lenses slowed 12-month axial elongation and cycloplegic refractive progression compared with single-vision spectacles, with acceptable overall safety and visual tolerability. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Source: Ophthalmology Science

DOI: 10.1016/j.xops.2026.101407