Twelve-Month Efficacy and Visual Tolerability of MyoPi Spectacle Lenses in Childhood Myopia: A Randomized Clinical Trial
In brief
MyoPi glasses reduced children's eye elongation by 0.16 mm in one year
In a randomized trial of 116 children, those wearing MyoPi lenses had 0.19 mm of eye elongation over 12 months, compared with 0.35 mm with standard single-vision glasses. Their prescription also worsened less, and no serious adverse events were reported. Whether the benefit persists beyond one year remains unknown.
- Journal
- Ophthalmology science (Q1)
- Published
- 10 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Lu Ye, Zhirong Liu, Hui Gao, Xiaobin Ren, Jiaqi Wang, Jiejing Bi, et al.
- PMID
- 42960268
- DOI
- 10.1016/j.xops.2026.101407
Why clinicians should know about it
- Picked for Ophthalmology (paper of the day, 31 October 2026): Randomized trial of childhood myopia control spectacle lenses
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: Of the 116 randomized children, 108 completed the 12-month follow-up. In adjusted bilateral mixed-effects models, model-estimated mean axial elongation (±standard error [SE]) was 0.19 ± 0.02 mm with MyoPi and 0.35 ± 0.02 mm with single-vision spectacles (between-group difference, -0.16 mm; 95% confidence interval [CI], -0.20 to -0.12; P < 0.001). Model-estimated mean cycloplegic SER progression (±SE) was -0.37 ± 0.04 and -0.75 ± 0.04 D, respectively (between-group difference, 0.38 D; 95% CI, 0.27-0.49; P < 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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.