Twelve-Month Efficacy and Visual Tolerability of MyoPi Spectacle Lenses in Childhood Myopia
- 1Optometry Center, Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an, China; Optometry Center, Affiliated People’s Hospital of Northwest University, Xi'an, China; Correspondence: Lu Ye, PhD, Xi'an People's Hospital (Xi'an Fourth Hospital), No. 21 Jiefang Road, Xi'an, Shaanxi 710004, China.
- 2Optometry Center, Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an, China
- 3Frontier Institute of Science and Technology and Interdisciplinary Research Center of Frontier Science and Technology, Xi'an Jiaotong University, Xi'an, China
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 Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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BibTeX
@article{luye2026twelvemonth,
title = {{Twelve-Month Efficacy and Visual Tolerability of MyoPi Spectacle Lenses in Childhood Myopia}},
author = {Lu Ye, PhD and Zhirong Liu, MS and Hui Gao, MS and Xiaobin Ren, PhD and Jiaqi Wang, MS and Jiejing Bi, MS and Yiming Guo, MS and Yijin Han, MS},
journal = {Ophthalmology Science},
year = {2026},
month = sep,
doi = {10.1016/j.xops.2026.101407},
url = {https://doi.org/10.1016/j.xops.2026.101407},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Twelve-Month Efficacy and Visual Tolerability of MyoPi Spectacle Lenses in Childhood Myopia
AU - Lu Ye, PhD
AU - Zhirong Liu, MS
AU - Hui Gao, MS
AU - Xiaobin Ren, PhD
AU - Jiaqi Wang, MS
AU - Jiejing Bi, MS
AU - Yiming Guo, MS
AU - Yijin Han, MS
PY - 2026
DA - 2026/09/10
JO - Ophthalmology Science
DO - 10.1016/j.xops.2026.101407
UR - https://doi.org/10.1016/j.xops.2026.101407
AB - 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 Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
SN - 2666-9145
ER -