{"title":"Multipoint Defocus Optics Technology Spectacle Lenses for Myopia Control in Children: A One-Year Interim Analysis of a Randomized Trial.","authors":"Yurui Zhang, Xiaotong Han, Ling Jin, Yi Ding, Decai Wang, Mingguang He, YangFa Zeng","doi":"10.1167/tvst.15.10.14","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the one-year efficacy of novel partition multipoint defocus optics technology (PMDOT) lenses in slowing myopia progression, compared to lenses with highly aspherical lenslets (HAL).</p><p><strong>Methods: </strong>This is a 1-year interim analysis of an ongoing 2-year, non-inferiority randomized controlled trial, in which 194 children ages 8 to 13 years with spherical equivalent refraction (SER) of -0.75 to -4.5 diopters (D) were randomized to either the PMDOT or HAL group. The primary outcome of the full trial was the mean between-group difference in SER change at 2 years, and the non-inferiority margin was -0.3 D. Secondary outcomes included changes in axial length (AL), choroidal thickness (ChT), and other biometric parameters, as well as best-corrected visual acuity (BCVA) at 2 years and subjective visual experience. Data from right eyes were used for the current analysis.</p><p><strong>Results: </strong>The study included 102 children in the PMDOT group and 92 in the HAL group. After 1 year, the mean ± SD changes in SER and AL were not statistically significantly different between the two groups (PMDOT vs. HAL SER -0.74 ± 0.49 D vs. -0.60 ± 0.48 D, AL 0.26 ± 0.20 mm vs. 0.19 ± 0.19 mm) based on per-protocol (PP) analysis. The between-group difference in SER change at 12 months was -0.09 D (two-sided 97% confidence interval [CI], -0.26 to 0.09). Except for the change in anterior chamber depth in the PP analysis, no significant between-group differences were observed for any secondary outcomes.</p><p><strong>Conclusions: </strong>PMDOT lenses were not inferior to HAL lenses in controlling myopia progression.</p><p><strong>Translational relevance: </strong>This trial demonstrated the clinical potential of PMDOT lenses for myopia control in schoolchildren.</p>","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"15 10","pages":"14"},"PeriodicalIF":2.7000,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13676226/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational Vision Science & Technology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1167/tvst.15.10.14","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: To evaluate the one-year efficacy of novel partition multipoint defocus optics technology (PMDOT) lenses in slowing myopia progression, compared to lenses with highly aspherical lenslets (HAL).
Methods: This is a 1-year interim analysis of an ongoing 2-year, non-inferiority randomized controlled trial, in which 194 children ages 8 to 13 years with spherical equivalent refraction (SER) of -0.75 to -4.5 diopters (D) were randomized to either the PMDOT or HAL group. The primary outcome of the full trial was the mean between-group difference in SER change at 2 years, and the non-inferiority margin was -0.3 D. Secondary outcomes included changes in axial length (AL), choroidal thickness (ChT), and other biometric parameters, as well as best-corrected visual acuity (BCVA) at 2 years and subjective visual experience. Data from right eyes were used for the current analysis.
Results: The study included 102 children in the PMDOT group and 92 in the HAL group. After 1 year, the mean ± SD changes in SER and AL were not statistically significantly different between the two groups (PMDOT vs. HAL SER -0.74 ± 0.49 D vs. -0.60 ± 0.48 D, AL 0.26 ± 0.20 mm vs. 0.19 ± 0.19 mm) based on per-protocol (PP) analysis. The between-group difference in SER change at 12 months was -0.09 D (two-sided 97% confidence interval [CI], -0.26 to 0.09). Except for the change in anterior chamber depth in the PP analysis, no significant between-group differences were observed for any secondary outcomes.
Conclusions: PMDOT lenses were not inferior to HAL lenses in controlling myopia progression.
Translational relevance: This trial demonstrated the clinical potential of PMDOT lenses for myopia control in schoolchildren.
期刊介绍：
Translational Vision Science & Technology (TVST), an official journal of the Association for Research in Vision and Ophthalmology (ARVO), an international organization whose purpose is to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders, is an online, open access, peer-reviewed journal emphasizing multidisciplinary research that bridges the gap between basic research and clinical care. A highly qualified and diverse group of Associate Editors and Editorial Board Members is led by Editor-in-Chief Marco Zarbin, MD, PhD, FARVO.
The journal covers a broad spectrum of work, including but not limited to:
Applications of stem cell technology for regenerative medicine,
Development of new animal models of human diseases,
Tissue bioengineering,
Chemical engineering to improve virus-based gene delivery,
Nanotechnology for drug delivery,
Design and synthesis of artificial extracellular matrices,
Development of a true microsurgical operating environment,
Refining data analysis algorithms to improve in vivo imaging technology,
Results of Phase 1 clinical trials,
Reverse translational ("bedside to bench") research.
TVST seeks manuscripts from scientists and clinicians with diverse backgrounds ranging from basic chemistry to ophthalmic surgery that will advance or change the way we understand and/or treat vision-threatening diseases. TVST encourages the use of color, multimedia, hyperlinks, program code and other digital enhancements.
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