Xue Li, Yingying Huang, Chenyao Liu, Xindan Chang, Zaifeng Cui, Qiulin Yang, Björn Drobe, Mark A Bullimore, Hao Chen, Jinhua Bao
{"title":"Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study.","authors":"Xue Li, Yingying Huang, Chenyao Liu, Xindan Chang, Zaifeng Cui, Qiulin Yang, Björn Drobe, Mark A Bullimore, Hao Chen, Jinhua Bao","doi":"10.1186/s40662-025-00427-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate myopia control efficacy in myopic children wearing spectacle lenses with highly aspherical lenslets (HAL) for 5 years.</p><p><strong>Methods: </strong>This is a randomized, double-masked extended trial. Myopic children aged 8 to 13 years who were originally allocated to the HAL group in the 2-year clinical trial. The HAL group underwent a 5-year assessment for myopia progression using cycloplegic spherical equivalent refraction (SER) and axial length (AL). An extrapolated single-vision spectacle lenses (ESVL) group was used as a control group. The 5-year myopia progression and axial elongation of the ESVL group was calculated based on the 2-year data from the single-vision spectacle lenses group in the same clinical trial, and the data for the following 3 years was estimated by assuming an annual reduction in SER by 9.7% and in AL by 15%. A generalized linear model approach was used to evaluate the treatment efficacy. The validity of the ESVL group was evaluated by comparing myopia progression in the first year of the 3-year estimates with a single-vision spectacle lenses (SVL2) group from a 1-year extended study of the same clinical trial.</p><p><strong>Results: </strong>Forty-three participants from the original HAL group completed the 5-year visit (74%). Five-year myopia progression [mean ± standard error (SE)] in the HAL group was - 1.27 ± 0.14 D. Compared with the ESVL (- 3.03 ± 0.18 D), myopia progression was - 1.75 ± 0.24 D less for the HAL group (P < 0.001). The mean AL elongation over 5 years was 0.67 ± 0.06 mm for the HAL group compared with 1.40 mm in the ESVL group (P < 0.001), AL elongation was slower by 0.72 ± 0.10 mm for the HAL group (P < 0.001). No significant differences were found for myopia (- 0.58 ± 0.04 D vs. - 0.56 ± 0.05 D) or AL elongation (0.28 ± 0.02 mm vs. 0.28 ± 0.02 mm) between the ESVL group and SVL2 group (P<sub>SER</sub> = 0.83; P<sub>AL</sub> = 0.93) in year 3.</p><p><strong>Conclusions: </strong>In this 5-year study, HAL spectacles reduced the rate of myopia progression and axial elongation, preventing the equivalent of 3 years of myopia progression and axial elongation. Long-term use of HAL spectacles also decreased the incidence of high myopia. Extrapolated control groups are valid for evaluating myopia progression in long-term studies. Trial registration The study was registered at the Chinese Clinical Trial Registry (ChiCTR2100047262), https://www.chictr.org.cn/showproj.html?proj=127182 .</p>","PeriodicalId":12194,"journal":{"name":"Eye and Vision","volume":"12 1","pages":"10"},"PeriodicalIF":4.1000,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11881363/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eye and Vision","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s40662-025-00427-3","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: To evaluate myopia control efficacy in myopic children wearing spectacle lenses with highly aspherical lenslets (HAL) for 5 years.
Methods: This is a randomized, double-masked extended trial. Myopic children aged 8 to 13 years who were originally allocated to the HAL group in the 2-year clinical trial. The HAL group underwent a 5-year assessment for myopia progression using cycloplegic spherical equivalent refraction (SER) and axial length (AL). An extrapolated single-vision spectacle lenses (ESVL) group was used as a control group. The 5-year myopia progression and axial elongation of the ESVL group was calculated based on the 2-year data from the single-vision spectacle lenses group in the same clinical trial, and the data for the following 3 years was estimated by assuming an annual reduction in SER by 9.7% and in AL by 15%. A generalized linear model approach was used to evaluate the treatment efficacy. The validity of the ESVL group was evaluated by comparing myopia progression in the first year of the 3-year estimates with a single-vision spectacle lenses (SVL2) group from a 1-year extended study of the same clinical trial.
Results: Forty-three participants from the original HAL group completed the 5-year visit (74%). Five-year myopia progression [mean ± standard error (SE)] in the HAL group was - 1.27 ± 0.14 D. Compared with the ESVL (- 3.03 ± 0.18 D), myopia progression was - 1.75 ± 0.24 D less for the HAL group (P < 0.001). The mean AL elongation over 5 years was 0.67 ± 0.06 mm for the HAL group compared with 1.40 mm in the ESVL group (P < 0.001), AL elongation was slower by 0.72 ± 0.10 mm for the HAL group (P < 0.001). No significant differences were found for myopia (- 0.58 ± 0.04 D vs. - 0.56 ± 0.05 D) or AL elongation (0.28 ± 0.02 mm vs. 0.28 ± 0.02 mm) between the ESVL group and SVL2 group (PSER = 0.83; PAL = 0.93) in year 3.
Conclusions: In this 5-year study, HAL spectacles reduced the rate of myopia progression and axial elongation, preventing the equivalent of 3 years of myopia progression and axial elongation. Long-term use of HAL spectacles also decreased the incidence of high myopia. Extrapolated control groups are valid for evaluating myopia progression in long-term studies. Trial registration The study was registered at the Chinese Clinical Trial Registry (ChiCTR2100047262), https://www.chictr.org.cn/showproj.html?proj=127182 .
期刊介绍:
Eye and Vision is an open access, peer-reviewed journal for ophthalmologists and visual science specialists. It welcomes research articles, reviews, methodologies, commentaries, case reports, perspectives and short reports encompassing all aspects of eye and vision. Topics of interest include but are not limited to: current developments of theoretical, experimental and clinical investigations in ophthalmology, optometry and vision science which focus on novel and high-impact findings on central issues pertaining to biology, pathophysiology and etiology of eye diseases as well as advances in diagnostic techniques, surgical treatment, instrument updates, the latest drug findings, results of clinical trials and research findings. It aims to provide ophthalmologists and visual science specialists with the latest developments in theoretical, experimental and clinical investigations in eye and vision.