改良光学离焦软性隐形眼镜控制学龄儿童近视:一项为期12个月的随机双盲对照试验。

IF 2.8 3区 医学 Q1 OPHTHALMOLOGY
Ophthalmic and Physiological Optics Pub Date : 2025-06-01 Epub Date: 2025-04-01 DOI:10.1111/opo.13501
Hanyu Zhang, Ka Yan Leung, Myra Leung, Wing Chun Tang, Chun Ki Wong, Ka King Liu, Dennis Yan Yin Tse, Paul H Lee, Carly Siu Yin Lam
{"title":"改良光学离焦软性隐形眼镜控制学龄儿童近视:一项为期12个月的随机双盲对照试验。","authors":"Hanyu Zhang, Ka Yan Leung, Myra Leung, Wing Chun Tang, Chun Ki Wong, Ka King Liu, Dennis Yan Yin Tse, Paul H Lee, Carly Siu Yin Lam","doi":"10.1111/opo.13501","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Defocus Incorporated Soft Contact (DISC) lenses with +2.50 D myopic defocus reduced myopia progression by 25% in a previous randomised clinical trial (RCT). The current study aimed to evaluate if a stronger myopic defocus, +3.50 D with variable myopic defocus (DISC3.5plus), could slow myopia progression compared with single vision (SV) soft contact lenses in a 12-month RCT.</p><p><strong>Methods: </strong>Conducted from December 2018 to January 2021, the current RCT randomly assigned myopic children to wear DISC3.5plus (n = 87) or SV (n = 80) lenses. Myopia progression and axial elongation were compared between the two groups. Analyses were performed for both enrolled and completed participants.</p><p><strong>Results: </strong>For all enrolled participants, the DISC3.5plus group had significantly less myopia progression (mean difference: -0.15 ± 0.07 D, p = 0.02) and axial elongation (mean difference: 0.04 ± 0.02 D, p = 0.04) than the SV group at 6 months but not at 12 months (myopia progression: p = 0.11; axial elongation: p = 0.13). For completed participants, the DISC3.5plus group (n = 33) had reduced myopia progression at both 6 months (0.25 ± 0.07 D, p = 0.001) and 12 months (0.19 ± 0.09 D, p = 0.049) compared with the SV group (n = 40), but not in axial elongation (6 months: p = 0.16; 12 months: p = 0.32). In January 2020, the coronavirus pandemic disturbed contact lens-wearing patterns.</p><p><strong>Conclusion: </strong>DISC3.5plus lenses significantly slowed myopia progression and axial elongation compared with SV lenses for all enrolled participants over 6 months. The pandemic hindered longer term efficacy follow-up and sample size; thus, further investigation with more participants is needed to confirm sustained treatment effects.</p>","PeriodicalId":19522,"journal":{"name":"Ophthalmic and Physiological Optics","volume":" ","pages":"969-981"},"PeriodicalIF":2.8000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087850/pdf/","citationCount":"0","resultStr":"{\"title\":\"Myopia control using a modified optical defocus soft contact lens in schoolchildren-A 12-month randomised double masked control trial.\",\"authors\":\"Hanyu Zhang, Ka Yan Leung, Myra Leung, Wing Chun Tang, Chun Ki Wong, Ka King Liu, Dennis Yan Yin Tse, Paul H Lee, Carly Siu Yin Lam\",\"doi\":\"10.1111/opo.13501\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Defocus Incorporated Soft Contact (DISC) lenses with +2.50 D myopic defocus reduced myopia progression by 25% in a previous randomised clinical trial (RCT). The current study aimed to evaluate if a stronger myopic defocus, +3.50 D with variable myopic defocus (DISC3.5plus), could slow myopia progression compared with single vision (SV) soft contact lenses in a 12-month RCT.</p><p><strong>Methods: </strong>Conducted from December 2018 to January 2021, the current RCT randomly assigned myopic children to wear DISC3.5plus (n = 87) or SV (n = 80) lenses. Myopia progression and axial elongation were compared between the two groups. Analyses were performed for both enrolled and completed participants.</p><p><strong>Results: </strong>For all enrolled participants, the DISC3.5plus group had significantly less myopia progression (mean difference: -0.15 ± 0.07 D, p = 0.02) and axial elongation (mean difference: 0.04 ± 0.02 D, p = 0.04) than the SV group at 6 months but not at 12 months (myopia progression: p = 0.11; axial elongation: p = 0.13). For completed participants, the DISC3.5plus group (n = 33) had reduced myopia progression at both 6 months (0.25 ± 0.07 D, p = 0.001) and 12 months (0.19 ± 0.09 D, p = 0.049) compared with the SV group (n = 40), but not in axial elongation (6 months: p = 0.16; 12 months: p = 0.32). In January 2020, the coronavirus pandemic disturbed contact lens-wearing patterns.</p><p><strong>Conclusion: </strong>DISC3.5plus lenses significantly slowed myopia progression and axial elongation compared with SV lenses for all enrolled participants over 6 months. The pandemic hindered longer term efficacy follow-up and sample size; thus, further investigation with more participants is needed to confirm sustained treatment effects.</p>\",\"PeriodicalId\":19522,\"journal\":{\"name\":\"Ophthalmic and Physiological Optics\",\"volume\":\" \",\"pages\":\"969-981\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087850/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmic and Physiological Optics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/opo.13501\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ophthalmic and Physiological Optics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/opo.13501","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/1 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:在之前的一项随机临床试验(RCT)中,带+2.50 D近视散焦的软性接触(DISC)镜片可使近视进展减少25%。本研究旨在通过一项为期12个月的随机对照试验,评估与单视力(SV)软性隐形眼镜相比,更强的近视离焦(+3.50 D +可变近视离焦(disc3.5 +))是否能减缓近视进展。方法:本随机对照试验于2018年12月至2021年1月进行,随机分配近视儿童配戴DISC3.5plus (n = 87)或SV (n = 80)镜片。比较两组近视进展及眼轴伸长。对入组和完成的参与者进行分析。结果:对于所有入组的参与者,DISC3.5plus组在6个月时的近视进展(平均差值:-0.15±0.07 D, p = 0.02)和轴向伸长(平均差值:0.04±0.02 D, p = 0.04)显著低于SV组,但在12个月时则没有(近视进展:p = 0.11;轴向伸长:p = 0.13)。对于完成的参与者,与SV组(n = 40)相比,DISC3.5plus组(n = 33)在6个月(0.25±0.07 D, p = 0.001)和12个月(0.19±0.09 D, p = 0.049)时的近视进展都有所减少,但在轴向伸长方面没有减少(6个月:p = 0.16;12个月:p = 0.32)。2020年1月,冠状病毒大流行扰乱了隐形眼镜佩戴模式。结论:在6个月的时间里,与SV镜片相比,DISC3.5plus镜片显著减缓了所有参与者的近视进展和轴向伸长。大流行阻碍了长期疗效随访和样本量;因此,需要更多参与者的进一步研究来确认持续的治疗效果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Myopia control using a modified optical defocus soft contact lens in schoolchildren-A 12-month randomised double masked control trial.

Purpose: Defocus Incorporated Soft Contact (DISC) lenses with +2.50 D myopic defocus reduced myopia progression by 25% in a previous randomised clinical trial (RCT). The current study aimed to evaluate if a stronger myopic defocus, +3.50 D with variable myopic defocus (DISC3.5plus), could slow myopia progression compared with single vision (SV) soft contact lenses in a 12-month RCT.

Methods: Conducted from December 2018 to January 2021, the current RCT randomly assigned myopic children to wear DISC3.5plus (n = 87) or SV (n = 80) lenses. Myopia progression and axial elongation were compared between the two groups. Analyses were performed for both enrolled and completed participants.

Results: For all enrolled participants, the DISC3.5plus group had significantly less myopia progression (mean difference: -0.15 ± 0.07 D, p = 0.02) and axial elongation (mean difference: 0.04 ± 0.02 D, p = 0.04) than the SV group at 6 months but not at 12 months (myopia progression: p = 0.11; axial elongation: p = 0.13). For completed participants, the DISC3.5plus group (n = 33) had reduced myopia progression at both 6 months (0.25 ± 0.07 D, p = 0.001) and 12 months (0.19 ± 0.09 D, p = 0.049) compared with the SV group (n = 40), but not in axial elongation (6 months: p = 0.16; 12 months: p = 0.32). In January 2020, the coronavirus pandemic disturbed contact lens-wearing patterns.

Conclusion: DISC3.5plus lenses significantly slowed myopia progression and axial elongation compared with SV lenses for all enrolled participants over 6 months. The pandemic hindered longer term efficacy follow-up and sample size; thus, further investigation with more participants is needed to confirm sustained treatment effects.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
5.10
自引率
13.80%
发文量
135
审稿时长
6-12 weeks
期刊介绍: Ophthalmic & Physiological Optics, first published in 1925, is a leading international interdisciplinary journal that addresses basic and applied questions pertinent to contemporary research in vision science and optometry. OPO publishes original research papers, technical notes, reviews and letters and will interest researchers, educators and clinicians concerned with the development, use and restoration of vision.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信