{"title":"配戴双焦点软性隐形眼镜对近视发展的影响：在中国学龄儿童中进行的为期一年的随机临床试验。","authors":"Yingyu Chen, Bi Yang, Ji Kou, Longqian Liu","doi":"10.1186/s12886-024-03678-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Myopia is prevalent in China; however, trials involving Chinese children wearing dual-focus soft contact lenses (DFSCL) are limited. Thus, the purpose of this study is to investigate the efficacy of DFSCL among Chinese school-age children.</p><p><strong>Methods: </strong>Sixty-four children aged 8-12 years with spherical equivalent refraction (SER) between - 0.75D and - 4.00D were recruited in this randomized controlled clinical study. The control group (32 subjects) wore single-vision spectacles (SVS), while the DFSCL group (32 subjects) wore daily disposable + 2.00 D defocus MiSight DFSCL. Follow-up examinations were performed every 3 months to compare the axial length (AL) growth and SER change between the groups for a period of 12 months by using the independent samples t-test or the Mann-Whitney U test. Statistical differences with a P < 0.05, when compared to the control group, are considered indicative of an effective intervention. Multivariate analysis and regression analysis were used to eliminate the effects of confounding factors on the results.</p><p><strong>Results: </strong>A total of 58 subjects, with 30 in the SVS group and 28 in the DFSCL group, completed the follow-up. After adjusting for baseline age, gender, AL and SER, AL growth was 0.33 ± 0.02 mm in the SVS group and 0.23 ± 0.03 mm in the DFSCL group (P = 0.004). SER change was - 0.53 ± 0.06 in the SVS group and - 0.44 ± 0.06 in the DFSCL group (P = 0.308). In the DFSCL group, AL and SER increased 0.11 mm and 0.09 D less than in the SVS group, respectively. Moreover, initial wear of DFSCL may cause occasional blurriness in near vision, and prolonged wear may lead to increased ocular discomfort symptoms such as dryness, itchiness, and foreign body sensation.</p><p><strong>Conclusion: </strong>MiSight DFSCL showed a reduction in AL growth during the first three months of wear. However, no significant benefits were observed during the subsequent nine months. No significant differences in the changes of SER were found.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2200064731. Registered 15 October 2022, http://www.chictr.org.cn/.</p>","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":null,"pages":null},"PeriodicalIF":16.4000,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443923/pdf/","citationCount":"0","resultStr":"{\"title\":\"Impact of wearing dual-focus soft contact lenses on myopia progression: a one-year randomized clinical trial in Chinese school-age children.\",\"authors\":\"Yingyu Chen, Bi Yang, Ji Kou, Longqian Liu\",\"doi\":\"10.1186/s12886-024-03678-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Myopia is prevalent in China; however, trials involving Chinese children wearing dual-focus soft contact lenses (DFSCL) are limited. Thus, the purpose of this study is to investigate the efficacy of DFSCL among Chinese school-age children.</p><p><strong>Methods: </strong>Sixty-four children aged 8-12 years with spherical equivalent refraction (SER) between - 0.75D and - 4.00D were recruited in this randomized controlled clinical study. The control group (32 subjects) wore single-vision spectacles (SVS), while the DFSCL group (32 subjects) wore daily disposable + 2.00 D defocus MiSight DFSCL. Follow-up examinations were performed every 3 months to compare the axial length (AL) growth and SER change between the groups for a period of 12 months by using the independent samples t-test or the Mann-Whitney U test. Statistical differences with a P < 0.05, when compared to the control group, are considered indicative of an effective intervention. Multivariate analysis and regression analysis were used to eliminate the effects of confounding factors on the results.</p><p><strong>Results: </strong>A total of 58 subjects, with 30 in the SVS group and 28 in the DFSCL group, completed the follow-up. After adjusting for baseline age, gender, AL and SER, AL growth was 0.33 ± 0.02 mm in the SVS group and 0.23 ± 0.03 mm in the DFSCL group (P = 0.004). SER change was - 0.53 ± 0.06 in the SVS group and - 0.44 ± 0.06 in the DFSCL group (P = 0.308). In the DFSCL group, AL and SER increased 0.11 mm and 0.09 D less than in the SVS group, respectively. Moreover, initial wear of DFSCL may cause occasional blurriness in near vision, and prolonged wear may lead to increased ocular discomfort symptoms such as dryness, itchiness, and foreign body sensation.</p><p><strong>Conclusion: </strong>MiSight DFSCL showed a reduction in AL growth during the first three months of wear. However, no significant benefits were observed during the subsequent nine months. No significant differences in the changes of SER were found.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2200064731. 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引用次数: 0
摘要
背景：近视在中国很普遍，但涉及中国儿童配戴双焦点软性隐形眼镜（DFSCL）的试验却很有限。因此，本研究旨在调查中国学龄儿童配戴双焦点软性隐形眼镜的疗效：本随机对照临床研究共招募了 64 名 8-12 岁、球面等效屈光度（SER）在- 0.75D 到 - 4.00D 之间的儿童。对照组（32 名受试者）佩戴单光眼镜 (SVS)，而 DFSCL 组（32 名受试者）每天佩戴一次性 + 2.00 D 散焦 MiSight DFSCL。每 3 个月进行一次随访检查，采用独立样本 t 检验或 Mann-Whitney U 检验比较两组在 12 个月内的轴长（AL）增长和 SER 变化。统计差异采用 P 结果：共有 58 名受试者完成了随访，其中 SVS 组 30 人，DFSCL 组 28 人。在对基线年龄、性别、AL 和 SER 进行调整后，SVS 组的 AL 增长率为 0.33 ± 0.02 mm，DFSCL 组为 0.23 ± 0.03 mm（P = 0.004）。SVS组的SER变化为- 0.53 ± 0.06，DFSCL组为- 0.44 ± 0.06（P = 0.308）。与 SVS 组相比，DFSCL 组的 AL 和 SER 分别减少了 0.11 mm 和 0.09 D。此外，初次配戴 DFSCL 可能会导致近距离视力偶尔模糊，长期配戴可能会导致眼部不适症状加重，如干涩、发痒和异物感：结论：MiSight DFSCL 在佩戴后的前三个月显示出 AL 增生的减少。结论：佩戴 MiSight DFSCL 的前三个月，AL 增生有所减少，但在随后的九个月中，没有观察到明显的益处。试验登记：试验注册：中国临床试验注册中心：ChiCTR2200064731。注册时间：2022 年 10 月 15 日，http://www.chictr.org.cn/。
Impact of wearing dual-focus soft contact lenses on myopia progression: a one-year randomized clinical trial in Chinese school-age children.
Background: Myopia is prevalent in China; however, trials involving Chinese children wearing dual-focus soft contact lenses (DFSCL) are limited. Thus, the purpose of this study is to investigate the efficacy of DFSCL among Chinese school-age children.
Methods: Sixty-four children aged 8-12 years with spherical equivalent refraction (SER) between - 0.75D and - 4.00D were recruited in this randomized controlled clinical study. The control group (32 subjects) wore single-vision spectacles (SVS), while the DFSCL group (32 subjects) wore daily disposable + 2.00 D defocus MiSight DFSCL. Follow-up examinations were performed every 3 months to compare the axial length (AL) growth and SER change between the groups for a period of 12 months by using the independent samples t-test or the Mann-Whitney U test. Statistical differences with a P < 0.05, when compared to the control group, are considered indicative of an effective intervention. Multivariate analysis and regression analysis were used to eliminate the effects of confounding factors on the results.
Results: A total of 58 subjects, with 30 in the SVS group and 28 in the DFSCL group, completed the follow-up. After adjusting for baseline age, gender, AL and SER, AL growth was 0.33 ± 0.02 mm in the SVS group and 0.23 ± 0.03 mm in the DFSCL group (P = 0.004). SER change was - 0.53 ± 0.06 in the SVS group and - 0.44 ± 0.06 in the DFSCL group (P = 0.308). In the DFSCL group, AL and SER increased 0.11 mm and 0.09 D less than in the SVS group, respectively. Moreover, initial wear of DFSCL may cause occasional blurriness in near vision, and prolonged wear may lead to increased ocular discomfort symptoms such as dryness, itchiness, and foreign body sensation.
Conclusion: MiSight DFSCL showed a reduction in AL growth during the first three months of wear. However, no significant benefits were observed during the subsequent nine months. No significant differences in the changes of SER were found.
Trial registration: Chinese Clinical Trial Registry: ChiCTR2200064731. Registered 15 October 2022, http://www.chictr.org.cn/.
期刊介绍：
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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