双焦软镜对近视进展影响的一年随机临床试验：中国学龄儿童。
Impact of wearing dual-focus soft contact lenses on myopia progression: a one-year randomized clinical trial in Chinese school-age children.
机构信息
Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Department of Optometry and Vision Sciences, West China Hospital, Sichuan University, Chengdu, 610041, China.
出版信息
BMC Ophthalmol. 2024 Sep 30;24(1):426. doi: 10.1186/s12886-024-03678-1.
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/.
背景
近视在中国很普遍；然而，涉及中国儿童佩戴双焦点软镜（DFSCL）的试验有限。因此，本研究旨在研究 DFSCL 在学龄儿童中的疗效。
方法
本随机对照临床试验招募了 64 名年龄在 8-12 岁、球镜等效屈光度（SER）在-0.75D 至-4.00D 之间的儿童。对照组（32 名受试者）佩戴单焦眼镜（SVS），而 DFSCL 组（32 名受试者）佩戴日戴型+2.00D 离焦软性隐形眼镜 MiSight DFSCL。在 12 个月的时间内，每隔 3 个月进行一次随访检查，通过独立样本 t 检验或 Mann-Whitney U 检验比较两组的眼轴（AL）生长和 SER 变化，当与对照组相比，P 值＜0.05 被认为是有效的干预。采用多元分析和回归分析消除混杂因素对结果的影响。
结果
共有 58 名受试者完成了随访，其中 SVS 组 30 名，DFSCL 组 28 名。在调整基线年龄、性别、AL 和 SER 后，SVS 组的 AL 生长为 0.33±0.02mm，DFSCL 组为 0.23±0.03mm（P=0.004）。SVS 组的 SER 变化为-0.53±0.06，DFSCL 组为-0.44±0.06（P=0.308）。在 DFSCL 组中，AL 和 SER 分别减少了 0.11mm 和 0.09D，比 SVS 组少。此外，DFSCL 的初始佩戴可能会导致偶尔的近视力模糊，长时间佩戴可能会导致眼睛不适症状加重，如干燥、瘙痒和异物感。
结论
MiSight DFSCL 在佩戴的前三个月显示出 AL 生长的减少。然而，在随后的九个月中没有观察到显著的益处。SER 变化没有显著差异。
试验注册
中国临床试验注册中心：ChiCTR2200064731。注册于 2022 年 10 月 15 日，http://www.chictr.org.cn/。
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