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[学龄儿童佩戴双焦点软性角膜接触镜的视觉表现:一项随机对照试验]

[Visual Performance of School-age Children Wearing Dual-Focus Soft Contact Lenses: A Randomized Controlled Trial].

作者信息

Chen Yingyu, Yang Bi, Kou Ji, Liu Longqian

机构信息

( 610041) Department of Ophthalmology & Laboratory of Optometry and Vision Sciences, West China Hospital, Sichuan University, Chengdu 610041, China.

出版信息

Sichuan Da Xue Xue Bao Yi Xue Ban. 2024 Sep 20;55(5):1272-1279. doi: 10.12182/20240960507.

Abstract

OBJECTIVE

To investigate the effect of wearing dual-focus soft contact lenses (DFSCL) on the visual performance of school-age children.

METHODS

In this randomized controlled clinical trial, 64 children aged 8 to 12 years with spherical equivalent refraction between -0.75 D and -4.00 D were recruited in our hospital in October 2022. Using the envelope method, the subjects were evenly and randomly assigned to the control group wearing single vision spectacles (SVS) or the intervention group wearing MiSight dual-focus soft contact lenses (DFSCL) from CooperVision. Follow-up examinations were conducted once every 3 months. The corrected visual acuity, contrast sensitivity function (CSF), and the scores for National Eye Institute Refractive Error Quality of Life Instrument-42 (NEI-RQL-42) were compared between the control and intervention groups.

RESULTS

By December 2023, a total of 58 subjects completed follow-up (30 in the SVS group and 28 in the DFSCL group). No significant difference in corrected visual acuity was observed between subjects wearing DFSCL and those wearing SVS. The CSF of the DFSCL group was comparable to that of the SVS group across the spatial frequencies of 3, 6, 12, and 18 cpd (>0.05). According to the results of the NEI-RQL-42 survey at the 6-month follow-up, the score for ocular discomfort symptoms was 89±14 in the SVS group and 79±16 in the DFSCL group (=0.008), reflecting that the DFSCL group had a 12.66% higher level of discomfort. For appearance, the score was 70±32 in the SVS group and 92±22 in the DFSCL group (=0.002), showing a 31.43% improvement in the DFSCL group.

CONCLUSION

In addition to providing the normal visual acuity and CSF, wearing MiSight DFSCL also leads to better satisfaction with the appearance.

摘要

目的

探讨佩戴双焦点软性角膜接触镜(DFSCL)对学龄儿童视觉性能的影响。

方法

在这项随机对照临床试验中,2022年10月我院招募了64名年龄在8至12岁、等效球镜度在-0.75 D至-4.00 D之间的儿童。采用信封法,将受试者均匀随机分为佩戴单焦点眼镜(SVS)的对照组或佩戴库博光学公司的MiSight双焦点软性角膜接触镜(DFSCL)的干预组。每3个月进行一次随访检查。比较对照组和干预组之间的矫正视力、对比敏感度函数(CSF)以及美国国立眼科研究所屈光不正生活质量量表-42(NEI-RQL-42)的得分。

结果

截至2023年12月,共有58名受试者完成随访(SVS组30名,DFSCL组28名)。佩戴DFSCL的受试者与佩戴SVS的受试者在矫正视力方面未观察到显著差异。DFSCL组在3、6、12和18 cpd的空间频率上的CSF与SVS组相当(>0.05)。根据6个月随访时的NEI-RQL-42调查结果,SVS组眼部不适症状得分为89±14,DFSCL组为79±16(P=0.008),表明DFSCL组的不适程度高12.66%。在外观方面,SVS组得分为70±32,DFSCL组为92±22(P=0.002),显示DFSCL组有31.43%的改善。

结论

佩戴MiSight DFSCL除了能提供正常视力和CSF外,还能使外观满意度更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52be/11536248/d70703e22898/scdxxbyxb-55-5-1272-1.jpg

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