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近视学龄儿童配戴同心双焦软性接触镜的视觉表现：一项随机对照试验

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

    摘要
  • 摘要:
    目的 研究配戴同心双焦设计软性接触镜（dual-focus soft contact lenses, DFSCL）对学龄儿童视觉表现的影响。
    方法 本随机对照临床试验于2022年10月于我院招募了64名等效球镜度在－0.75 D至－4.00 D之间的8～12岁儿童。采用信封法随机分配为两组，每组32名受试者，分别配戴单光框架眼镜（single vision spectacles, SVS）和MiSight DFSCL。每3个月进行一次随访检查，比较对照组和干预组的矫正视力、对比敏感度功能（contrast sensitivity function, CSF）和美国国家眼科研究所——屈光不正生活质量问卷42题（National Eye Institute Refractive Error Quality of Life Instrument-42, NEI-RQL-42）评分。
    结果 截止2023年12月，共有58名受试者完成了随访（SVS组30人，DFSCL组28人）。配戴MiSight DFSCL后的矫正视力和配戴SVS后的矫正视力差异没有统计学意义。在3、6、12、18 cpd的空间频率下，DFSCL组的CSF与SVS组相当（P>0.05）。在随访的第6个月进行的NEI-RQL-42问卷调查中，眼部不适症状方面，SVS组得分为89±14，DFSCL组为79±16（P=0.008），DFSCL组较SVS组差12.66%；外观方面，SVS组得分为70±32，DFSCL组为92±22（P=0.002），DFSCL组较SVS组好31.43%。
    结论 除能提供同样正常的视觉敏锐度和对比敏感度，配戴MiSight DFSCL还能获得更好的外观满意度。

     

    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 (P>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 (P=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 (P=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.

     

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