穿着软隐形眼镜的儿童的六年安全数据

发布:

研究摘要摘要

纸标题:在6年内佩戴每日一次性隐形眼镜的儿童的眼部健康

作者:吉尔·伍兹(1),黛比·琼斯(1,2),林登·琼斯(1,2),苏珊娜·琼斯(3),克里斯·亨特(3),保罗·张伯伦(4),约翰·麦克纳利(4)

1:验光与视觉科学学院眼部研究与教育中心(核心),滑铁卢大学,加拿大滑铁卢大学AVE W 200
2: Centre for Eye & Vision Research, Hong Kong
3:VisionCare Research Ltd.,Farnham,英国萨里
4:Coopervision,Inc。美国普莱森顿,美国

Date:2021年8月

参考:眼科生理学。

Summary

This study investigated the safety of daily disposable soft contact lens (omafilcon A) wear in children during a 6 year double masked trial, totalling 653 patient-wearing years. The 8 to 12-year-old neophyte cohort were successful contact lens wearers with minimal impact on ocular physiology. No contact lens related serious adverse events (corneal infections, microbial keratitis) or significant changes on biomicroscopy (eg. hypoxia) were recorded during the 6 year period. Importantly, no adverse events were observed in children under 10 years of age, providing assurance of an acceptable range of safety in this young age group. The rate of corneal infiltrative events was 0.61% with a mean age of adverse event presentation of 12.6±2.0岁。这突出了定期重新教育患者和父母对安全隐形眼镜磨损和隐形眼镜卫生的重要性。不良事件(大约三分之一)和停用(9.7%)的最高比例发生在佩戴的第一个月中。在临床上,这意味着应该在第一个月密切关注儿童,以尽早确定和管理不良事件。这项研究的结果表明,适合年龄少8岁的儿童可以连续多年成功佩戴每日一次性水凝胶隐形眼镜。这应该使眼保健医生对儿童每日一次性软接触镜的长期安全充满信心。

这对我的练习意味着什么?

最重要的是,与基线相比,与并发症发生率非常低有关,与并发症发生率非常低有关,平均而言,生物显微镜检查的发生率很低。在最可能出现问题时,请定期与您的患者一起检查。

我们仍然需要学习什么?

We still need to learn about the safety profile of daily disposable contact lenses in younger children (6-8 years) as there is increasing popularity of myopia control contact lenses in this age group.

抽象的

标题:在6年内佩戴每日一次性隐形眼镜的儿童的眼部健康

作者:吉尔·伍兹(Jill Woods),黛比·琼斯(Debbie Jones),林登·琼斯(Lyndon Jones),苏珊娜·琼斯(Susannajones),克里什(Chrishunt),保罗·张伯伦(Paul Chamberlain),约翰·麦克纳利(John McNally)

目的:为了报告儿童的眼部健康和安全性,可与软水凝胶每日可见的隐形眼镜相吻合,然后在一项双掩盖临床试验中进行了6年,该试验调查了旨在控制近视进展的双重焦点隐形眼镜的性能。

方法:Children aged 812 years, naïve to contact lens wear, were enrolled across four international sites. During years 1–3, children were randomised to either MiSight 1 day or Proclear 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 46. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0–4 grading scales; grade 0 represented no findings.

Results:144名儿童入学:69f:75m;平均年龄10.1岁;平均环长式球形 - 等效折射-2.11d;种族包括34个东亚洲,12个西亚和79名白种人。92完成了6年。由于眼部不良事件(AE),只有三名受试者停产。没有与隐形眼镜相关的AE被归类为严重。浸润AES的发病率为0.61%(6.1/1000佩戴年; 95%CI:0.24% - 1.57%)。最常见的生物显微镜检查结果是边缘,鳞茎和tarsal高度症和tarsal粗糙度。所有生物显微镜检查结果中有99%为1级或更低。 After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear.

Conclusions:在整个6年中,没有与隐形眼镜相关的严重AE,生物显微镜没有明显变化。结果表明,这个年龄的儿童可以成功地佩戴每日可容纳的水凝胶晶状体,对眼生理的影响很小。

Clare Maher_small

关于克莱尔

克莱尔马赫是临床验光师在悉尼ustralia, and a third year Doctor of Medicine student, with a keen interest in research analysis and scientific writing.

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