Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada.
Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada; Centre for Eye & Vision Research, Hong Kong.
Cont Lens Anterior Eye. 2021 Aug;44(4):101391. doi: 10.1016/j.clae.2020.11.011. Epub 2021 Feb 4.
To report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression.
Children aged 8-12 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 4-6. 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.
144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction -2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6-years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%-1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear.
Across the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.
报告儿童佩戴软性水凝胶日戴型抛弃式隐形眼镜的眼部健康和安全性，这些儿童参与了一项为期 6 年的双盲临床试验，研究一种旨在控制近视进展的双焦点隐形眼镜的性能，在该试验中，他们接受了为期 6 年的随访。
本研究纳入了 4 个国际研究点的 8-12 岁初次接触隐形眼镜的儿童。在第 1-3 年，儿童随机分配至使用麦迪逊视佳 1 天（均为欧普康明公司的水凝胶材料，即甲基丙烯酸羟乙酯共聚物）或保视宁 1 天。两种镜片的材料和设计完全相同，除了前光学区设计不同。在第 3 年末，所有戴保视宁 1 天的儿童均转换为麦迪逊视佳 1 天，因此在第 4-6 年期间所有儿童均戴麦迪逊视佳 1 天。所有儿童均同意每天至少佩戴镜片 10 小时，每周至少佩戴 6 天。在镜片发放后，研究访视时间为 1 周、1 个月、6 个月和每 6 个月 1 次，直到 6 年。每次访视时，均记录眼部测量值和主观反应。眼前节检查采用 0-4 级评分；0 级表示无发现。
共纳入 144 名儿童：69 名女性，75 名男性；平均年龄为 10.1 岁；平均睫状肌麻痹等效球镜度为-2.11D；种族包括 34 名东亚人、12 名西亚人和 79 名高加索人。92 名儿童完成了 6 年的随访。只有 3 名儿童因眼部不良事件（AE）而退出。无接触镜相关 AE 被归类为严重事件。浸润性 AE 的发生率为 0.61%（6.1/1000 佩戴年；95%CI：0.24%-1.57%）。最常见的眼前节检查发现是角膜缘、球结膜和睑板充血以及睑板粗糙。所有眼前节检查发现中，99%为 1 级或更低。经过 6 年的镜片佩戴后，眼前节检查结果显示眼部健康状况与佩戴前相似。
在 6 年的随访期间，没有与接触镜相关的严重 AE，眼前节检查也未显示出明显变化。结果表明，这个年龄段的儿童可以成功佩戴日戴型水凝胶隐形眼镜，对眼部生理功能的影响极小。
