Li Lim, Moody Kurt, Tan Donald T H, Yew Khoo Chong, Ming Por Yong, Long Quah Boon
Singapore National Eye Centre, Singapore.
Eye Contact Lens. 2009 Jul;35(4):188-95. doi: 10.1097/ICL.0b013e3181abb5bb.
Previous studies in the United States have evaluated the benefits of soft contact lenses (CLs) in 8- to 12-year-old children and 13- to 17-year-old teens. This study was undertaken in Singapore and evaluated the safety, efficacy, and physiologic performance of daily disposable soft lenses in a population of children.
In this open-label, bilateral, 3-month dispensing study, 59 children (8-11 years) were fit with etafilcon A spherical or toric daily disposable lenses (1-DAY ACUVUE or 1-DAY ACUVUE for ASTIGMATISM, Vistakon, Jacksonville, FL). All subjects were neophytes requiring visual correction in both eyes. The refractive inclusion criteria were plano to -9.00 diopter (D) with astigmatism of < or =2.00DC in both eyes, or hyperopia of +0.50 to +6.00D with astigmatism of 0.75D or less. The subjects underwent follow-up evaluations, which included a questionnaire for parents and subjects, at 1 week, 1 month, and 3 months.
Of the 59 subjects enrolled, 53 (90%) completed the study successfully. Six subjects were discontinued because of lens handling difficulties (four), unacceptable lens fit (one), and an adverse event (one). Adverse events were reported in three subjects, including the discontinuation, and in each case were due to a chalazion. Overall vision quality, overall comfort, and end-of-day comfort were graded significantly better at each of the follow-up visits compared with baseline with spectacles (P< or =0.0001). Both handling and reported symptoms improved during the course of the study. The questionnaire results indicated that most of both parents and subjects preferred CLs to spectacles across a wide variety of aspects including vision, comfort, handling, and appearance. Significantly, more limbal and bulbar hyperemia was noted at follow-up visits than at baseline (P=0.0001); however, no instances of hyperemia greater than grade 2 were noted at any visit. Significantly, more corneal staining was also noted at the 1- and 3-month follow-up visits than at baseline (21% at 3 months).
A high proportion of Singaporean children requiring vision correction are able to successfully wear daily disposable soft CLs over a 3-month period. Overall, slit lamp findings showed the prevalence of corneal staining in this study to be 21% at 3 months, which is lower than that previously reported in adults, but higher than that reported in the US Contact Lenses in Pediatrics study (6%).
美国此前的研究评估了软性隐形眼镜(CL)对8至12岁儿童以及13至17岁青少年的益处。本研究在新加坡开展,评估了日抛型软性隐形眼镜在儿童群体中的安全性、有效性和生理性能。
在这项开放标签、双侧、为期3个月的配镜研究中,59名8至11岁儿童佩戴了依他氟康A球面或复曲面日抛型隐形眼镜(1-DAY ACUVUE或1-DAY ACUVUE for ASTIGMATISM,美国眼力健公司,杰克逊维尔,佛罗里达州)。所有受试者均为双眼需要视力矫正的新手。屈光纳入标准为双眼屈光度平光至-9.00屈光度(D)且散光≤2.00DC,或双眼远视+0.50至+6.00D且散光0.75D或更低。受试者在第1周、第1个月和第3个月接受随访评估,其中包括对家长和受试者的问卷调查。
在纳入的59名受试者中,53名(90%)成功完成了研究。6名受试者因镜片操作困难(4名)、镜片适配不佳(1名)和不良事件(1名)而退出。3名受试者报告了不良事件,包括退出的那名受试者,且每例均因睑板腺囊肿。与基线时佩戴眼镜相比,每次随访时的总体视力质量、总体舒适度和日间结束时的舒适度评分均显著更高(P≤0.0001)。在研究过程中,操作和报告的症状均有所改善。问卷调查结果表明,在视力、舒适度、操作和外观等多个方面,大多数家长和受试者都更喜欢隐形眼镜而非眼镜。值得注意的是,随访时观察到的角膜缘和球结膜充血比基线时更多(P = 0.0001);然而,在任何一次随访中均未发现充血程度超过2级的情况。同样值得注意的是,在第1个月和第3个月的随访中观察到的角膜染色也比基线时更多(3个月时为21%)。
很大比例的需要视力矫正的新加坡儿童能够在3个月内成功佩戴日抛型软性隐形眼镜。总体而言,裂隙灯检查结果显示,本研究中3个月时角膜染色的发生率为21%,低于此前在成人中报告的发生率,但高于美国儿童隐形眼镜研究中报告的发生率(6%)。