Sankaridurg Padmaja, Chen Xiang, Naduvilath Thomas, Lazon de la Jara Percy, Lin Zhi, Li Li, Smith Earl L, Ge Jian, Holden Brien A
Brien Holden Vision Institute, Sydney, New South Wales, Australia.
Optom Vis Sci. 2013 Sep;90(9):961-9. doi: 10.1097/OPX.0000000000000017.
Type and incidence of adverse events and rate of discontinuations for 2 years of daily wear with silicone hydrogel contact lenses in Chinese children with myopia.
Two hundred forty children aged 7 to 14 years were enrolled in a prospective randomized clinical trial from November 2008 to April 2009. Children with myopia of up to -3.50 diopters (D) spherical equivalent with astigmatism less than or equal to -0.75 D were randomized to one commercial and three experimental lens designs of Lotrafilcon B silicone hydrogel lenses (four groups) used bilaterally on a daily wear, monthly replacement schedule. The main outcome measures were incidence per 100 patient-years (incidence, in percentage) of adverse events and rate of discontinuations.
There were no events of microbial keratitis. Fifty-five adverse events (incidence, 14.2%) were seen. There were also 12 recurrent events. The type and incidence percentage were contact lens papillary conjunctivitis (16 events, 4.1%), superior epithelial arcuate lesions (SEALs, six events, 1.5%), corneal erosions (eight events, 2.1%), infiltrative keratitis (five events, 1.3%), asymptomatic infiltrative keratitis (seven events, 1.8%), and asymptomatic infiltrates (13 events, 3.42%). There were differences in the incidence of SEALs between groups (p = 0.023), with the incidence of SEALs being greater with one of the experimental designs. No event resulted in any vision loss. Seventy participants (29.2%) discontinued, with one-third (26 participants, 10.8%) occurring in the first month of lens wear. Discomfort and non-lens-related reasons such as safety concern and disinterest were frequently cited reasons for discontinuations.
Adverse events with daily wear of silicone hydrogels in children were mainly mechanical in nature, and significant infiltrative events were few. The large number of dropouts in the early days of lens wear and their reasons for discontinuation suggest that adaptation and patient motivation are critical for survival in lens wear.
探讨中国近视儿童每日佩戴硅水凝胶隐形眼镜2年的不良事件类型、发生率及停用率。
2008年11月至2009年4月，240名7至14岁儿童参加了一项前瞻性随机临床试验。等效球镜度近视达-3.50屈光度（D）且散光小于或等于-0.75 D的儿童被随机分为四组，分别佩戴一种市售Lotrafilcon B硅水凝胶镜片设计及三种实验性镜片设计，双侧每日佩戴，每月更换。主要观察指标为每100患者年不良事件的发生率（以百分比表示）及停用率。
未发生微生物性角膜炎事件。共出现55例不良事件（发生率为14.2%）。还有12例复发事件。不良事件类型及发生率分别为：隐形眼镜乳头状结膜炎（16例，4.1%）、上皮性弓形病变（SEALs，6例，1.5%）、角膜糜烂（8例，2.1%）、浸润性角膜炎（5例，1.3%）、无症状浸润性角膜炎（7例，1.8%）及无症状浸润（13例，3.42%）。各实验组间SEALs发生率存在差异（p = 0.023），其中一种实验性设计的SEALs发生率更高。无不良事件导致视力丧失。70名参与者（29.2%）停用，其中三分之一（26名参与者，10.8%）在佩戴镜片的第一个月发生。不适以及与镜片无关的原因（如安全担忧和兴趣缺乏）是常见的停用原因。
儿童每日佩戴硅水凝胶隐形眼镜的不良事件主要为机械性，严重浸润性事件较少。镜片佩戴初期大量的停用情况及其原因表明，适应能力和患者积极性对于持续佩戴隐形眼镜至关重要。
