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Abstract：
To ascertain the safety of soft contact lens (SCL) wear in children through a retrospective chart review including real-world clinical practice settings.
The study reviewed clinical charts from 963 children: 782 patients in 7 US eye care clinics and 181 subjects from 2 international randomised clinical trials (RCTs). Subjects were first fitted while 8-12 years old with various SCL designs, prescriptions and replacement schedules, and observed through to age 16. Clinical records from visits with potential adverse events (AEs) were electronically scanned and reviewed to consensus by an Adjudication Panel.
The study encompassed 2713 years-of-wear and 4611 contact lens visits. The cohort was 46% male, 60% were first fitted with daily disposable SCLs, the average age at first fitting was 10.5 years old, with a mean of 2.8 ± 1.5 years-of-wear of follow-up observed. There were 122 potential ocular AEs observed from 118/963 (12.2%) subjects; the annualised rate of non-infectious inflammatory AEs was 0.66%/year (95% CI 0.39-1.05) and 0.48%/year (0.25-0.82) for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4/10 000 years-of-wear (95% CI 1.8-29.6). Both were in teenage boys and one resulted in a small scar without loss of visual acuity.
This study estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL wearers from 8 through to 16 years of age. Both rates are comparable to established rates among adults wearing SCLs.
The study reviewed clinical charts from 963 children: 782 patients in 7 US eye care clinics and 181 subjects from 2 international randomised clinical trials (RCTs). Subjects were first fitted while 8-12 years old with various SCL designs, prescriptions and replacement schedules, and observed through to age 16. Clinical records from visits with potential adverse events (AEs) were electronically scanned and reviewed to consensus by an Adjudication Panel.
The study encompassed 2713 years-of-wear and 4611 contact lens visits. The cohort was 46% male, 60% were first fitted with daily disposable SCLs, the average age at first fitting was 10.5 years old, with a mean of 2.8 ± 1.5 years-of-wear of follow-up observed. There were 122 potential ocular AEs observed from 118/963 (12.2%) subjects; the annualised rate of non-infectious inflammatory AEs was 0.66%/year (95% CI 0.39-1.05) and 0.48%/year (0.25-0.82) for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4/10 000 years-of-wear (95% CI 1.8-29.6). Both were in teenage boys and one resulted in a small scar without loss of visual acuity.
This study estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL wearers from 8 through to 16 years of age. Both rates are comparable to established rates among adults wearing SCLs.
摘要：
通过回顾性图表审查，包括真实世界的临床实践设置，以确定儿童佩戴软性隐形眼镜（SCL）的安全性。
该研究回顾了963名儿童的临床图表：7个美国眼科护理诊所的782名患者和2个国际随机临床试验（RCT）的181名受试者。受试者在8-12岁时首次安装各种SCL设计，处方和更换时间表，一直观察到16岁。对具有潜在不良事件(AE)的访视的临床记录进行电子扫描,并由裁决小组进行审查以达成共识。
该研究涵盖了2713年的佩戴和4611次隐形眼镜访问。该队列为46％的男性，60%的人首先安装了每日一次性SCL，第一次试穿的平均年龄是10.5岁，观察到平均2.8±1.5年的随访磨损。从118/963（12.2％）受试者中观察到122例潜在的眼部AE；接触镜乳头状结膜炎的非感染性炎性AE的年发生率为0.66％/年（95％CI0.39-1.05）和0.48％/年（0.25-0.82）。经过裁决,确定了两个推测或可能的微生物性角膜炎（MK）病例，磨损率为7.4/10.000年（95%CI1.8-29.6）。两者都是十几岁的男孩，其中一个导致了小疤痕而没有视力丧失。
这项研究估计了8至16岁的SCL佩戴者队列中的MK率和其他炎性AE率。两种比率均与佩戴SCL的成年人的既定比率相当。
该研究回顾了963名儿童的临床图表：7个美国眼科护理诊所的782名患者和2个国际随机临床试验（RCT）的181名受试者。受试者在8-12岁时首次安装各种SCL设计，处方和更换时间表，一直观察到16岁。对具有潜在不良事件(AE)的访视的临床记录进行电子扫描,并由裁决小组进行审查以达成共识。
该研究涵盖了2713年的佩戴和4611次隐形眼镜访问。该队列为46％的男性，60%的人首先安装了每日一次性SCL，第一次试穿的平均年龄是10.5岁，观察到平均2.8±1.5年的随访磨损。从118/963（12.2％）受试者中观察到122例潜在的眼部AE；接触镜乳头状结膜炎的非感染性炎性AE的年发生率为0.66％/年（95％CI0.39-1.05）和0.48％/年（0.25-0.82）。经过裁决,确定了两个推测或可能的微生物性角膜炎（MK）病例，磨损率为7.4/10.000年（95%CI1.8-29.6）。两者都是十几岁的男孩，其中一个导致了小疤痕而没有视力丧失。
这项研究估计了8至16岁的SCL佩戴者队列中的MK率和其他炎性AE率。两种比率均与佩戴SCL的成年人的既定比率相当。
