Simons K, Preslan M
Krieger Children's Eye Center, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, USA.
Br J Ophthalmol. 1999 May;83(5):582-7. doi: 10.1136/bjo.83.5.582.
A prospective study of the efficacy of amblyopia treatment in preschool children has recently been called for, requiring an untreated control group. The present study assessed data from patients with amblyopia untreated owing to lack of compliance, or with amblyopia risk factors, to determine outcome.
Longitudinal data were obtained from 18 4-6 year old patients who had initially been screened for amblyopia, strabismus, and/or bilateral refractive error, failed to comply with prescribed treatment, and in whom amblyopia was detected at a rescreening approximately a year later. The data from three previous studies comparing outcome of patients compliant and non-compliant with amblyopia treatment were also reanalysed.
One child of the 18, who wore glasses sporadically, showed some improvement in visual acuity in the amblyopic eye. Otherwise, no child showed an improvement, and seven of the 17 (41%) for whom visual acuities were available at both screenings showed a deterioration of visual acuity in the amblyopic eye, including three who apparently developed amblyopia for the first time. A child with an ametropic risk factor for amblyopia whose visual acuity was not obtained at the first screening and who was largely non-compliant presented with amblyopia at the second screening. The reanalysed data from the three previous studies demonstrated a significantly poorer visual acuity outcome in the amblyopic eye in the non-compliant patient groups than in the compliant groups in each study.
Preschool children with amblyopia or its risk factors are at risk of having the current amblyopia deteriorate, or of developing amblyopia, if not treated. These results raise questions about the ethical acceptability of a prospective study of amblyopia treatment at these ages.
最近有人呼吁对学龄前儿童弱视治疗的疗效进行前瞻性研究,这需要一个未接受治疗的对照组。本研究评估了因依从性差而未接受治疗的弱视患者或有弱视危险因素患者的数据,以确定治疗结果。
纵向数据来自18名4 - 6岁的患者,这些患者最初接受了弱视、斜视和/或双眼屈光不正的筛查,未遵守规定的治疗,大约一年后在重新筛查时被检测出患有弱视。还重新分析了之前三项比较弱视治疗依从性和不依从性患者治疗结果的研究数据。
18名儿童中,有1名偶尔戴眼镜的儿童弱视眼视力有一定改善。除此之外,没有儿童视力得到改善,17名在两次筛查中均有视力数据的儿童中有7名(41%)弱视眼视力下降,其中3名显然是首次出现弱视。一名有弱视屈光不正危险因素的儿童,首次筛查时未获得视力数据且基本不依从治疗,在第二次筛查时出现了弱视。对之前三项研究重新分析的数据表明,在每项研究中,不依从治疗的患者组弱视眼的视力结果明显比依从治疗的患者组差。
患有弱视或有弱视危险因素的学龄前儿童,如果不接受治疗,目前的弱视有恶化或发展为弱视的风险。这些结果引发了关于在这些年龄段进行弱视治疗前瞻性研究伦理可接受性的问题。