Yang Hsin-Yu, Tsai Der-Chong, Yang Yu-Chieh, Wang Chiao-Yu, Lee Chia-Wei, Huang Pei-Wei
Department of Ophthalmology, Taipei Veterans General Hospital Yuanshan and Suao Branch, Yilan, Taiwan.
National Yang Ming Chiao Tung University School of Medicine, Taipei, Taiwan.
PLoS One. 2024 Dec 31;19(12):e0312935. doi: 10.1371/journal.pone.0312935. eCollection 2024.
Myopia has been a rising problem globally. Early-onset myopia significantly increases the risk of high myopia later in life. Despite the proven benefits of increased outdoor time, optimal strategies for preventing early-onset myopia in premyopic children need further investigation.
This randomized controlled trial aims to evaluate the efficacy of optical (Defocus Incorporated Multiple Segments [DIMS] spectacle lenses) and pharmacological (0.01% atropine eye drops) interventions in preventing myopia among premyopic preschoolers. We will recruit 234 premyopic, asymptomatic 5-to-6-year-old children who will have received cycloplegic autorefraction examination in a countywide kindergarten eye care program in Yilan County, Taiwan. Eligible participants will be randomly assigned to DIMS spectacles (n = 78), 0.01% atropine (n = 78), or usual care (n = 78). In the DIMS group, preschoolers will be instructed to wear spectacles at home before entering elementary school but to wear them all the time after school entry. In the atropine group, subjects will be given 0.01% atropine eyedrops nightly throughout the study period. All participants will be encouraged to spend time outdoors for 2 hours every day. During the 18-month study period, cycloplegic spherical equivalent (SE) refraction, axial length, and subfoveal choroidal thickness will be measured every three months, and parents-administered questionnaires regarding risk factors for myopia will be performed every nine months.
The change in mean cycloplegic SE.
The cumulative percentage of incident myopia, the cumulative percentage of a fast myopic shift of SE, and the changes in mean axial length.
OTHER PRE-SPECIFIED OUTCOMES: The time to myopia onset, alteration in subfoveal choroidal thickness, and levels of near work/outdoor activities.
This study is registered at www.clinicaltrials.gov as NCT06200194.
This trial will provide insights into myopia prevention strategies and inform new eye care policies for early identification and intervention in premyopic preschoolers.
近视在全球范围内一直是一个日益严重的问题。早发性近视会显著增加日后患高度近视的风险。尽管增加户外活动时间已被证明有益，但预防近视前期儿童早发性近视的最佳策略仍需进一步研究。
这项随机对照试验旨在评估光学干预（离焦整合多区域[DIMS]眼镜片）和药物干预（0.01%阿托品滴眼液）对预防近视前期学龄前儿童近视的效果。我们将招募234名近视前期、无症状的5至6岁儿童，这些儿童在台湾宜兰县全县幼儿园眼保健项目中接受了睫状肌麻痹验光检查。符合条件的参与者将被随机分配到DIMS眼镜组（n = 78）、0.01%阿托品组（n = 78）或常规护理组（n = 78）。在DIMS组中，学龄前儿童将被要求在进入小学前在家佩戴眼镜，但入学后要一直佩戴。在阿托品组中，受试者在整个研究期间每晚使用0.01%阿托品滴眼液。鼓励所有参与者每天户外活动2小时。在18个月的研究期间，每三个月测量一次睫状肌麻痹等效球镜度（SE）、眼轴长度和黄斑中心凹下脉络膜厚度，每九个月进行一次家长填写的关于近视危险因素的问卷调查。
睫状肌麻痹平均SE的变化。
新发近视的累积百分比、SE快速近视性移位的累积百分比以及平均眼轴长度的变化。
近视发病时间、黄斑中心凹下脉络膜厚度的改变以及近距工作/户外活动水平。
