PDF(Pubmed)
Abstract：
BACKGROUND: Myopia, characterized by excessive axial elongation of the eyeball, increases risks of having sight-threatening diseases and impose a financial burden to healthcare system. Although myopic control interventions showed their effectiveness in slowing progression, the efficacy varies between individuals and does not completely halt progression. The study aims to investigate the efficacy of combining 0.01% atropine administered twice daily with optical defocus for myopia control in schoolchildren.
METHODS: This is a prospective, parallel-group, single-blinded, randomized, active-control trial (ClinicalTrials.gov identifier: NCT06358755). Myopic schoolchildren with no previous myopic control interventions aged between 7 to 12 years will be recruited. They will be randomly allocated into two groups (n = 56 per group) after baseline measurement. Both groups will receive 0.01% atropine twice per day for 18 months (one drop in the morning and the other drop at night before bedtime). Defocus incorporated multiple segments (DIMS) spectacle lenses will be prescribed in atropine plus optical defocus (ATD) treatment group while single vision spectacle lenses will be given in atropine only (AT) group. Cycloplegic refraction and axial lengths will be monitored every 6 months over 18-month study period. The primary outcomes are changes in cycloplegic refraction and axial lengths relative to the baseline over the study period.
CONCLUSIONS: The result will examine the combination effect of low dose atropine and myopic defocus on myopia control in a randomized controlled study. The findings will also explore the potential benefits of applying 0.01% atropine twice per day on myopic control and its potential side effects.
METHODS: This is a prospective, parallel-group, single-blinded, randomized, active-control trial (ClinicalTrials.gov identifier: NCT06358755). Myopic schoolchildren with no previous myopic control interventions aged between 7 to 12 years will be recruited. They will be randomly allocated into two groups (n = 56 per group) after baseline measurement. Both groups will receive 0.01% atropine twice per day for 18 months (one drop in the morning and the other drop at night before bedtime). Defocus incorporated multiple segments (DIMS) spectacle lenses will be prescribed in atropine plus optical defocus (ATD) treatment group while single vision spectacle lenses will be given in atropine only (AT) group. Cycloplegic refraction and axial lengths will be monitored every 6 months over 18-month study period. The primary outcomes are changes in cycloplegic refraction and axial lengths relative to the baseline over the study period.
CONCLUSIONS: The result will examine the combination effect of low dose atropine and myopic defocus on myopia control in a randomized controlled study. The findings will also explore the potential benefits of applying 0.01% atropine twice per day on myopic control and its potential side effects.
摘要：
背景：近视，以眼球轴向过度伸长为特征，增加了患有威胁视力疾病的风险，并给医疗保健系统带来了经济负担。尽管近视控制干预措施显示了它们在减缓进展方面的有效性，疗效因个体而异,并不能完全阻止进展.该研究旨在研究每天两次给予0.01％阿托品与光学散焦相结合控制学龄儿童近视的疗效。
方法：这是一个前瞻性的，平行组，单盲,随机化，主动对照试验（ClinicalTrials.gov标识符：NCT06358755）。将招募年龄在7至12岁之间没有近视控制干预措施的近视学童。基线测量后，将其随机分为两组（每组n=56）。两组都将每天两次接受0.01％的阿托品，持续18个月（早上一滴，晚上睡前一滴）。阿托品加光学散焦（ATD）治疗组将规定多段散焦（DIMS）眼镜镜片，而单视力眼镜镜片仅在阿托品（AT）组中给予。在18个月的研究期间，每6个月监测一次晶状体麻痹屈光度和轴向长度。主要结果是在研究期间，睫状肌麻痹屈光度和轴向长度相对于基线的变化。
结论：该结果将在一项随机对照研究中检验低剂量阿托品和近视散焦对近视控制的联合作用。研究结果还将探讨每天两次使用0.01％阿托品对近视控制的潜在益处及其潜在副作用。
方法：这是一个前瞻性的，平行组，单盲,随机化，主动对照试验（ClinicalTrials.gov标识符：NCT06358755）。将招募年龄在7至12岁之间没有近视控制干预措施的近视学童。基线测量后，将其随机分为两组（每组n=56）。两组都将每天两次接受0.01％的阿托品，持续18个月（早上一滴，晚上睡前一滴）。阿托品加光学散焦（ATD）治疗组将规定多段散焦（DIMS）眼镜镜片，而单视力眼镜镜片仅在阿托品（AT）组中给予。在18个月的研究期间，每6个月监测一次晶状体麻痹屈光度和轴向长度。主要结果是在研究期间，睫状肌麻痹屈光度和轴向长度相对于基线的变化。
结论：该结果将在一项随机对照研究中检验低剂量阿托品和近视散焦对近视控制的联合作用。研究结果还将探讨每天两次使用0.01％阿托品对近视控制的潜在益处及其潜在副作用。
