School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong.
Centre for Eye and Vision Research (CEVR), Shatin, Hong Kong.
PLoS One. 2024 Jun 26;19(6):e0306050. doi: 10.1371/journal.pone.0306050. eCollection 2024.
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.
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.
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.
近视的特征是眼球轴向过度伸长，增加了发生威胁视力疾病的风险，并给医疗保健系统带来经济负担。尽管近视控制干预措施已证明在减缓进展方面有效，但个体之间的疗效存在差异，并且无法完全阻止进展。本研究旨在探讨每日两次 0.01%阿托品联合光学离焦在儿童近视控制中的疗效。
这是一项前瞻性、平行组、单盲、随机、活性对照试验（ClinicalTrials.gov 标识符：NCT06358755）。招募年龄在 7 至 12 岁之间、无既往近视控制干预措施的近视学龄儿童。在基线测量后，将他们随机分配到两组（每组 56 人）。两组均在 18 个月内每天接受 0.01%阿托品滴眼两次（早晨滴一次，晚上睡前滴一次）。在阿托品加光学离焦（ATD）治疗组中，将开具包含多个离焦段的 DIMS 眼镜处方，而在仅使用阿托品（AT）组中，将开具单光眼镜处方。在 18 个月的研究期间，每 6 个月监测一次睫状肌麻痹验光和眼轴长度。主要结局是在研究期间，相对于基线，睫状肌麻痹验光和眼轴长度的变化。
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离焦对近视控制的联合作用。研究结果还将探讨每天两次应用 0.01%阿托品对近视控制的潜在益处及其潜在的副作用。
