Efficacy and Safety of 0.01% Atropine Eye Drops and Novel Lenslet-ARray-Integrated Spectacle Lenses for the Prevention of Myopia Progression Among Children with Premyopia: A Randomized Clinical Trial

Previous studies have suggested that premyopia shows high prevalence and high risk of progression to myopia among children. Therefore, the purpose of this study was to investigate the efficacy and safety of 0.01% atropine eye drops and novel positive Lenslet-ARray-Integrated spectacle lenses (LARI) in slowing myopia onset and myopic shift among children with premyopia in China. This was a prospective randomized controlled trial. A total of 400 children aged 6-12 years with premyopia in both eyes were enrolled. Subjects were randomly divided into four groups in equal proportions: 0.01% atropine eye drops group (group A), LARI group (group S), combination group (group AS), and control group without any clinical intervention (group E). Measurements were conducted at baseline and at 3-, 6-, and 12-month follow-up. The incidence of myopia and the percentage of patients with fast myopic shift over 1 year were the primary outcomes. The secondary outcomes were changes in cycloplegic spherical equivalent refraction (SE) and axial length (AL). Changes in uncorrected visual acuity (UCVA), corneal curvature (CC), subfoveal choroidal thickness (SFCT), and intraocular pressure (IOP) were the exploratory outcomes. Adverse events were also recorded. The incidence of myopia and the percentage of patients with fast myopic shift in groups A, S, and AS were significantly lower than those in group E. Treatment with 0.01% atropine, LARI, and their combination decreased myopia progression by 55.88%, 64.71%, and 77.94%, and axial elongation by 65.00%, 75.00%, and 77.50%, respectively. Further analyses were conducted based on age stratification. SFCT in intervention groups increased significantly. No serious adverse events were detected. These 1-year results suggest that, combined with the progression of SE, the reduction in AL, and the increase in SFCT, 0.01% atropine and LARI can be used as effective and safe treatments for the prevention of myopia progression in children with premyopia. Combination therapy showed superior efficacy in this cohort, but long-term effects beyond 12 months remain unknown. ChiCTR2500098887.