AUTHOR=Li Binbin , Yu Shiao , Gao Shasha , Sun Guangli , Pang Xuena , Li Xiuhong , Wang Ming , Zhang Fengyan , Fu Aicun 

TITLE=Effect of 0.01% atropine combined with orthokeratology lens on axial elongation: a 2-year randomized, double-masked, placebo-controlled, cross-over trial

JOURNAL=Frontiers in Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1358046

DOI=10.3389/fmed.2024.1358046

ISSN=2296-858X

ABSTRACT=To evaluate the effect of 0.01% atropine combined with orthokeratology (OK) lens on axial elongation in schoolchildren with myopia. Sixty children aged 8-12 years with spherical equivalent refraction from -1.00D to -4.00D in both eyes were enrolled in this randomized, double-masked, placebo-controlled, cross-over trial. Children who had been wearing OK lenses for 2 months were randomly assigned into combination group (combination of OK lens and 0.01% atropine) for 1 year followed by control group (combination of OK lens and placebo) for another 1 year or vice versa. This trial was registered in the Chinese Clinical Trial Registry (Number: ChiCTR2000033904, 16/06/2020). The primary outcome was changes in axial length.Data of right eyes were analyzed. There were statistically significant differences in the changes in axial length (AL) between combination and control groups after generalized estimating equation model adjusting for age and baseline spherical equivalent refraction (SER) (p=0.001). The mean axial elongation difference between combination and control groups was 0.10 mm in the first year (0.10±0.13 mm vs. 0.20±0.15 mm; p =0.01), and 0.09 mm in the second year (0.22±0.10 mm vs. 0.13 ±0.14 mm; p=0.01), respectively. The mean axial elongation difference of two groups in the first year was similar to that in the second year during the cross-over treatment.In central Mainland China in myopic children, the treatment of combination therapy is more effective than single OK lens in controlling axial elongation.