Impact of wearing dual-focus soft contact lenses on myopia progression: a one-year randomized clinical trial in Chinese school-age children.

Abstract

Background: Myopia is prevalent in China; however, trials involving Chinese children wearing dual-focus soft contact lenses (DFSCL) are limited. Thus, the purpose of this study is to investigate the efficacy of DFSCL among Chinese school-age children.

Methods: Sixty-four children aged 8-12 years with spherical equivalent refraction (SER) between - 0.75D and - 4.00D were recruited in this randomized controlled clinical study. The control group (32 subjects) wore single-vision spectacles (SVS), while the DFSCL group (32 subjects) wore daily disposable + 2.00 D defocus MiSight DFSCL. Follow-up examinations were performed every 3 months to compare the axial length (AL) growth and SER change between the groups for a period of 12 months by using the independent samples t-test or the Mann-Whitney U test. Statistical differences with a P < 0.05, when compared to the control group, are considered indicative of an effective intervention. Multivariate analysis and regression analysis were used to eliminate the effects of confounding factors on the results.

Results: A total of 58 subjects, with 30 in the SVS group and 28 in the DFSCL group, completed the follow-up. After adjusting for baseline age, gender, AL and SER, AL growth was 0.33 ± 0.02 mm in the SVS group and 0.23 ± 0.03 mm in the DFSCL group (P = 0.004). SER change was - 0.53 ± 0.06 in the SVS group and - 0.44 ± 0.06 in the DFSCL group (P = 0.308). In the DFSCL group, AL and SER increased 0.11 mm and 0.09 D less than in the SVS group, respectively. Moreover, initial wear of DFSCL may cause occasional blurriness in near vision, and prolonged wear may lead to increased ocular discomfort symptoms such as dryness, itchiness, and foreign body sensation.

Conclusion: MiSight DFSCL showed a reduction in AL growth during the first three months of wear. However, no significant benefits were observed during the subsequent nine months. No significant differences in the changes of SER were found.

Trial registration: Chinese Clinical Trial Registry: ChiCTR2200064731. Registered 15 October 2022, http://www.chictr.org.cn/.