[Visual Performance of School-age Children Wearing Dual-Focus Soft Contact Lenses: A Randomized Controlled Trial].

Objective: To investigate the effect of wearing dual-focus soft contact lenses (DFSCL) on the visual performance of school-age children.

Methods: In this randomized controlled clinical trial, 64 children aged 8 to 12 years with spherical equivalent refraction between -0.75 D and -4.00 D were recruited in our hospital in October 2022. Using the envelope method, the subjects were evenly and randomly assigned to the control group wearing single vision spectacles (SVS) or the intervention group wearing MiSight dual-focus soft contact lenses (DFSCL) from CooperVision. Follow-up examinations were conducted once every 3 months. The corrected visual acuity, contrast sensitivity function (CSF), and the scores for National Eye Institute Refractive Error Quality of Life Instrument-42 (NEI-RQL-42) were compared between the control and intervention groups.

Results: By December 2023, a total of 58 subjects completed follow-up (30 in the SVS group and 28 in the DFSCL group). No significant difference in corrected visual acuity was observed between subjects wearing DFSCL and those wearing SVS. The CSF of the DFSCL group was comparable to that of the SVS group across the spatial frequencies of 3, 6, 12, and 18 cpd (P>0.05). According to the results of the NEI-RQL-42 survey at the 6-month follow-up, the score for ocular discomfort symptoms was 89±14 in the SVS group and 79±16 in the DFSCL group (P=0.008), reflecting that the DFSCL group had a 12.66% higher level of discomfort. For appearance, the score was 70±32 in the SVS group and 92±22 in the DFSCL group (P=0.002), showing a 31.43% improvement in the DFSCL group.

Conclusion: In addition to providing the normal visual acuity and CSF, wearing MiSight DFSCL also leads to better satisfaction with the appearance.