Objective:

2

To evaluate the effects and safety of auricular acupressure combined with periocular thumbtack needle (AATN) therapy for premyopia children.

Methods:

2

This multi-center

randomized

controlled trial was conducted in 8 Chinese hospitals

and 298 premyopic children aged 6 to 10 years were recruited between October 2020 and February 2022. Eligible participants were randomly assigned to the treatment group or the control group via a simple randomization method. All the participants in both groups were provided with standard intensive eye health instruction through phone calls

WeChat or hospital visits once a week

and the children in the treatment group received AATN therapy additionally. Following 12-week treatment

participants were followed up at 3-month intervals

with the entire study extending over a 9-month duration from baseline to the final assessment. The primary outcome was the mean change in spherical equivalent (SE) from baseline to 36 weeks. The secondary outcomes included the rate of children with stable myopia (MSR)

uncorrected visual acuity (UCVA)

axial length (AL)

corneal curvature (CC)

accommodative amplitude (AMP) and intraocular pressure (IOP) at baseline

6

12

24 and 36 weeks. Safety assessment included analysis of treatment-related adverse events (AEs)

such as allergic reactions and skin damage.

Results:

2

Totally

298 children with premyopia were included

151 in the treatment group and 147 in the control group. At the 36th week

the SE was –0.81±0.55 D in the control group and –0.65±0.44 D in the treatment group (

P

=0.002). The treatment group demonstrated superior SE control efficacy compared with the control group

with differences of –0.29±0.37 D and –0.49±0.44 D

respectively (

P

<

0.01). The children in the treatment group achieved a MSR of 57.78% with more favorable outcome than 37.10% in the control group (

P

<

0.01). The adjusted mean change in AMP from baseline to 9th month was 8.85±4.02 in the control group and 9.85±3.41 in the treatment group (

P

=0.018). AL increased by a mean of 0.35±0.28 mm in the control group and 0.20±0.42 mm in the treatment group (

P

=0.004). No significant differences in UCVA or CC were found between the two groups (

P

>

0.05) and no AEs were reported.

Conclusion:

2

AATN therapy was effective for controlling the onset of myopia and SE

enhancing ocular accommodation

and mitigating AL. (Registration No. ChiCTR2000039299)