Table 1 Eligibility criteria

Inclusion criteria

1. Children aged 5 to < 9 years

2. Meeting the following refractive criteria by cycloplegic refraction:

- SER: − 0.75 to less than − 6.00 D

- Astigmatism: ≤ 1.50 D

- Anisometropia: ≤ 2.00 D

3. BCVA: 0.2 logMAR or better OU at screening visit (visit 1)

4. Able to accomplish SAT-001 (capable of comprehending and executing written and verbal instructions)

5. Providing signed informed consent (for < 6 years old, providing agreement with a marked indication after full information and understanding)

Exclusion criteria

1. History of myopia intervention, including atropine use within 3 days prior to baseline (visit 2)

2. Current or prior use of multifocal lenses, orthokeratology, or RGP within 1 month prior to baseline (visit 2)

3. Ocular abnormalities in the cornea, lens, central retina, iris, or ciliary body or malignant tumors in the orbital area

4. History of eye diseases (e.g., strabismus, amblyopia, and nystagmus)

5. History of ocular surgery (e.g., eyelid, strabismus, intraocular, or refractive surgery)

6. Down’s syndrome or cerebral palsy

7. Participation in other clinical trial medications or investigational devices within 6 months prior to screening visit (visit 1)

8. Significant systemic diseases (e.g., congenital heart disease or respiratory, endocrine, and neurological diseases)

9. Systemic diseases that could impact visual acuity and visual field

10. History of growth hormone treatment within 1 month prior to baseline (visit 2)

11. Other reasons at the discretion of the investigator