Overview
A multicenter randomized controlled trial, evaluating the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children. Participants included children(aged 6 to 12 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
Description
This multicenter randomized controlled trial will be conducted in three hospitals: Beijing Tongren Hospital, and another two subcenters. The whole study will last for five years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up and the end of the study. The intervention measure used will be 650 nm low-level red-light. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
Eligibility
Inclusion Criteria:
- Children aged 6 to 12 years
- The cycloplegic spherical equivalent error (SER) is -6D to 1D (> -6D, ≤1D) in both eyes
- Astigmatism of 2.5 D or less (≤2.5D)
- Willing to participate in the study and sign the informed consent form
Exclusion Criteria:
- Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens
- With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia
- With refractive media opacification (keratopathy, lens opacity, etc.)
- Allergy to cycloplegia drugs
