650nm Low-level Red-light for Myopia Control and Prevention in Children

Capital Medical University

Status: Active, not recruiting

Conditions: Myopia

Treatments: Device: 650 nm low-level red-light

Study type: Interventional

Funder types: Other

Identifiers

NCT05786586

TongrenJY2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 572 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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572 participants in 2 patient groups

650 nm low-level red-light, plus single vision spectacle lenses

Experimental group

Description:

Children in the treatment group are expected to receive 6 minutes irradiation of 650 nm low-level red-light daily, divided into two times a day, each lasting for 3 minutes. Single vision spectacle lenses are allowed for myopic children.

Treatment:

Device: 650 nm low-level red-light

Control

No Intervention group

Description:

Single vision spectacle lenses are allowed for myopic children. No intervention was given.