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

NCT ID: NCT05786586

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-26
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed 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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

650 nm low-level red-light

Intervention Type: DEVICE

650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

650 nm low-level red-light

650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital of The Capital Institute of Pediatrics

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ying Jie, MD

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Jie

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TongrenJY2022

Identifier Type: -

Identifier Source: org_study_id