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

Repeated Exposure to 650nm Low-level Red-light for Myopia Control and Prevention in Children: a Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: 650 nm low-level red-light

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.

• Study Type: Interventional
• Enrollment (Estimated): 572
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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
No Intervention: Control; Single vision spectacle lenses are allowed for myopic children. No intervention was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in axial length	Use an optical biometer to measure the axial length.	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Change in spherical equivalent error	Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Choroid thickness	Use an enhanced-depth imaging technique (based on Optical coherence tomography )	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Change in steep keratometry	Use an optical biometer	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Change in flat keratometry	Use an optical biometer	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Change in length thickness	Use an optical biometer	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Change in anterior chamber depth	Use an optical biometer	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Change in central corneal thickness	Use an optical biometer	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fundus injury related to 650 nm low-level red-light irridiation	Any potential fundus injury related to 650 nm low-level red-light irridiation would be checked through Fundus photography and coherence tomography examination	Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: Beijing Children's Hospital; Children's Hospital of The Capital Institute of Pediatrics
• Investigators: Principal Investigator: Ying Jie, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: TongrenJY2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No