A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents

Recruiting

• Conditions: Myopia
• Interventions: Device: 650 nm low-level red-light

• Registration Number: NCT05832723
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 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 real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. 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 Timeline

• Study First Submitted: 2023-03-19
• Study Start: 2023-04-15
• Study First Submitted QC: 2023-04-15
• Study First Posted: 2023-04-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-03-28
• Study Completion: 2026-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Children aged 7 to 18 years
2. The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
3. Astigmatism of 2.5 D or less (≤2.5D)
4. Willing to participate in the study and sign the informed consent form

Exclusion Criteria

1. Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
2. Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
3. Mental diseases
4. Similar interventions have been used in the past year
5. Allergic to cycloplegic agents or to red light
6. The 650nm red light intervention was not suitable for the condition evaluated by the researchers
7. are currently using atropine or similar drugs, or have stopped using them for less than 1 month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
650 nm low-level red-light	650 nm low-level red-light	Children who are exposed to the 650 nm low-level red-light will be recruited into the cohort, the exposure factor is red-light irradiation. The study does not give interventions, but only recruit children who received or who is receiving the 650 nm low-level red-light intervention for observation.

Primary Outcome Measures

Name	Time	Method
Change in spherical equivalent error	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	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.
Change in axial length	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an optical biometer to measure the axial length

Secondary Outcome Measures

Name	Time	Method
Change in Choroid thickness to measure	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an enhanced-depth imaging technique (based on Optical coherence tomography )
Change in flat keratometry	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an optical biometer to measure
Change in length thickness	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an optical biometer to measure
Change in steep keratometry	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an optical biometer to measure
Change in anterior chamber depth	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an optical biometer to measure
Change in central corneal thickness	Baseline, six-month follow-up, one-year follow-up, two-year follow-up	Use an optical biometer to measure

Trial Locations

Locations (1)

Red light; 🇨🇳 Beijing, Beijing, China