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

A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: 650 nm low-level red-light

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Kai Cao; Phone Number: 01058265900; Email: caozhi@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Red light
      • Contact: Kai Cao; Phone Number: 01058265900; Email: anzhen602@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children aged 7-18 years, and is willing to use 650 nm low-level red-light to control or prevent myopia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: 650 nm low-level red-light; Typically, children who uses the 650 nm low-level red-light will be recruited into this study. The use of any other myopia intervention is not restricted except for low concentrations of atropine. Because atropine will cause pupils dilated, the amount of light entering the eye can not be controlled, and red-light is a laser, to be safe, we need to take certain consideration of the amount of light-entering. Participants receive the 650 nm low-level red-light intervention not because they are enrolled in a study, they would receive the intervention in the same manner and intensity if they were not enrolled in the study.

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
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fundus injury related to 650 nm low-level red-light irridiationexamination	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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Ying Jie, PhD, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): March 28, 2026
• Study Completion (Estimated): March 28, 2026

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: April 15, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: TongrenJY2023

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