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

NCT05832723 | Recruiting

• 1 other identifier: TongrenJY2023
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Choroid thickness to measure

  Baseline, six-month follow-up, one-year follow-up, two-year follow-up

• Change in steep keratometry

  Baseline, six-month follow-up, one-year follow-up, two-year follow-up

• Change in flat keratometry

  Baseline, six-month follow-up, one-year follow-up, two-year follow-up

• Change in length thickness

  Baseline, six-month follow-up, one-year follow-up, two-year follow-up

• Change in anterior chamber depth

  Baseline, six-month follow-up, one-year follow-up, two-year follow-up

Other Outcomes (1)

• Fundus injury related to 650 nm low-level red-light irridiationexamination

  Baseline, six-month follow-up, one-year follow-up, two-year follow-up

Study Arms (1)

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

Interventions

650 nm low-level red-light DEVICE

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.

650 nm low-level red-light

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
• Mental diseases
• Similar interventions have been used in the past year
• Allergic to cycloplegic agents or to red light
• The 650nm red light intervention was not suitable for the condition evaluated by the researchers
• are currently using atropine or similar drugs, or have stopped using them for less than 1 month

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Red light

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Ying Jie, PhD

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Cao

CONTACT

01058265900; caozhi@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 27, 2023
• Study Start: April 15, 2023
• Primary Completion: March 28, 2026
• Study Completion: March 28, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)