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NCT Number: NCT05832723

A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for 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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Red light

Beijing, Beijing Municipality, 100005, China

Location status: Recruiting

Location contact

Kai Cao

CONTACT

[email protected]

01058265900

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in axial length

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an optical biometer to measure the axial length

  2. Change in spherical equivalent error

    Time frame: 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.

Secondary outcomes

  1. Change in Choroid thickness to measure

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an enhanced-depth imaging technique (based on Optical coherence tomography )

  2. Change in steep keratometry

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an optical biometer to measure

  3. Change in flat keratometry

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an optical biometer to measure

  4. Change in length thickness

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an optical biometer to measure

  5. Change in anterior chamber depth

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an optical biometer to measure

  6. Change in central corneal thickness

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Use an optical biometer to measure

Other outcomes

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

    Time frame: Baseline, six-month follow-up, one-year follow-up, two-year follow-up

    Any potential fundus injury related to 650 nm low-level red-light irridiation would be checked through Fundus photography and coherence tomography examination

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Cao

CONTACT

[email protected]

01058265900

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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