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NCT Number: NCT05786586

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

650 nm low-level red-light

Device

650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina

Primary outcomes

  1. Change in axial length

    Time frame: 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

    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, three-year follow-up, four-year follow-up, five-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

    Time frame: 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

    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, three-year follow-up, four-year follow-up, five-year follow-up

    Use an optical biometer

  3. Change in flat keratometry

    Time frame: 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

    Use an optical biometer

  4. Change in length thickness

    Time frame: 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

    Use an optical biometer

  5. Change in anterior chamber depth

    Time frame: 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

    Use an optical biometer

  6. Change in central corneal thickness

    Time frame: 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

    Use an optical biometer

Other outcomes

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Collaborators

  • Beijing Children's Hospital
  • Children's Hospital of The Capital Institute of Pediatrics

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2023
Registry last updated
Sep 25, 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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