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NCT Number: NCT07330180

Multicenter RCT: LED Red Light Dose-Response in Myopia Progression Control

The goal of this clinical trial is to verify the effectiveness and safety of non-laser LED red light combined with defocus lens therapy for controlling myopia progression and evaluate the impact of different intervention durations in 6-14 years old children and adolescents with myopia (spherical equivalent refraction: -6.00D ≤ SER ≤ -1.00D), regardless of gender. The main questions it aims to answer are:

[primary hypothesis or outcome measure 1]: Does the combination of Yingtong Vision Rehabilitation Instrument (non-laser LED red light) and Hoya DIMS defocus lens show non-inferior effectiveness to Hoya DIMS defocus lens alone in controlling 6-month axial length change? [primary hypothesis or outcome measure 2]: Do different single intervention durations (2min, 3min, 4min) of non-laser LED red light affect the effectiveness (e.g., axial length change at multiple time points, 12-month SER change) and safety of the combined therapy? If there is a comparison group: Researchers will compare Test Group A (2min PBM therapy + DIMS lenses), Test Group B (3min PBM therapy + DIMS lenses), Test Group C (4min PBM therapy + DIMS lenses), and Control Group D (DIMS lenses alone)] to see if the combined therapy has similar or better myopia control effects and comparable safety, and to identify the optimal intervention duration.

Participants will:

Complete screening examinations (axial length, refractive error, visual acuity, IOP, fundus photography, OCT, etc.) and sign the informed consent form.

Be randomly assigned to one of the four groups and receive the corresponding intervention (use the Yingtong Vision Rehabilitation Instrument as per group-specific duration twice a day, with ≥4-hour interval, plus DIMS lenses; or only DIMS lenses).

Attend regular follow-up visits at 30 days, 3 months, 6 months, 9 months, and 12 months for efficacy and safety assessments (including repeated ocular examinations and adverse event reporting).

Cooperate with the entire 12-month trial process and comply with the device usage specifications and follow-up requirements.

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Key information

Conditions

Myopia Eye Diseases Myopia, Degenerative Myopia, Progressive Refractive Errors

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 6 to 14 years old, regardless of gender;
  • After cycloplegic autorefraction, monocular or binocular spherical equivalent refraction (SER) meets: -6.00D ≤ SER ≤ -1.00D, and binocular best-corrected visual acuity (BCVA) ≥ 0.8 (logMAR 0.1; Snellen 20/25);
  • Binocular anisometropia ≤ 1.50D; astigmatism ≤ 2.50D;
  • Able to understand the purpose of the study, willing to participate in this clinical verification, sign the informed consent form personally or through their legal guardian, and cooperate with the entire trial process (12 months).

Exclusion criteria

  • Photophobia or allergy to cycloplegic agents (e.g., tropicamide or cyclopentolate);
  • Received any of the following myopia control measures within one month (including but not limited to): low-concentration atropine eye drops, orthokeratology lenses, myopia control-related frame glasses, low-level red light therapy, defocus soft contact lenses, or defocus RGP lenses;
  • Subjects with ocular diseases that may affect visual acuity or refractive error (e.g., lens disorders such as cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, etc.);
  • Neurological diseases (previous convulsion history, epilepsy, tic disorders, central nervous system developmental abnormalities) or mental and psychological diseases;
  • Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function impairment, severe liver and kidney dysfunction, acute or chronic sinusitis, or diabetes mellitus;
  • Binocular manifest strabismus or any other pathological changes of the eyeball or acute inflammatory ocular diseases;
  • Subjects deemed inappropriate by the investigator.

Treatment and study plan

Yingtong Vision Rehabilitation Instrument

Device

Input voltage: 6V (4 × 1.5V alkaline dry batteries). Red light wavelength: 650nm; light spot diameter: outer diameter 5.0mm, inner diameter 1.5mm.

Light source output power: 1.6 mW (±0.1mW at 30mm from the observation window). The Yingtong Vision Rehabilitation Instrument should be used twice a day under the regular communication and supervision of hospital optometrists/coordinators (via phone, WeChat, etc.), with an interval of at least 4 hours.

Hoya DIMS multi-point myopia defocus lens

Device

Frame glasses worn on the bridge of the nose

Primary outcomes

  1. 6-month axial length change

    Time frame: 6-month

    The difference in axial length at 6 months after trial initiation compared with the baseline axial length

Secondary outcomes

  1. 1-, 3-, 9- and 12-month axial length changes

    Time frame: 1-, 3-, 9- and 12-month

    The difference in axial length at 1-, 3-, 9- and 12-month after trial initiation compared with the baseline axial length

  2. 12-month spherical equivalent refraction (SER) change

    Time frame: 12-month

    The difference in spherical equivalent refraction at 12-month after trial initiation compared with the baseline spherical equivalent refraction

Other outcomes

  1. Adverse event rate and serious adverse event rate

    Time frame: 1-, 3-, 6-, 9- and 12-month

    Adverse event rate and serious adverse event rate

  2. 12-month visual adverse event rate

    Time frame: 12-month

    BVCA decrease ≥0.2 logMAR

Study contacts

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

Xiaojuan Wang, Doctor

CONTACT

[email protected]

19537634457

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Multicenter, Open-Label, Parallel-Group, Randomized Controlled Study Comparing the Dose-Response Relationship of LED Red Light in Controlling Myopia Progression

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

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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