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

December 29, 2025 updated by: Xiaojuan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 401122
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • The Second People's Hospital of Foshan City
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
    • Liaoning
      • Shenyang, Liaoning, China, 110032
        • The Fourth People's Hospital of Shenyang City
    • Nanning
      • Guilin, Nanning, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
    • Shanxi
      • Xi’an, Shanxi, China, 710001
        • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group A
PBM therapy with single intervention duration of 2 minutes + wearing Hoya DIMS defocus lens
Device: Yingtong Vision Rehabilitation Instrument

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.

Device: Hoya DIMS multi-point myopia defocus lens
Frame glasses worn on the bridge of the nose
Experimental: Test Group B
PBM therapy with single intervention duration of 3 minutes + wearing Hoya DIMS defocus lens
Device: Yingtong Vision Rehabilitation Instrument

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.

Device: Hoya DIMS multi-point myopia defocus lens
Frame glasses worn on the bridge of the nose
Experimental: Test Group C
PBM therapy with single intervention duration of 4 minutes + wearing Hoya DIMS defocus lens
Device: Yingtong Vision Rehabilitation Instrument

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.

Device: Hoya DIMS multi-point myopia defocus lens
Frame glasses worn on the bridge of the nose
Active Comparator: Control Group D
Wearing Hoya DIMS defocus lens only
Device: Hoya DIMS multi-point myopia defocus lens
Frame glasses worn on the bridge of the nose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-, 3-, 9- and 12-month
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
12-month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-, 3-, 6-, 9- and 12-month
12-month visual adverse event rate
Time Frame: 12-month
BVCA decrease ≥0.2 logMAR
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20251009041118960

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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