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

NCT07330180 | Not Yet Recruiting

• 1 other identifier: 20251009041118960
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Myopia; Myopia, Progressive

Keywords

Myopia; Children; Axial Length; Red-light Therapy

Outcome Measures

Primary Outcomes (1)

• 6-month axial length change

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

  6-month

Secondary Outcomes (2)

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

  1-, 3-, 9- and 12-month

• 12-month spherical equivalent refraction (SER) change

  12-month

Other Outcomes (2)

• Adverse event rate and serious adverse event rate

  1-, 3-, 6-, 9- and 12-month

• 12-month visual adverse event rate

  12-month

Study Arms (4)

Test Group A

EXPERIMENTAL

PBM therapy with single intervention duration of 2 minutes + wearing Hoya DIMS defocus lens

Device: Yingtong Vision Rehabilitation Instrument; Device: Hoya DIMS multi-point myopia defocus lens

Test Group B

EXPERIMENTAL

PBM therapy with single intervention duration of 3 minutes + wearing Hoya DIMS defocus lens

Device: Yingtong Vision Rehabilitation Instrument; Device: Hoya DIMS multi-point myopia defocus lens

Test Group C

EXPERIMENTAL

PBM therapy with single intervention duration of 4 minutes + wearing Hoya DIMS defocus lens

Device: Yingtong Vision Rehabilitation Instrument; Device: Hoya DIMS multi-point myopia defocus lens

Control Group D

ACTIVE COMPARATOR

Wearing Hoya DIMS defocus lens only

Device: Hoya DIMS multi-point myopia defocus lens

Interventions

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.

Test Group A; Test Group B; Test Group C

Hoya DIMS multi-point myopia defocus lens DEVICE

Frame glasses worn on the bridge of the nose

Control Group D; Test Group A; Test Group B; Test Group C

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (7)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 401122, China

Location

The Second People's Hospital of Foshan City

Foshan, Guangdong, 528000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

The Fourth People's Hospital of Shenyang City

Shenyang, Liaoning, 110032, China

Location

The First Affiliated Hospital of Guangxi Medical University

Guilin, Nanning, 530021, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710001, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Xiaojuan Wang, Doctor

CONTACT

19537634457; 153803468@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Optometry Center

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)