LED Low-Intensity Red Light for Myopia Control in Youth: Efficacy and Safety Study

January 21, 2026 updated by: Shanghai Eye Disease Prevention and Treatment Center

Exploratory Study on the Efficacy and Safety of LED Low-Intensity Red Light for Controlling Myopia Progression in Children and Adolescents

The purpose of this clinical trial was to investigate the efficacy and safety of repetitive low-intensity single-wavelength red light from an LED light source in controlling myopia progression in children and adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myopia is the most prevalent ocular condition among children and adolescents worldwide. In recent years, optical interventions for myopia prevention and control have gained increasing attention, with low-intensity red light (wavelength: 650 nm) emerging as a promising therapeutic approach. Clinical studies have preliminarily demonstrated the efficacy of repeated low-level red light (RLRL) therapy in slowing myopia progression in pediatric populations. Existing research has primarily utilized semiconductor laser diodes due to their high monochromaticity and concentrated beam intensity. However, concerns persist regarding the safety of red light irradiation in clinical myopia management. The primary risks include potential damage to intraocular structures from prolonged or high-intensity exposure, coupled with the high cost of laser-based systems, which limits their widespread adoption.

In contrast to laser sources, light-emitting diodes (LEDs) operate via non-thermal mechanisms and deliver significantly lower energy output, mitigating the risk of thermal or photochemical tissue damage. Investigating the efficacy and safety of low-intensity red LED light for controlling myopia progression in children and adolescents is therefore of critical scientific and clinical importance.This study aims to evaluate the effectiveness and safety of repeated low-intensity, single-wavelength (650 nm) red LED light therapy in slowing axial elongation in children aged 8-12 years over a 3-month treatment period. Participants will receive RLRL therapy at home under parental supervision in addition to wearing single-vision spectacles, following a standardized protocol. Key outcome measures, including axial length (AL), visual acuity, cycloplegic spherical equivalent refraction (SER), intraocular pressure (IOP), slit-lamp biomicroscopy, optical coherence tomography (OCT), and optical biometry, will be assessed at baseline and at 1-week, 1-month, and 3-month follow-up intervals.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200041
        • Shanghai Eye Disease Prevention & Treatment Center

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:

  1. Age: 8-12 years old
  2. Simple myopia: equivalent spherical lens ≤ -0.5D and > -6.0D after any cycloplegia, astigmatism ≤ 2.5D, anisometropia ≤ 1.5D
  3. The best corrected visual acuity in one eye is 0.8 and above
  4. Normal fundus, or only leopard-shaped fundus
  5. Sign informed consent and be able to participate in the study

Exclusion Criteria:

  1. Rule out hereditary myopia
  2. The subject has other congenital eye diseases, such as congenital cataract, congenital glaucoma, etc
  3. Presence of strabismus or other binocular vision abnormalities
  4. refractive media opacity: corneal opacity, cataract or intraocular lens surgery
  5. There are eye diseases that affect retinal function
  6. Children who had used or were using orthokeratology, atropine and other myopia control measures could be enrolled after stopping treatment for three months
  7. There are other systemic disease abnormalities
  8. Other reasons that the research doctor considers unsuitable for inclusion in the project

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LED Red light: 1.6 mW/twice daily
Device: Red light treatment with 1.6mW LED light source
In addition to using a powered single vision glasses lens (SVS) to correct distance refraction, the subjects underwent two red light treatments using a 1.6mW LED light source therapy device from Monday to Friday, each treatment was 3 minutes, and the interval was 4 hours.
Sham Comparator: LED Red light: 0.001 mW/twice daily
Device: Red light treatment with 0.001mW LED light source
In addition to using a powered single vision glasses lens (SVS) to correct distance refraction, subjects were treated with red light twice from Monday to Friday using a 0.001mW LED light source therapy instrument, each time for 3 minutes, with an interval of 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects in the intervention group received red light treatment with 1.6mW LED light source during 3 months
Time Frame: 1 week，1 ,3months
Subjects in the intervention group received red light treatment with 1.6mW LED light source for 3 months, and the change of axial length was compared with the increase of axial length in the blank group
1 week，1 ,3months

Collaborators and Investigators

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

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Beijing Airdoc Technology Co., Ltd.

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 (Actual)

April 16, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLED-2025

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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