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

NCT07375589 | Completed DMC

• 1 other identifier: RLED-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Ametropia

Keywords

Myopia

Outcome Measures

Primary Outcomes (1)

• Subjects in the intervention group received red light treatment with 1.6mW LED light source during 3 months

  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

Study Arms (2)

LED Red light: 1.6 mW/twice daily

EXPERIMENTAL

Device: Red light treatment with 1.6mW LED light source

LED Red light: 0.001 mW/twice daily

SHAM COMPARATOR

Device: Red light treatment with 0.001mW LED light source

Interventions

Red light treatment with 0.001mW LED light source DEVICE

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.

LED Red light: 0.001 mW/twice daily

Red light treatment with 1.6mW LED light source DEVICE

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.

LED Red light: 1.6 mW/twice daily

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Rule out hereditary myopia
• The subject has other congenital eye diseases, such as congenital cataract, congenital glaucoma, etc
• Presence of strabismus or other binocular vision abnormalities
• refractive media opacity: corneal opacity, cataract or intraocular lens surgery
• There are eye diseases that affect retinal function
• Children who had used or were using orthokeratology, atropine and other myopia control measures could be enrolled after stopping treatment for three months
• There are other systemic disease abnormalities

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Beijing Airdoc Technology Co., Ltd.: collaborator

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200041, China

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: April 16, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-04

Locations

CN (1)