CompletedNot Applicable

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

China40 participantsStarted 2025-04-16

Plain-language 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.

Who can participate

Age range

8 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 week，1 ,3months

Trial details

NCT IDNCT07375589

SponsorShanghai Eye Disease Prevention and Treatment Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Myopia trials