Focused LED red-light treatment for adults with nearsightedness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm, open-label pilot will enroll 14 myopic adults (18–50 years) with spherical equivalent refractions of −0.50 to −6.00 D to receive focused LED-based repeated low-level red-light (fLED-RLRL) therapy. Participants will use a home device (650 ± 10 nm, 0.20 mW) twice daily for 3 minutes per session, five days per week for 28 days while wearing single-vision spectacles. The primary outcomes are changes in choroidal thickness and choroidal blood flow, and secondary outcomes focus on safety and tolerability. Key exclusions include recent myopia-control treatments within 6 months, prior ocular surgery, strabismus, and other ocular or systemic abnormalities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-50 years.
2. SE refractions between -0.50 and -6.00 diopters (D)
3. Astigmatism of 1.50 D or less.
4. Best corrected monocular visual acuity better than 20/20 (Snellen equivalent).
5. Willingness to provide written informed consent and comply with the treatment protocol.

Exclusion Criteria:

1. Strabismus or binocular vision abnormalities in either eye.
2. Ocular abnormalities in either eye or other systemic abnormalities.
3. Previous or current use of myopia control interventions (e.g., orthokeratology, low-dose atropine, pirenzepine) within the past 6 months.
4. History of ocular surgeries (e.g., cataract surgery and LASIK/SMILE).
5. Afterimage time \> 5 minutes (contraindications to RLRL therapy).

Where it's running

• The Hong Kong Polytechnic University
  Hong Kong, Hong Kong, China Recruiting

Study contacts

• Study coordinator: Mingguang He
• Email: mingguang.he@polyu.edu.hk
• Phone: 85234002795

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.