Focused LED red-light treatment for adults with nearsightedness
Safety and Efficacy of Focused LED-Based Repeated Low-Level Red-Light Therapy in Myopic Adults: A Single-Arm Pilot Study
This pilot tests whether short, home-based red LED light sessions can thicken the choroid and boost choroidal blood flow in adults ages 18–50 with mild to moderate myopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT07369804 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–50 years old with mild to moderate myopia (SE −0.50 to −6.00 D), astigmatism ≤1.50 D, best-corrected visual acuity better than 20/20, and no recent myopia-control treatments or ocular surgery.
Not a fit: Patients with high myopia beyond −6.00 D, significant ocular disease, prior ocular surgery, binocular vision disorders like strabismus, recent myopia-control interventions, or an afterimage time >5 minutes are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the therapy could increase choroidal thickness and blood flow and potentially support a noninvasive home-based approach to reduce myopia-related eye changes.
How similar studies have performed: Similar low-level red-light protocols have produced short-term choroidal thickening and slowed progression in pediatric studies, but adult data are limited and this adult protocol is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hong Kong, Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.