RecruitingNot Applicable

LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia

China158 participantsStarted 2025-12-31

Plain-language summary

The goal of this clinical trial is to learn if LED repeated low-level red light (RLRL) therapy works to treat pathologic myopia in adults. It will also learn about the safety of LED-RLRL. The main questions it aims to answer are: Does LED-RLRL modulate choroidal microcirculation to retard retinal atrophy in pathological myopia? What medical problems do participants have when receiving LED-RLRL therapy? Researchers will compare with a sham device (identical in appearance but delivering \<10% of the original device's energy output) to see if LED-RLRL works to treat pathologic myopia. Participants will: Take LED-RLRL or sham LED-RLRL twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months. Visit the clinic once every 3 months for checkups and tests. Keep a diary of their symptoms and their visual perception.

Who can participate

Age range

18 Years – 55 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 range: 18 to 55 years old; * Baseline visual acuity: Best Corrected Visual Acuity (BCVA) ≥ 0.1 (LogMAR ≤ 1.0); * Meeting the diagnostic criteria for high myopia: Spherical Equivalent (SE) ≤ -6.00 D and Axial Length (AL) ≥ 26.0 mm; * Meeting one of the following pathological fundus changes: (i) Fundus manifestations corresponding to Category 2 (diffuse chorioretinal atrophy), Category 3 (patchy chorioretinal atrophy), or Category 4 (macular atrophy associated with choroidal neovascularization) of the META-PM classification criteria\*; (ii) Category 1 of the META-PM classification criteria\* complicated with macular schisis; (iii) BCVA \< 0.6; Exclusion Criteria: * Concurrent with other ophthalmic diseases that may affect visual acuity or outcome assessment, including active myopic choroidal neovascularization (CNV) requiring anti-VEGF therapy, macular hole, vitreous hemorrhage, diabetic retinopathy, retinal detachment, retinal vein occlusion, optic neuritis, uveitis, severe cataract, and glaucoma; * Systemic contraindications: Photosensitive epilepsy, autoimmune diseases (e.g., systemic lupus erythematosus), or pregnant/lactating women; Patients who have undergone intraocular surgery, laser treatment, or ophthalmic medication therapy within 3 months prior to enrollment; * Patients unable to comply with regular follow-up (e.g., due to remote residence) or with cognitive impairment; * Opaque refractive media that hinder fundus examination.

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

Choroidal vascular density

Timeframe: From enrollment to the end of treatment at 12 months

Choroidal vessel volume index

Timeframe: From enrollment to the end of treatment at 12 months

Trial details

NCT IDNCT07312214

SponsorShanghai Eye Disease Prevention and Treatment Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Yan Xu, MD

(021)62982727 drxuyan_2004@163.com

View on ClinicalTrials.gov More Pathologic Myopia trials