Low-level red light to slow retinal thinning in pathologic myopia

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 randomized controlled trial will assign adults with pathologic myopia to either active repeated low-level red light (RLRL) therapy or a visually identical sham device that delivers <10% of the energy. Participants will use the device at home twice daily for 3 minutes per session, five days per week, over 12 months, with clinic visits and tests every three months and symptom diaries kept between visits. Primary interests are whether RLRL modulates choroidal microcirculation and retards progression of retinal atrophy, and whether the therapy is well tolerated over long-term use. The sham control and standardized treatment schedule are intended to separate true biological effects from placebo and routine-care influences.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Eye Disease Prevention and Treatment Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yan Xu, MD
• Email: drxuyan_2004@163.com
• Phone: (021)62982727

Similar studies

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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.