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

A Randomized Controlled Trial of LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia

This trial will test whether twice-daily low-level red light therapy can slow retinal atrophy in adults with pathologic myopia and is safe to use.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07312214 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–55 with high myopia (spherical equivalent ≤ −6.00 D and axial length ≥ 26.0 mm) and signs of pathologic myopia on fundus exam (META-PM categories 2–4, or category 1 with macular schisis, or reduced central vision meeting the trial criteria) are ideal candidates.

Not a fit: People with active myopic choroidal neovascularization requiring anti-VEGF, other retinal diseases (macular hole, diabetic retinopathy, retinal detachment, retinal vein occlusion), very advanced vision loss, or those outside the age/axial length criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If effective, RLRL could slow retinal atrophy progression in pathologic myopia and help preserve vision by improving choroidal microcirculation.

How similar studies have performed: Prior RLRL trials, mainly in children, have shown signals for slowing axial elongation and increasing choroidal thickness, but applying RLRL to slow retinal atrophy in adults with pathologic myopia is largely untested.

Eligibility criteria

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 this trial is running

Shanghai

• Shanghai Eye Disease Prevention and Treatment Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yan Xu, MD

Conditions Pathologic Myopia; repeated low-level red light; LED; myopia; treatment