LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia
A Randomized Controlled Trial of LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia
Shanghai Eye Disease Prevention and Treatment Center
158 participants
Dec 31, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if repeated low-level red light (RLRL) therapy works to treat pathologic myopia in adults. It will also learn about the safety of RLRL. The main questions it aims to answer are: Does RLRL modulate choroidal microcirculation to retard retinal atrophy in pathological myopia? What medical problems do participants have when receiving RLRL therapy? Researchers will compare RLRL to a sham RLRL device (identical in appearance but delivering \<10% of the original device's energy output) to see if RLRL works to treat pathologic myopia. Participants will: Take RLRL or sham 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
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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.
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Interventions
An RLRL device (660 nm, 65 mW/cm²). Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
A sham RLRL device (identical in appearance but delivering \<10% of the original device's energy output) . Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
Locations(1)
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NCT07312214