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.
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;
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.
Parallel
LED red light
DeviceAn LED-RLRL device (Airdoc PBM-LED, Model No.: AI-PBM01, Beijing Airdoc Technology Co., Ltd.) was adopted. It has a working wavelength of 650 nm, with an output power of 1.39 mW at the light source, and the output power is 1.39 mW ± 0.1 mW at a position 30 mm away from the observation window glass. Twice daily, 3 minutes per session, 5 days per week, for a total duration of 12 months.
Sham LED red light
DeviceA sham LED-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.
Choroidal vascular density
Choroidal vessel volume index
Choroidal thickness
Distance between Bruch's membrane and choroidal-scleral interface
Retinal thickness
Retinal vascular density
Changes in BCVA
best-corrected visual acuity
Incidence of allergic reactions
including photophobia, blurred near vision, afterimage, elevated IOP, headache, nausea, and vomiting
Changes in AL
axial length
Changes in SE
spherical equivalent
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