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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Eye Disease Prevention and Treatment Center

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LED red light
  • Sham LED red light

Treatment groups

158 Participants
are divided into 2 treatment groups