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

NCT07312214 | Recruiting

• 1 other identifier: EC-20250506-04
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pathologic Myopia

Keywords

repeated low-level red light; LED; myopia; treatment

Outcome Measures

Primary Outcomes (2)

• Choroidal vascular density

  From enrollment to the end of treatment at 12 months

• Choroidal vessel volume index

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (5)

• Choroidal thickness

  From enrollment to the end of treatment at 12 months

• Distance between Bruch's membrane and choroidal-scleral interface

  From enrollment to the end of treatment at 12 months

• Retinal thickness

  From enrollment to the end of treatment at 12 months

• Retinal vascular density

  From enrollment to the end of treatment at 12 months

• Proportion of participants developed diffuse chorioretinal atrophy

  From enrollment to the end of treatment at 12 months

Other Outcomes (6)

• Changes in BCVA

  From enrollment to the end of treatment at 12 months

• Incidence of allergic reactions

  From enrollment to the end of treatment at 12 months

• Changes in AL

  From enrollment to 12-month

Study Arms (2)

Treatment

EXPERIMENTAL

An RLRL device.

Device: LED red light

Control

SHAM COMPARATOR

A sham RLRL device.

Device: Sham LED red light

Interventions

LED red light DEVICE

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.

Treatment

Sham LED red light DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Yan Xu, MD

CONTACT

(021)62982727; drxuyan_2004@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 31, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)