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

NCT ID: NCT07312214

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-30

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

Detailed Description

Pathological myopia (PM) is a major cause of irreversible visual impairment and blindness in adults, characterized by progressive axial elongation, choroidal thinning, impaired choroidal microcirculation, and subsequent retinal atrophy, which currently lacks effective therapeutic interventions. Against this clinical backdrop, this prospective randomized controlled trial is designed to systematically investigate the therapeutic efficacy and safety of repeated low-level red light (RLRL) therapy in adult patients with PM. The core research objectives are twofold: first, to verify whether RLRL can modulate choroidal microcirculatory function and thereby retard the progression of retinal atrophy in PM patients, and second, to comprehensively assess the safety profile of long-term RLRL administration by monitoring adverse events. To achieve these goals, the study will adopt a randomized controlled design, where eligible participants will be randomly assigned to either the active treatment group or the sham control group. The active treatment group will receive RLRL therapy, while the control group will be administered interventions using a sham RLRL device-this device is identical in appearance and operation mode to the active RLRL device but has an energy output of less than 10% of the original, aiming to exclude the placebo effect. The intervention regimen for both groups is standardized: participants will receive the assigned intervention twice daily, with each session lasting 3 minutes, 5 days per week, for a continuous 12-month course. During the study period, all participants will undergo regular follow-up visits at the clinic every 3 months, where a series of comprehensive assessments will be performed, including but not limited to visual acuity measurement, fundus examination, optical coherence tomography (OCT) for choroidal thickness and retinal structure evaluation, and choroidal blood flow dynamic detection to quantify microcirculatory changes. Additionally, participants will be instructed to maintain a detailed daily diary, recording the occurrence time, duration, and severity of any subjective symptoms (e.g., eye fatigue, photophobia) as well as changes in visual perception (e.g., contrast sensitivity, visual field changes), which will serve as supplementary data for safety monitoring and efficacy evaluation. Collectively, this study is expected to provide high-quality evidence for the clinical application of RLRL in the management of PM by clarifying its regulatory effect on choroidal microcirculation and its role in delaying retinal atrophy, while defining its safety boundaries.

Conditions

Pathologic Myopia

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment

An RLRL device.

Group Type: EXPERIMENTAL

LED red light

Intervention Type: 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.

Control

A sham RLRL device.

Group Type: SHAM_COMPARATOR

Sham LED red light

Intervention Type: 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.

Interventions

LED red light

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.

Intervention Type: DEVICE

Sham LED red light

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Xu, MD

Role: CONTACT

Phone: (021)62982727

Email: drxuyan_2004@163.com

Other Identifiers

EC-20250506-04

Identifier Type: -

Identifier Source: org_study_id