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

NCT07312214 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Pathologic Myopia

Interventions

DEVICE

LED red light

An 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.

DEVICE

Sham LED red light

A 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.

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2028-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07312214 on ClinicalTrials.gov