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RECRUITING
NCT07312214
NA

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

Sponsor: Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial of LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2025-12-31

Completion Date

2028-12-30

Last Updated

2026-05-15

Healthy Volunteers

No

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.

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China