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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Shanghai Eye Disease Prevention and Treatment Center
RECRUITING
Shanghai
Contact Information
Primary
Yan Xu, MD
drxuyan_2004@163.com
(021)62982727
Time Frame
Start Date: 2025-12-31
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 158
Treatments
Experimental: Treatment
An RLRL device.
Sham_comparator: Control
A sham RLRL device.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Eye Disease Prevention and Treatment Center

This content was sourced from clinicaltrials.gov