Efficacy Superiority Trial of Red Light Myopia Control Device Based on LED Light Source

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

Based on the Tongren Myopia and Amblyopia Therapeutic Apparatus (a 650nm low-level red-light device) developed by the research team in the previous phase, the device was modified by replacing the light source with LED light. Subsequently, a population study was conducted to evaluate its efficacy and safety in myopia prevention and control.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• Willing to use myopia treatment devices based on LED light sources or fake light sources Aged 6-18 years old For both eyes, the myopic spherical equivalent refraction after cycloplegic computerized refraction: -0.50D to -6.00D, and astigmatism ≤ 2.50D Spherical equivalent anisometropia of both eyes ≤ 2.50D Corrected visual acuity (for both near and far) ≥ 1.0 Intraocular pressure (IOP) 10-21mmHg No active ocular inflammation, no history of ocular trauma, no history of ocular surgery, and no ocular or systemic organic diseases that affect visual changes Voluntarily participate in this project and sign the informed consent form The subject has not used other myopia control methods in the past six months Have records of refractive error and axial length measurements six months before enrollment

Locations
Other Locations
China
Beijing Tongren Hospital
RECRUITING
Beijing
Contact Information
Primary
Kai Cao
anzhen602@163.com
01058265900
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 206
Treatments
Experimental: LED red-light
Sham_comparator: control
Fake light, with a light source power that is one-tenth of that of real LED light
Related Therapeutic Areas
Sponsors
Leads: Beijing Tongren Hospital

This content was sourced from clinicaltrials.gov