NCT07208617Not yet recruitingNot Applicable
Efficacy Superiority Trial of Red Light Myopia Control Device Based on LED Light Source
Beijing Tongren Hospital1 site in 1 country206 target enrollmentStarted: February 12, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Axial length
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Subjects with systemic diseases or immune diseases that affect compliance, such as tumors, heart diseases (including those with implanted electronic devices in the body, such as cardiac pacemakers), severe liver and kidney diseases, epilepsy, and autoimmune diseases Subjects with mental illnesses that affect the implementation of the intervention measures in this trial Subjects with refractive media opacity (corneal lesions, lens opacity, etc.) or ocular diseases: macular diseases, moderate to severe dry eye, corneal diseases, cataracts, vitreoretinal diseases, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve dysplasia, or other ocular diseases Subjects allergic to cycloplegics Other circumstances where the researcher deems it inappropriate for the subject to participate in the trial for safety reasons or in the interest of the patient
Arms & Interventions
control
Sham Comparator
Fake light, with a light source power that is one-tenth of that of real LED light
Intervention: Control (Device)
LED red-light
Experimental
Intervention: RED-light device using LED light source (Device)
Outcomes
Primary Outcomes
Axial length
Time Frame: Baseline and 6-month follow-up
Key parameter monitoring myopia progression
Spherical equivalent error
Time Frame: Baseline and 6-month follow-up
Secondary Outcomes
No secondary outcomes reported
Investigators
Ying Jie
Dr
Beijing Tongren Hospital
Study Sites (1)
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