Development of Bioluminescent Myopia Prevention and Control Instrument and Evaluation of Its Effe… (NCT07208617) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development of Bioluminescent Myopia Prevention and Control Instrument and Evaluation of Its Effect on Myopia
China206 participantsStarted 2026-02-12
Plain-language 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.
Who can participate
Age range6 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dys…