Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Red light, Single vision spectacle lenses.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study, led by Jie ying from the Ophthalmology Department of Beijing Tongren Hospital Affiliated to Capital Medical University, is a researcher-initiated clinical trial (IIT) designed to evaluate the therapeutic efficacy of low-intensity red light therapy in adult patients with high myopia (spherical equivalent ≤ -6.00D) and extreme myopia (spherical equivalent ≤ -10.00D). With the escalating global prevalence of high and extreme myopia-especially in East Asia including China-and pathological myopia becoming a leading cause of irreversible blindness in Chinese adults, red light therapy has shown promising effects in slowing myopia progression in children but lacks clinical evidence for adult populations, which constitutes the core rationale for this research.
Interventions
- Device Red light
Subjects receive low-intensity single-wavelength red light therapy using the Tongren Myopia and Amblyopia Therapeutic Apparatus , administered twice daily for 3 minutes per session with an interval of at least 4 hours, combined with single-vision frame glasses. - Other Single vision spectacle lenses
Myopia correction, optic way
Primary outcome measures
- Axial length [Time frame: Baseline, 3-month, 6-month, 9-month, 12-month]
- Sphearical equivalent error [Time frame: Baseline, 3-month, 6-month, 9-month, 12-month]
Eligibility criteria
Inclusion criteria
Aged 18 to 45 years old. Spherical equivalent refraction of -6.00D to -20.00D in one or both eyes measured by cycloplegic computer optometry.
Intraocular pressure (IOP) ranging from 10 to 21 mmHg. Clear crystalline lens (cataract excluded). No active ocular inflammation, history of ocular trauma or surgery, and no ocular or systemic organic diseases that affect visual acuity changes.
Voluntarily participate in the study and sign the informed consent form. Willing to use the Tongren Myopia and Amblyopia Therapeutic Apparatus (Patent No.: 202022533301.4, manufactured by Hunan Yifan Technology Co., Ltd.) or accept the above-mentioned control treatment.
Exclusion criteria
Patients with the following ocular diseases: choroidal neovascularization, macular hemorrhage, macular schisis, extensive chorioretinal atrophy, and refractive media opacity (such as corneal lesions, lens opacity, etc.).
Subjects with systemic or immune diseases that affect compliance, including tumors, heart diseases (with implanted electronic devices such as cardiac pacemakers), severe hepatic and renal diseases, epilepsy, autoimmune diseases, etc.
Subjects with mental disorders that interfere with the implementation of intervention measures in this trial.
Hypersensitivity to cycloplegic agents. Other circumstances deemed inappropriate for participation in the trial by the investigator for safety reasons or the patient's benefit.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tongren Hospital — Beijing
Identifiers
NCT: NCT07412678 · TREC2026KY007ck