Myopia
Conditions
Brief summary
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
DEVICERed 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.
Myopia correction, optic way
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length | Baseline, 3-month, 6-month, 9-month, 12-month |
| Sphearical equivalent error | Baseline, 3-month, 6-month, 9-month, 12-month |
Countries
China
Contacts
CONTACTKai Cao
Outcome results
None listed