Myopia
Conditions
Interventions
Trial group:The treatment involves the use of red LED light (EagleTec LED Vision Rehabilitation Device), administered twice daily, with each session lasting 3 minutes. The two daily sessions should be
Control group:Red LED light (EagleTec LED Vision Rehabilitation Device) is to be used twice daily. Each 3-minute session consists of continuous red light exposure, concluding upon completion.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age 6 to 12 years, either sex; 2. Hyperopia reserve depletion >= 0.75 D/year, or myopia progression >= 0.75 D/year, or axial length increase >= 0.4 mm/year; 3. -3.00 D <= cycloplegic spherical equivalent refractive error <= 0 D; (Either criterion 2 or 3 must be met); 4. Signed informed consent agreeing to undergo screening and 3-month follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of other ocular diseases, including, but not limited to: color blindness or color vision deficiency, history of photophobia, ocular surface diseases, infectious conjunctivitis, corneal diseases (e.g., keratoconus or suspected keratoconus, corneal degeneration, etc.), cataract, uveitis, vitreoretinal diseases (macular diseases, retinitis pigmentosa, congenital stationary night blindness, etc.), or optic nerve disorders. 2. Photophobia or known allergy to cycloplegic agents (such as tropicamide or cyclopentolate, etc.). 3. Having received any one or more of the following myopia control interventions within the recent 1 month (including, but not limited to): low-concentration atropine eye drops, orthokeratology lenses, myopia control spectacles, low-intensity red light therapy, defocus soft contact lenses, or defocus RGP lenses. 4. History of neurological disorders (e.g., prior convulsions, epilepsy, tic disorders, central nervous system developmental abnormalities), psychiatric or psychological diseases, or any other condition deemed ineligible by the investigator. 5. Manifest strabismus >= 5 prism diopters (PD). 6. Astigmatism > 2.00 D; anisometropia > 1.50 D; best-corrected visual acuity (BCVA) < 0.8.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in axial length changes at 1 and 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Submacular choroidal thickness change at 3 months as measured by OCT;Best-Corrected Visual Acuity;Difference in refractive progression and change in central corneal curvature at 3 months; | — |
Countries
China
Contacts
Public ContactShi Bingjie
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed