Myopia
Conditions
Interventions
Intervention group:A 1.6mW vision rehabilitation device.
Control group:A 0.001mW vision rehabilitation device.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Age: 8-12 years old (2) Simple Myopia: In either eye, after cycloplegia, the spherical equivalent is -3.0 D, with astigmatism <= 2.5 D, and anisometropia<= 1.5 D. (3) Monocular Best-Corrected Visual Acuity (BCVA) of 0.8 or better. (4) Normal ocular fundus, or presence of only a tessellated fundus. (5) Ability to provide signed informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: (1) Subjects with other congenital eye diseases, such as congenital cataract or congenital glaucoma. (2) Presence of manifest strabismus or other disorders of binocular vision. (3) Opacities of the refractive media: e.g., corneal opacity, cataract, or status post intraocular lens implantation. (4) Presence of ocular diseases affecting retinal function. (5) Children who have used or are using other myopia control measures (e.g., orthokeratology lenses, atropine) can only be enrolled after discontinuing such treatments for at least three months. (6) Presence of other systemic disorders or abnormalities. (7) Other reasons deemed by the investigator as making the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with rapid axial length progression (=0.2 mm); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with myopic progression (=0.50 D) in spherical equivalent after cycloplegia;Proportion of subjects exhibiting axial length regression (change from baseline = -0.05 mm) following photobiomodulation therapy;Change in choroidal thickness after receiving photobiomodulation therapy;Changes in cone photoreceptor density; | — |
Countries
China
Contacts
Public ContactXiangui He
Shanghai Eye Disease Prevention and TreatmentCenter
Outcome results
None listed