Children and adolescents have mild to moderate myopia
Conditions
Interventions
NA:NA
Sponsors
Hainan Eye Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. The age at enrollment was >= 6 years old and <18 years old; 2. The patient was diagnosed as myopic according to the Guidelines for Prevention and Treatment of Myopia issued by the General Office of the National Health Commission (Medical Letter [2018] No. 393); 3. Optometry after cycloplegia in both eyes -6.00D < SE<= -0.75D; 4. Diopter deviation <1.5 days; 5. Use myopic amblyopia therapeutic instrument (model: BBL2020-01, hereinafter referred to as therapeutic instrument) to control myopia; 6. The subject and his/her guardian can understand the purpose of this study and sign the informed consent. The subject can cooperate with the treatment and related ophthalmic examination.
Exclusion criteria
Exclusion criteria: 1. Strabismus and/or amblyopia; 2. Tumor, heart disease, hypertension, epilepsy, etc.; 3. Use of implantable electronic devices (e.g., pacemakers); 4. Photophobia or inability to open eyes normally due to keratitis, trichiasis, trauma, etc.; 5. Subjects with systemic diseases: history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, severe liver and kidney dysfunction; 6. Use atropine at the same time; 7. Suffer from eye diseases that affect vision or refractive error (such as cataract and other lens damage diseases, glaucoma, macular disease, keratopathy, pigmentosis, retinal detachment, severe vitreous opacity, etc.); 8. For internal or external use of photosensitive drugs, photosensitive diseases, solar dermatitis, mentally unhealthy subjects, pregnant women, etc.; 9. The therapeutic apparatus is not applicable after evaluation by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length change from baseline at 1, 3, 6, and 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in diopter (computerized and subjective optometry) at 1, 3, 6, and 12 months;Change in choroidal thickness from baseline at 1, 3, 6, and 12 months; | — |
Countries
China
Contacts
Public ContactXingwu Zhong
Hainan Eye Hospital
Outcome results
None listed