Myopia
Conditions
Keywords
Children and adolescents, Myopia, Prevention and control, Red light
Brief summary
To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.
Interventions
DEVICELLLT（Low Level Laser Therapy）
2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Students of grade 1-4 in the participating schools; * Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） \>-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D \<cycloplegic SE≤0.50D; * Students whose mother and/or father are in myopia status (SE \< -3.0D for either of eyes); * Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.
Exclusion criteria
* Students whose parents do not sign informed consent; * Students who have strabismus and/or other binocular vision abnormality; * Students who have other eye diseases and/or systematic diseases; * Students who have DC \<=-1.5D; * Students whose difference of SE between the two eyes \>=1.5D; * Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year cumulative incidence of myopia (%) in the intervention group and the control group. | 1 year | Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The progress of spherical equivalent(SE,D) of children in intervention group and control group. | 1 year | The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon). |
| The progress of axial length of children in intervention group and control group. | 1 year | The axial length will be measured using IOLMaster. |
| The progress of choroidal thickness in children in pre-myopia state in intervention group and control group. | 1 year | The choroidal thickness will be measured using SS-OCT. |
| The change of uncorrected visual acuity (UCVA) of children in intervention group and control group. | 1 year | The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts. |
Countries
China
Outcome results
None listed