Clinical Study on Brain Visual Perception Training for Prevention and Control of Myopia in Children with Premyopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 156
- Primary Endpoint
- changes in axial length after 1 year
Study Overview
Brief Summary
The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.
The main questions it aims to answer are: Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children Participants will: The training group will receive 20 minutes of brain visual perception training once a day for a period of one year. Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (D) and having at least 1parent with an SER in either eye of -3.00D or less.
Exclusion Criteria
- •Children have astigmatism of 1.50D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.
Arms & Interventions
brain visual perception training group
Conduct brain visual perception training through a visual training system to improve binocular visual balance. Train 2 projects per day, each lasting 10 minutes.
Intervention: brain visual perception training group (Device)
control group
no intervention
Outcomes
Primary Outcomes
changes in axial length after 1 year
Time Frame: 1 year after the baseline
the difference in the changes of axial length between the intervention group and the control group
Secondary Outcomes
- changes in cycloplegic spherical equivalent after 1year(1 year after the baseline)