Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning
Overview
- Phase
- Phase 4
- Intervention
- Atropine Sulfate 0.01% Eye Drop
- Conditions
- Myopia
- Sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- spherical equivalent progression in over two years
- Last Updated
- 4 years ago
Overview
Brief Summary
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.
Detailed Description
Investigators are going to conduct a multi-centered randomized clinical trial that myopic children are randomly allocated into three groups: 0.01% atropine， 0.04% atropine and orthokeratology in order to evaluate the efficacy and side effects of different intervention methods and establish a risk factor model to predict the efficacy of myopia intervention, and to provide precise intervention plans and clinical decisions for the control of myopia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •children aged from 8-15 years old;
- •children with spherical degree ranged from -1.0D to -4.0D, cylindrical degree less than -1.50D, astigmatism with the rule less than -1.25D, astigmatism with other axial distribution less than -0.50, anisometropia less than -1.50D;
- •children with BCVA less than 0.1 LogMAR for both eyes;
- •children without other eye diseases except for ametropia
Exclusion Criteria
- •children with other eye diseases: amblyopia, strabismus, eye trauma, etc;
- •children with cycloplegia contradictions;
- •children who have used atropine or orthokeratology;
- •children who are severly allergic with atropine;
- •children who are using other eye drops for treatment;
- •children who have contraindications to orthokeratology or cannot cooperate with it;
- •children with severe heart, lung, liver and kidney diseases
Arms & Interventions
0.01% atropine
use atropine sulfate 0.01% eye drop every night before sleep for two years
Intervention: Atropine Sulfate 0.01% Eye Drop
0.04% atropine
use atropine sulfate 0.04% eye drop every night before sleep for two years
Intervention: Atropine Sulfate 0.04% Eye Drop
orthokeratology
wear orthokeratology lens every night for two years
Intervention: Orthokeratology
Outcomes
Primary Outcomes
spherical equivalent progression in over two years
Time Frame: 2 years
equals sphere +1/2 cylinder
axial length change over two years
Time Frame: 2 years
measured by IOL-Master
Secondary Outcomes
- choroidal thickness change over two years(2 years)
- intraocular pressure change over two years(2 years)
- lens power change over two years(2 years)
- choroidal blood flow density change over two years(2 years)
- anterior chamber depth change over two years(2 years)
- corneal topography change over two years(2 years)