Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning

Conditions
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Myopia

Intervention / Treatment
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* Drug: Atropine Sulfate 0.01% Eye Drop
* Device: Orthokeratology
* Drug: Atropine Sulfate 0.04% Eye Drop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.01% atropine<br>use atropine sulfate 0.01% eye drop every night before sleep for two years | Drug: Atropine Sulfate 0.01% Eye Drop<br>* use one drop into subconjunctiva<br>|
| Experimental: 0.04% atropine<br>use atropine sulfate 0.04% eye drop every night before sleep for two years | Drug: Atropine Sulfate 0.04% Eye Drop<br>* use one drop into subconjunctiva<br>|
| Experimental: orthokeratology<br>wear orthokeratology lens every night for two years | Device: Orthokeratology<br>* wear orthokeratology at night while sleeping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spherical equivalent progression in over two years | equals sphere +1/2 cylinder | 2 years | 
| axial length change over two years | measured by IOL-Master | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lens power change over two years | calculated by Bennett-Rabetts formula | 2 years | 
| choroidal thickness change over two years | measured by SS-OCT | 2 years | 
| choroidal blood flow density change over two years | measured by OCTA | 2 years | 
| anterior chamber depth change over two years | measured by IOL-Master | 2 years | 
| intraocular pressure change over two years | measured by a non-contact tonometer | 2 years | 
| corneal topography change over two years | measured by Pentacam | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia progression, atropine, orthokeratology