Clinical trial NCT05357326: Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model
Official title: Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myopia
Keywords: myopia progression
atropine
orthokeratology
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2022-05-02
Enrollment: 186
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: spherical equivalent progression in over two years
timeFrame: 2 years
measure: axial length change over two years
timeFrame: 2 years
Secondary outcomes:
measure: lens power change over two years
timeFrame: 2 years
measure: choroidal thickness change over two years
timeFrame: 2 years
measure: choroidal blood flow density change over two years
timeFrame: 2 years
measure: anterior chamber depth change over two years
timeFrame: 2 years
measure: intraocular pressure change over two years
timeFrame: 2 years
measure: corneal topography change over two years
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jianfeng Zhu
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Jianfeng Zhu
role: STUDY_CHAIR
References: