Myopia
Conditions
Keywords
myopia progression, atropine, orthokeratology
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.
Interventions
DRUGAtropine Sulfate 0.01% Eye Drop
use one drop into subconjunctiva
DEVICEOrthokeratology
wear orthokeratology at night while sleeping
DRUGAtropine Sulfate 0.04% Eye Drop
use one drop into subconjunctiva
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| spherical equivalent progression in over two years | 2 years | equals sphere +1/2 cylinder |
| axial length change over two years | 2 years | measured by IOL-Master |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lens power change over two years | 2 years | calculated by Bennett-Rabetts formula |
| choroidal thickness change over two years | 2 years | measured by SS-OCT |
| corneal topography change over two years | 2 years | measured by Pentacam |
| anterior chamber depth change over two years | 2 years | measured by IOL-Master |
| choroidal blood flow density change over two years | 2 years | measured by OCTA |
| intraocular pressure change over two years | 2 years | measured by a non-contact tonometer |
Countries
China
Contacts
Primary ContactJianfeng Zhu
Backup ContactJiangnan He
Outcome results
None listed