Status:
UNKNOWN
Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Collaborating Sponsors:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Myopia
Eligibility:
All Genders
8-15 years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05357326
Start Date
July 1 2021
End Date
August 31 2023
Last Update
May 2 2022
Active Locations (1)
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1
Jianfeng Zhu
Shanghai, Shanghai Municipality, China, 200040