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

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Treatments: Atropine; Ophthalmic Solutions

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