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

Phase 4

• Conditions: Myopia
• Interventions: Drug: Atropine Sulfate 0.01% Eye Drop; Drug: Atropine Sulfate 0.04% Eye Drop; Device: Orthokeratology

• Registration Number: NCT05357326
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2022-04-26
• Last Update Submitted: 2022-04-26
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.01% atropine	Atropine Sulfate 0.01% Eye Drop	use atropine sulfate 0.01% eye drop every night before sleep for two years
0.04% atropine	Atropine Sulfate 0.04% Eye Drop	use atropine sulfate 0.04% eye drop every night before sleep for two years
orthokeratology	Orthokeratology	wear orthokeratology lens every night for two years

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Jianfeng Zhu; 🇨🇳 Shanghai, Shanghai, China