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

Myopia Clinical Trial

Official title:

Multi-centered Clinical Trial on Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model Based on Deep Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357326
• Other study ID #: SHYB2021003
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2021
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Jianfeng Zhu
• Phone: 13501822932
• Email: jfzhu1974[@]Hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: August 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine Sulfate 0.01% Eye Drop
use one drop into subconjunctiva

Device:
• Orthokeratology
wear orthokeratology at night while sleeping

Drug:
• Atropine Sulfate 0.04% Eye Drop
use one drop into subconjunctiva

Locations

Country	Name	City	State
China	Jianfeng Zhu	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spherical equivalent progression in over two years	equals sphere +1/2 cylinder	2 years
Primary	axial length change over two years	measured by IOL-Master	2 years
Secondary	lens power change over two years	calculated by Bennett-Rabetts formula	2 years
Secondary	choroidal thickness change over two years	measured by SS-OCT	2 years
Secondary	choroidal blood flow density change over two years	measured by OCTA	2 years
Secondary	anterior chamber depth change over two years	measured by IOL-Master	2 years
Secondary	intraocular pressure change over two years	measured by a non-contact tonometer	2 years
Secondary	corneal topography change over two years	measured by Pentacam	2 years