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

Sponsor

Shanghai Eye Disease Prevention and Treatment Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05357326

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other), Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)

186

Enrollment

Location

Arms

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: Atropine Sulfate 0.01% Eye Drop Device: Orthokeratology Drug: Atropine Sulfate 0.04% Eye Drop	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.Children are randomly allocated into three groups: 0.01% atropine, 0.04% atropine and orthokeratology, each group includes 62 children.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 0.01% atropine use atropine sulfate 0.01% eye drop every night before sleep for two years	Drug: Atropine Sulfate 0.01% Eye Drop use one drop into subconjunctiva
Experimental: 0.04% atropine use atropine sulfate 0.04% eye drop every night before sleep for two years	Drug: Atropine Sulfate 0.04% Eye Drop use one drop into subconjunctiva
Experimental: orthokeratology wear orthokeratology lens every night for two years	Device: Orthokeratology wear orthokeratology at night while sleeping

Arm

Intervention/Treatment

Active Comparator: 0.01% atropine

use atropine sulfate 0.01% eye drop every night before sleep for two years

Drug: Atropine Sulfate 0.01% Eye Drop

use one drop into subconjunctiva

Experimental: 0.04% atropine

use atropine sulfate 0.04% eye drop every night before sleep for two years

Drug: Atropine Sulfate 0.04% Eye Drop

use one drop into subconjunctiva

Experimental: orthokeratology

wear orthokeratology lens every night for two years

Device: Orthokeratology

wear orthokeratology at night while sleeping

Outcome Measures

Primary Outcome Measures

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

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
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
intraocular pressure change over two years [2 years]
measured by a non-contact tonometer
corneal topography change over two years [2 years]
measured by Pentacam

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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