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

Shanghai Eye Disease Prevention and Treatment Center

Status and phase: Unknown; Phase 4

Conditions: Myopia

Treatments: Drug: Atropine Sulfate 0.04% Eye Drop; Drug: Atropine Sulfate 0.01% Eye Drop; Device: Orthokeratology

Study type: Interventional

Funder types: Other

Identifiers

NCT05357326

SHYB2021003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 3 patient groups

0.01% atropine

Active Comparator group

Description:

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

Treatment:

Drug: Atropine Sulfate 0.01% Eye Drop

0.04% atropine

Experimental group

Description:

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

Treatment:

Drug: Atropine Sulfate 0.04% Eye Drop

orthokeratology

Experimental group

Description:

wear orthokeratology lens every night for two years

Treatment:

Device: Orthokeratology