NCT05357326

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-07-01
• Completion: 2023-08-31
• First posted: 2022-05-02
• Last updated: 2022-05-02

Locations

1 site across 1 country: China