NCT05939882

Low Concentration Atropine in the Prevention of Myopia in Children.

A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.

Detailed description

The main questions this double-blind, randomized controlled clinical study aims to answer are: 1. To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children. 2. To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression. Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DRUG	low concentration atropine (0.01%)	low concentration atropine (0.01%)
DRUG	low concentration atropine (0.02%)	low concentration atropine (0.02%)
DRUG	low concentration atropine (0.04%)	low concentration atropine (0.04%)
DRUG	Placebo	Placebo eye drop

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: China