NCT04699357

The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Shanghai Eye Disease Prevention and Treatment Center

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control. Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.

Conditions

• High Myopia

Interventions

Type	Name	Description
DRUG	Atropine	different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children

Timeline

• Start date: 2021-07-04
• Primary completion: 2024-08-21
• Completion: 2024-09-01
• First posted: 2021-01-07
• Last updated: 2026-03-12

Locations

3 sites across 1 country: China