NCT07176949

Early-Onset Myopia Intervention Project

Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.

Conditions

• Myopia
• Pre-myopia

Interventions

Type	Name	Description
DRUG	0.01% atropine eye drops	Participants will use 0.01% atropine eyedrops nightly for myopia control.
DRUG	0.05% atropine eye drops	Participants will use 0.05% atropine eyedrops nightly for myopia control.
DEVICE	Spectacle lenses with highly aspherical lenslets	These are a special type of eyeglass lenses designed primarily to slow down the progression of myopia (nearsightedness) in children. The center of the lens provides a clear correction for distance vision, just like regular glasses. The surrounding area contains hundreds of tiny, invisible, and highly aspherical (complex curved) microlenses. These microlenses create a special optical effect. While the child looks straight ahead clearly, peripheral light rays are focused in front of the retina. This is called "myopic defocus." Research suggests that this myopic defocus signal helps to control the excessive elongation of the eyeball, which is the main cause of myopia getting worse.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2028-05-31
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: China