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RECRUITING
NCT07176949
NA

Early-Onset Myopia Intervention Project

Sponsor: Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

508

Start Date

2025-06-01

Completion Date

2028-05-31

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China