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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• Age 3-6 years, gender unrestricted;

• Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D;

• Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6;

• Accept regular follow-up, written informed consent from guardians, verbal informed consent from children;

• Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.

Locations
Other Locations
China
Shanghai Eye Disease Prevention and Treatment Center
RECRUITING
Shanghai
Contact Information
Primary
Xiangui He, Prof
xianhezi@163.com
+86 15000755422
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 508
Treatments
No_intervention: No Intervention
No intervention for myopia control
Experimental: Spectacle Lenses with Highly Aspherical Lenslets
Wearing spectacle lenses with highly aspherical lenslets for myopia control
Experimental: 0.01% Atropine
Nightly use of 0.01% atropine eyedrops for myopia control
Experimental: 0.05% Atropine
Nightly use of 0.05% atropine eyedrops for myopia control
Related Therapeutic Areas
Sponsors
Leads: Shanghai Eye Disease Prevention and Treatment Center

This content was sourced from clinicaltrials.gov