Early-Onset Myopia Intervention Project

Not Applicable

Recruiting

• Conditions: Myopia; Pre-myopia
• Interventions: Device: Spectacle lenses with highly aspherical lenslets; Drug: 0.01% atropine eye drops; Drug: 0.05% atropine eye drops

• Registration Number: NCT07176949
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2027-06-01
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

• 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.

Exclusion Criteria

• Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery;
• Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.);
• Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks;
• Allergy or contraindication to cycloplegic drugs;
• Epilepsy or other mental disorders unable to expressing consent;
• Other conditions deemed unsuitable for participation by the researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spectacle Lenses with Highly Aspherical Lenslets	Spectacle lenses with highly aspherical lenslets	Wearing spectacle lenses with highly aspherical lenslets for myopia control
0.01% Atropine	0.01% atropine eye drops	Nightly use of 0.01% atropine eyedrops for myopia control
0.05% Atropine	0.05% atropine eye drops	Nightly use of 0.05% atropine eyedrops for myopia control

Primary Outcome Measures

Name	Time	Method
Changes in cycloplegic spherical equivalence	2 year	Measured by an auto-refractometer

Secondary Outcome Measures

Name	Time	Method
Changes in axial length	2 years	Measured by an IOL-Master
Proportion of subjects with non-rapid myopia progression	2 years	Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.
The duration of non-rapid myopia progression	2 years	Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center; 🇨🇳 Shanghai, Shanghai Municipality, China