Early-Onset Myopia Intervention Project (EOM)

Shanghai Eye Disease Prevention and Treatment Center

Status: Enrolling

Conditions: Myopia; Pre-myopia

Treatments: Drug: 0.01% atropine eye drops; Device: Spectacle lenses with highly aspherical lenslets; Drug: 0.05% atropine eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT07176949

EC-20240712-11

Details and patient eligibility

About

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.

Enrollment: 508 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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508 participants in 4 patient groups

No Intervention

No Intervention group

Description:

No intervention for myopia control

Spectacle Lenses with Highly Aspherical Lenslets

Experimental group

Description:

Wearing spectacle lenses with highly aspherical lenslets for myopia control

Treatment:

Device: Spectacle lenses with highly aspherical lenslets

0.01% Atropine

Experimental group

Description:

Nightly use of 0.01% atropine eyedrops for myopia control

Treatment:

Drug: 0.01% atropine eye drops

0.05% Atropine

Experimental group

Description:

Nightly use of 0.05% atropine eyedrops for myopia control

Treatment:

Drug: 0.05% atropine eye drops