Early-Onset Myopia Intervention Project

NCT ID: NCT07176949

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-05-31

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.

Conditions

Myopia; Pre-myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Intervention

No intervention for myopia control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Spectacle Lenses with Highly Aspherical Lenslets

Wearing spectacle lenses with highly aspherical lenslets for myopia control

Group Type: EXPERIMENTAL

Spectacle lenses with highly aspherical lenslets

Intervention Type: DEVICE

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.

0.01% Atropine

Nightly use of 0.01% atropine eyedrops for myopia control

Group Type: EXPERIMENTAL

0.01% atropine eye drops

Intervention Type: DRUG

Participants will use 0.01% atropine eyedrops nightly for myopia control.

0.05% Atropine

Nightly use of 0.05% atropine eyedrops for myopia control

Group Type: EXPERIMENTAL

0.05% atropine eye drops

Intervention Type: DRUG

Participants will use 0.05% atropine eyedrops nightly for myopia control.

Interventions

0.01% atropine eye drops

Participants will use 0.01% atropine eyedrops nightly for myopia control.

Intervention Type: DRUG

0.05% atropine eye drops

Participants will use 0.05% atropine eyedrops nightly for myopia control.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangui He, Prof

Role: CONTACT

xianhezi@163.com

+86 15000755422

Facility Contacts

Tianyu Cheng, Dr

Role: primary

s70444@126.com

+86 18817552005

Other Identifiers

EC-20240712-11

Identifier Type: -

Identifier Source: org_study_id