Early-Onset Myopia Intervention Project

NCT07176949 | Recruiting

• 1 other identifier: EC-20240712-11
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in cycloplegic spherical equivalence

  Measured by an auto-refractometer

  2 year

Secondary Outcomes (3)

• Changes in axial length

  2 years

• Proportion of subjects with non-rapid myopia progression

  2 years

• The duration of non-rapid myopia progression

  2 years

Other Outcomes (10)

• Changes in choroid/retina thickness

  2 years

• Changes in BCVA

  2 years

• Changes in IOP

  2 years

Study Arms (4)

No Intervention

NO INTERVENTION

No intervention for myopia control

Spectacle Lenses with Highly Aspherical Lenslets

EXPERIMENTAL

Wearing spectacle lenses with highly aspherical lenslets for myopia control

Device: Spectacle lenses with highly aspherical lenslets

0.01% Atropine

EXPERIMENTAL

Nightly use of 0.01% atropine eyedrops for myopia control

Drug: 0.01% atropine eye drops

0.05% Atropine

EXPERIMENTAL

Nightly use of 0.05% atropine eyedrops for myopia control

Drug: 0.05% atropine eye drops

Interventions

0.01% atropine eye drops DRUG

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

0.01% Atropine

0.05% atropine eye drops DRUG

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

0.05% Atropine

Spectacle lenses with highly aspherical lenslets 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.

Spectacle Lenses with Highly Aspherical Lenslets

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Xiangui He, Prof

CONTACT

+86 15000755422; xianhezi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 16, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)