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NCT Number: NCT07176949

Early-Onset Myopia Intervention Project

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.

Recruiting

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Tianyu Cheng, Dr

CONTACT

[email protected]

+86 18817552005

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.01% atropine eye drops

Drug

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

0.05% atropine eye drops

Drug

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

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.

Primary outcomes

  1. Changes in cycloplegic spherical equivalence

    Time frame: 2 year

    Measured by an auto-refractometer

Secondary outcomes

  1. Changes in axial length

    Time frame: 2 years

    Measured by an IOL-Master

  2. Proportion of subjects with non-rapid myopia progression

    Time frame: 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.

  3. The duration of non-rapid myopia progression

    Time frame: 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.

Other outcomes

  1. Changes in choroid/retina thickness

    Time frame: 2 years

    Measured by SS-OCT

  2. Changes in BCVA

    Time frame: 2 years

    Best corrected visual acuity

  3. Changes in IOP

    Time frame: 2 years

    Intraocular pressure

  4. Changes in AMP

    Time frame: 2 years

    Amplitude of Accommodation

  5. Changes in Stereopsis

    Time frame: 2 years

    Using Titmus Fly Test

  6. Changes in TBUT

    Time frame: 2 years

    Tear Film Break-Up Time

  7. Changes in anterior segment parameters

    Time frame: 2 years

    Measured by Pentacam

  8. Changes in Hemodynamic Parameters of the Ocular Fundus

    Time frame: 2 years

    Measured by SS-OCTA

  9. Compliance indicators

    Time frame: 2 years

    Daily wearing duration, wearing habits and patterns, frequency of eye drops use.

  10. Side Effects and Adverse Events

    Time frame: 2 years

    Incidence of glare, diplopia, blurred vision, photophobia, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangui He, Prof

CONTACT

[email protected]

+86 15000755422

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

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

Acronym: EOM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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