Status:
RECRUITING
Early-Onset Myopia Intervention Project
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Conditions:
Myopia
Pre-myopia
Eligibility:
All Genders
3-6 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT07176949
Start Date
June 1 2025
End Date
May 31 2028
Last Update
September 16 2025
Active Locations (1)
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1
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China