Early-Onset Myopia Intervention Project
Recruiting now · Not applicable
Conditions studied: Myopia, Pre-myopia
In brief
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.
Key facts
- Study ID
- NCT07176949
- Run by
- Shanghai Eye Disease Prevention and Treatment Center
- People needed
- 508
- Starts
- 2025-06-01
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2025-09-16
Who can join
Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Shanghai Eye Disease Prevention and Treatment Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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