Actively Recruiting
Early-Onset Myopia Intervention Project
Led by Shanghai Eye Disease Prevention and Treatment Center · Updated on 2025-09-16
508
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early-Onset Myopia Intervention Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3-6 years, gender unrestricted
- Bilateral cycloplegic spherical equivalent (SE) 64 +0.75 D, astigmatism 64-2.5 D, anisometropia 642.5 D
- Best corrected visual acuity: 6450.5 for ages 3-5, 6450.7 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiangui He, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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