Early-Onset Myopia Intervention Project
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorShanghai Eye Disease Prevention and Treatment Center
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- 0.01% atropine eye drops
- 0.05% atropine eye drops
- Spectacle lenses with highly aspherical lenslets
Treatment groups
508 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov