Early-Onset Myopia Intervention Project

Official title

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

Overview

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.

Interventions

• Drug 0.01% atropine eye drops
  Participants will use 0.01% atropine eyedrops nightly for myopia control.
• Drug 0.05% atropine eye drops
  Participants will use 0.05% atropine eyedrops nightly for myopia control.
• Device Spectacle lenses with highly aspherical lenslets
  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. Th

Primary outcome measures

• Changes in cycloplegic spherical equivalence [Time frame: 2 year]

Secondary outcome measures (3)

• Changes in axial length [Time frame: 2 years]
• Proportion of subjects with non-rapid myopia progression [Time frame: 2 years]
• The duration of non-rapid myopia progression [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Eye Disease Prevention and Treatment Center — Shanghai

Identifiers

NCT: NCT07176949 · EC-20240712-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗