Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial

Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.

Inclusion Criteria: * Age between 3 and 6 years (inclusive), regardless of gender or ethnicity. * Cycloplegic spherical equivalent refraction (SER) of the worse eye \> -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D. * Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6. * At least one parent with SER ≤-3.00D Exclusion Criteria: * Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.). * Individuals with known allergies or contraindications to cycloplegic agents. * Previous use of myopia management treatment (spectacles, atropine; CLs). * Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis. * Individuals unable to cooperate with examinations or communicate. * Any other conditions deemed by the investigator as unsuitable for participation in the study.