This is a single-center, randomized, double-blind, controlled study to test whether a new type of eyeglass lens - a "dual-action" lens that combines two technologies (multiple defocus zones and dot diffusion) - can slow the progression of nearsightedness (myopia) in children and teenagers.
About the participants: Children and adolescents with myopia who meet the study requirements will be randomly assigned (like flipping a coin) to one of two groups. One group will wear the new dual-action lenses, and the other group will wear Stellest lenses, an established myopia-control lens. Neither the participants, their families, nor the eye doctors doing the follow-up exams will know which lens each child is wearing.
About the study: Participants wear their assigned glasses at least 12 hours every day for 12 months and visit the clinic about every 3 months (5 visits in total). At each visit, doctors check eyesight, measure the length of the eyeball, and perform other eye exams. The main goal is to compare how much myopia progresses in the two groups after 12 months, measured by a painless dilated-eye (cycloplegic) refraction test. The study also tracks how comfortable and acceptable the lenses are, and how long children actually wear them each day.
Why this research matters: Myopia in children is increasing worldwide, and effective ways to slow it down are still limited. This study will show whether combining two proven optical technologies in one lens works as well as existing options and is safe and comfortable for daily wear.
Age 6-14 years.
After cycloplegia with 1% cyclopentolate hydrochloride eye drops (Cyclogyl/Saifeijie), spherical equivalent (SE) of both eyes between -0.50 D and -4.00 D.
Astigmatism of both eyes ≤ 1.50 D; anisometropia ≤ 1.50 D. Best-corrected visual acuity (BCVA) ≥ 5.0.
No use of myopia-control methods within the past 3 months, including defocus lenses, dot diffusion lenses, orthokeratology lenses, defocus soft contact lenses, progressive-addition spectacles, atropine eye drops, red-light therapy, or acupuncture.
Current or past glaucoma, corneal disease, or other organic eye diseases.
Significant systemic disease, psychiatric disorder, or systemic collagen metabolic disease. Diagnosed amblyopia, constant strabismus, or other congenital eye diseases.
Allergy to the materials or products of the study lenses.
Allergy to cycloplegic agents or other ophthalmic examination medications.
Parallel
Dual-Action Myopia-Control Spectacle Lens
DeviceSpectacle lenses that combine two myopia-control optical technologies in a single lens: multiple defocus zones (multipoint peripheral defocus design) and dot diffusion technology (a light-scattering treatment that reduces contrast of the peripheral retinal image). The two technologies are intended to act together to slow axial elongation and myopia progression. Lenses are worn as daily-wear spectacles, with participants instructed to wear them at least 12 hours per day throughout the 12-month study period. This lens is investigational and not currently marketed.
Stellest Myopia-Control Spectacle Lens（Highly Aspherical Lenslet Target / HALT Lens）
DeviceStellest spectacle lenses incorporate Highly Aspherical Lenslet Target (HALT) technology: a constellation of highly aspherical micro-lenslets distributed across the lens surface, which creates a volume of myopic defocus in front of the retina to slow eye growth. Lenses are worn as daily-wear spectacles, with participants instructed to wear them at least 12 hours per day throughout the 12-month study period. Stellest is an established, marketed myopia-control lens used here as the active comparator.
Change in Cycloplegic Spherical Equivalent (SE) From Baseline at 12 Months
The primary efficacy outcome is the change in spherical equivalent (SE, in diopters) measured by cycloplegic (dilated-eye) refraction from baseline to Month 12. SE is calculated as sphere + ½ × cylinder. Cycloplegic refraction is performed after administration of cycloplegic eye drops, using the same autorefractor and standardized procedure at each visit. A smaller change (less myopic shift) indicates better myopia control. The right eye is designated as the study (observation) eye.
Change in Axial Length (AL) From Baseline at 12 Months
Change in axial length (mm) measured by ocular biometry (e.g., IOLMaster) from baseline to Month 12 in the study eye. A smaller increase indicates better myopia control. AL is also assessed at Months 3, 6, and 9.
Corneal Curvature
Corneal curvature (K values) measured by corneal topography/keratometry at each visit, as part of routine ocular assessment.
Exploratory Analysis of Factors Associated With Myopia Progression and Myopia-Control Practice
Exploratory analysis of factors such as age at myopia onset, sex, daily wearing time, and visual habits (e.g., near-work and outdoor time), based on questionnaire data, to understand myopia-control diagnosis and treatment patterns in children and adolescents.
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