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Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Summary
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.
Official title: A Randomized, Double-Blind, Controlled Clinical Study of Dual-Action Preventive Lenses for Controlling Myopia Progression in Children and Adolescents
Key Details
Gender
All
Age Range
6 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10-05
Completion Date
2028-04-30
Last Updated
2026-10-02
Healthy Volunteers
Yes
Conditions
Interventions
Dual-Action Myopia-Control Spectacle Lens
Spectacle 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）
Stellest 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.
Locations (1)
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China