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Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07854457
Lead Sponsor Shanghai Eye Disease Prevention and Treatment Center
Conditions
(from sponsor)
Myopia, Refractive Errors
Related terms Myopia, Refractive Errors
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov