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Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Summary
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
Official title: A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
Key Details
Gender
All
Age Range
6 Years - 13 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2023-06-03
Completion Date
2026-12-31
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Double Helix Design Defocus Lens Spectacle (RACE)
Double Helix Design Defocus Lens Spectacle wearing more than 10h/day.
single-vision spetacle lens
single-vision spetacle lens wearing more than 10h/day.
Locations (1)
Xiangui He
Shanghai, Shanghai Municipality, China