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ACTIVE NOT RECRUITING
NCT05894382
NA

Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

Sponsor: Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

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

Interventions

DEVICE

Double Helix Design Defocus Lens Spectacle (RACE)

Double Helix Design Defocus Lens Spectacle wearing more than 10h/day.

DEVICE

single-vision spetacle lens

single-vision spetacle lens wearing more than 10h/day.

Locations (1)

Xiangui He

Shanghai, Shanghai Municipality, China