NCT05894382

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

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-03
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2023-06-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: China