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

NCT05894382 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2025-12-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-03
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894382 on ClinicalTrials.gov