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

NCT05894382 | Active Not Recruiting

• 1 other identifier: 20230421v1.3
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Spherical Equivalent change

  cycloplegic SE change

  1 year

Secondary Outcomes (2)

• Axial Length change

  1 year

• Visual Acuity change

  1 year

Study Arms (2)

Group A

EXPERIMENTAL

Double Helix Design Defocus Lens Spectacle (RACE) for 2 years

Device: Double Helix Design Defocus Lens Spectacle (RACE)

Group B

PLACEBO COMPARATOR

1. st year: single-vision spectacle lenses 2. nd year: double helix design defocus lens spectacle (RACE)

Device: Double Helix Design Defocus Lens Spectacle (RACE); Device: single-vision spetacle lens

Interventions

single-vision spetacle lens DEVICE

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

Group B

Double Helix Design Defocus Lens Spectacle (RACE) DEVICE

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

Group A; Group B

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Race: Chinese children and adolescents.
• Age 6-13 years, gender unrestricted.
• Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
• Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
• Refractive astigmatism and astigmatism are no more than 1.5D.
• During the study period, willing to wear glasses provided by the researcher only (\>10 hours) and without additional interventions.
• Willing to be randomly assigned.
• Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.

You may not qualify if:

• Allergic or intolerant to medications used for ciliary muscle paralysis.
• Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study.
• Received defocus lenses for nearsightedness treatment in the past.
• Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
• History of eye surgery (including strabismus correction surgery).
• Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
• Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
• Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Xiangui He

Shanghai, Shanghai Municipality, 201103, China

Location

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 3, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-05

Locations

CN (1)