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.

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: Double Helix Design Defocus Lens Spectacle (RACE); Device: single-vision spetacle lens

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201103
      • Recruiting
      • Xiangui He
      • Contact: Linlin Du; Phone Number: +862153555032; Email: dllcrco@shsyf.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Allergic or intolerant to medications used for ciliary muscle paralysis.
2. 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.
3. Received defocus lenses for nearsightedness treatment in the past.
4. 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.).
5. History of eye surgery (including strabismus correction surgery).
6. Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
7. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Double Helix Design Defocus Lens Spectacle (RACE) for 2 years	Device: Double Helix Design Defocus Lens Spectacle (RACE); Double Helix Design Defocus Lens Spectacle wearing more than 10h/day.
Placebo Comparator: Group B; st year: single-vision spectacle lenses; nd year: double helix design defocus lens spectacle (RACE)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical Equivalent change	cycloplegic SE change	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Axial Length change	1 year
Visual Acuity change	1 year

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: 20230421v1.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No