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

Not Applicable

Recruiting

• Conditions: Myopia, Progressive
• Interventions: Device: Double Helix Design Defocus Lens Spectacle (RACE); Device: single-vision spetacle lens

• Registration Number: NCT05894382
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study Start: 2023-06-03
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	single-vision spetacle lens	1. st year: single-vision spectacle lenses 2. nd year: double helix design defocus lens spectacle (RACE)
Group B	Double Helix Design Defocus Lens Spectacle (RACE)	1. st year: single-vision spectacle lenses 2. nd year: double helix design defocus lens spectacle (RACE)
Group A	Double Helix Design Defocus Lens Spectacle (RACE)	Double Helix Design Defocus Lens Spectacle (RACE) for 2 years

Primary Outcome Measures

Name	Time	Method
Spherical Equivalent change	1 year	cycloplegic SE change

Secondary Outcome Measures

Name	Time	Method
Axial Length change	1 year
Visual Acuity change	1 year

Trial Locations

Locations (1)

Xiangui He; 🇨🇳 Shanghai, Shanghai, China