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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Device: Double Helix Design Defocus Lens Spectacle (RACE)
* Device: single-vision spetacle lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length change |  | 1 year | 
| Visual Acuity change |  | 1 year |