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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-03

Study Completion Date

2026-12-31

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.

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Detailed Description

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Conditions

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Myopia, Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Double Helix Design Defocus Lens Spectacle (RACE)

Intervention Type DEVICE

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

Group B

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

Group Type PLACEBO_COMPARATOR

Double Helix Design Defocus Lens Spectacle (RACE)

Intervention Type DEVICE

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

single-vision spetacle lens

Intervention Type DEVICE

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

Interventions

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Double Helix Design Defocus Lens Spectacle (RACE)

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

Intervention Type DEVICE

single-vision spetacle lens

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No