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

Myopia, Progressive Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894382
• Other study ID #: 20230421v1.3
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• Double Helix Design Defocus Lens Spectacle (RACE)
Double Helix Design Defocus Lens Spectacle wearing more than 10h/day.
• single-vision spetacle lens
single-vision spetacle lens wearing more than 10h/day.

Locations

Country	Name	City	State
China	Xiangui He	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical Equivalent change	cycloplegic SE change	1 year
Secondary	Axial Length change		1 year
Secondary	Visual Acuity change		1 year