Using special glasses to control myopia in children

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 tests if special glasses can help slow down worsening eyesight in children aged 6 to 13 who have myopia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 6 Years to 13 Years
• Sex: All
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05894382 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of double helix defocus lens spectacles designed to inhibit the progression of myopia in children and adolescents aged 6 to 13. The intervention involves a randomized controlled trial where participants will wear these specially designed glasses for over 10 hours daily. The study aims to assess both the safety and efficacy of this innovative optical design compared to standard single-vision lenses. By generating defocusing signals, the glasses are expected to help manage the worsening of myopia in young patients.

Who should consider this trial

Good fit: Ideal candidates are Chinese children and adolescents aged 6 to 13 with mild to moderate myopia.

Not a fit: Patients with other eye diseases or those who have recently undergone treatments for myopia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly slow down the progression of myopia in children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: While the approach is innovative, similar studies have shown promise in using optical designs to manage myopia, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Xiangui He — Shanghai, Shanghai, China (Recruiting)

Conditions Myopia, Progressive