Comparing electronic spectacles and low dose atropine for myopia in children

Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children

This study is testing whether electronic glasses or low-dose atropine can help slow down worsening eyesight in children aged 6 to 13.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 6 Years to 13 Years
• Sex: All
• Sponsor: Kubota Vision Inc. (Industry-sponsored)
• Locations: 1 site (Hsinchu)
• Trial ID: NCT06034379 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of an electronic spectacle prototype and low-dose atropine in slowing myopia progression in children aged 6 to 13. Participants will be randomly assigned to one of three groups: wearing the electronic device alone, wearing it with daily atropine drops, or using atropine drops without the device. The study will measure changes in refractive error and axial length over 12 months, with assessments conducted at multiple time points. The trial aims to provide insights into innovative treatments for myopia in a pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 13 with myopia ranging from -0.50 to -10.00 diopters.

Not a fit: Patients with severe eye conditions, systemic diseases, or those currently pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new approach to managing myopia in children, potentially reducing its progression.

How similar studies have performed: While the use of atropine for myopia management has been studied, the combination with electronic spectacles represents a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. The subject must be between 6 and 13 years of age (inclusive).
2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT.
4. Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
5. Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
6. Best corrected distance VA of at least 20/25 in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating
2. History of severe dry eye, strabismus, or amblyopia
3. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., diabetes, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with the participation in the study at the investigator's discretion.
4. Use of systemic or ocular medications (e.g., chronic steroid use) that are known to interfere with vision and ocular accommodation at the investigator's discretion.
5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
6. Any active ocular infection.
7. Any accommodative or binocular anomalies including amblyopia.
8. Any physical or mental developmental delay.
9. Any relevant ocular or systemic condition deemed unacceptable by the investigator that may negatively impact the subject's performance or ability to successfully complete the study (at the investigator's discretion)
10. Anisometropia greater than 1.50D

Where this trial is running

Hsinchu

• CMU Hsinchu Hospital — Hsinchu, Taiwan (Recruiting)

Conditions Myopia