Electronic Spectacles Versus Low Dose Atropine in Young Myopes

Recruiting now · Not applicable

Conditions studied: Myopia

In brief

This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the investigational CP1 device. Primary endpoint: Difference in the 12-month change of cycloplegic spherical refractive error and axial length between each of the three treatment groups.

Key facts

Study ID

NCT06034379

Run by

Kubota Vision Inc.

People needed

45

Starts

2023-10-01

Expected to finish

2025-12-01

Last updated by the study team

2024-12-12

Who can join

Age: 6 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject must be between 6 and 13 years of age (inclusive).
• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
• 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.
• Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
• Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
• Best corrected distance VA of at least 20/25 in each eye.

You may not qualify if…

• Currently pregnant or lactating
• History of severe dry eye, strabismus, or amblyopia
• 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.
• 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.
• Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, strabismus surgery etc.) or orthokeratology
• Any active ocular infection.
• Any accommodative or binocular anomalies including amblyopia.
• Any physical or mental developmental delay.
• 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)
• Anisometropia greater than 1.50D

Where it is running

• CMU Hsinchu Hospital — Hsinchu, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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