Status:
RECRUITING
Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Lead Sponsor:
Kubota Vision Inc.
Collaborating Sponsors:
China Medical University Hospital
Conditions:
Myopia
Eligibility:
All Genders
6-13 years
Phase:
NA
Brief Summary
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 atrop...
Detailed Description
The eSpectacle clinical prototype (CP1) device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights onto the peripheral retina. In this pilot investigation, we aim t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06034379
Start Date
October 1 2023
End Date
December 1 2025
Last Update
December 12 2024
Active Locations (1)
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1
CMU Hsinchu Hospital
Hsinchu, Taiwan