Electronic Spectacles Versus Low Dose Atropine in Young Myopes
ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorKubota Vision Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- eSpectacle Clinical prototype (CP1) device
- 0.01% atropine
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Kubota Vision Inc.
Lead sponsor
China Medical University Hospital
Collaborator
Source ClinicalTrials.gov