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Electronic Spectacles Versus Low Dose Atropine in Young Myopes
Sponsor: Kubota Vision Inc.
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 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.
Official title: Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children
Key Details
Gender
All
Age Range
6 Years - 13 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-10-01
Completion Date
2025-12
Last Updated
2024-12-12
Healthy Volunteers
Yes
Conditions
Interventions
eSpectacle Clinical prototype (CP1) device
The CP1 device consists of a clear 15° central aperture and projects +9.00D defocused micro-LED lights of approximately 4800 nits illumination to the peripheral retina.
0.01% atropine
Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.
Locations (1)
CMU Hsinchu Hospital
Hsinchu, Taiwan