Clinical Trial

Electronic Spectacles Versus Low Dose Atropine in Young Myopes

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 12, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-11; most recent amendment 2024-12-08.
Status change: Not Yet Recruiting → Recruiting 2024-12-08
Trial Details
NCT Number NCT06034379
Lead Sponsor Kubota Vision Inc.
Collaborators: China Medical University Hospital
Conditions Myopia
Enrollment 45 participants
Start Date 2023-10-01
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-12