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RECRUITING
NCT06034379
NA

Electronic Spectacles Versus Low Dose Atropine in Young Myopes

Sponsor: Kubota Vision Inc.

View on ClinicalTrials.gov

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

DEVICE

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.

DRUG

0.01% atropine

Atropine is a and anticholinergic medication which can be used for dilation and cycloplegia.

Locations (1)

CMU Hsinchu Hospital

Hsinchu, Taiwan