drugset / Trial / NCT06034379

Electronic Spectacles Versus Low Dose Atropine in Young Myopes

NCT06034379

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-10-01
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atropine Other / unclassified 0.01 % Other

Indications