drugset / Trial / NCT06034379
Electronic Spectacles Versus Low Dose Atropine in Young Myopes
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atropine | Other / unclassified | 0.01 % | Other |