Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
NCT05803863 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2023-04-07
Summary
The goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops (0,01%; 0,05%) in Vietnamese children. The main questions it aims to answer are:
1. How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
2. How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
3. How is the difference in rebound phenomena between 2 atropine groups?
Conditions
- Myopia
Interventions
- DRUG
-
Myatro
myopia control with 0.01% atropine drops
- DRUG
-
Myatro XL
myopia control with 0.05% atropine drops
Sponsors & Collaborators
-
University of Medicine and Pharmacy at Ho Chi Minh City
lead OTHER
Principal Investigators
-
Dung TM Nguyen, MD · University of Medicine and Pharmacy at Ho Chi Minh City
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-15
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Vietnam
Study Locations
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