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?
The study is prospective, comparative, open label. Participants are Vietnamese children. Prescribing drops : 1 drops/eye/night/ 12 months Wash-out: 12 months The atropine drops in this study are commercially available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
University Medical Center HCMC
Ho Chi Minh City, Vietnam
Efficacy (SE) of Atropine drops
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Time frame: 12 months
Efficacy (AL) of Atropine drops
axial length (mm)
Time frame: 12 months
pupil size
change in pupil size (mm)
Time frame: 12 months
amplitude of accommodation
change in amplitude of accommodation (D)
Time frame: 12 months
adverse symptoms 1
rate of photophobia
Time frame: 12 months
adverse symptoms 2
rate of reading difficulties
Time frame: 12 months
rebound effect (SE)
change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction)
Time frame: 12 months
rebound effect (AL)
change in axial length(mm) after wash-out
Time frame: 12 months
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