Myopia
Conditions
Keywords
myopia control, low-dose atropin, Vietnamese children
Brief 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?
Detailed description
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.
Interventions
DRUGMyatro
myopia control with 0.01% atropine drops
DRUGMyatro XL
myopia control with 0.05% atropine drops
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, comparative, open label
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* myopic 2 eyes (SE above from -0.75 D, astigmatism below -1.50D) * 8 - 13 years old * Vietnamese, speaking Vietnamese * BCVA from 8/10 each eye
Exclusion criteria
* Using any contact lens in less than 3 months * Other eye diseases than myopia * History of eye trauma, surgeries * Having chronic systemic diseases or having medications affecting eye. * Having contraindications of atropine drops * Pre-known allergies to atropine drops * Undergoing another myopia control treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (SE) of Atropine drops | 12 months | measured by change in spherical equivalent (D) (Objective cycloplegic refraction) |
| Efficacy (AL) of Atropine drops | 12 months | axial length (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse symptoms 1 | 12 months | rate of photophobia |
| adverse symptoms 2 | 12 months | rate of reading difficulties |
| pupil size | 12 months | change in pupil size (mm) |
| rebound effect (AL) | 12 months | change in axial length(mm) after wash-out |
| rebound effect (SE) | 12 months | change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction) |
| amplitude of accommodation | 12 months | change in amplitude of accommodation (D) |
Countries
Vietnam
Contacts
Primary ContactDung TM Nguyen, MD
Outcome results
None listed