Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management

Study Overview
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Brief Summary
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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: How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles? How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles? How is the difference in rebound phenomena between 2 atropine groups?

Detailed Description
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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.

Official Title
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Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management

Conditions
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Myopia

Intervention / Treatment
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* Drug: Myatro
* Drug: Myatro XL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, comparative, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myatro<br>Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months | Drug: Myatro<br>* myopia control with 0.01% atropine drops<br>* Other names: Atropine 0.01%;|
| Experimental: Myatro XL<br>Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months | Drug: Myatro XL<br>* myopia control with 0.05% atropine drops<br>* Other names: Atropine 0.05%;|
| No Intervention: Conventional spectacles<br>Prescribing conventional spectacles and follow-up in 24 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (SE) of Atropine drops | measured by change in spherical equivalent (D) (Objective cycloplegic refraction) | 12 months | 
| Efficacy (AL) of Atropine drops | axial length (mm) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupil size | change in pupil size (mm) | 12 months | 
| amplitude of accommodation | change in amplitude of accommodation (D) | 12 months | 
| adverse symptoms 1 | rate of photophobia | 12 months | 
| adverse symptoms 2 | rate of reading difficulties | 12 months | 
| rebound effect (SE) | change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction) | 12 months | 
| rebound effect (AL) | change in axial length(mm) after wash-out | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia control, low-dose atropin, Vietnamese children