Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
NCT ID: NCT05803863
Last Updated: 2023-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
108 participants
INTERVENTIONAL
2023-04-15
2025-12-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Myatro
Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Myatro
myopia control with 0.01% atropine drops
Myatro XL
Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Myatro XL
myopia control with 0.05% atropine drops
Conventional spectacles
Prescribing conventional spectacles and follow-up in 24 months.
No interventions assigned to this group
Interventions
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Myatro
myopia control with 0.01% atropine drops
Myatro XL
myopia control with 0.05% atropine drops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 8 - 13 years old
* Vietnamese, speaking Vietnamese
* BCVA from 8/10 each eye
Exclusion Criteria
* 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
8 Years
13 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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Thi Mong Dung Nguyen
Principal Investigator
Principal Investigators
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Dung TM Nguyen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Locations
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University Medical Center HCMC
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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137221050
Identifier Type: -
Identifier Source: org_study_id
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