Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Overview
- Phase
- Phase 4
- Intervention
- Myatro
- Conditions
- Myopia
- Sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Efficacy (SE) of Atropine drops
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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:
- 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
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.
Investigators
Thi Mong Dung Nguyen
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City
Eligibility Criteria
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
Arms & Interventions
Myatro
Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Intervention: Myatro
Myatro XL
Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Intervention: Myatro XL
Outcomes
Primary Outcomes
Efficacy (SE) of Atropine drops
Time Frame: 12 months
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Efficacy (AL) of Atropine drops
Time Frame: 12 months
axial length (mm)
Secondary Outcomes
- adverse symptoms 1(12 months)
- adverse symptoms 2(12 months)
- rebound effect (AL)(12 months)
- amplitude of accommodation(12 months)
- pupil size(12 months)
- rebound effect (SE)(12 months)