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

Phase 4

Not yet recruiting

• Conditions: Myopia
• Interventions: Drug: Myatro XL; Drug: Myatro

• Registration Number: NCT05803863
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

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.

Study Timeline

• Study First Submitted: 2023-03-25
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07
• Study Start: 2023-04-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myatro XL	Myatro XL	Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Myatro	Myatro	Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center HCMC; 🇻🇳 Ho Chi Minh City, Vietnam