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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05803863
• Other study ID #: 137221050
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: Dung TM Nguyen, MD
• Phone: (+84) 982 701 459
• Email: bsnguyenthimongdung[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Myatro
myopia control with 0.01% atropine drops
• Myatro XL
myopia control with 0.05% atropine drops

Locations

Country	Name	City	State
Vietnam	University Medical Center HCMC	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (SE) of Atropine drops	measured by change in spherical equivalent (D) (Objective cycloplegic refraction)	12 months
Primary	Efficacy (AL) of Atropine drops	axial length (mm)	12 months
Secondary	pupil size	change in pupil size (mm)	12 months
Secondary	amplitude of accommodation	change in amplitude of accommodation (D)	12 months
Secondary	adverse symptoms 1	rate of photophobia	12 months
Secondary	adverse symptoms 2	rate of reading difficulties	12 months
Secondary	rebound effect (SE)	change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction)	12 months
Secondary	rebound effect (AL)	change in axial length(mm) after wash-out	12 months