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

NCT05803863 | Unknown Phase 4 DMC

• 1 other identifier: 137221050
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Myopia

Keywords

myopia control; low-dose atropin; Vietnamese children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• pupil size

  12 months

• amplitude of accommodation

  12 months

• adverse symptoms 1

  12 months

• adverse symptoms 2

  12 months

• rebound effect (SE)

  12 months

Study Arms (3)

Myatro

EXPERIMENTAL

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

Drug: Myatro

Myatro XL

EXPERIMENTAL

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

Drug: Myatro XL

Conventional spectacles

NO INTERVENTION

Prescribing conventional spectacles and follow-up in 24 months.

Interventions

Myatro DRUG

myopia control with 0.01% atropine drops

Also known as: Atropine 0.01%

Myatro

Myatro XL DRUG

myopia control with 0.05% atropine drops

Also known as: Atropine 0.05%

Myatro XL

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• myopic 2 eyes (SE above from -0.75 D, astigmatism below -1.50D)
• years old
• Vietnamese, speaking Vietnamese
• BCVA from 8/10 each eye

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University Medical Center HCMC

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Dung TM Nguyen, MD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dung TM Nguyen, MD

CONTACT

(+84) 982 701 459; bsnguyenthimongdung@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, comparative, open label

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 7, 2023
• Study Start: April 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)