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

University of Medicine and Pharmacy at Ho Chi Minh City

Status and phase: Not yet enrolling; Phase 4

Conditions: Myopia

Treatments: Drug: Myatro XL; Drug: Myatro

Study type: Interventional

Funder types: Other

Identifiers

NCT05803863

137221050

Details and patient eligibility

About

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?

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Myatro

Experimental group

Description:

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

Treatment:

Drug: Myatro

Myatro XL

Experimental group

Description:

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

Treatment:

Drug: Myatro XL

Conventional spectacles

No Intervention group

Description:

Prescribing conventional spectacles and follow-up in 24 months.