Clinical Trial WATCH | Ophthalmology

0.01% Atropine Eye Drops in Children With Myopia and Intermittent Exotropia: The AMIXT Randomized Clinical Trial

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Published on MedED: 21 August 024
Source: JAMA Ophthalmology
Date Originally Published: 3 July 2024
Type of article: Clinical Trial Watch
MedED Catalogue Reference: MOCL005

Category: Ophthalmology
Category Cross-reference: 
Paediatrics & Neonatology
Keywords: atropine, myopia, paediatrics, exotropia, ICT 


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This summary is intended to provide a snapshot of the original research. It is in no way a substitute for the original research article, nor is it intended to be a complete reflection of the original research. 

Originally published in JAMA Ophthalmology, 3 July  2024

This placebo-controlled, double-masked, randomized trial assessed the efficacy and safety of 0.01% atropine eye drops for controlling myopia progression and managing intermittent exotropia (IXT) in children aged 6 to 12 years.

The study included 300 children (50.1% male, mean age 9 years), randomly assigned in a 2:1 ratio to receive either 0.01% atropine (66.7%, 200 children) or placebo (33.3%, 100 children) eye drops, administered nightly for 12 months.

At the end of the study, the atropine group showed slower spherical equivalent progression and axial length elongation compared to the placebo group, with mean changes of −3.06 D versus 0.12 D, respectively. The atropine group also experienced a reduction in near-magnitude exodeviation, whereas the placebo group saw an increase.

The incidence of photophobia and blurred near vision was similar between groups (6.0% vs. 8.0% and 6.0% vs. 7.0%, respectively).

These findings support the use of 0.01% atropine eye drops to slow the progression of myopia while minimally affecting exotropia and binocular vision.



Chinese Clinical Trial Registry Identifier: ChiCTR2000039827.

 


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