Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind,...

Area of Science:

• Ophthalmology
• Pediatric Ophthalmology
• Clinical Trials

Background:

• Myopia is a leading cause of visual impairment globally.
• Low-dose atropine eye drops have shown promise in controlling myopia progression in Asian children.
• Limited data exists on the efficacy and safety of low-dose atropine in non-Asian populations.

Purpose of the Study:

• To evaluate the efficacy and safety of 0.02% atropine eye drops for myopia control in Caucasian children.
• To compare the effects of different low-dose atropine concentrations (0.01% and 0.02%) on myopia progression.
• To assess the long-term effects of atropine therapy cessation.

Main Methods:

• A prospective, randomized, placebo-controlled, double-blind trial (AIM study) involving 300 children aged 8-12 years.
• Participants received either 0.02% atropine or placebo for one year, with subsequent treatment adjustments.
• Primary outcome: change in cycloplegic refraction after one year; secondary outcomes: change in axial length and safety profiles.

Main Results:

• The study is ongoing, with recruitment initiated in October 2021.
• Primary efficacy endpoint is the change in cycloplegic refraction (D/year).
• Secondary endpoints include changes in axial length (mm/year) and safety assessments.

Conclusions:

• The AIM study will provide crucial evidence on the effectiveness and safety of low-dose atropine for myopia control in a German (Caucasian) pediatric population.
• Findings will inform clinical practice and treatment guidelines for childhood myopia.
• The study adheres to ethical standards and will disseminate results through publications and presentations.