Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms
Abstract:IntroductionMyopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and … Show more
“…Two atropine RCTs are currently ongoing in Germany. The AIM (Low-dose AtropIne for Myopia Control in Children) study, funded by the German Research Foundation (DFG), is a randomized, placebo-controlled, double-blind, multicenter trial investigating the safety and efficacy of 0.02 % and 0.01 % atropine compared with placebo over a total of 3 years [18]. AIM is currently in the recruitment phase (83 % of 300 children, 15.03.2023).…”
Over the past decade, atropine has emerged as an effective intervention for preventing myopia in children. Multiple randomized controlled trials, mainly from Asia, have demonstrated the safety and efficacy of topical atropine for myopia control. Both efficacy and side effects exhibit a positive dose-response relationship. This review focuses on new data from studies with predominantly white populations, ethnicity-dependent differences in efficacy and side effects, and primary prevention of incident myopia with atropine.
“…Two atropine RCTs are currently ongoing in Germany. The AIM (Low-dose AtropIne for Myopia Control in Children) study, funded by the German Research Foundation (DFG), is a randomized, placebo-controlled, double-blind, multicenter trial investigating the safety and efficacy of 0.02 % and 0.01 % atropine compared with placebo over a total of 3 years [18]. AIM is currently in the recruitment phase (83 % of 300 children, 15.03.2023).…”
Over the past decade, atropine has emerged as an effective intervention for preventing myopia in children. Multiple randomized controlled trials, mainly from Asia, have demonstrated the safety and efficacy of topical atropine for myopia control. Both efficacy and side effects exhibit a positive dose-response relationship. This review focuses on new data from studies with predominantly white populations, ethnicity-dependent differences in efficacy and side effects, and primary prevention of incident myopia with atropine.
“…These complications can lead to permanent vision loss if not detected and treated in a timely manner [6]. Treatment options for myopia management, such as topical atropine, are effective in slowing the progression of myopia [7].…”
Purpose: The treatment of childhood myopia often involves the use of topical atropine, which has been demonstrated to be effective in decelerating the progression of myopia. It is crucial to monitor intraocular pressure (IOP) to ensure the safety of topical atropine. This study aims to identify the optimal machine learning IOP-monitoring module and establish a precise baseline IOP as a clinical safety reference for atropine medication. Methods: Data from 1545 eyes of 1171 children receiving atropine for myopia were retrospectively analyzed. Nineteen variables including patient demographics, medical history, refractive error, and IOP measurements were considered. The data were analyzed using a multivariate adaptive regression spline (MARS) model to analyze the impact of different factors on the End IOP. Results: The MARS model identified age, baseline IOP, End Spherical, duration of previous atropine treatment, and duration of current atropine treatment as the five most significant factors influencing the End IOP. The outcomes revealed that the baseline IOP had the most significant effect on final IOP, exhibiting a notable knot at 14 mmHg. When the baseline IOP was equal to or exceeded 14 mmHg, there was a positive correlation between atropine use and End IOP, suggesting that atropine may increase the End IOP in children with a baseline IOP greater than 14 mmHg. Conclusions: MARS model demonstrates a better ability to capture nonlinearity than classic multiple linear regression for predicting End IOP. It is crucial to acknowledge that administrating atropine may elevate intraocular pressure when the baseline IOP exceeds 14 mmHg. These findings offer valuable insights into factors affecting IOP in children undergoing atropine treatment for myopia, enabling clinicians to make informed decisions regarding treatment options.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.