Nearsightedness or myopia will affect 50% of the world population by 2050. The condition is more than an inconvenience that can be corrected with glasses or contact lenses, it is caused by elongation of eyeball which can stretch and thin the inner parts of the eye. This increases the risk of retinal detachment, glaucoma, and macular degeneration, and can lead to blindness. Eye growth occurs during childhood and adolescence, which therefore form the time period for intervention.
Pharmacological intervention with high dose (0.5-1.0%) atropine eye drops have been reported to be the most effective treatment in reduction of eye growth and myopia progression. However, the side effects photophobia and reading difficulty have hampered the use of high dose atropine, and has favored the less effective low dose (0.01-0.05%), causing a clinical dilemma for eye care professionals.
This proposal aims to compare atropine 0.05% to 0.5% treatment in children with progressive myopia, and to evaluate safety, adherence, and non-response. We will perform a 3 year, double-masked, multicenter, randomized controlled trial, the Myopia Atropine Dose (MAD) Trial, with 550 children. The primary outcomes are progression of refractive error and axial length after 3 years followed by an observation period of 2 years. The 3 years correspond to the requirements of the International Myopia Institute: as the eye grows relatively slowly this period of intervention is needed in order to show clinically meaningful outcomes; the observation period is needed to assess any rebound effects. The results of this study will offer insights for myopia management in the Netherlands and help reduce blindness from myopia.