The increased prevalence of
myopia in the United States and other regions of the world, and the sight-threatening problems associated with higher levels of
myopia have led to great interest in research designed to reduce these rates. As most of the progression of
myopia occurs in childhood, these investigations have been directed toward slowing the progression of
myopia in children. Treatments described to potentially slow the progression of
myopia have included pharmacological interventions, multifocal
spectacles, and multifocal correction created by
contact lenses. Although some
contact lens clinical trials have demonstrated promising results in slowing the progression of
myopia, many of these studies have significant limitations, including only short follow-up times, limited randomization, and incomplete masking. Such limitations have underscored the need to develop a more robust clinical study design, so that future studies can demonstrate whether
contact lenses, as well as other medical devices, can be used in a safe and effective manner to control
myopia progression. We review previous key studies and discuss study design and regulatory issues relevant to future clinical trials.