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Assessment of Clinical Trials for Devices Intended to Control Myopia Progression in Children

Robboy, Marc W. O.D.; Hilmantel, Gene O.D., M.S.; Tarver, Michelle E. M.D., Ph.D.; Eydelman, Malvina B. M.D.

doi: 10.1097/ICL.0000000000000476
Review Article

Abstract: 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.

Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.

Address correspondence to Malvina B. Eydelman, M.D., 10903 New Hampshire Avenue, Silver Spring, MD 20993; e-mail:

The authors have no funding or conflicts of interest to disclose.

The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services (DHHS).

Accepted December 10, 2017

© 2018 Contact Lens Association of Ophthalmologists, Inc.