The prevalence of myopia is high and increasing. Approximately 5 billion people around the world are expected to be myopic by the year 2050. Methods to slow the progression of myopia and therefore potentially decrease the associated sight-threatening complications have been the subject of a number of investigations. A workshop, sponsored by the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists, Inc, convened myopia experts from around the world to discuss principles to consider in the design of clinical trials investigating the effectiveness and safety of myopia control devices. Experts discussed parameters such as study endpoints, duration, enrollment criteria, patient-reported outcomes, recruitment, and retention. The discussions among the experts, FDA, and audience members should help to facilitate the development and evaluation of reasonably safe and effective myopia control devices.
College of Optometry (J.J.W.), The Ohio State University, Columbus, OH; Office of Device Evaluation (M.W.R., G.N.H., M.E.T., M.B.E.), Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD; Division of Cornea and Refractive Surgery (N.A.A.), Shiley Eye Institute, La Jolla, CA; Refractive Surgery and the Cornea Service (D.K.D.), University of Pittsburgh Medical Center Eye Center, Pittsburgh, PA; Concord Eye Center (C.L.M.), Concord, NH; Omni Eye Services (C.J.Q.), Iselin, NJ; and Wilmer Eye Institute (M.X.R.), Johns Hopkins Medicine, Baltimore, MD.
Address correspondence to Malvina B. Eydelman, M.D., 10903 New Hampshire Avenue, Silver Spring, MD; e-mail: email@example.com
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).
Participant travel was provided by the following cosponsoring organizations: American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists.
Accepted March 11, 2018