Food and Drug Administration, 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 co-sponsored workshop: Controlling the progression of myopia: Contact lenses and future medical devices

Jeffrey J. Walline, Marc W. Robboy, Gene Hilmantel, Michelle E. Tarver, Natalie A. Afshari, Deepinder K. Dhaliwal, Christie L. Morse, Christopher J. Quinn, Michael X. Repka, Malvina B. Eydelman

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)205-211
Number of pages7
JournalEye and Contact Lens
Volume44
Issue number4
DOIs
StatePublished - Jan 1 2018

Keywords

  • Clinical study design
  • Contact lenses
  • Myopia
  • Progression
  • Regulatory science

ASJC Scopus subject areas

  • Ophthalmology

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