TY - JOUR
T1 - 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
T2 - Controlling the progression of myopia: Contact lenses and future medical devices
AU - Walline, Jeffrey J.
AU - Robboy, Marc W.
AU - Hilmantel, Gene
AU - Tarver, Michelle E.
AU - Afshari, Natalie A.
AU - Dhaliwal, Deepinder K.
AU - Morse, Christie L.
AU - Quinn, Christopher J.
AU - Repka, Michael X.
AU - Eydelman, Malvina B.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
KW - Clinical study design
KW - Contact lenses
KW - Myopia
KW - Progression
KW - Regulatory science
UR - http://www.scopus.com/inward/record.url?scp=85049393506&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049393506&partnerID=8YFLogxK
U2 - 10.1097/ICL.0000000000000511
DO - 10.1097/ICL.0000000000000511
M3 - Article
C2 - 29923881
AN - SCOPUS:85049393506
SN - 1542-2321
VL - 44
SP - 205
EP - 211
JO - Eye and Contact Lens
JF - Eye and Contact Lens
IS - 4
ER -