Medical Devices

Public Workshop - Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices, September 30, 2016

The Food and Drug Administration (FDA), American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens Association of Ophthalmologists, Inc. (CLAO) are cosponsoring a public workshop entitled, “Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices”.

The purpose of the workshop was to discuss the increasing prevalence of myopia and to obtain consensus for clinical trial design attributes when contact lenses or other medical devices are studied for controlling the progression of myopia.

Date, Time and Location:

This meeting was held September 30, 2016, beginning at 8:00 a.m. – 6:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

The meeting was webcast.

Agenda

TimeTitleSpeaker
8:00Welcome from CDRHWilliam Maisel
8:05Welcome from American Academy of Ophthalmology  Tim Steinemann
Welcome from American Academy of OptometryJeffrey J. Walline 
Welcome from American Association for Pediatric Ophthalmology and Strabismus Christie Morse
Welcome from American Optometric AssociationChristopher Quinn
Welcome from American Society of Cataract and Refractive SurgeryNatalie Afshari
Welcome from Contact Lens Association of Ophthalmologists, Inc.Deepinder K. Dhaliwal
8:15Demographics and Natural History of Myopia in the United StatesDonald Mutti
8:25Demographics and Natural History of Myopia Outside of the United StatesIan Morgan
8:35Contact Lens Use in a Pediatric Population: Behaviors and HygieneRobin Chalmers
8:45Complications of Contact Lens UseJodhbir Mehta
8:55Challenges to the Design of Clinical Trials to Prevent or Halt Progression of MyopiaJeffrey J. Walline
9:05Research Conducted on Myopia Control DevicesDavid Berntsen
9:15US Regulation of Contact LensesJ. Angelo Green
9:25Incorporating the Patient Perspective in the Evaluation of Medical DevicesKatie O’Callaghan
9:35Patient/Caregiver Perspectives on Trials of Myopia Control: Patient-Centric Outcomes and Barriers to Trial Participation and RetentionAnne Hawthorn
9:55Question/Answer 
10:05BREAK 
10:20PANEL 1: SELECTION OF TRIAL PARTICIPANTS
--Question 1
MODERATOR: Natalie Afshari & Christie Morse
PANELISTS: Jane Gwiazda, Donald Mutti, Pauline Cho, Marc Robboy (FDA), Malvina Eydelman (FDA)
12:20LUNCH 
1:20PANEL 2: STUDY DESIGN & CLINICAL OUTCOMES
--Question 2
--Question 3
--Question 4
MODERATOR:  Michael Repka & Christopher Quinn
PANELISTS: Pauline Cho, David Berntsen, Helen Swarbrick, Jodhbir Mehta, Gene Hilmantel (FDA), Malvina Eydelman (FDA)
3:30BREAK 
3:45PANEL 3:  PATIENT-CENTRIC FACTORS & OUTCOMES
--Question 5
MODERATOR: Deepinder K. Dhaliwal & Donald Mutti
PANELISTS: Jeffrey J. Walline, Robin Chalmers, Tim Steinemann, Katie O’Callaghan (FDA), Michelle E. Tarver (FDA)
5:30MODERATOR SUMMARIES
--PANEL 1
--PANEL 2
--PANEL 3
 
5:45CONCLUDING REMARKSTim Steinemann
Jeffrey J. Walline
Christie Morse
Christopher Quinn
Natalie Afshari
Debbie Jacobs
6:00ADJOURN 

Documents

For questions regarding workshop content please contact:

Michelle Tarver, M.D., Ph.D., Ophthalmologist / Epidemiologist, Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED), Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 2504, Silver Spring, MD 20993, 301-796-6884, email: michelle.tarver@fda.hhs.gov.

 

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