Public Workshop: FDA/AAO Workshop on Developing Novel Endpoints for Premium Intraocular Lenses, March 28, 2014
The Food and Drug Administration (FDA) is announcing the following co-sponsored public workshop entitled "FDA/American Academy of Ophthalmology (AAO) Workshop on Developing Novel Endpoints for Premium Intraocular Lenses.”
The purpose of this workshop is to discuss current challenges in the assessment of innovative intraocular lens (IOL) designs with a focus on endpoint methodologies used in evaluating IOL safety and effectiveness. The primary goal of the workshop is to improve the regulatory science around the approval of premium IOLs and the efficiency with which they get to market.
This meeting will be held March 28, 2014, beginning at 8:30 a.m. at the following location:
FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503, Silver Spring, MD, 20993
Webcast participants will be sent technical system requirements and will be sent connection access information after registration. If you have never attended a Connect Pro event, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview.
|Time||Subject||Name of Speaker/Moderator|
|8:30||Welcome/Innovation at FDA||Jeffrey Shuren|
|8:35||Innovation in Ophthalmic Devices and AAO Goals for the Workshop||Paul Sternberg|
|8:40||FDA Goals for the Workshop||Malvina Eydelman|
|8:45||Overview of IOLs and their Regulation||Tina Kiang|
|8:52||Limitations of Existing Endpoints for Premium IOLs||Malvina Eydelman|
|9:00||CMS and Reimbursement for NTIOL||John McInnes|
|9:10||Adverse Event (AE) Grid Rates and History||Walter Stark|
|9:20||Current Safety Events with Premium IOLs||Doug Koch|
|9:30||Need for Update of Grid Rates and Other Safety Endpoints||Eva Rorer|
|9:35||Methods for Updating AE Rates and the FDA-AAO IOL Registry||Anne Coleman|
|10:00||Development of Validated Instruments||Michelle Tarver|
|10:08||Current Methods for Assessing Visual Disturbances||Oliver Schein|
|10:18||Limitations of Current Patient Reported Outcome (PRO) Measures||Cynthia Owsley|
|10:28||Different Methods for Capturing PROs||Susan Vitale|
|10:37||One Approach to Filling Measurement Gaps for PRO Endpoints||Stephen Joel Coons|
|11:15||Importance of Objective Measures of Accommodation||Gene Hilmantel|
|11:25||Current Methods for Objectively Measuring Accommodation||Sanjeev Kasthurirangan|
|11:35||Challenges and Potential Solutions to Overcome Challenges||Adrian Glasser|
|12:10||Surgeon Expectations for IOLs Providing Near Vision||David Chang|
|12:20||New Categories of IOLs for Improved Near Performance||Don Calogero|
|12:30||Current Methods and Potential Alternatives for the Subjective Assessment of Accommodation and EDF||Scott MacRae|
|3:50||Development of Group Summary Presentations|
|4:20||Presentation of Breakout Session Summaries|
|5:20||Closing Remarks AAO||Thomas Oetting|
|5:25||Closing Remarks FDA||Malvina Eydelman|
Registration is $250 for Academy members, $400 for non-members and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. The deadline for registration is March 27, 2014 at 5:00 p.m. EDT. There will be no on-site registration on the day of the public workshop. Early registration is recommended because facilities are limited and, therefore FDA may limit the number of participants from each organization. To register for the public workshop, please visit the American Academy of Ophthalmology (AAO) website: www.aao.org/IOLworkshop
Those interested in attending but are unable or unwilling to access the electronic registration site should fax the PDF form on the AAO website to (415) 561-8575. Those without internet access should contact AAO Customer Service to register at (415) 561-8540 or (866) 561-8558 (toll free). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If there are any questions with registration, please contact the AAO administrative offices at (415) 561-8540. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, email@example.com.
For questions regarding workshop content please contact Dr. Michelle Tarver, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2504, Silver Spring, MD 20993-0002, 301-796-5620, email: firstname.lastname@example.org.