Medical Devices

Public Workshop: FDA/AAO Workshop on Developing Novel Endpoints for Premium Intraocular Lenses, March 28, 2014

The Food and Drug Administration (FDA) announced 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 was 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 was to improve the regulatory science around the approval of premium IOLs and the efficiency with which they get to market.


Date, Time and Location

This meeting was 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

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Webcast

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Transcript

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Agenda

TimeSubjectName of Speaker/Moderator
8:30Welcome/Innovation at FDAWilliam Maisel
8:35Innovation in Ophthalmic Devices and AAO Goals for the WorkshopPaul Sternberg
8:40FDA Goals for the WorkshopMalvina Eydelman
8:45Overview of IOLs and their RegulationTina Kiang
8:52Limitations of Existing Endpoints for Premium IOLsMalvina Eydelman
9:00Medicare IOL Payment PoliciesJohn McInnes
9:10Adverse Event (AE) Grid Rates and HistoryWalter Stark
9:20Current Safety Events with Premium IOLsDoug Koch
9:30Pseudophakic Dysphotopsia: Undesired Optical Imagery Associated with Premium vs. Standard IOLsSamuel Masket
9:40Need for Update of Grid Rates and Other Safety EndpointsEva Rorer
9:55Methods for Updating AE Rates and the FDA-AAO IOL RegistryAnne Coleman
9:45Questions 
10:05Development of Validated InstrumentsMichelle Tarver
10:13Current Methods for Assessing Visual DisturbancesOliver Schein
10:23Limitations of Current Patient Reported Outcome (PRO) MeasuresCynthia Owsley
10:33Different Methods for Capturing PROsSusan Vitale
10:42One Approach to Filling Measurement Gaps for PRO EndpointsStephen Joel Coons
10:50Questions 
11:05Break 
11:15Importance of Objective Measures of AccommodationGene Hilmantel
11:25Current Methods for Objectively Measuring AccommodationSanjeev Kasthurirangan
11:35Challenges and Potential Solutions to Overcome ChallengesAdrian Glasser
11:55Questions 
12:10Surgeon Expectations for IOLs Providing Near VisionDavid Chang
12:20New Categories of IOLs for Improved Near PerformanceDon Calogero
12:30Current Methods and Potential Alternatives for the Subjective Assessment of Accommodation and EDFScott MacRae
12:45Questions 
1:00LUNCH 
2:00Breakout Sessions:
  • Premium IOL Safety Assessments
  • PRO Measures
  • Objective Assessments of Accommodation
  • Subjective Assessments of Accommodation and Extended Depth of Focus
 
3:50Development of Group Summary Presentations 
4:20Presentation of Breakout Session Summaries 
5:20Closing Remarks AAOThomas Oetting
5:25Closing Remarks FDAMalvina Eydelman

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Registration to Attend the Workshop

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.

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Contact Us

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, susan.monahan@fda.hhs.gov.

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: michelle.tarver@fda.hhs.gov.

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Page Last Updated: 07/11/2014
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