Innovation in Ophthalmic Devices and AAO Goals for the Workshop: - PowerPoint PPT Presentation

Innovation in Ophthalmic Devices and AAO Goals for the Workshop: Paul Sternberg, MD Academy Past President G.W. Hale Professor and Chairman, Department of Ophthalmology and Visual Sciences Associate Dean for Clinical Affairs, Chief Medical Officer and Assistant Vice Chancellor for Adult Health Affairs, Vanderbilt University

Disclosures No Financial Relationships to Disclose 0 AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Clinical Device Trials 0 AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Task Force on Ophthalmic Device Research Centers  Membership  Paul Sternberg, Chair  Stanley Chang  Eugene de Juan  Malvina Eydelman 0  Sharon Freedman  Eve Higginbotham  Malik Kahook  Joel Schuman  Paul Sieving  Michelle Tarver AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Recommendations of Task Force  The Task Force recommended • Forming Centers of Innovation • Intraocular Lenses (IOLs) focus of pilot  Endpoint Development 0  Clinical Trial Center Establishment  The Board of Trustees • Deferred the Centers of Innovation • Approved the IOL Workshop to Develop Endpoints AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Academy Goals for Workshop  Increase quality of care  Increase access to devices to US public 0  Increase treatment options available to patients  Identify key priorities for endpoint development  Facilitate cooperation amongst all stakeholders AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Workshop Planning Committee Academy FDA Malik Kahook, MD, Co-Chair Malvina Eydelman, MD Thomas Oetting, MD, Co-Chair Don Calogero, MS John Berdahl, MD Gene Hilmantel, OD, MS David Chang, MD 0 Tina Kiang, PhD Nicole Fram, MD Eva Rorer, MD Thomas Harvey, MD Michelle Tarver, MD, PhD Douglas Koch, MD Samuel Masket, MD Walter Stark, MD Elizabeth Yeu, MD AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Future Steps  Workshop Breakout Group Recommendations • Develop Consensus statements  Work with FDA, academicians, and industry to continue activities from workshop to enhance IOL innovation 0 • Develop and conduct preclinical and clinical studies • Resources required from all stakeholders for both activities  Utilizing 501 (3(c)) entities may facilitate this process – Example: H. Dunbar Hoskins Center for Quality Eye Care AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG