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

innovation in ophthalmic devices and aao goals for the
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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


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Innovation in Ophthalmic Devices and AAO Goals for the Workshop:

Paul Sternberg, MD Academy Past President G.W. Hale Professor and Chairman, Department

  • f Ophthalmology and Visual Sciences

Associate Dean for Clinical Affairs, Chief Medical Officer and Assistant Vice Chancellor for Adult Health Affairs, Vanderbilt University

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WWW.AAO.ORG AMERICAN ACADEMY OF OPHTHALMOLOGY

Disclosures

No Financial Relationships to Disclose

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WWW.AAO.ORG AMERICAN ACADEMY OF OPHTHALMOLOGY

Clinical Device Trials

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WWW.AAO.ORG AMERICAN ACADEMY OF OPHTHALMOLOGY

Task Force on Ophthalmic Device Research Centers

  • Membership
  • Paul Sternberg, Chair
  • Stanley Chang
  • Eugene de Juan
  • Malvina Eydelman
  • Sharon Freedman
  • Eve Higginbotham
  • Malik Kahook
  • Joel Schuman
  • Paul Sieving
  • Michelle Tarver
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WWW.AAO.ORG AMERICAN ACADEMY OF OPHTHALMOLOGY

Recommendations of Task Force

  • The Task Force recommended
  • Forming Centers of Innovation
  • Intraocular Lenses (IOLs) focus of pilot

 Endpoint Development  Clinical Trial Center Establishment

  • The Board of Trustees
  • Deferred the Centers of Innovation
  • Approved the IOL Workshop to Develop Endpoints
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WWW.AAO.ORG AMERICAN ACADEMY OF OPHTHALMOLOGY

Academy Goals for Workshop

  • Increase quality of care
  • Increase access to devices to US public
  • Increase treatment options available to

patients

  • Identify key priorities for endpoint

development

  • Facilitate cooperation amongst all

stakeholders

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AMERICAN ACADEMY OF OPHTHALMOLOGY WWW.AAO.ORG

Workshop Planning Committee

Academy

Malik Kahook, MD, Co-Chair Thomas Oetting, MD, Co-Chair John Berdahl, MD David Chang, MD Nicole Fram, MD Thomas Harvey, MD Douglas Koch, MD Samuel Masket, MD Walter Stark, MD Elizabeth Yeu, MD

FDA

Malvina Eydelman, MD Don Calogero, MS Gene Hilmantel, OD, MS Tina Kiang, PhD Eva Rorer, MD Michelle Tarver, MD, PhD

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WWW.AAO.ORG AMERICAN ACADEMY OF OPHTHALMOLOGY

Future Steps

  • Workshop Breakout Group Recommendations
  • Develop Consensus statements

 Work with FDA, academicians, and industry to continue

activities from workshop to enhance IOL innovation

  • 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