Public Workshop - FDA/American Glaucoma Society Workshop on the Validity, Reliability, and Usability of Glaucoma Imaging Devices, October 5, 2012
The Food and Drug Administration (FDA) is announcing a public workshop entitled “FDA/American Glaucoma Society Workshop on the Validity, Reliability, and Usability of Glaucoma Imaging Devices.” The topic to be discussed relates to imaging of the posterior segment of the eye (e.g. retinal nerve fiber layer, optic nerve head, ganglion cell layer) using Optical Coherence Tomography (OCT, time-domain and spectral-domain), with particular emphasis on normative databases and the diagnostic performance of OCT for therapeutic glaucoma products (regulatory considerations) and clinical decision making (clinical practice considerations).
The purpose of this workshop is to discuss issues related to the use of OCT technology (time domain and spectral domain) in the diagnosis and treatment of glaucoma. In addition, we will discuss approaches to verify/validate new diagnostic technologies as well as normative/reference databases and how they impact the diagnostic use of OCT devices.
Date, Time and Location
This workshop will be held October 5, 2012, beginning at 8:00 am at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Sections B & C)
Silver Spring, MD 20993
The workshop will be webcasted.
Agenda
| Time | Subject | Name of Speaker |
|---|
| 8:00-8:50am | Welcome and Introductions | Jeffrey M. Liebmann, MD
Malvina B. Eydelman, MD |
| Opening Remarks | William Maisel, MD, MPH |
| The Benefit of Early Glaucoma Detection | Rohit Varma, MD , MPH |
| Public Health Concerns (false positives and false negatives) | Joshua D. Stein, MD, MS |
| The Impact of Current Diagnostic Practice Patterns (clinical reference methods) on the Evaluation of New Diagnostic Technologies | David S. Friedman, MD, MPH, PhD |
| Current Regulatory Pathways for Glaucoma Imaging Devices | Malvina B. Eydelman, MD |
| 8:50-9:25am | Glaucoma Structural Diagnostic Technologies | Kuldev Singh, MD , MPH
Henry D. Jampel, MD, MHS |
| Qualitative Optic Disc Photography | George A. Cioffi, MD |
| Quantitative HRT | George A. Cioffi, MD |
| Quantitative GDX | Murray Fingeret, OD |
Time Domain and Spectral-Domain OCT Including Similarities and Differences between these Technologies (Link to video shown during presentation  ) | Joel S. Schuman, MD |
| Clinical Applications of SD-OCT (diagnosis, risk stratification, longitudinal assessment) | Teresa C. Chen, MD |
| 9:45-11:30am | Characterization of OCT as a Measurement Tool | David S. Greenfield, MD
Gadi Wollstein, MD |
| How to Assess Reliability and Quality of a Scan, Patient Dependent Factors: Effect of Pupil Size, Media Opacity, and Anatomic Variations on Measurements, Operator Dependent Factors: Centration, Alignment, Instructions | Gianmarco Vizzeri, MD |
| Instrument Dependent Factors (Image segmentation, image registration) | Donald C. Hood, BA, MSC, PhD |
| Measurement Validation: Terminology and Concepts | Gene Hilmantel, OD, MS |
| Validation (Agreement and Precision) of Peripapillary Nerve Fiber Layer, Optic Nerve Head and Macula-Based Measurements | Christopher A. Girkin, MD, MSPH |
| Variability in Peripapillary Nerve Fiber Layer and Optic Nerve Head Measurements—Implications for Detecting Change | Donald L. Budenz, MD, MPH |
| Measurement Validation: Considerations in Premarket Review | Gene Hilmantel, OD, MS |
| 12:30-2:20pm | OCT Normative Databases: Construction, Reliability, and Usability | Malik Y. Kahook, MD
Shan C. Lin, MD |
| Review of Normative Database Construction in Available OCT Models Highlighting Differences | Robert D. Fechtner, MD |
| Statistical Approaches for Determining Normal Limits in Databases | Kouros Nouri-Madhavi , MD |
| Stratification of Normative Data | Linda Zangwill, PhD |
| Review of how Normative Database Information is Displayed by Software/Printouts and Described in Labeling for Various Models | Richard K. Lee, MD, PhD |
| How does Construction and Statistical Modeling Within OCT Normative Databases Compare with Standard Automated Perimetry Databases? | Gustavo V. de Moraes, MD |
| Normative Database Construction, Reliability and Usability: Considerations in Premarket Review | Kristen L. Meier, PhD |
| 2:40-4:30pm | OCT Diagnostic Performance for Glaucoma | Robert N. Weinreb, MD
Dale K. Heuer, MD |
| Considerations for Evaluation of Diagnostic Performance | Felipe A. Medeiros, MD, PhD |
| Diagnostic Performance Studies: Peripapillary Nerve Fiber Layer | Felipe A. Medeiros, MD, PhD |
| Diagnostic Performance Studies: Optic Nerve Head Measurements | Robert T. Chang, MD |
| Diagnostic Performance Studies: Macular Measurements | Sanjay G. Asrani, MD |
| “Screening”: Can OCT Imaging be Used to Differentiate Normal from Glaucomatous Eyes in the General Population | Anne L. Coleman, MD, PhD |
| Considerations in Characterizing the Diagnostic Performance of a Device | Eva M. Rorer, MD |
| | Closing Remarks |
Registration to Attend the Workshop
To register for the workshop, please visit the American Glaucoma Society (AGS) website.
AGS will charge a registration fee to cover its share of the expenses associated with the workshop. The registration fee is $200 for AGS members and $300 for non-AGS members. Registration is available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 17, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration will be available beginning at 7:30am on the morning of October 5, 2012. AGS will charge an on-site registration fee of $400.
If you require special accommodations due to a disability, please contact Ms. Cindy Garris, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration,10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5861; email: Cynthia.Garris@fda.hhs.gov.
Webcasts
Contact Us
For questions regarding workshop content please contact:
LCDR Brad Cunningham
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Phone: (301)796-6620
email: bradley.cunningham@fda.hhs.gov
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