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U.S. Department of Health and Human Services

Medical Devices

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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

TimeSubjectName of Speaker
8:00-8:50amWelcome and IntroductionsJeffrey M. Liebmann, MD
Malvina B. Eydelman, MD
Opening RemarksWilliam Maisel, MD, MPH
The Benefit of Early Glaucoma DetectionRohit Varma, MD , MPH
Public Health Concerns (false positives and false negatives)Joshua D. Stein, MD, MS
The Limitations of Current Reference Standards for ProgressionDavid S. Friedman, MD, MPH, PhD
Current Regulatory Pathways for Glaucoma Imaging DevicesMalvina B. Eydelman, MD
8:50-9:25amGlaucoma Structural Diagnostic TechnologiesKuldev Singh, MD , MPH
Henry D. Jampel, MD, MHS
Qualitative Optic Disc PhotographyGeorge A. Cioffi, MD
Quantitative HRTGeorge A. Cioffi, MD
Quantitative GDXMurray Fingeret, OD

Time Domain and Spectral-Domain OCT Including Similarities and Differences between these Technologies 

(Link to video shown during presentation disclaimer icon )

Joel S. Schuman, MD
Clinical Applications of SD-OCT (diagnosis, risk stratification, longitudinal assessment)Teresa C. Chen, MD
9:45-11:30amCharacterization of OCT as a Measurement ToolDavid 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, InstructionsGianmarco Vizzeri, MD
Instrument Dependent Factors (Image segmentation, image registration)Donald C. Hood, BA, MSC, PhD
Measurement Validation:Terminology and Concepts
Measurement Validation:Considerations in Premarket Review
 
Gene Hilmantel, OD, MS
Characterization of SDOCT as a Measurement: Validation (Agreement and Precision) of Macular, Nerve Fiber Layer and Optic nerve head measurementsChristopher A. Girkin, MD, MSPH
Variability in Peripapillary Nerve Fiber Layer and Optic Nerve Head Measurements—Implications for Detecting ChangeDonald L. Budenz, MD, MPH
Measurement Validation: Considerations in Premarket ReviewGene Hilmantel, OD, MS
12:30-2:20pmOCT Normative Databases: Construction, Reliability, and UsabilityMalik Y. Kahook, MD
Shan C. Lin, MD
Review of Normative Database Construction in Available OCT Models Highlighting DifferencesRobert D. Fechtner, MD
Statistical Approaches for Determining Normal Limits in DatabasesKouros Nouri-Madhavi , MD
Stratification of Normative DataLinda Zangwill, PhD
Review of how Normative Database Information is Displayed by Software/Printouts and Described in Labeling for Various ModelsRichard 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 ReviewKristen L. Meier, PhD
2:40-4:30pmOCT Diagnostic Performance for GlaucomaRobert N. Weinreb, MD
Dale K. Heuer, MD
Considerations for Evaluation of Diagnostic PerformanceFelipe A. Medeiros, MD, PhD
Diagnostic Performance Studies: Peripapillary Nerve Fiber LayerFelipe A. Medeiros, MD, PhD
Diagnostic Performance Studies: Optic Nerve Head MeasurementsRobert T. Chang, MD
Diagnostic Performance Studies: Macular MeasurementsSanjay G. Asrani, MD
“Screening”: Can OCT Imaging be Used to Differentiate Normal from Glaucomatous Eyes in the General PopulationAnne L. Coleman, MD, PhD
Considerations in Characterizing the Diagnostic Performance of a DeviceEva 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