Dr. Jaffe is a vitreo-retinal surgeon/professor of ophthalmology at Duke University Eye Center and the founder and Director of the OCT Reading Center at Duke. In addition to managing the business aspects of the center, he oversees and participates in the development of OCT data submission, entry, and analysis methodology. Dr. Jaffe works closely with Dr. Cynthia Toth and the staff to develop the OCT Reading Center Manual of Procedures, OCT technician certification protocols, and study procedures. He has published extensively on OCT and a variety of clinical research topics. He has given numerous national and international invited lectures on OCT and organized/co-directed the highly successful “Art of OCT” course held in Durham, North Carolina in May 2003. This course provided state-of-the-art information on OCT theory and practical applications to a large audience of physicians and technicians/imagers from around the U.S. and Canada.
Dr. Jaffe has been actively engaged in clinical research for nearly 20 years. He has extensive clinical trials experience and has served as Principal Investigator for more than 15 NEI-sponsored, individual investigator initiated, and industry-sponsored clinical trials. These trials have included interventional trials for AMD, diabetic retinopathy and uveitis.
Vice-Director, Director of Grading
Dr. Toth is a vitreo-retinal surgeon/professor of ophthalmology at Duke University Eye Center and Vice Director of the OCT Reading Center at Duke. As Director of Grading, she supervises the grading protocols, standards for grading, audit procedures and certification of graders for the OCT Reading Center. She works closely with OCT graders to maintain and test consistency in grading and adjudication of OCT scans. She teaches OCT courses at the American Academy of Ophthalmology, at clinical trials meetings and locally, educating investigators, OCT technicians and OCT graders. She co-authored the OCT Reading Center Manual of Procedures and Grading Manual.
Dr. Toth has over a decade of research experience with OCT and is a recognized leader in vitreo-retinal applications. This research includes initial studies to demonstrate relationships between primate retinal morphology and OCT images, and also includes the first OCT images of retinal pathology (laser lesions) evolving over time (in collaboration with James Fujimoto, PhD). Dr. Toth has published extensively on the biology and technology of OCT imaging of the eye, in animal models and in human studies. She has been an invited speaker nationally and internationally on OCT methodology and interpretation. She has been an investigator on NIH sponsored grant that supported partnership between biomedical engineers in OCT research (Joseph Izatt, PhD) and clinical applications of the technology.
Dr. Stinnett serves as the biostatistician for the OCT Reading Center at Duke. She provides expertise in data file creation, auditing, querying, updating and transfer. She analyzes OCT data for reproducibility and provides status reports to study sponsors.
Dr. Stinnett is a member of the faculty of the Duke Clinical Research Institute (DCRI) with an appointment as Assistant Research Professor in both the Department of Biostatistics and Bioinformatics and in the Department of Ophthalmology. For over four years, she was the Director of Statistical Operations at the DCRI and responsible for the management of approximately 35 statisticians who design, manage and analyze data from clinical trials. For six years, she taught in the Duke Clinical Research Training Program. As biostatistician for the Duke Eye Center, Dr. Stinnett works with faculty, fellows and residents in a variety of roles. She assists with planning and implementation of research projects including creating data collection instruments and data files, executing statistical analyses, and interpreting results. She writes statistical methods sections of publications and assists with writing results. She also lectures to residents on research designs and statistical methods.
For the Eye Center, Dr. Stinnett has analyzed data from projects that include: risk factors for peripheral vascular disease, associated factors in age-related macular degeneration (AMD), impact on visual acuity of translocation surgery for AMD, impact of argon laser trabeculoplasty, comparison of methods for measuring retinal thickness, vision-related quality of life in patients with branch vein occlusion, comparison of films used in detection of AMD, comparison of raters and views (stereo and non-stereo photographs) in measures of glaucoma, assessment of physician skills with respect to guidelines of practice in ophthalmology, comparison of ultrasound with OCT and fluorescein angiograms for diagnosis of macular edema, comparison of silicone oil versus gas in treatment of macular holes, comparison of pressure monitors and tonopens for pressure measurements in glaucoma, comparison of drugs for controlling PVR in rabbits, and assessment of inter-rater agreement in OCT grading.
Ms. Young serves as the Project Manager for all trials conducted at the OCT Reading Center at Duke. She manages the workflow for several multi-center trials, helps certify and train OCT technicians at study sites, and works with study site principal investigators and study coordinators to review OCT protocols. She enters, inventories and backs up OCT scan data from study sites into a secure database. She assigns scans to graders and enters grading data into a computerized database that she helped develop. She prepares reports and transmits them to study Coordinating Centers and helped write the OCT Reading Center at Duke’s Manual of Procedures.
Ms. Young has over ten years of experience in ophthalmic imaging; she is an experienced fundus photographer, fluorescein angiographer and certified clinical trial photographer. She has extensive OCT methodology and analysis experience and helped develop custom OCT database software for currently ongoing OCT Reading Center clinical trials. She assisted in the production of the “Art of OCT” course in May 2003 and assisted Mr. Hoffmeyer in a similar course held in Liverpool, England in October, 2003 for the British Ophthalmic Photographers Association.