From One Room to Worldwide Recognition

Around the world, investigators depend on Duke Reading Center to interpret optical coherence tomography (OCT), visual field and other ophthalmic images to determine treatment efficacy for all stages of clinical trials —from early phase testing to phase four.

Data generated by Duke Reading Center has helped to support FDA, European, and Asian regulatory approvals of several of the most important current drug treatments for retinal diseases such as uveitis, macular degeneration, and diabetes. It has also generated many research publications in respected peerreviewed journals.

Established in 2001 by Glenn Jaffe, MD and colleague Cynthia Toth, MD in a small patient room in the original Duke Eye Center clinic when optical coherence tomography (OCT) was a newly available technology and there were few treatments for retinal diseases.

Jaffe and Toth had a vision for Duke Reading Center—to become the premier institute for ophthalmic image reading in the world—to advance treatment for blinding eye diseases.

“We saw the potential to be at the cutting edge of clinical trials and as practicing retina specialists, wanted to help get these drugs into the market to help our own patients.” says Jaffe, Robert Machemer M.D. Distinguished Professor of Ophthalmology, and vitreoretinal diseases division chief.

Creating the Center seemed like a natural fit for Duke which has a long history of expertise in vitreoretinal diseases and eye imaging. Toth, Joseph A.C. Wadsworth Distinguished Professor of Ophthalmology is a pioneer in OCT who has revolutionized the technology in adult and pediatric patients—from the exam lane to the operating room, to the NICU. (see An Engineer at Heart: Cynthia Toth’s 25 years of revolutionizing eye care and surgery, page 4).

Jaffe and his team created a proprietary standardization method for image collection and image reading to ensure exceptional reproducibility. Photographers, technicians, and readers are certified to ensure images are acquired and results are standardized. To date, more than 20,000 photographers and technicians have been certified around the world.

Each project has a team of individuals— project managers serve as the point of contact for the sponsor and study site, data managers program the grading forms, obtain data and report results, readers or graders who evaluate the images and look for changes over time, and directors of grading who are physicians who oversee the reading. Indeed, the original vision of Jaffe and Toth has been realized: the Duke Reading Center plays an essential role in studies that result in new treatments or new indications being approved for eye diseases and has become the premier reading center in the world.

“We’re very proud of our accomplishments and that Duke Reading Center plays a pivotal role in development of new treatments for blinding eye diseases,” says Jaffe.