DSG has launched a registry for the American Society for Cataract and Refractive Surgery (ASCRS). The project is being led by R. Doyle Stulting, M.D., Ph.D., an eye doctor at Emory University who is chair of the ASCRS Refractive Clinical Committee.

Ectasia is not a mood disorder but a complication of laser-based eye surgery. “The ectasia registry is a giant step forward in addressing one of the most challenging complications of LASIK that we face today,” said Stulting.

The first phase of the project could estimate the prevalence of corneal ectasia after LASIK and identify risk factors that may predict its occurrence. The registry could allow identification of risk factors that are not currently recognized. In Phase II of the project, ASCRS, FDA and DSG, under Dr. Stulting’s leadership, will collaborate to define and implement prospective clinical studies. Phase II will include prospective observational studies aimed at determining the incidence of this complication and more precisely quantifying the impact of preoperative factors.

“Working with DSG and Dr. Stulting on this project enabled us to contribute our expertise in designing and conducting ophthalmic clinical trials to the development of a much needed solution to this evolving clinical problem,” said Barbara S. Fant, Pharm.D., Clinical Research Consultants.

DSG’s electronic data capture (EDC) application, eCaseLink, is being used to design and host the registry, as well as to collect and manage the data. As is typically the case in postmarketing studies, much of the data will be accessible to the physicians who gather it. “We are honored that our technology has been chosen by ASCRS, CRC, and Dr. Stulting to further this important research on corneal ectasia,” said Tony Varano, president & CEO of DSG. “We welcome the opportunity to work with medical and patient advocacy organizations such as ASCRS.”

Registries in general are becoming a business unto themselves, with increasingly competitive technology providers such as Outcome, Ninaza and United Biosource vying to enable such projects.