DSG and Clinical Research Consultants, Inc. Develop a Global Registry for Corneal Ectasia under Sponsorship of ASCRS.

In Phase II of Project, ASCRS, FDA, CRC, and DSG Will Collaborate to Define and Implement Prospective Clinical Studies

MALVERN, Pa. -- DSG, Inc., a leading provider of electronic data capture software for clinical trials, and Clinical Research Consultants, Inc. (CRC), today announced that they have designed and are hosting the International Ectasia Registry sponsored by the American Society for Cataract and Refractive Surgery (ASCRS) and developed under the direction of R. Doyle Stulting, M.D., Ph.D., Professor of Ophthalmology, Emory University and Chair of the ASCRS Refractive Clinical Committee.

Corneal Ectasia is a rare complication of LASIK surgery in which the internal pressure of the eye causes an outward reshaping of the cornea, resulting in progressive loss of vision.

DSG's electronic data capture (EDC) application, eCaseLink, is being used to set up, design and host the registry; manage data collection; and serve as a central repository for physicians and researchers to collect and review data globally. ECaseLink also incorporates user self-registration, enabling users to register themselves as participants in the Registry. ECaseLink is one of the first successfully deployed EDC software applications on the market, currently being used in more than 250 trials globally.

"We are honored that our technology has been chosen by ASCRS, CRC, and Dr. Stulting to further this important research on corneal ectasia by creating the International Ectasia Registry with unique and challenging global registry requirements," said Tony Varano, president & CEO of DSG. He continued, "We welcome the opportunity to work with medical and patient advocacy organizations such as ASCRS and share our breadth of experience and knowledge in clinical and outcomes research. Our technology was also recently chosen to host a global data repository for The Accelerated Cure Project for Multiple Sclerosis."

"The ectasia registry is a giant step forward in addressing one of the most challenging complications of LASIK that we face today," said Dr. Doyle Stulting, Emory University. "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," added Barbara S. Fant, Pharm.D., Clinical Research Consultants, Inc.

ASCRS is the primary sponsor for Phase I of the project, which is designed to estimate the prevalence of corneal ectasia after LASIK and identify risk factors that may predict its occurrence

The Registry may allow identification of risk factors that are not currently recognized. In Phase II of the project, ASCRS, FDA, CRC, 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.

A test database of the registry was demonstrated at the ASCRS meeting in Boston August 10-13, 2006, and at the ESCRS meeting in London September 12, 2006.

Since 1992, DSG, Inc. has supported clinical trial data collection with innovative technology solutions including EDC, electronic patient diaries and digital on-demand CRF publishing management software. DSG's products allow user friendly, accurate and efficient data capture at any investigator site regardless of the site's technological infrastructure. DSG has successfully supported over 200 clinical trials at more than 300 companies, at over 14,000 sites worldwide. For more information, please visit www.dsg-us.com.

Clinical Research Consultants, Inc. (CRC) was established in 1992 to provide quality regulatory and clinical consulting services to assist medical device and diagnostic product manufacturers in successfully meeting strict governmental requirements to obtain FDA approvals. CRC is internationally recognized for its core expertise in the development, clinical evaluation, and FDA approval of ophthalmic medical devices.

The American Society of Cataract and Refractive Surgery (ASCRS) is an independent non-profit organization founded in 1974 to disseminate information about anterior segment ophthalmic surgery. Through its educational programs and services, ASCRS has become the physicians' primary source of up-to-date information on scientific developments within the field, as well as the regulatory decisions that affect ophthalmic practices.