EyeWorld India March 2013 Issue

47 EWAP CORNEA March 2013 Expanding corneal tissue availability Largest cornea clinical trial today compares preservation time T he largest clinical trial in the field of cornea diseases and surgery at the moment eventually may increase the number of corneal grafts available for transplantation. The Cornea Preservation Time Study (CPTS) will track the transplantation success rate in endothelial keratoplasty with donor cornea preserved in storage medium at 4 degrees Celsius for up to seven days versus donor cornea preserved in storage media for eight to 14 days. “Right now, surgeons and eye banks are reluctant to go beyond seven by Vanessa Caceres EyeWorld Contributing Writer days,” said study chair Jonathan H. Lass, MD , director, University Hospitals Eye Institute, and Charles I. Thomas Professor and chair, Department of Ophthalmology and Visual Sciences, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA. However, the U.S. FDA has approved the storage of cornea tissue in approved media at 4 degrees Celsius for up to 14 days, leading investigators to believe that there may be a waste of good tissue occurring. “The eye banks many times are hitting one week to place the tissue and must then explore other options with surgeons out of the country so that the tissue gets utilized,” Dr. Lass said. Study details To compare the results of cornea donor tissue at one week versus eight to 14 days, study investigators at 40 participating clinical sites nationwide are enrolling up to 1,330 patients. As of the beginning of January, the study had enrolled 556 eyes, said Dr. Lass. Patients are randomized into one of two groups. Eyes in the first group receive tissue that has been preserved for up to seven days. Eyes in the second group receive tissue that has been preserved for eight to 14 days. Neither the surgeon nor the patient know to which group the eye was randomized. Investigators will follow patients for up to three years to see if the two groups have any difference in transplantation success or differences in the number of transplanted endothelial cells. Investigators believe they will find no significant difference in outcomes comparing the two groups. The trial began in April 2012. Because of the three-year follow-up, early 2017 is the soonest point at which results will be available, Dr. Lass said. The CPTS is supported with a $12.3 million grant from the National Eye Institute, Dr. Lass said. The Jaeb Center for Health Research in Tampa, Fla., USA, is collecting the study data. Research benefits Although the U.S. does not Clear Equivocal Cloudy CPTS corneal recipient stroma clarity grading scale for endothelial keratoplasty Source: George Rosenwasser, MD continued on page 48