Increased Donor Pool for Corneal Tissue Transplants

A major new study finds that cornea transplants using older tissue work as well as tissue from younger donors. These results may help to change eye bank policy that limits the age for donors to 65 years or younger and, by including candidates as old as 75, could expand the donor pool by up to 35 percent.

The study, called the "Cornea Donor Study" (CDS), involved 1,101 participants between the ages of 40 and 80. The participants were randomly chosen to receive either younger or older cornea tissue. The researchers determined that the five-year success rate for transplants was the same, 86 percent, for those receiving corneas from donors aged 12 to 65 and from donors 66 to 75. A transplant was considered a failure if a repeat transplant was needed or if the cornea remained cloudy for at least three months. The study was published in the April issue of Ophthalmology.

"This new research has come at a good time," said Paul A. Sieving, M.D., Ph.D., director of the National Eye Institute (NEI). "The pressure on eye banks to provide corneas is increasing. The results of this study will expand the available donor pool and should persuade surgeons to use corneas from older donors. These changes will greatly benefit the growing number of individuals who need corneal transplants."

The cornea, a clear dome-shaped surface that covers the front of the eye, offers protection and helps focus light entering the eye. Corneal transplant is recommended for people with scarring of the cornea from injections or injuries, hereditary corneal failure, corneal failure after other eye surgery such as cataract surgery, and other conditions. Corneal tissue for transplant comes from recently deceased donors.

According to the NEI, more than 33,000 corneal transplants are performed annually in the United States. For the past ten years, the availability of donor corneas has been adequate. However, a decrease in supply could result from recent changes in the U.S. Food and Drug Administration (FDA) regulations that took effect in June 2007. These new regulations require additional screening and testing of potential donors for contagious disease, registration of eye banks, more detailed records and labels, and stricter quarantine procedures.

Dr. Edward Holland of the University of Cincinnati and Cincinnati Eye Institute, who helped lead the study, said the findings provide scientific evidence showing that older donors can be used as reliably in corneal transplantation as younger donors and noted that there is a great shortage of donor corneas internationally, providing an opportunity for corneas that are not used in the United States to be used elsewhere.