Center For Sight ophthalmologist William Lahners, M.D., has been selected to participate in the national “Cornea Preservation Time Study” to determine if corneas transplanted up to two weeks after donation work as well as corneas transplanted up to one week after donation. About 40 clinical sites around the country, including Center For Sight, are conducting the study sponsored by the National Eye Institute of the National Institutes of Health.
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The supply of donated corneas nationwide meets current needs – about 46,000 transplants in 2011. But with an aging population and health concerns about the future donor pool, researchers want to ensure the supply can meet an expected growth in demand over the next two to three decades.
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“Over the past 20 years, corneal transplant specialists have gotten comfortable using corneas up to one week after being harvested from the donor, when in fact the donor tissue can be used up to two weeks later,” said Dr. Lahners, Medical Director and Director of Laser Vision Services at Center For Sight. Dr. Lahners is a fellowship-trained in Cornea and External Disease, Refractive Surgery, and Glaucoma. He was recently honored by the American Academy of Ophthalmology – earning prestigious Achievement Award for his research and presentations on vision correcting technologies. He is also an Assistant Clinical Professor of Ophthalmology for the University of South Florida.
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Interested patients may call senior clinical research coordinator Ginger Mortiz, R.N., at 941-925-2020 to learn more.
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The U.S. Food and Drug administration permits corneas to be stored in preservation medium at refrigerator temperature up to two weeks after donation. Presently, the excess supply of donated corneas in the United States – about 20 percent annually – are shipped overseas where they are successfully transplanted more than a week after donation. “The result of doubling the window for corneal transplants will increase the pool of donated corneas; an important public health concern,” Dr. Lahners said.
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Patients who need corneal transplants are typically 50 and older. According to projections by the U.S. Census Bureau, that population will grow from about 99 million in 2011 to about 133 million by 2030 in this country. While the number of patients will grow the number of potential donors is waning.
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“All of these issues disqualify potential donors: food contamination, such as madcow disease and the recent listeria outbreak in cantaloupe; the growing number and spread of infectious diseases such as HIV and West Nile virus, which have no cure; high-risk behaviors such as methamphetamine use – which is at epidemic levels in some parts of the country – IV drug use and imprisonment; the growing number of people diagnosed with Alzheimer’s or other neurologic diseases of unknown origin; and the aging population itself, which is less suited to donate because corneas age and deteriorate;” explained Dr. Marian Macsai, Chief of the Division of Ophthalmology at NorthShore University Health System and current chair of the Eye Bank Association of America. “Add them up and you’ve got a shrinking donor pool.”
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“In addition to fewer donors to rely on, the growing list of disqualifiers requires greater scrutiny of the sources,” Dr. Lahners said. “We need more time to analyze the donor and test blood to ensure the safety of the recipient and quality of the cornea received.”
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The five-year study is being conducted in Sarasota as well as at university-based and private clinics across the United States. Researchers will compare the outcomes of 1,330 corneal transplants. Half the patients will receive transplants within seven days of donor death, half within eight to 14 days.
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People suffering from diseases affecting the corneal endothelium, the critical back cell layer of the cornea that keeps the cornea from swelling, including Fuchs’ Endothelial Corneal Dystrophy, an age-related disease that may be inherited; and pseudophakic/aphakic corneal edema, a complication following cataract surgery, will be enrolled.
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All patients will undergo a corneal transplant called an endothelial keratoplasty. The surgeon takes a slice from the back of a healthy donated cornea, opens a small slit in the patient’s eye, scrapes out the diseased endothelial cells and replaces them with the donor cells. Transplant patients will be examined over the next three years, to determine if the cornea has remained clear or becomes clouded due to poor functioning or death of the transplanted cells.
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Although results of the study directly apply only to the use of donor corneas used for this specific operation and these conditions, researchers hope that results could be extended to donor corneas used for other types of transplants and other diseases.
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“The Cornea Preservation Time Study is a model for the type of research we must continue to pursue in order to creatively target critical issues such as donor organ shortages,” said Dr. Lahners. “This project offers the potential of immediate, life-altering impact for thousands of people.
