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The Human Tissue “box” that shows up at your hospital or surgery center and its contents go through quite a journey, which we in the eye banking world call the Cycle of Giving, to reach your destination.
The Human Tissue “box” (Figure 1) that shows up at your hospital or surgery center and its contents go through quite a journey, which we in the eye banking world call the Cycle of Giving, to reach your destination.
The history of corneal transplants began more than 100 years ago in 1905 when the first surgery was performed.1 The first eye bank was established in New York City in 1944.2 As more eye banks were founded throughout the country, they formed a strong network which lead to the creation of the Eye Bank Association of America (EBAA) in 1961, the Cornea Society in 1975, and the development of medical standards for all accredited eye banks in 1980.2
In conjunction with the expanding presence and impact of eye banks, the Uniform Anatomical Gift Act (UAGA) was passed in 1968, establishing a regulatory framework for the donation of organs, tissues, and eyes in the U.S.2 This act ensured compliance with a donor’s wishes upon his death to donate to science, medicine, and education. This legislation has gone through two revisions over the years and has been adopted in some form in the majority of states.2
In addition, most states have implemented a donation symbol on their driver’s licenses which confirms an individual’s designation to be a part of her state’s registry as an eye, organ, and tissue donor. Today, most donor registrations have evolved to first-person authorizations, a legally binding agreement that ensures the donor’s wishes are carried out at the time of death.
The symbiotic advancements in the fields of eye banking and state donation policies have had a profound impact. As recently as 10 years ago, corneal transplant surgeons had to put their patients on a wait list until tissue became available. Now, due to the increased number of registered donors and ocular tissue available, surgeries can be scheduled in advance. Corneal transplants have become the most successful and most common form of human transplant performed.3
The Cycle of Giving begins with the need for ocular tissue.
It could be an individual with a progressive eye disease requiring a corneal transplant to preserve or restore his sight. It could be someone suffering from glaucoma who needs a piece of sclera for her glaucoma shunt. Or, it could be a scientist in need of human ocular tissue to take his research to the next level.
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The reasons may vary but the necessity is always there (Figure 2).
Next in the Cycle of Giving is the selfless act of individuals who committed to being a donor upon their passing or a family’s willingness to authorize the donation on behalf of their loved one.
At the time of their passing, hospitals are required by Centers for Medicare and Medicaid Services (CMS) conditions of participation to report the death to their designated Organ Procurement Organization (OPO).
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The OPO will then triage the donor’s information to the eye bank contracted with the hospital. The state’s first-person authorization registry will then be checked to see if the decedent chose to be a donor. If so, the eye bank will contact the next of kin (NOK) to inform them of their loved one’s wishes and to ask a series of medical and social history questions. If the decedent is not on the registry, the NOK will need to provide authorization in order to move forward with donation.
The medical and social history screening obtained by the eye bank, as well as a review of the donor’s medical information and records, is used to uncover any potential contraindications for donation as deemed by the U.S. Food and Drug Administration (FDA). This process is critical to ensuring the safety of ocular tissue for transplant.
As soon as the eye bank completes the screening and determines that the individual is a sutiable ocular donor, a trained eye bank technician is dispatched to the hospital, coroner’s office, or funeral home to procure the ocular tissue (Figure 3). The recovery must be completed within 24 hours of the individual’s death, or sooner, depending on certain research protocols.
The technician is trained to recover corneas, whole eyes, or specific ocular tissues following medical standards designed to cause the least amount of damage to the tissue as well as to treat the donor with the utmost level of dignity. In addition to the ocular recovery, the technician will draw a blood sample for serological testing of infectious diseases.
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Ocular tissue is then brought back to the eye bank, allowing the tissue evaluation process to begin (Figure 4). Each tissue is rated using specific criteria established by the eye bank’s medical director. The endothelial cell density of each cornea is determined using a specular microscope. The health of the cells and cell morphology are also thoroughly evaluated by the eye bank technician during this process.
Next, the ocular tissue is examined under a slit lamp looking for clarity, evidence of prior surgeries, trauma, foreign bodies, infections, dystrophies, and recovery damage to ensure the cornea is in the appropriate condition for transplant.
Most eye banks also utilize optical coherence tomography (OCT) to measure corneal thickness to ensure the tissue is prepared to a surgeon’s specifications.
The physical evaluation of the ocular tissue, donor medical and ocular history, and serologic testing results are reviewed as a whole in order to determine the suitability of the tissue for transplant. This final step is the eligibility determination, performed by an eye bank technician specifically knowledgeable in FDA, EBAA, and medical standards for one last review before a tissue is offered to a surgeon.
For each tissue requested by a surgeon, an eye bank distribution staff offers tissue specifically to meet the needs of an individual patient.
The surgeon specification includes the type of tissue best suited for each patient. The majority of corneal transplants are full thickness (for penetrating keratoplasty [PK], or eye bank-prepared partial thickness (for Descemet’s stripping with endothelial keratoplasty [DSEK] and Descemet’s membrane endothelial keratoplasty [DMEK]).
In order to accomplish all that is needed to meet each surgeon’s preferences, eye banks work 24 hours a day, seven days a week. Tissue not only needs to be recovered within 24 hours, it must also be evaluated, prepared, and in a surgeon’s hands within just a few days. Regulations state that tissue expires in 14 days, but surgeons in the United States typically require a much quicker turnaround (Figure 4).
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The FDA regulates all eye banks and completes unscheduled inspections to ensure recipient safety and to prevent the transmission of communicable disease. It is also important for all medical professionals to ensure that their local eye bank is accredited by the EBAA. The EBAA inspects each eye bank at least once every three years, though inspections may become more frequent if a location receives infractions.
Each eye bank is required to have a quality assurance program to ensure it is inspection ready at all times and is adhering to the policies and procedures established by the eye bank’s medical director, FDA, and EBAA.
The Cycle of Giving completes with a corneal transplant recipient of human ocular donor tissue. Current EBAA statistics show that eye banks provided nearly 80,000 corneas for transplant in 2015, a far cry from the few used back in 1944.2,4 In addition, a 2013 study revealed that the lifetime benefit of corneal transplants is an extraordinary $5.5 billion.5
Many donor families long to know the outcome of their loved one’s tissue. Eye banks encourage discussion with transplant patients about the gift they receive. The eye bank can then facilitate anonymous correspondence between donor families and recipients, share donor and recipient stories, and advocate for donation.
The following examples are excerpts from correspondence between a donor mom and a recipient.6
The donor mom wrote, “To know that my daughter’s corneas are helping you see the world more clearly has brought me much joy over the years.”
The cornea transplant recipient wrote back, “Not one day goes by that I don’t think about my donor and give thanks.”
An additional service most eye banks provide to surgical facilities is a Handling of Human Eye Tissue Program. A representative can come out to a hospital or surgery center to verify compliance with joint commission standards and provide education on the best practices for inspection of the tissue, tissue information sheets, tissue labels, understanding post-operative outcome forms, and adverse reaction forms.
The Cycle of Giving is complex but extremely successful in the United States. This success, however, is not met everywhere around the world and much more needs to be done.
Today, only one in 70 corneas required to restore sight to all in need are available worldwide. About half of the world is without access to corneal transplants, and the total need worldwide is estimated at more than 12 million. In order to fulfill this need and serve the global community, eye banks are working diligently to help develop eye banking in other countries.7
In addition to helping develop eye banking practices around the world, eye banks are involved in developing alternative therapies to eliminate corneal blindness. Approaches such as the use of a selective portion of the cornea to help several patients, gene therapy, autologous endothelial cells, and synthetic corneas are all being researched.
Eye banks will be working alongside corneal surgeons and researchers for optimal patient outcomes both today and in the future.
1. Crawford AZ, Patel DV, McGhee CN. A brief history of corneal transplantation: From ancient to modern. Oman J Ophthalmol. 2013 Sep;6(Suppl 1):S12-7.
2. Lee WB, Meinecke E, Varnum B. The Evolution of Eyebanking and Corneal. Transplantation: A Symbiotic Relationship. Int Ophthalmol Clinics. 2013;53:115- 29.
3. Chu W. The past twenty-five years in eye banking. Cornea. 2000 Sep;19(5):754-65.
4. Eye Bank Association of America. 2015 Eye Banking Statistical Report. Available at: http://restoresight.org/wp-content/uploads/2016/03/2015-Statistical-Report.pdf. Accessed 5/22/17.
5. Eye Bank Association of America. Vision-Restored Cornea Transplants Performed in 2013 Will Have a Lifetime Benefit of Nearly $6 Million. Available at: http://restoresight.org. Accessed 5/23/17.
6. Eversight Illinois. Vision. Spring 2017. Available at: http://eversightvision.org/illinois/about-us/publications.htm. Accessed 5/23/17.
7. Gain P, Jullienne R, He Z, Aldossary M, Acquart S, Cognasse F, Thuret G. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016 Feb;134(2):167-73.