SPECIAL CORNEA ISSUE

The National Eye Bank Center… On the Cutting Edge

Providing pre-cut tissue to surgeons and local eye banks.

BY GERALD J. COLE

The National Eye Bank Center (NEBC) is the first centralized eye banking facility of its kind, and offers surgeons access to a large volume of ocular tissue for sight-restoring corneal transplant procedures and other ocular surgery. Recently expanded to more than double its original space, the NEBC facility is located in Memphis, Tenn., capitalizing on FedEx's global hub and a thriving biotech community. The NEBC boasts several clean rooms for aseptic processing of tissue and a state-of-the-art research and training area.

The NEBC is operated by Tissue Banks International (TBI), a non-profit network of eye and tissue banks. TBI established the NEBC in 2005 to more effectively offer precut corneas for emerging lamellar transplant techniques, improve operational efficiency and ease compliance with increasingly stringent regulatory requirements.

Each year, thousands of corneas are distributed by the NEBC, and the volume of tissue prepared at the facility continues to grow dramatically. The large concentration of ocular tissue at the NEBC allows TBI to direct tissue for its optimal use — whether for traditional corneal allografts, pre-cut corneas or the new TBI VisionGraft Sterile Corneas.

Services for Surgeons

TBI and the NEBC offer a wide range of ocular tissue for transplant. Tissue can be prepared to surgeon specifications to best meet the needs of individual patients. In addition to corneas available for penetrating keratoplasty (PKP), the NEBC offers a variety of other services.

A National Eye Bank technician pre-cuts tissue for corneal transplant with an IntraLase femtosecond laser.

These include:

■ Pre-cut corneas for lamellar keratoplasty. The NEBC was among the first eye-banking facilities to offer pre-cut corneas for Descemet's stripping automated endothelial keratoplasty (DSAEK) and anterior lamellar keratoplasty (ALK). Surgeons can select graft diameter and segment thickness. Technicians can also undermine tissue for DSAEK to ensure an even posterior cut for larger grafts. The suitability of the cut is verified using slit-lamp, cell counts and OCT imaging for the utmost in verifying corneal thickness and graft quality.

■ Pre-cut corneas for laser-enabled keratoplasty. The NEBC also offers pre-cut corneas for full-thickness keratoplasty using the IntraLase femtosecond laser. Surgeons can select any cut pattern including top-hat, mushroom, zigzag or their own custom cut.

Allowing the NEBC to pre-cut tissue for surgeries can provide significant time and cost savings to surgeons and surgical facilities. Costs for improperly cut tissue are absorbed by the eye bank, and there are no delays for equipment malfunction or maintenance. Processing fees for tissue prepared by the NEBC are typically a pass-through cost for insurance.

■ Other ocular tissue. The NEBC provides more than just corneas. Sclera in a variety of shapes and sizes is available, as is fascia latta, pericardium, limbal cell grafts and whole globes.

■ Services for local eye banks. Although the NEBC is operated by TBI and provided to the TBI network of eye banks, these same services are also available to any eye bank. This is an ideal service for eye banks that wish to take advantage of TBI's advanced tissue preparation, quality control and tissue safety. It is also a plus for surgeons who would like to utilize TBI's cornea-preparation services but prefer to use tissue obtained by their local eye banks for their transplant surgeries.

Advanced Technologies

The NEBC is on the cutting edge of eyebanking technologies. It has been among the first eye banking facilities to integrate new equipment and services into its operations.

■ Moria microkeratome. The Moria microkeratome remains the preferred method for preparation of pre-cut corneas for DSAEK and ALK. NEBC technicians have prepared thousands of pre-cut cornea allografts using the microkeratome and are highly-skilled in its applications.

■ Femtosecond laser. The IntraLase femtosecond laser is used at the NEBC by certified technicians to prepare corneas for laser enabled keratoplasty. The laser is also used for surgeons' custom preparation of corneal tissue as well as in the preparation of TBI's new Visiongraft Sterile cornea.

■ Visante OCT. The NEBC was the first and still one of few eye-banking facilities to implement optical coherence tomography into its eye-banking procedures using the Visante OCT imaging system. Corneas are screened with the Visante when they arrive at the NEBC to exclude donor tissue compromised by LASIK or other refractive procedures. Pre-cut corneas for DSAEK or ALK are screened after processing to verify the thickness, uniformity and quality of pre-cut tissue prior to its release for transplantation.

■ Operating room microscopes. Another area of distinction for the NEBC is its use of operating room microscopes in the preparation of pre-cut tissue. Use of these microscopes offers technicians better visualization of the cornea and contributes to more successful cuts.

NEBC's Latest: The VisionGraft Sterile Cornea

The VisionGraft Sterile Cornea was developed at the NEBC and made available for the first time in 2009. The VisionGraft Sterile Cornea (patent pending) is an irradiated cornea for use in tectonic transplant procedures. It offers additional patient safety and dramatic reduction in the risk for disease transmission. It is also ready to use at room temperature and shelf-stable for at least one year, making it ideal to have in stock for use in trauma/emergency procedures as well as for scheduled surgeries. It can be offered as a whole cornea graft or can be pre-cut to surgeon specifications.

■ For glaucoma. Many surgeons are now using the VisionGraft Sterile Cornea for coverage of glaucoma tubes and other applications in which sclera or pericardium would be used. The clarity of the material allows functional assessment of the tubes for drainage implant surgery and superior cosmetic results for patients.

■ For trauma. The VisionGraft Sterile Cornea is ideal for emergency procedures such as a cornea perforation. Because it is shelf-stable, doctors can have it ready as an inventory item, available whenever they need it, and won't need to call an eye bank to find emergency tissue.

■ Other applications. TBI anticipates other applications for the VisionGraft Sterile Cornea, with exciting potential for use in anterior lamellar and deep anterior lamellar procedures. Early surgical outcomes for these procedures have been promising and further evaluations are underway. It also shows potential for use in keratoprosthesis surgeries. The VisionGraft Sterile Cornea is not offered for use in penetrating keratoplasty or endothelial replacement transplants.

The National Eye Bank provides corneal transplant tissue for eyes such as this, which shows severe scarring and vascularization after corneal laceration.

The Future of the NEBC

TBI and the NEBC continue to look for new ways to better meet the needs of ophthalmologists and their patients. TBI is researching new pre-cutting techniques and continue to explore new applications for the VisionGraft Sterile Cornea. The NEBC anticipates continued growth in tissue volumes as cornea transplantation and other ophthalmic surgeries continue to evolve. Tissue Banks International is committed to being leaders in the eye banking community, and hope that surgeons can see the difference. OM

Gerald J. Cole is President and CEO of Tissue Banks International. Mr. Cole is a member of the Board of Directors of the Eye Bank Association of America and was recipient of the Eye Bank Association of America's Service Award in 1993. He is also active in the American Association of Tissue Banks and has authored articles for numerous publications.