Eye banking and the EBAA

Eye banks are non-profit organizations that recover, evaluate, process, store, and distribute donated human corneas and other ocular tissue for transplantation, research, and education. In the United States, eye banking is coordinated and standardized largely through the Eye Bank Association of America (EBAA), the nationally recognized accrediting and standards-setting body for the field, while the donated tissue itself is regulated by the U.S. Food and Drug Administration (FDA) as a human cell, tissue, or cellular and tissue-based product (HCT/P).[1][2] The most common product of eye banking is the donor cornea, which is used in corneal transplantation (keratoplasty) to restore sight in people with corneal blindness or visual impairment.[3]

Eye banking is closely related to, but distinct from, solid-organ donation. Unlike hearts, livers, and kidneys, corneal tissue is avascular and can be recovered after circulatory death and stored for days, which makes ocular tissue substantially more abundant and logistically flexible than transplantable solid organs.[3][4]

Definition and scope

An eye bank acts as an intermediary between the eye donor and the surgeon. Its core functions are to receive donor referrals, obtain consent or authorization, recover ocular tissue, screen donors and test for transmissible disease, evaluate tissue quality, process tissue into surgeon-ready grafts, preserve and store it, and distribute it for transplantation, research, or training.[3] Eye banks share much of their regulatory and operational structure with the broader category of tissue bank, and ocular tissue is regulated under the same federal framework as other human tissue.[2]

The recovery and processing pipeline

Referral and authorization

Recovery begins with a death referral. Under the federal hospital Conditions of Participation, U.S. hospitals must notify their designated organ donation network of all deaths and imminent deaths, including notification of an organ procurement organization (OPO), an eye bank, and/or a tissue bank, so that the potential for donation can be evaluated.[5] OPOs, eye banks, and tissue banks may check the state donor registry to determine whether the deceased registered as a donor; if there is no first-person registration, consent (authorization) for donation is sought from the next of kin or other legally authorized representative.[6]

Because corneal tissue is recovered after death rather than from a beating-heart donor, ocular recovery is time-sensitive but is generally performed within roughly 24 hours of death, and recovery is often coordinated with, or follows, organ and other tissue recovery for the same donor.[6]

Recovery

Recovery is performed either as whole-globe (enucleation) removal or, increasingly, as in-situ excision of the corneoscleral disc, by a trained technician under aseptic conditions. The cornea, together with a rim of surrounding sclera (the corneoscleral rim), is the principal tissue retrieved for transplantation.[3]

Serologic and infectious-disease testing

A blood sample from the donor is tested for relevant communicable disease agents and diseases. FDA regulation requires that all HCT/P donors be screened and tested for agents including HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and others, and that a donor-eligibility determination be made before the tissue is released for transplantation.[2][7]

Evaluation: slit-lamp and specular microscopy

Recovered corneas are graded for transplant suitability. Slit-lamp biomicroscopy is used by eye-bank technicians or ophthalmologists to inspect the epithelium, stroma, and endothelium for defects, scars, infiltrates, folds, or surgical scars that would disqualify the tissue.[3] Specular microscopy is used to image the corneal endothelium and to measure endothelial cell density (ECD), the count of endothelial cells per square millimeter, which is a key determinant of a graft's suitability and longevity.[3][8]

Processing for lamellar keratoplasty (DSAEK and DMEK pre-cut tissue)

Modern eye banks increasingly deliver surgeon-ready, partial-thickness grafts rather than only whole corneas, mirroring the shift from full-thickness penetrating keratoplasty (PK) toward endothelial keratoplasty.[3][8]

• For Descemet stripping automated endothelial keratoplasty (DSAEK), the corneoscleral rim is pressurized and a microkeratome is used to dissect the cornea, leaving a thin posterior layer of stroma with Descemet membrane and endothelium as the donor graft.[8]
• For Descemet membrane endothelial keratoplasty (DMEK), eye banks prepare ("pre-strip" or "pre-load") an even thinner graft consisting of only Descemet membrane and endothelium, commonly using a submerged technique (sometimes called SCUBA, submerged cornea using backgrounds away) to separate the membrane while minimizing endothelial damage.[8]

This pre-cutting and pre-loading work shifts technically demanding tissue preparation from the operating room to the eye bank, where it is performed under controlled, validated conditions.[8]

Storage media

Donor corneas intended for transplantation in the United States are typically preserved by cold (hypothermic) storage in a chondroitin-sulfate-based corneal preservation medium, most commonly Optisol-GS, and held at approximately 2 to 8 degrees Celsius until distribution. This preservation approach permits storage for a number of days, allowing time for testing, evaluation, processing, and shipment.[3][8]

Distribution

Once a donor is determined eligible and the tissue is evaluated, processed, and released, the eye bank distributes it to a transplant surgeon for a scheduled procedure, or directs tissue not used clinically toward research and surgical training.[3]

The Eye Bank Association of America (EBAA)

Founding and role

The EBAA was established in 1961, growing out of the American Academy of Ophthalmology and Otolaryngology; it began with 38 founding eye banks and has since expanded across the United States and to Canada, Puerto Rico, and internationally.[1] EBAA describes itself as the nationally recognized accrediting and standards-setting body for eye banks, with the stated mission of restoring sight worldwide.[1]

Medical Standards, accreditation, and certification

EBAA adopted its first set of Medical Standards at its annual meeting in 1980, establishing baseline requirements for the recovery, evaluation, preservation, and distribution of ocular tissue. Building on those standards, the association launched its eye-bank accreditation program in 1981 to verify member compliance, and it established the Certified Eye Bank Technician (CEBT) credential to support the competence and professionalism of personnel who recover, process, and evaluate ocular tissue.[1][9] EBAA's Medical Standards and accreditation framework operate alongside, and are intended to be consistent with, FDA's federal regulation of ocular tissue.[1][2]

Statistical reporting

EBAA collects and publishes annual eye-banking statistics from its member banks, providing the primary public source of U.S. eye-banking volume data.[10] As a long-running cumulative milestone, EBAA reported that its member eye banks transplanted the two-millionth cornea provided by member institutions in September 2019.[1]

Key statistics

The following figures are drawn from EBAA's annual eye-banking statistical reporting and are point-in-time values that should be re-confirmed against the latest EBAA report at the time of use.

According to EBAA reporting for calendar year 2025:[10]

• U.S. eye banks recovered 143,081 ocular tissues from 72,143 donors.
• 52,396 keratoplasty procedures were performed domestically in the United States (up about 1.6 percent from 2024).
• The most common domestic procedures were DMEK (19,042), DSAEK (15,953), and PK (14,802), reflecting the dominance of endothelial (partial-thickness) keratoplasty.
• 25,565 tissue units were exported internationally (down about 4.4 percent from 2024).
• 86,261 units of U.S. tissue were distributed for keratoplasty overall (domestic plus export).
• 23,213 ocular tissues were provided for research and training.
• About 66.7 percent of corneal donors were listed on a donor registry.

EBAA also reports that, cumulatively since 1961, its member eye banks have provided tissue for more than 2,549,946 individuals whose sight was restored through corneal transplantation (figure as of EBAA's 2025 reporting).[10]

For context, EBAA's 2024 report (the prior cycle) recorded 141,735 total ocular tissue recoveries from 71,778 donors, with both donors and total corneas donated up roughly 3 percent over 2023.[3]

Abundance of corneal tissue versus solid-organ scarcity

Eye banking is notable for a comparatively favorable supply position relative to solid-organ donation. Because the cornea is avascular, can be recovered after cardiac death, and can be stored for days under hypothermic preservation, a large share of deaths can yield transplantable corneal tissue, and U.S. eye banks routinely recover and export a surplus.[3][4] By contrast, solid organs such as kidneys, livers, and hearts require near-immediate transplantation, depend on a much smaller pool of eligible (often brain-dead, ventilated) donors, and remain in chronic shortage relative to waiting lists.[4] In the United States, domestic demand for corneas is generally met, which is why a substantial volume of U.S.-recovered tissue is exported each year.[3][10]

International eye banking and the global cornea shortage

The relative abundance of corneal tissue in the United States is not mirrored worldwide. A widely cited global survey by Gain and colleagues, published in 2016, found that corneal transplant tissue is critically scarce in much of the world: the authors estimated only about one cornea available for every 70 needed and reported that roughly 53 percent of the world's population had little or no access to corneal transplantation.[11] The same survey identified on the order of 184,000 corneal transplants performed in 2012 across 116 countries, supplied by hundreds of eye banks, while large populations remained underserved.[11] The World Health Organization recognizes corneal opacity as a significant cause of avoidable blindness and visual impairment globally, underscoring that the principal global constraint is access to safe donor tissue and surgical capacity rather than the biology of the graft itself.[3][11]

These disparities drive both international tissue sharing (including export of surplus U.S. tissue) and research into complementary solutions such as corneal bioengineering and cultured endothelial-cell therapies.[3][11]

FDA regulation and donor eligibility

Ocular tissue for transplantation is regulated by the FDA as a human cell, tissue, or cellular and tissue-based product (HCT/P) under Title 21 of the Code of Federal Regulations, Part 1271. Establishments that recover, process, store, or distribute corneas must register and list their HCT/Ps with the FDA, follow current good tissue practice to prevent contamination and disease transmission, and make a documented donor-eligibility determination based on donor screening and testing before tissue is released for transplant.[2][7] See FDA regulation of human tissue (HCT/Ps) for the full regulatory framework.

Donor screening includes a review of the donor's medical and behavioral history for risk factors and relevant communicable disease agents and diseases, and laboratory testing of a donor blood sample (for example, for HIV, HBV, and HCV).[2][7] Certain conditions of the eye or general health (for example, active ocular infection, prior corneal surgery affecting graft quality, or specified transmissible diseases) can render tissue ineligible for transplantation; such tissue may instead be directed to research or training where permitted.[3][7] EBAA's Medical Standards layer additional eye-specific quality and eligibility requirements on top of the federal baseline.[1][2]

Ethics, consent, and the OPO relationship

As with all deceased donation, eye banking depends on valid consent or authorization, either through first-person donor registration or through authorization by a legally authorized representative, and on the ethical principle that recovery should respect the wishes and dignity of the donor and family.[6] Because hospitals are required to refer all deaths to a donation network, eye banks frequently receive referrals through, and coordinate recovery with, OPOs and tissue banks; a single donor may give organs, eye tissue, and other tissue, with recovery sequenced among the recovering agencies.[5][6] This coordination is intended to maximize the gift of donation while ensuring that each recovering organization operates within its own regulatory and consent obligations.[5][6]

See also

• Corneal transplantation (keratoplasty)
• Tissue bank
• FDA regulation of human tissue (HCT/Ps)
• Organ donation

References

• Eye Bank Association of America. "History of EBAA and Eye Banking." https://restoresight.org/about-us/history-of-ebaa-and-eye-banking/
• Electronic Code of Federal Regulations. "21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products." https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
• American Academy of Ophthalmology (EyeWiki). "Eye Banking." https://eyewiki.org/Eye_Banking
• Gain P, Jullienne R, He Z, et al. "Global Survey of Corneal Transplantation and Eye Banking." JAMA Ophthalmology, 2016. https://aurionbiotech.com/wp-content/uploads/2021/04/JAMA-survey-2016.pdf
• Electronic Code of Federal Regulations. "42 CFR 482.45 - Condition of participation: Organ, tissue, and eye procurement." https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-C/section-482.45
• Donate Life New York State / New York State Department of Health. "Organ Donation Frequently Asked Questions." https://www.health.ny.gov/professionals/patients/donation/faqs.htm
• U.S. Food and Drug Administration. "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products
• Eye Bank preparation of endothelial keratoplasty grafts (DSAEK/DMEK), peer-reviewed literature. "Eye-bank Preparation of Endothelial Tissue." PubMed Central. https://pmc.ncbi.nlm.nih.gov/articles/PMC4131679/
• Eye Bank Association of America. "EBAA Procedures Manual." https://restoresight.org/wp-content/uploads/2017/12/EBAA-Procedures-Manual-2017.pdf
• Eye Bank Association of America. "Statistical Report" (annual eye-banking statistical reporting; figures cited from the 2025 report). https://restoresight.org/members/publications/statistical-report/
• Gain P, Jullienne R, He Z, et al. "Global Survey of Corneal Transplantation and Eye Banking" (global shortage estimates: 1 cornea available per 70 needed; ~53% of the world's population with little or no access). JAMA Ophthalmology, 2016. https://www.semanticscholar.org/paper/Global-Survey-of-Corneal-Transplantation-and-Eye-Gain-Jullienne/412698b39e76476dba9658d137faa96598809683