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Eye Banking

An eye bank is a public institution licensed by the Minister of Health, Labour and Welfare, based on the Organ Transplant Law, that allocates corneas donated after death to patients awaiting corneal transplantation.

Its roles are summarized into the following three.

Securing Donors

Promotion of eye donation registration: Promoting a system to register one’s intention to donate eyes during lifetime.

General awareness activities: Providing accurate information about transplant medicine and supporting free decision-making.

Confirmation of intent at medical sites: Establishing a system to confirm the donor’s intention to donate will be an important future issue.

Safe supply of corneas

Infection screening: Serological tests are performed at the time of donation to prevent the introduction of infections.

Management based on medical standards: Records and management are conducted to ensure donated corneas are safely used for transplantation.

Fair and equitable supply

Waiting patient list: Each eye bank creates a list and allocates corneas in principle according to registration order.

Emergency and wide-area allocation: In emergencies such as corneal perforation, priority response is given according to prescribed procedures. If the facility cannot handle it, wide-area allocation to other prefectural eye banks is possible.

Overseas, the Eye Bank Association of America (EBAA) was established in 1961, standardizing procedures for tissue recovery, preservation, and distribution. The EBAA’s accreditation program is also recognized by the U.S. Food and Drug Administration (FDA).

Q How can I donate my corneas to an eye bank?
A

By registering as an eye donor with the eye bank in your prefecture, you can indicate your intention to donate your corneas after death. Even if you are not registered, donation is possible with the consent of your family. The important thing is to share your intention to donate with your family during your lifetime. You can find your nearest eye bank on the Japan Eye Bank Association website.

  • 1905: Zirm performed the world’s first human corneal transplant.
  • 1928: Filatov in the Soviet Union successfully performed transplantation using cadaver corneas, opening the way for donor tissue preservation.
  • 1944: Paton established the world’s first eye bank, the Eye Bank for Sight Restoration, in New York.
  • 1974: McCarey and Kaufman developed a corneal preservation medium, enabling storage for 7–10 days.
  • 1957: The first corneal transplant in Japan was performed at Iwate Medical University, causing social controversy due to lack of legal basis.
  • 1958: The Corneal Transplantation Act was enacted.
  • 1963: Keio University Eye Bank and Juntendo Eye Bank were established as the first eye banks in Japan.
  • 1965: The Japan Eye Bank Association (then the Japan Eye Bank Foundation) was established.
  • 1979: The law was revised to the Corneal and Kidney Transplantation Act.
  • 1997: The Organ Transplant Act was enacted, allowing organ donation from brain-dead donors.
  • 2010: The revised Organ Transplant Act allowed donation with family consent even without the donor’s written will, and enabled donation from individuals under 15.

3. Donor Eligibility Criteria and Evaluation

Section titled “3. Donor Eligibility Criteria and Evaluation”

Based on the Eye Donor Eligibility Criteria (revised December 1, 2023), the following conditions are contraindications for use.

ContraindicationExamples
Death of unknown cause
Active infectious diseaseSystemic
SeropositiveHIV, HBV, HCV, etc.
Slow virus infectionCJD, SSPE, PML
MalignancyIntraocular tumor, leukemia, etc.
OtherSARS

There is no age limit if no contraindications apply. Even with a history of eye conditions such as cataracts, glaucoma, myopia, or hyperopia, donation is possible if the cornea is clear.

Precautions (to be confirmed by interview)

Section titled “Precautions (to be confirmed by interview)”
  • Suspected CJD: History of human growth hormone administration, history of dura mater or corneal transplantation, history of overseas travel after 1980
  • West Nile fever: Overseas travel within 4 weeks before death, fever after return
  • Rabies: Overseas travel within 7 years, history of mammal bite abroad
  • Placenta injection history: History of human placental extract injection

Items requiring information provision to the transplant surgeon

Section titled “Items requiring information provision to the transplant surgeon”

If any of the following apply, it is not a contraindication but information should be provided to the transplant surgeon.

  • Alzheimer’s disease (requires differentiation from CJD)
  • Eyes with prior refractive surgery
  • Eyes with prior intraocular surgery
  • Endogenous eye diseases such as iritis
  • Positive syphilis serology
  • Positive HBc antibody

Measurement of corneal endothelial cell density is important in evaluating donor corneal quality. Endothelial cell density is confirmed by specular microscopy. The minimum endothelial cell density for transplantable corneas is generally 2200 cells/mm²1, 2).

Q Can I donate corneas even if I have eye diseases?
A

Yes, even if you have eye diseases such as cataracts, glaucoma, myopia, or hyperopia, donation is possible as long as the cornea is clear. There is no age limit. As long as there are no contraindicated infections or malignant tumors, many people can donate corneas.

4. Corneal retrieval, preservation, and supply

Section titled “4. Corneal retrieval, preservation, and supply”

After death, the donated eyeball is removed by a physician. For removal, the skin around the eye is disinfected, and a sterile field is secured with drapes. The conjunctiva is incised 360° along the limbus, Tenon’s capsule is dissected, and the rectus muscles are cut to remove the eyeball. Care is taken not to damage the eyelids or eyelashes.

Clean procedures are performed in a clean bench. The eyeball is disinfected with diluted PA-iodine solution, and the remaining conjunctiva about 5 mm from the limbus is dissected. A circular incision of the sclera is made parallel to the limbus with a width of 5–7 mm, and the iris and ciliary body are removed to obtain a corneoscleral button. Extreme care is taken not to damage the corneal endothelium.

The corneoscleral button is stored in preservation medium (Optisol-GS®) at 4°C. Surgery is ideally performed as early as possible after removal, and corneal transplantation is generally performed within 10 days.

In Europe, organ culture is widely used. It allows preservation at 34°C for up to 4–5 weeks1, 2), offering the advantage of longer storage compared to the 4°C storage method.

In corneal endothelial transplantation such as DSAEK and DMEK, pre-cut corneas processed in advance with a microkeratome or femtosecond laser may be used1). Overseas eye banks can also provide pre-cut corneas with a pre-stripped cap.

In Japan, corneal transplantation is performed based on the Act on Organ Transplantation (Organ Transplant Law). Only eye banks accredited by the Minister of Health, Labour and Welfare can coordinate transplants, and separate coordination permission is required for eyeballs and sclera.

Unless the individual has expressed in writing that they do not wish to donate, donation is possible with the consent of a representative as the consensus of the family. For individuals aged 12 to under 18, a committee document certifying that there is no abuse is required.

With the 2010 amendment, priority donation to relatives became possible when all of the following conditions are met:

  • The donor is 15 years of age or older
  • The donor indicates in writing their intention to donate organs and their intention for priority donation to relatives
  • The relative (spouse, child, or parent) is registered as a transplant candidate
  • Medical suitability criteria are met

However, donors who died by suicide are excluded from priority donation to relatives.

The physician who performed the transplant is required to keep the original transplant record for five years and report a copy to the coordinating eye bank.

Japan has experienced a chronic shortage of donor corneas for many years. There are also many potential waiting patients not included in the statistics of the Japan Eye Bank Association. The number of organ donors per million population in Japan is 0.88, which is significantly lower than in Spain (46.9), the United States (31.96), and South Korea (11.18).

To compensate for the domestic shortage of corneas, imported corneas from overseas eye banks (mainly from the United States) are widely used. Donor corneas from U.S. eye banks come with detailed information such as the donor’s infection history, medical history, and corneal endothelial cell count.

Responding to diversifying transplant techniques

Section titled “Responding to diversifying transplant techniques”

Corneal transplantation has diversified from penetrating keratoplasty (PKP) to endothelial keratoplasty (DSAEK), Descemet membrane endothelial keratoplasty (DMEK), deep anterior lamellar keratoplasty (DALK), and others. Accordingly, there is a demand for corneal grafts suitable for each procedure, such as pre-cut corneas, but domestic eye banks are not fully meeting this need, and corneas that match requirements are heavily dependent on imports.

The biggest challenge for eye banks today is to secure a sufficient number of donors and to supply safe corneas suitable for the diversifying transplantation techniques.

Q Why does Japan continue to face a shortage of corneas?
A

Although public interest in organ donation is increasing, only about 13% of people actually carry a donor card. Additionally, if the individual’s wishes are not shared with family members, those wishes may not be honored. It remains important to establish systems for confirming wishes in medical settings and to continue public awareness activities.

  1. Dunker SL, Veldman MHJ, Wisse RPL, et al. Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Trial. Ophthalmology. 2021;128(8):1152-1159.
  2. Darvish N, Gruenert A, Gabel-Obermaier B, et al. The Corneal Transplant Follow-up Study (COTS): HLA class II matching and corneal graft rejection. Br J Ophthalmol. 2022;106(1):132-138.
  3. Gain P, Jullienne R, He Z, Aldossary M, Acquart S, Cognasse F, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167-73. PMID: 26633035.

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