Eye Bank Association Kerala
Reg.No.ER.47/1970
St.Alphonsa Block
Little Flower Hospital & Research Centre
Angamaly-683572
Ph:09747115757,0484-3954740, 0484-3096666 E-mail:eyebankang@gmail.com
Eye Donation
1. Introduction

Eye donation is an act of donating one's eyes (Cornea) after his/her death. It is an act of charity, purely for the benefit of the society and is totally voluntary. No eye donation is possible without the consent of the relatives and unless the relatives are motivated, they do not sign the consent. The motivational force has to come from friends, neighbors, colleges, volunteers and social workers. It is one of the biggest challenges faced by health care professionals and social workers. Motivation for eye donations are carried out at various levels like self-motivated eye donation, motivation through volunteers and hospital based programmes.



2. Contraindications for Eye Donation

The decision to perform the eye donation is depended only after checking the records of the diseased. Some disease can potentially be transmitted by corneal transplantation and hence have to be ruled out. The list of conditions/diseases which are considered to be the contraindications are the following.

 Contraindications for eye donation
1 Active Viral Hepatitis
2 Acquired immunodeficiency syndrome (AIDS) of HIV
3 Active viral encephalitis or encephalitis of unknown origin
4 Creutzfeldt-Jakob disease
5 Suspected rabies and persons who, within the past six months, were bitten by an animal suspected to be infected with rabies
CONDITIONS WITH POTENTIAL RISK OF TRANSMISSION OF LOCAL OR SYSTEMIC COMMUNICABLE DISEASE FROM DONOR TO RECIPIENT
6 Death of unknown cause and likelihood of exclusionary criteria as outlined in this list
7 Death with progressive neurodegenerative disease of unknown etiology, including but not limited to the following:

1. Chronic idiopathic demyelinating polyneuropathy
2. Amyotrophic lateral sclerosis
3. Multiple sclerosis
4. Huntington’s chorea
5. Alzheimer’s disease
6. Dementia (exceptions include dementia due to CVA, brain tumor, head trauma, or medication or drug-induced)
7. Myasthenia gravis
8. Parkinson’s syndrome
9. Parkinson’s like disease
10. Creutzfeldt-Jakob disease
8 Active meningitis
9 Active viral encephalitis of unknown origin or progressive encephalopathy (including but not limited to subacutesclerosingpanencephalitis, and progressive multifocal leukoencephalopathy)
10 Active septicemiaat the time of death

Septicemia at any time prior to death – i.e. hospital admission – which is shown through clinical evidence to not be present just prior to or at the time of death, may be acceptable for transplantation.

Clinical evidence of sepsis (including, but not limited to, bacteremia, viremia, fungemia, septicemia, sepsis syndrome, systemic infection, systemic inflammatory response syndrome (SIRS), or septic shock):

1) Clinical evidence of infection; and
2) Two or more of the following systemic responses to infection if unexplained by other disease processes:
a) Temperature of >38○ C (100.4○ F);
b) Heart rate >90 beats/min;
c) Respiratory rate >20 breaths/min or PaCO2 <32; or
d) WBC > 12,000 cells/mm3, <4,000 cells/mm3, or >10% immature (band) forms.
3) More severe signs of sepsis include unexplained hypoxemia, elevated lactate, oliguria, altered mentation, and hypotension.
4) Positive (pre-mortem) blood cultures might be associated with the above signs.

The following are examples of specific exclusions for systemic viral disease (viremia) which is active at the time of death: Active Chikengunia, Active H1N1 Influenza, Active Dengue Fever
11 Active viral hepatitis
12 Congenital rubella
13 Reye’s syndrome
14 Suspected rabies and persons who, within the past six months, were bitten by an animal suspected to be infected with rabies
15 Active miliary tuberculosis
16 Patients on ventilator for >72 hrs
17 Hepatitis B surface antigen positive donors
18 HTLV-I or HTLV-II infection
19 Hepatitis C seropositive donors
20 HIV seropositive donors
21 Active syphilis or seropositive for syphilis. It is acceptable to transplant an “RPR reactive” donor tissue only if a subsequent FTA confirmatory test on the same blood sample results “FTA negative.” In this case, the donor is considered seronegative for Syphilis.
22 Leprosy
  CONDITIONS WITH POTENTIAL RISK OF TRANSMISSION OF NON-COMMUNICABLE DISEASE FROM DONOR TO RECIPIENT
  Death due to cyanide poisoning
23 Intrinsic eye disease

1. Active ocular or intraocular inflammation conjunctivitis, sclerits, iritis, uveitis, vitreitischoroiditis, keratitis, and retinitis (at the time of death).
2. Retinoblastoma.
3. Malignant tumours of the anterior ocular segment.
4. Known adenocarcinoma in the eye of primary or metastatic origin.
24 Potential contamination from drowning. Drowning cases must be reviewed and approved on a case-by-case basis by the Medical Director The following maligancies of blood or lymphatic system:

1. Hodgkins disease
2. Lymphosarcoma
3. Myelomas
4. Leukemias
5. Active disseminated lymphomas
  CONDITIONS THAT WILL AFFECT GRAFT OUTCOME
25 Congenital or acquired disorders of the eye that would preclude a successful outcome for the intended use (e.g. a central donor corneal scar for an intended penetrating keratoplasty, keratoconous, or keratoglobus). Corneas which have undergone refractive surgical procedures, etc.

NOT SUITABLE FOR PKP OR ALK:
i. superficial disorders of the conjunctiva or corneal surface involving the central optical area of the corneal button
ii. Prior surgery which compromises the corneal stroma
iii. Local eye disease, disorder, or pathology affecting the anterior stroma

NOT SUITABLE FOR PKP OR EK:
i. Local eye disease, disorder, or pathology affecting the posterior stroma or corneal endothelium
ii. Endothelial density below 2000 cells per square millimeter

Scleratissue for transplantation:

i. Criteria are the same as listed for penetrating keratoplasty, except that tissue with local eye disease, disorder, or pathology affecting only the cornea (listed above) is acceptable for use.
ii. Structural defects will not be acceptable for use

BEHAVIORAL / HISTORY, LABORATORY AND MEDICAL EXCLUSION CRITERIA.
HIV or high risk for HIV corneas from: persons meeting any of the following criteria should not be offered for transplantation
26 Men who have had sex with other men in the preceding 5 years (homosexual behavior)
27 Persons who report nonmedical intravenous, intramuscular, or subcutaneous injection of drugs in the preceding 5 years (IV drug abuse)
28 Persons with hemophilia or related clotting disorders who have received human-derived clotting factor concentrate
29 Men and women who have engaged in sex for money or drugs in the preceding 5 years (commercial sex workers)
30 Persons who have had sex in the preceding 12 months with any person described in item 26-29 above or with a person known or suspected to have HIV infection
31 Persons who have been exposed in the preceding 12 months to known or suspected HIV-infected blood through percutaneous inoculation or through contact with an open wound, or mucous membrane
32 Children meeting any of the exclusionary criteria listed above for adults should not be accepted as donors
33 Children born to mother with HIV infection or mothers who meet the behavioral or laboratory exclusionary criteria for adult donors regardless of their HIV status should not be accepted as donors unless HIV infection and be definitely excluded in the child as follows:

i) children >18 months of age who are born to mothers with or at risk for HIV infection, who have not been breast fed within the last 12 months and whose HIV antibody tests, physical examination, and review of medical records to not indicate evidence of HIV infection can be accepted as donors

ii) Children < 18 months of age who are born to mothers with or at risk for HIV infection or children of mothers with or at risk of HIV infection who have been breast fed within the past 12 months should not be accepted as donors regardless of their HIV test results
34 Persons who cannot be tested for HIV infection because of refusal, inadequate blood samples (e.g. haemodilution that could result in false-negative tests), or any other reasons
35 Persons with a repeatedly reactive screening assay for HIV-1 or HIV-2 antibody regardless of the results of supplemental assays
36 Persons whose history, physical examination, medical records, or autopsy reports reveal other evidence of HIV infection or high-risk behavior, such as diagnosis of AIDS, unexplained mucous membranes hemorrhages kaposi’s sarcoma, unexplained lymphadenopathy lasting >1 month, unexplained temperature > 100.5F (38.6 C) or >10 days, unexplained persistent diarrhea, male-to-male sexual contact, sexually transmitted diseases, or needle tracks or other signs of parenteral drug abuse

Physical evidence of recent tattooing, ear piercing, or body piercing. Persons who have undergone tattooing, ear piercing, or body piercing in the preceding 12 months, in which sterile procedures were not used (e.g., contaminated instruments and or/ink were used), or instruments that had not been sterilized between uses were used
37 Persons who have been incarcerated or served time in prison >72 hours
38 Persons living with another person with Hepatitis B or C
 INTERVAL BETWEEN DEATH, ENUCLEATION, EXCISION, AND PRESERVATION
39 Death-to-Preservation time varies according to circumstances of death, storage of the body after death, and storage of tissue between enucleation and preservation in media.
» If ambient temperature is hot (e.g. summer weather), then eyes must be preserved or refrigerated within six (6) hours of death

» If ambient temperature is not hot (e.g. winter weather), then eyes must be preserved or cooled within eight (8) hours of death

» If ocular area including eyes, or the entire body, or enucleated eyes are continuously cooled within the above constraints of 6 or 8 hours, respectively, then tissue can be preserved no later than 24 hours from time of death

With documentation, the above time requirements maybe waived on a case-by-case basis if tissue is continuously refrigerated and deemed medically suitable by the medical director. Factors to consider include mortuary cleanliness and documentation of cooling / temperature log.




 
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