Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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B.1.1. ACTIVITIES

B.1.1.1.Donor detection

See generic requirements in section A.3.1.1

B.1.1.2.Donor consent

See generic requirements in section A.3.1.2

B.1.1.3. Donor evaluation

B.1.1.3.1.General

The suitability of a specific individual for eye tissue and placental tissue donation should be documented and should be based on medical and social history, clinical status, physical assessment, testing and autopsy (if performed) according to the generic EU GTPs (see generic requirements in section A.1.).

B.1.1.3.2. Medical evaluation

See generic requirements in section A.3.1.6.

B.1.1.3.2.1.Anamnesis

See generic requirements in section A.3.1.6

B.1.1.3.2.2.Social evaluation

See generic requirements in section A.3.1.6.3

B.1.1.3.2.3. Physical evaluation

1. All prospective ocular tissue donors should undergo a thorough physical examination as close as possible prior to donation with special attention to physical signs of HIV disease, infectious hepatitis, and injecting illegal drug use (see generic requirements in section A.3.1.6.4).  Additionally gross inspection of the orbit with special concentration on the cornea with a view to the medical contra indications (see A.3.1.6.5) should be performed.  Each eye bank should have a consistent policy for conducting and documenting this examination.

 

B.1.1.3.2.4.Exclusion criteria

1. The selection criteria for ocular tissue donors are based on a risk analysis in relation to the use of the donor tissue.  Indications for such risks are to be identified with the help of anamnesis, appropriate sources such as donor's medical files and consultation of treating physicians, biological testing, post mortem examination, and other suitable examinations, e.g. autopsy results.  Unless the donation is justifiable based on a documented risk evaluation performed by the responsible person, donors are to be excluded from donating, if one or more of the exclusion criteria should apply.

2. The Minimum set of contraindications for use of ocular tissue for transplant purposes are set out below.  Individual eye banks may have additional exclusionary criteria.  Some criteria listed as generally exclusionary may be acceptable depending on the storage method used for tissue preservation.

B.1.1.3.2.4.1.Exclusion criteria for cornea donors: Penetrating Keratoplasty

1. In addition to the exclusion criteria mentioned section A.3.1.6.5. of the generic GTP requirements, screening of ocular tissue donors should be conducted for the following disorders, which are potentially health threatening for the recipient(s) or pose a risk to the success of the surgery, and should not be offered for surgical purposes:

B.1.1.3.2.4.1.1.Post Mortem Time

Corneal preservation should occur as soon as possible after death, however no later than seventy two (72) hours post mortem for donor corneas intended for organ culture, and no later than sixteen (16) hours post mortem for donor corneas intended for short-time cultivation (hypothermic storage).  All time intervals for each donor (death to enucleation and preservation) should be recorded.

B.1.1.3.2.4.1.2. Eye diseases and ocular surgery

a)     Ocular inflammation (including known ocular involvement by systemic disease);

b)    Congenital or acquired disorders of the eye or previous ocular surgery that would prejudice graft outcome;.

c)     Malignant tumours of the anterior segment;.

d)    Receipt of a corneal, scleral or limbal graft;

e)     Malignant tumours of the eye e.g. retinoblastoma, melanoma, adenocarcinoma; also congenital, malignant posterior chamber-tumours;

f)     Corneal disorders including keratoconus, keratoglobus, dystrophy;

g)     Corneal opacity, scarring, or pterygium, which involves the central optical area of the corneal button (may be considered for posterior lamellar procedures).

Intrinsic eye disease

a)     Active ocular or intraocular inflammation: conjunctivitis, keratitis, scleritis, iritis, uveitis, vitreitis, choroiditis, retinitis;

b)    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, keratoconus, and keratoglobus;

c)     Pterygia or other superficial disorders of the conjunctiva or corneal surface involving the central optical area of the corneal button.

Prior intraocular or anterior segment surgery

a)     Refractive corneal procedures, e.g., radial keratotomy, lamellar inserts, etc.

b)    Laser photoablation surgery is allowed to be used in cases of tectonic grafting and posterior lamellar procedures.

c)     Corneas from patients with anterior segment (e.g., cataract, intraocular lens, glaucoma filtration surgery) may be used if screened by specular microscopy and meet the Eye Bank’s endothelial standards.

d)    Laser surgical procedures such as argon laser trabeculoplasty, retinal and panretinal photocoagulation do not necessarily preclude use for penetrating keratoplasty but should be cleared by the medical director.

e)     Corneal surgery e.g. radial keratotomy, laser refractive surgery: photorefractive keratectomy (PRK) or laser in situ keratomileusis (LASIK)

f)     Excimer (Lasik, Lasek etc.), past PKPs and other refractive surgeries (ast. KT, PTK, rad. KT etc.) are not acceptable if usage is planned for PKP, DALK, LKP; if usage is planned for DLEEK, DSAEK it would be acceptable.

Many defects or disorders, and many surgeries on the eye e.g. for cataract removal, glaucoma, retinal therapy are not contraindications, where corneal tissue is screened by endothelial microscopy.  They should not be considered contraindications to donation but the cornea should be assessed for suitability for the intended surgical procedure.

B.1.1.3.2.4.1.3. Infections

Persons with significant local bacterial, viral, parasitic or mycotic infection including meningitis of the eye cannot be considered as ocular tissue donors.

Donors suffering from bacterial forms of septicaemia may be acceptable at the discretion of the eye bank medical director but only when the corneas are stored in an organ culture which allows detection of a potential bacterial contamination of the tissue.

B.1.1.3.2.4.1.4. Invalid laboratory test results

Tissue banks may only accept tissue from donors with a plasma dilution of more than fifty (50) per cent, if the test methods applied to such plasma are validated.

B.1.1.3.2.4.1.5. Vaccination

Persons who received a post-expositional vaccination against rabies within the last twelve (12) months or a live vaccination, e.g. against poliomyelitis, yellow fever, rubella, measles, mumps, within the last four (4) weeks prior to removal of the cornea cannot be considered as donors.

B.1.1.3.2.4.1.6. Malignancies

Donors suffering from malignant diseases may be considered for cornea donation, except donors suffering from retinoblastoma, haematological neoplasia and malignant tumours of the fundus.

B.1.1.3.2.4.1.7. Donor age

Provided that corneas are examined to exclude those with inadequate endothelium, no upper donor age limit needs to be set, but other age-related corneal changes must be taken into account.  The lower age limit is less certain and will depend on surgical demand.

B.1.1.3.2.4.2. Exclusion criteria for ocular tissue donors: Anterior Lamellar or Patch Keratoplasty

Criteria are the same as listed for penetrating keratoplasty except that tissue with local eye disease affecting the corneal endothelium or previous ocular surgery that does not compromise the corneal stroma e.g. aphakia, iritis, is acceptable for use.  Death to preservation time may be extended.

B.1.1.3.2.4.3. Exclusion criteria for ocular tissue donors: Posterior Lamellar / Endothelial Keratoplasty

Criteria are the same as listed for penetrating keratoplasty except that tissue with local non-infectious anterior pathology that does not affect the posterior stroma and endothelium is acceptable for use.  Surgeons should be notified of any such pathology prior to placing the tissue for transplant.

B.1.1.3.2.4.4. Exclusion criteria for ocular tissue donors: Epikeratoplasty

Criteria are the same as listed for penetrating keratoplasty except that tissue with local eye disease affecting the corneal endothelium e.g. aphakia, iritis, is acceptable for use.  Death to preservation time may be extended.

B.1.1.3.2.5. Exclusion criteria for scleral tissue donors

Criteria are the same as listed for penetrating keratoplasty except that tissue with local eye disease affecting the cornea is acceptable for use.  Death to preservation time may be extended.

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