Monday, May 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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44. Past refractive surgeries of donor corneas are acceptable if donor corneas are planned for

 

o

Penetrating keratoplasty (PKP)

o

Deep anterior lamellar keratoplasty (DALK)

o

Lamellar keratoplasty (LKP)

o

Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

 

45. After enucleation

 

o

the bulbus should be immersed in organ culture solution

o

the eye area and conjunctiva should be disinfected using a suitable disinfectant (e.g. PVD iodine)

o

the donor appearance is to be restored

o

the maximum recommended storage time of whole eye in moist chamber is 72 hours.

 

46. Corneas intended for organ culture should be preserved as soon as possible after death, however no later than

 

o

16 hours post mortem

o

24 hours post mortem

o

48 hours post mortem

o

72 hours post mortem.

 

 

47. Corneas intended for short-term hypothermic storage should be preserved as soon as possible after death, however no later than

 

o

16 hours post mortem

o

24 hours post mortem

o

48 hours post mortem

o

72 hours post mortem.

 

 

48. The excised corneoscleral discs that are to be transplanted as a viable living tissue may be stored

 

o

in organ culture medium at temperatures from +10 to +40°C

o

in hypothermic storage medium at temperatures below 0°C

o

according to the instructions prescribed by the medium/solution manufacturer

o

by freezing at sub-zero temperatures between -75ºC to - 196ºC for up to 2 years.

 

 

49. Microbiology testing

 

o

is to be performed from the organ culture medium surrounding the donor cornea within 72 hours after cornea excision

o

is not required during hypothermic storage of corneas

o

is necessary from the organ culture medium only in the case of suspected contamination

o

method should be chosen and validated by taking into account antimicrobial effects of antibiotics in the culture medium / preservation solution.

 

 

50. Microscopic evaluation for corneas intended for penetrating keratoplasty

 

o

is performed with laser keratome

o

is necessary only when macroscopic evaluation reveals induction of swelling of the intercellular space

o

should include determination of endothelial cell density

o

should be performed in uniform manner in accordance with the approved and validated standard operating procedures

 

 

51. The condition of the corneal endothelium is crucial for

 

o

the maintenance of corneal hydration and transparency

o

detection of congenital abnormalities of the anterior chamber, iris or lens

o

evaluating the suitability of corneas intended for anterior lamellar procedures

o

evaluating the suitability of corneas intended for penetrating keratoplasty

 

 

52. Slit lamp evaluation of cornea

 

o

reveals epithelial defects

o

should be performed only for enucleated eyes

o

should include inspection of limbal area for signs of corneal pathology or post mortem artifacts

o

can be used for endothelial cell count assessment

 

 

53. Donor corneas with an endothelial cell count of less than 2000 endothelial cells per mm2 in the final examination may be used for

 

o

all corneal transplantations

o

elective penetrating keratoplasty

o

elective anterior lamellar keratoplasty

o

all corneal transplantations when accepted by the transplanting surgeon

 

 

 

54. Amniotic membrane donors shall be screened at least for

 

o

congenital or acquired disorders of the eye or previous ocular surgery

o

significant local bacterial, viral, paracital or mycotic infection of the genital tract

o

malignant tumours of the eye

o

gestational diabetes of the donor

 

 

55. After retrieval until earliest processing of the tissue, the donor placentas are to be stored

 

o

less than 1 hour at temperatures of 2-40°C

o

at least 6 hours at temperatures of +2-10°C

 

o

a maximum of 6 hours at temperatures of -75°C to -85°C

 

o

a maximum of 6 months at temperatures of -75°C to -85°C

 

 

56. During preservation of placental tissue

 

o

at least one sterility test of a placenta sample stored in preservative is to be performed

o

the placenta shall be kept under laminar air flow

o

the amniotic membrane shall be detached from nitrocellulose membrane

o

the amniotic membrane may be decontaminated using antibiotics

 

57. Amniotic membrane shall be stored

 

o

in sterile organ culture medium at room temperature for a maximum of 6 months

o

in sterile glycerol in a freezer at -75°C to -85°C for a maximum of 12 months

o

in liquid nitrogen, vapor phase

o

as freeze dried in room temperature

 

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