Amnitrans Eyebank / Hoornvliesbank - Quality Control

Quality criteria

To assess whether a donor cornea is suitable for penetrating keratoplasty, Amnitrans Eyebenk uses the following exclusion criteria:

Slitlamp

• Past refractive- or intraocular surgery, or inflammation
• Opacities in Bowman’s layer, stroma or Descemet’s membrane, with the exception of an arcus senilis
• Arcus senilis with a clear optical center of 7.0 mm or less
• Ophthalmic examination: Epithelial damage or abrasion; Hassall Henle warts &endothelial pigment desposition or -precipitates; PAS; scars

Microscopy 1st evaluation

• Corneal endothelial cell count less than 2300 cells/mm2
• Compromised endothelial vitality over a surface area of 5% or more as assessed with trypan blue staining or leakage
• Compromised endothelial vitality over a surface area of 5% or more as assessed with provoked swelling
• Polymegatism with a variation in cell size of 1:2 or more
• Polymorphism over an area of 5% or more
• Overall morphology and/or combination with relative contraindications

Microscopy 2nd evaluation

• Corneal endothelial cell count less than 2300 cells/mm2
• Endothelial cell loss >25% (compared to 1st evaluation)
• Overall morphology and/or combination with relative contraindications

Serology and microbiology

• Positive serology for listed virological disease
• Positive microbiologic cultures of cornea culture medium
• Positive microbiologic cultures (taken 24 hours after 2nd evaluation) of corneal transport medium with a 48-72 hours window

For corneas eligible for lamellar keratoplasty relevant criteria apply.

Tissue discard rate

Amnitrans Eyebank aims to work with a tissue discard rate of less than 40% (approximate average of all 81 eyebanks in the EU).

Contamination 

The safety of the organ culture preservation system may be reflected by the percentage of positive cultures taken from the media.

Surgeon satisfaction 

Surgeon satisfaction is monitored through surveys at the time of transplantation (0-time), and at 6 and 12 months after surgery. For each cornea, the surgeon is requested to score the tissue performance at a scale from 1 to 5 (1=bad, 2=poor, 3=acceptable, 4=good, and 5=excellent). In the table below, the running average is shown for each parameter in a given year.

* Estimated values corrected for not allocated corneas.

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