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Preclinical validation of an innovative corneal bioreactor versus organ culture for long term storage: a randomized controled study
Author(s) -
Garcin T.,
Forest F.,
Verhoeven P.,
Pugniet J.L.,
Peyragrosse T.,
Rogues F.,
Herbepin P.,
Perrache C.,
Acquart S.,
He Z.,
Gain P.,
Thuret G.
Publication year - 2017
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2017.01544
Subject(s) - cornea , vial , medicine , ophthalmology , significant difference , andrology , surgery , chemistry , chromatography
Purpose The organ culture ( OC ) is a passive corneal storage, gold standard in Europe for decades. The bioreactor ( BR ) is a sterile transparent device that allows active storage: transcorneal pressure gradient and fluid renewal. Aim: To compare quality of human corneas stored for 1 month in our BR versus (vs) OC . Methods Randomized controled preclinical study, authorized by the French Biomedicine Agency and an IRB , including only fresh scientific paired human corneas >2000cells/mm2 and <10% difference between both corneas at day (D)2. Immediately at retrieval, one cornea was randomized and stored in OC and the other in BR , both with the same commercial medium (CorneaMax). At D26 only OC corneas were transferred to a deswelling medium (CorneaJet). We calculated that 49 pairs were needed to show a difference of 500 viable cells/mm 2 between groups. Assessments were performed at D2, 26, 28. Main criterion: viable ECD ( vECD ) determined by triple staining Hoechst/Ethidium/Calcein at D28, blind of storage method. Secondary criteria: average transparency (T), central corneal thickness ( CCT ) and microbiology. Results We retrieved 60 pairs, included 52 pairs at D2, analyzed 50 pairs (1 contamination per group). At D2 ECD in BR was 2607±340 vs 2576±357cells/mm2 in OC (p=0.243). At D26 ECD was >2000cells/mm2 for 92% of corneas in BR vs 58% in OC (p<0.001). At D28 vECD was higher in BR 2188±379 vs 1687±389cells/mm2 in OC , with 76% of corneas >2000 viable cells/mm2 in BR vs 22% in OC (p<0.001); T didn't differ and CCT was higher in BR with 684±52 vs 608±53 μ m in OC (p<0.001). Conclusions Restoring IOP and renewing medium significantly improves endothelial cell survival while avoiding deleterious deswelling necessary in OC : after 1 month‐storage, the BR provides much more corneas suitable for transplantation and higher quality grafts that could survive longer in recipients.