Abstract
Purpose :
As stated on the RE-One website "RE-One is a sterile medical device for transport microscopic observation and handling of ocular bulbs for the purpose of cornea procurement and research in Ophthalmology". As the first transport chamber to aid in corneal excisions from a whole globe, RE-One has been purported to help recovery technicians that struggle with recovery-induced errors by providing a more ergonomically, controlled platform for corneal excisions. The purpose of our study was to validate the RE-One whole globe chamber as a modality for excising corneal tissue from whole globe, by comparing it to traditional in situ excision technique, across a variety of measures.
Methods :
Twenty-eight bilateral research donor eyes (n=56) were either aseptically excised in situ or enucleated and excised utilizing the RE-One chamber. The corneas were evaluated via spectral microscopy, slit lamp examination and underwent endothelial staining with Trypan Blue. The circularity of scleral rim and endothelial cell loss were analyzed by a masked reader using ImageJ software.
Results :
Across the primary endpoint measures of the corneal suitability (p=.24), circularity of scleral rim (p=0.66), endothelial cell loss (p= .35), endothelial cell density (p=0.3) and recovery-induced stress lines (p=.71), there were no statistically significant differences between the RE-One corneas and in situ corneas. The difference between the largest and smallest sections of scleral rim was statistically significant (p<.0001), indicative of RE-One corneas having more uniformity of the scleral rim. Additional sub-group analyses of phakic vs. pseudophakic eyes and endothelial cell densities > 2,000c/mm2 vs < 2,000 c/mm2 did not yield further statistically significant differences between the two groups.
Conclusions :
The initial results of our study suggest that RE-One is an ideal platform for technicians struggling with scleral rim size. RE-One may provide a better stage for training technicians on corneal excisions. Although among other endpoint measures, there were no other statistical significances, we postulate the lack of difference between RE-One and in situ groups, may be secondary to skilled, experienced technicians who participated in the study. Future analysis is planned to examine the role of RE-One across a spectrum of skill levels for the technicians involved in procurement of corneal tissue.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.