P18-A148†Assymetrical injector for endothelium-in DMEK without the need of pull-through technique.

PURPOSE: One of latest surgical development of preloaded Descemet membrane endothelial keratoplasty (DMEK) is the delivery of the graft with the endothelium inwards, which allows for a very fast operation, but requires a pull-through surgical technique. Although the tri-folded, endo-in DMEK technique has significant advantages, the absence of proper surgical instruments that could allow their use without the 'pull-through' technique still restricts the wide use of such an operation. None of the available commercial DMEK injectors could be used for tri-folded DMEK (endothelium-inward) orientation, as it requires the graft to be intently secured within the injector. This report presents a retrospective eye bank validation study of an asymmetrical injector designed to orientally implant a tri-folded DMEK graft without needing a pull-through technique. METHODS: The injector is made from transparent plastic, allowing microscopic tissue validation directly before injection. The device is asymmetrical, so the orientation of the graft can be controlled and validated according to the best eye bank practice, which is critical for successful tri-folded DMEK graft clinical application. Four different designs of the internal compartment of the injectors were evaluated with DMEK tissues. Mates from two pairs were tested on each device type, totaling 16 grafts, all loaded with folded, endo-in grafts. The tissue was prepared, loaded into the injector, and ejected to imitate the tissue manipulation in DMEK operation. RESULTS: After graft loading the delivery of the endothelium-in grafts was performed by injection, without the need for a pull-through technique. One graft (6.25%) has double-scrolled (changed its folding) within the injector with a larger (1.5 mm) internal compartment. The loss of valuable cells was between 3-23% (13.98% average). No significant differences in cell loss were observed between injectors with different internal compartment sizes. Higher viability loss (17.3% +/- 5.7) was observed for the grafts with >20 days death to prep-days in comparison with grafts stored with less than two weeks (10.9% +/-2.1). CONCLUSION: The TissueGUARD injector is the only injector that currently allows oriented, tri-folded DMEK injection without the need for a pull-through technique. The average cell loss after loading and ejection was 13.98%, which is comparable/better than the current best practice with the precut-preloaded technique of naturally folded DMEK.

Alcohol Abuse Is Associated With Alterations in Corneal Endothelial Cell Morphology.

PURPOSE: Alcohol consumption is highly prevalent throughout the world. We sought to detect, in a large sample of cornea donors, whether alcohol abuse is associated with changes in corneal endothelial morphology after accounting for other comorbidities including tobacco use. METHODS: At a single eye bank, 10,322 eyes from a total of 5624 unique donors underwent imaging with a Konan CellChek D specular microscope. Demographic information and medical history were associated with each tissue. Images were analyzed using a standardized protocol for assessment of endothelial cell density, hexagonality, and variation. In this retrospective analysis, a multivariable regression was conducted to assess for an association between alcohol abuse and corneal endothelial metrics. Measurements were averaged across eyes for each donor. Bonferroni corrections were applied to account for multiple comparisons. RESULTS: Among 5624 donors, the mean (standard deviation) endothelial cell density was 2785 (383.0) cells/mm 2 . Indicators of alcohol abuse were present in 1382 donors (24.5%). In a multivariable regression model that included age, sex, tobacco use, history of cataract surgery, and diabetes mellitus, alcohol abuse was associated with a decrease of 60.9 cells/mm 2 [95% confidence interval (CI), -83.0 to -38.7 cells/mm 2 , P = 7.6 × 10 -8 ], an increase in the coefficient of variation by 0.0048 (95% CI, 0.17-0.79, P = 0.002), and a decrease in percent hexagonality by 0.93% (95% CI, -1.3 to -0.6, P = 4.5 × 10 -7 ). CONCLUSIONS: Alcohol abuse is associated with significant alterations to corneal endothelial density and morphology.

Comparison of the Modified Jones Tube Technique and the DMEK EndoGlide Technique With and Without Viscoelastic Material for DMEK Tissue Preparation.

PURPOSE: The aim of this study was to compare endothelial cell loss for DMEK (Descemet membrane endothelial keratoplasty) tissue preparation techniques using the modified Jones tube and the DMEK EndoGlide with and without viscoelastic material to protect the endothelium. METHODS: This ex vivo study included 10 DMEK grafts prepared using each of the 3 abovementioned techniques. After tissue preparation, transport conditions were simulated for a minimum of 45 hours before deployment of the DMEK tissue and quantification of endothelial cell loss. Comparisons between preparation technique groups were made using the Wilcoxon rank-sum test. RESULTS: The Jones tube group had a mean endothelial cell loss of 11.0 ± 4.8% compared with the EndoGlide group with 12.9 ± 6.7% and the EndoGlide with viscoelastic group with 25.7 ± 15.0%. The differences between the EndoGlide with viscoelastic group and the other 2 were statistically significant both before (P < 0.01 and P = 0.01) and after (P = 0.01 and P = 0.02) adjusting for baseline characteristics. The difference between the EndoGlide and Jones tube groups was not significant (P = 0.73 and P = 0.53 after adjustment). Microscopy revealed endothelial cell loss in the area of viscoelastic use for the EndoGlide with viscoelastic group. CONCLUSIONS: Both the Jones tube and DMEK EndoGlide resulted in similar low rates of endothelial cell loss after tissue preparation, transport, and deployment. However, use of viscoelastic material to protect the endothelium using the DMEK technique actually resulted in increased cell loss in the area of its application resulting in overall higher rates of cell loss across the DMEK tissue.

Comparison of corneal endothelial cell density and morphology with Optisol GS and Life4C storage media in the eye bank: a 5-year retrospective analysis.

Purpose: Optisol GS and Life4C are corneal storage media used by eye banks worldwide. We sought to determine if either solution was associated with superior corneal endothelial cell density (ECD) or morphology in a large cohort of donor corneas. Methods: From January 2016 through December 2020, 10,316 corneas from 5,624 unique donors were acquired and analyzed at Rocky Mountain Lions Eye Bank. In April 2019, Life4C replaced Optisol GS as the sole storage medium. We compared ECD and morphology before and after April 2019, and excluded corneas processed within the transition period. Univariable and multivariable regression analyses accounted for age, sex, tobacco use, heavy alcohol use, and diabetes. Only right corneas were analyzed to account for the correlation between eyes. Results: Of 5042 right corneas analyzed, 3486 were stored in Optisol GS and 1556 in Life4C. There was no significant difference in ECD across groups (2794 vs. 2793 cells/mm2 in Optisol GS and Life4C, p=0.88). In multivariate analyses, there was no significant difference in corneal ECD (0.6 cells/mm2 higher with Life4C, p=0.96) or hexagonality (0.22% higher with Life4C, p=0.31). However, the coefficient of variation was significantly lower in the Life4C group (-0.0039, p=0.03). After adjustment for above factors, corneas in Life4C demonstrated a 3.1% decreased likelihood of exhibiting CV values greater than 0.40 (p=0.009). Conclusions: This study demonstrates comparable and favorable outcomes using both storage media and confirms their overall efficacy. The decreased CV in Life4C is not of clinically significant magnitude, but merits further research in clinical and long-term settings.

Viability of preloaded Descemet membrane endothelial keratoplasty grafts with 96-hour shipment.

OBJECTIVE: To assess feasibility and compare the effects of 96-hour shipment of Descemet membrane endothelial keratoplasty (DMEK) grafts as a scroll or a tri-fold on cell viability. METHODS AND ANALYSIS: DMEK grafts were prepared at the Rocky Mountain Lions Eye Bank. Twenty pre-stripped DMEK grafts, paired from 10 donors, were either tri-folded in an endothelium-in configuration using microforceps and loaded into a plastic Treyetech cartridge, or suctioned in a scrolled endothelium-out configuration into a modified Jones Tube. Grafts were shipped via FedEx to a secondary location and back for 48 hours each way, resulting in a total shipping time of 96 hours. After shipping, grafts were removed from inserters onto glass slides and unfolded using viscoelastic with endothelium facing upwards. Calcein-AM stained grafts were imaged with a fluorescent microscope and endothelial cell loss (ECL) was measured using trainable segmentation in Fiji by a masked grader. RESULTS: A total of 20 grafts were shipped for 96 hours, split between preloaded tri-folded (n=10) and preloaded scrolled (n=10) tissues. No significant difference in ECL was observed across groups after prolonged shipping (14.8% vs 13.7% ECL respectively, p=0.68). CONCLUSION: For preloaded DMEK after 96 hours, both scrolled and tri-folded tissue demonstrated clinically acceptable levels of ECL. The data suggest a wider window of time for endothelial cell viability and is promising for the prospect of international shipment of preloaded grafts.