To investigate the incidence of adverse reactions after corneal transplantation, reported to the Eye Bank Association of America.
Incidence of adverse reactions from January 1, 2007, to December 31, ...2014, was analyzed.
Of the 354,930 transplants performed in the United States, adverse reactions were reported in 494 cases (0.139%). Primary graft failure (PGF) predominated (n = 319; 0.09%) followed by endophthalmitis (n = 99; 0.028%) and keratitis (n = 66; 0.019%). The procedure type predominantly associated with PGF was endothelial keratoplasty (EK) in 56% (n = 180; 11 per 10,000 grafts), followed by penetrating keratoplasty (PK) in 42% (n = 135; 6.9 per 10,000 grafts). The procedure type predominantly associated with endophthalmitis and keratitis was EK in 63% (n = 104; 6.3 per 10,000 grafts) followed by PK in 34% (n = 56; 2.8 per 10,000 grafts), anterior lamellar keratoplasty in 1% (n = 2; 2.7 per 10,000 grafts), and keratoprosthesis in 1% (n = 2; 12.4 per 10,000 grafts). Although the incidence of PGF and endophthalmitis between PK and EK was noteworthy, the difference was not statistically significant (P = 0.098). Endophthalmitis-associated pathogens were isolated in 78% of cases: predominantly Candida species (65%), gram-positive organisms (33%), and gram-negative rods (2%). Keratitis-associated pathogens were isolated in 64% of cases: predominantly Candida species (81%), Herpes simplex virus (7%), gram-negative organisms (7%), and gram-positive organisms (5%).
PGF was the most commonly reported adverse reaction, disproportionately associated with EK. An increasingtrend in the rate of endophthalmitis and keratitis was observed, disproportionately associated with EK and Candida species.
To examine barriers and facilitators to adoption of Descemet membrane endothelial keratoplasty (DMEK) for treatment of endothelial dysfunction.
Anonymous electronic surveys were emailed to surgeons ...ordering corneal transplant tissue in the past 18 months from 2 eye banks in the United States (US).
Of 365 surgeons emailed, 118 (32%) completed the survey. Most respondents were located at an urban site (59%), were in private practice (64%), and had been in practice for >10 years (53%). Participants performing DMEK (n = 70) were more likely to have been in practice for ≤10 years than those not performing DMEK (56% vs. 35%, respectively, P = 0.03). Among respondents not performing DMEK (n = 48, 41%), the most frequently reported barriers were technical difficulty (n = 30, 63%), a lack of experience (n = 29, 60%), low surgical volume (n = 20, 42%), and risk of postoperative complications (n = 19, 40%). Most (n = 46, 96%) respondents not performing DMEK were interested in doing so, with the following reported as helpful resources: wet laboratory courses (n = 35, 73%), eye bank-prepared tissue: preloaded/prestripped (n = 32, 67%), back-up tissue in case of inadvertent graft damage (n = 29, 60%), higher surgical volume to support the learning curve (n = 28, 58%), and surgical mentorship (n = 22, 46%). Only a minority wanted more data to highlight superiority over other EK procedures (n = 12, 25%).
There is substantial interest in learning to perform DMEK among the surgical community. Barriers identified in this survey may be addressed to help surgeons increase DMEK adoption.
To determine graft quality and feasibility of Descemet membrane endothelial keratoplasty (DMEK) grafts that are prestripped and preloaded into injectors by eye bank technicians before shipping to ...surgeons.
DMEK grafts (n = 31) were prepared from donor corneas and preloaded into Straiko Modified Jones tubes and set inside viewing chambers filled with 20 mL of Optisol-GS. Preloaded grafts were evaluated using specular microscopy and slit-lamp biomicroscopy. Endothelial cell loss (ECL) was captured by vital dye staining and quantified using FIJI. A subset of preloaded tissues was subjected to a shipping validation and 5-day storage assay. Fourteen additional DMEK grafts (not preloaded) were examined to quantify damage resulting from prestripping alone.
Specular microscopy was able to be performed for all preloaded tissues. Average ECL for preloaded tissues quantified by vital dye staining and FIJI after overnight storage was 16.8% ± 5.9%, and differed from slit-lamp ECL estimation by an average of 5.3% ± 3.6%. The average damage caused by prestripping alone was 9.3% ± 5.9%, and it was significantly less than that of preloaded tissues (P < 0.01). Average ECL for preloaded tissues subjected to round-trip shipping events was 18.5% ± 12.4%, and ECL for tissues stored at 4°C for 5 days after preloading was 13.1% ± 9.5%.
It is possible to prepare, evaluate, and ship DMEK grafts loaded inside a glass carrier and viewing chamber. The ability to evaluate tissues after processing allows for adherence to the Eye Bank Association of America Medical Standards, and for surgeons to receive the most accurate tissue information.
To report endothelial cell loss (ECL) caused by a novel S-stamp preparation technique for Descemet membrane endothelial keratoplasty (DMEK).
Six cadaveric human corneas were prepared for DMEK ...transplantation using a single standardized technique, including the application of a dry ink gentian violet S-stamp to the stromal side of Descemet membrane. Endothelial cell death was evaluated and quantified using computerized analysis of vital dye staining.
ECL caused by the S-stamp was 0.6% (range 0.1%-1.0%), which comprised less than one-tenth of the total ECL caused by our preparation of the DMEK graft from the start to finish, including recovery, prestripping, S-stamping, and trephination (13.7% total ECL, range 9.9%-17.6%).
Our novel S-stamp donor tissue preparation technique is intuitive to learn and holds the promise of preventing iatrogenic primary graft failure due to upside-down grafts without causing unacceptable increases in ECL.
To ascertain whether death-to-preservation time (DPT) is associated with donor endothelial cell density (ECD), primary graft failure (PGF), and infection.
Donor corneas aged older than 10 years with ...ECD 2000 to 4500 cells/mm2 were procured between 2011 and 2018 by a single eye bank. Donor corneas were analyzed retrospectively for the main outcome measures of PGF, infection, and ECD. Means and proportions of study parameters were compared between corneas with long and short DPT, defined as greater or less than 14 hours, respectively, excluding corneas with a history of intraocular surgery or diabetes. Multivariate analyses were performed using logistic regression, adjusting for donor age at time of death, history of diabetes mellitus, and history of cataract surgery.
Among 12,015 corneas, those with long DPT had a statistically but not clinically significant higher ECD than that of corneas with short DPT (2754 vs. 2724 cells/mm2, P < 0.01). There was no difference in PGF and infections in corneas with long versus short DPT (0.28% vs. 0.26%, P = 0.86; 0.43% vs. 0.29%, P = 0.51, respectively).
Longer DPT is not associated with a clinically meaningful reduction in donor ECD, PGF, or infection.
To evaluate endothelial cell damage after eye bank preparation and passage through 1 of 2 different injectors for Descemet membrane endothelial keratoplasty grafts.
Eighteen Descemet membrane ...endothelial keratoplasty grafts were prepared by Lions VisionGift with the standard partial prepeel technique and placement of an S-stamp for orientation. The grafts were randomly assigned to injection with either a glass-modified Jones tube injector (Gunther Weiss Scientific Glass) or a closed-system intraocular lens injector (Viscoject 2.2; Medicel). After injection, the grafts were stained with the vital fluorescent dye Calcein AM and digitally imaged. The percentage of cell loss was calculated by measuring the area of nonfluorescent pixels and dividing it by the total graft area pixels.
Grafts injected using the modified Jones tube injector had an overall cell loss of 27% ± 5% 95% confidence interval, 21%-35%. Grafts injected using the closed-system intraocular lens injector had a cell loss of 32% ± 8% (95% confidence interval, 21%-45%). This difference was not statistically significant (P = 0.3). Several damage patterns including damage due to S-stamp placement were observed, but they did not correlate with injector type.
In this in vitro study, there was no difference in the cell loss associated with the injector method. Grafts in both groups sustained significant cell loss and displayed evidence of graft preparation and S-stamp placement. Improvement in graft preparation and injection methods may improve cell retention.
The aim of this study was to evaluate preparation outcomes of tissue prepared for Descemet membrane endothelial keratoplasty (DMEK) from diabetic and nondiabetic donors.
In this nonrandomized, ...consecutive case series, DMEK grafts were prepared from diabetic and nondiabetic donors by experienced technicians in 2 eye banks using slightly different, modified submerged manual preparation techniques to achieve "prestripped" graft tissue. Graft preparation results were analyzed retrospectively. The main outcome measure was the rate of unsuccessful (failed) DMEK graft preparations, defined as tears through the graft area that prevent tissue use.
A total of 359 corneas prepared from 290 donors (114 diabetic and 245 nondiabetic) were included in the statistical analysis of graft preparation failure. There were no significant differences between diabetic and nondiabetic donor tissue characteristics with respect to donor age, death to preservation time, death to preparation time, endothelial cell density, percent hexagonality, or coefficient of variation. DMEK tissue preparation was unsuccessful in 19 (5.3%) cases. There was a significant difference in the site-adjusted rate of DMEK preparation failure between diabetic 15.3%; 95% confidence interval (CI), 9.0-25.0 and nondiabetic donors (1.9%; 95% CI, 0.8-4.8), and the corresponding site-adjusted odds ratio of DMEK graft preparation failure in diabetic donor tissue versus nondiabetic donor tissue was 9.20 (95% CI, 2.89-29.32; P = 0.001).
Diabetes may be a risk factor for unsuccessful preparation of donor tissue for DMEK. We recommend caution in the use of diabetic tissue for DMEK graft preparation. Further study is needed to identify what subset of diabetic donors is at risk for unsuccessful DMEK graft preparation.
To describe the intraoperative and early postoperative complications using preloaded Descemet membrane endothelial keratoplasty (DMEK) grafts with intraocular injection of the graft in Optisol-GS and ...omission of trypan blue restaining.
This is a retrospective case series of 132 consecutive eyes with Fuchs endothelial dystrophy or endothelial failure who underwent DMEK using preloaded donor tissue prepared as previously described. The graft was not restained with trypan blue by the surgeon, and Optisol-GS was injected with the graft into the eye instead of being rinsed from the injector. Early postoperative complications (0-8 wk) including intraoperative fibrin formation, intraocular inflammation, elevated intraocular pressure, partial graft detachment requiring rebubble, and early graft failure were recorded.
No eyes developed intraoperative fibrin formation or postoperative inflammation (such as toxic anterior segment syndrome) or elevated intraocular pressure. For eyes with Fuchs corneal dystrophy, our rebubble rate was 21% (22/106 eyes). Early graft failure was noted in 2% (3/132 eyes), which is similar to previous reports.
Our results suggest that injection of Optisol-GS into the anterior chamber during DMEK graft injection does not lead to increases in intraoperative or early postoperative complications. Trypan blue restaining is not necessary for intraoperative visualization. This simplification can reduce graft manipulation and save time and resources for this procedure.
The purpose of this study was to report trends in the prevalence of early graft failure after endothelial keratoplasty in the United States.
Descemet membrane endothelial keratoplasty (DMEK) and ...Descemet stripping automated endothelial keratoplasty (DSAEK) graft volumes were collected from records maintained by 6 major eye banks in the United States from January 1, 2013, to December 31, 2018. The prevalence and presumed cause of early graft failures (defined as a graft with persistent edema or regrafted within 8 weeks after keratoplasty) each year were sourced from surgeon-reported adverse events. Failed graft cases from the 3 eye banks were compared with nonfailures at the donor and recipient levels to perform subset analysis of factors associated with early graft failure.
A total of 51,887 endothelial keratoplasty tissues were distributed during the study period; 72% were DSAEK grafts. The total number of early graft failures reported was 168 of 14,284 (1.18%) for DMEK and 322 of 37,603 (0.86%) for DSAEK. Early DMEK failures decreased from 2013 (7.69%) to 2018 (0.68%). In generalized linear mixed model analyses adjusting for donor tissue characteristics, recipient age, and diagnosis, an association of borderline significance was found between higher donor age and early failure odds ratio (95% confidence interval): 1.03 (1.00-1.05); unit change of 1 yr and DSAEK odds ratio 1.02 (1.00-1.04); unit of change 1 yr cases.
The proportion of early graft failures in DMEK decreased over time and was comparable with failure rates in DSAEK at the end of the study period. The surgical learning curve might have played a role.
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