Purpose: To investigate the effects of expansion in eye bank donor age from 75 to 80 years on corneal endothelial cell density (ECD) and surgeon acceptance rate of donated tissues. Methods: Conducted as a single-site retrospective analysis, the study examined 25,969 donor corneas from 2018 to 2022. After the increase in the donor age limit in August 2022, the sample included donors aged 2 to 75 years (n = 25,558) and 76 to 80 years (n = 411). Donor characteristics, corneal ECD, and tissue acceptance rates were compared across age groups stratified by 5-year intervals. Results: Increasing the donor age upper limit produced 411 more corneal donations, which resulted in 208 more surgeries. The average corneal ECD in donors between the ages of 71 and 75 years was 2349 cells/mm2 (95% CI, 2332–2367), and in donors between the ages of 76 and 80 years, the average corneal ECD was 2227 cells/mm2 (95% CI, 2159–2296). Our results demonstrated a lower average corneal ECD in the 76- to 80-year-old group in comparison with the 71- to 75-year-old group by 122 cells/mm2 (95% CI, 51–193, P < 0.001). Tissue from donors aged 71 to 75 years had a 48% surgeon acceptance rate, whereas tissue from those aged 76 to 80 years had a significantly lower 38% acceptance rate (P = 0.003). Conclusions: Corneas from donors of older ages are viable and suitable for use in transplant surgery but are significantly less likely to be selected by surgeons. Age bias by surgeons against older corneas is a possible reason for this finding and warrants further exploration.

Purpose: The purpose of this study was to determine the effect of head trauma on corneal endothelial cell density (ECD) in eye bank donors 50 years or older. Methods: This is a retrospective study of 128 corneas from 67 donors 50 years or older with cause of death secondary to head trauma, gunshot wound to the head (n = 26), motor vehicle accident with head trauma (n = 33), a fall with sustained head trauma (n = 47), and non-head trauma–related deaths (n = 22). Corneal data were recovered from Saving Sight Eye Bank (Kansas City, MO) database between January 2018 and August 2021. Donor characteristics, ECD, and focal endothelial cell loss on specular microscopy were examined between groups. A linear mixed effects model and a mixed effects logistic regression were used to compare ECD and examine the association between head trauma and focal endothelial cell loss. Results: The average ECD in the head trauma group was 2471 ± 342 cells/mm2 and 2588 ± 282 cells/mm2 in the nonhead trauma group (P value = 0.24). After adjusting for age, death-to-preservation time, and pseudophakia, the ECD difference between the head trauma and nonhead trauma groups was −105 ± 112 cells/mm2 (P value = 0.35). The odds of having focal endothelial cell loss were not statistically significant (P value = 0.42) between the head trauma (odds = 0.93) and nonhead trauma (odds = 0.69) groups. Conclusions: There were no differences in ECD and focal endothelial cell loss between the head trauma and nonhead trauma groups in eye bank donors 50 years or older.

Purpose: The purpose of this study was to examine the effect of head trauma–related deaths on corneal endothelial cell density (ECD) in eye bank donors. Methods: This is a retrospective study of 287 corneas from donors with causes of death secondary to motor vehicle accident with sustained head trauma (n = 50), gunshot wound to the head (n = 138), fall with sustained head trauma (n = 2), and non-head–related traumatic causes of death (n = 97). Donors older than age 50 years were excluded due to concern for undiagnosed Fuchs endothelial dystrophy as a potential confounder for the cause of endothelial cell loss. Donor characteristics, ECD, and focal endothelial cell loss on specular microscopy were compared between the groups. Donors in the head trauma and nonhead trauma groups were matched by age; there were 42 age-matched donors in both groups. Results: Age and ECD were negatively correlated (Pearson correlation coefficient = −0.57). Death-to-preservation time was not significantly different between the 2 groups ( P value = 0.59). The mean ECD in the head trauma group was 2859 ± 370 cells/mm 2 and 3041 ± 464 cells/mm 2 in the nonhead trauma group. The head trauma group had a lower ECD (178 ± 70 cells/mm 2 , P value = 0.013). After matching for age, the difference in ECD between the 2 groups was −94 ± 82 cells/mm 2 ( P value = 0.26). The adjusted odds of having focal endothelial cell loss was not statistically significant ( P value = 0.50) between the groups. Conclusions: After statistical adjustments, there were no differences between the head trauma and nonhead trauma groups.

PURPOSE To determine whether donor diabetes mellitus (DM) severity is associated with differences in endothelial cell density (ECD) and surgically unsuitable tissue. METHODS Raw data were obtained from Saving Sight Eye Bank (Kansas City, MO) including 10,454 donated eyes from 5346 eligible donors from July 2014 through May 2017. Donors were grouped into 5 categories by their insulin use and the presence of microvascular end-organ complications. The categories were non-DM (NDM), noninsulin-dependent DM without complications (NIDDMnc), noninsulin-dependent DM with complication (NIDDMc), insulin-dependent DM without complications, and insulin-dependent DM with complication. Outcome variables included ECD and tissue transplant suitability. Mixed effects models were used to adjust for the random effect of repeated measures and fixed effects of donor age, race, lens status, and death to refrigeration and death to preservation times. Interaction effects of DM severity group and donor age and DM severity group and lens status were included in the models. RESULTS One thousand six hundred eighty-four (32.1%) donors had a diagnosis of DM. Six hundred fifty-eight donors were in the NIDDMnc group, 225 in the NIDDMc group, 404 in the insulin-dependent DM without complication group, and 397 in the insulin-dependent DM with complication group. Compared with non-DM, donors with DM were older (P < 0.001) and more likely to be pseudophakic (P < 0.001). DM severity groups did not affect adjusted ECD at mean donor age. There was no statistically significant ECD interaction between DM severity group and lens status. There was a statistically significant ECD crossover interaction with NIDDMnc and donor age (P < 0.001). In phakic eyes, NIDDMc was associated with a statistically significantly lower odds of transplant suitability (odds ratio 0.62, P = 0.006). CONCLUSIONS DM severity does not affect lowering adjusted ECD at mean donor age. DM severity and pseudophakia were not associated with lower adjusted ECD. NIDDMnc was associated with an attenuation of the age-dependent decrease in ECD. NIDDMc was associated with decreased transplant suitability in phakic eyes. Future studies should include age, lens status, and interaction effects in their models of ECD and transplant suitability.

Background: To evaluate the association between corneal central endothelial cell count (CECC) with reactivity for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-lymphotropic virus-1 (HTLV1), and syphilis from an eye bank database. Methods: Eye bank data included 19,159 donors and 38,318 corneas screened for HBV, HCV, HIV, HTLV1, and syphilis from July 2007–May 2015. Linear and binary mixed effects models were used to determine the adjusted marginal effect a positive viral screening test had on CECC and morphology, respectively. The models were adjusted for age, race, gender, lens status, and death to preservation. Eyes with missing data were excluded from the analysis. Statistical significance was defined as P values <0.05. Results: A total of 18,097 donors and 35,136 corneas were included in the final analysis. Average CECC for eyes with negative viral screening was 2,597±436 while the average CECC for eyes screening positive for syphilis, HBV, HCV, HIV, and HTLV1 were 2,638±392 (P=0.073), 2,569±419 (P=0.815), 2,603±363 (P=0.207), 2,615±360 (P=0.733), and 2,625±436 (P=0.362) respectively. Conclusions: The presence of HBV, HCV, HIV, HTLV1, and syphilis display no association with a statistically significant difference in CECC when compared to normal non-diseased donors.

Importance:Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival.Objective:To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study.Design, Setting, and Participants:This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included.Interventions:The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days.Main Outcomes and Measures:Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images.Results:The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (-103 [-196 to -9] cells/mm2), lower screening ECD (-234 [-331 to -137] per 500 cells/mm2), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm2), and operative complications (-324 [-516 to -133] in cells/mm2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD.Conclusions and Relevance:Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.

Purpose: To quantify consistency of endothelial cell density (ECD) measurements among technicians in a single US eye bank operating under typical operating conditions. Methods: In this retrospective analysis of 51 microscopy technicians using a semiautomated counting method on 35,067 eyes from July 2007 to May 2015, technician- and date-related marginal ECD effects were calculated using linear regression models. ECD variance was correlated with the number of specular microscopy technicians. Results: Technician mean ECDs ranged from 2386 ± 431 to 3005 ± 560 cells/mm2. Nine technicians had statistically and clinically significant marginal effects. Annual mean ECDs adjusted for changes in technicians ranged from 2422 ± 433 to 2644 ± 430 cells/mm2. The period of 2007 to 2009 had statistically and clinically significant marginal effects. There was a nonstatistically significant association between the number of technicians and ECD standard deviation. Conclusions: There was significant ECD variability associated with specular microscopy technicians and with the date of measurement. We recommend that eye banks collect data related to laboratory factors that have been shown to influence ECD variability.

Purpose: To evaluate the association between corneal endothelial cell density (ECD) and donor topical glaucoma medication use in an eye bank database. Methods: Raw eye bank data included 19,159 donors over the period July 2007 to May 2015. Free-text, donor medication lists were retrospectively searched for glaucoma medication. Exclusion criteria were age less than 40 years, history of eye surgery, endothelial trauma, guttae, and cell densities <1000 or >3300/mm2. Analysis of covariance was used to test differences in cell density between groups while adjusting for age. Linear regression was used to test the correlation of independent interval variables while adjusting for age. Results: Twelve thousand one hundred fifty-seven donors were included in the final analysis; 134 were on topical glaucoma medication. The mean ECD for donors not on glaucoma medication and pooled donors on glaucoma medication was 2561 ± 348 and 2516 ± 320 cells/mm2, respectively (P = 0.42). Subgroup analysis by medication class resulted in nonstatistically significant differences between ECDs of nonmedicated donors and donors on alpha agonists (P = 0.76), beta blockers (P = 0.90), carbonic anhydrase inhibitors (P = 0.13), cholinergics (P = 0.37), and prostaglandin analogs (P = 0.62). The number of glaucoma medication classes used by donors was not a statistically significant predictor of endothelial density (P = 0.298). Conclusions: Donors on topical glaucoma medication do not have ECDs statistically significantly lower than donors not on medication.

Purpose: To analyze the factors affecting central corneal endothelial cell density (ECD) in an eye bank corneal donor database. Methods: The Lion's Eye Institute corneal donor database consisting of 18,665 donors (34,234 corneas) aged 20 years or older was analyzed. In particular, differences in the ECD based on age, sex, race, prior ocular surgery, a history of systemic diseases, and smoking were investigated. Furthermore, risk factors for donor cell count inadequacy (defined here as ECD less than 2000/mm2) were identified. Results: ECD decreased with age. Regarding race, the average ECD of African American donors was higher than those of white or Hispanic donors. A history of diabetes mellitus (DM) and ocular surgery were associated with a lower ECD. Donor medical history of hypertension, glaucoma, depression, dementia, Parkinson disease, hyper- or hypothyroidism, or smoking did not seem to affect the ECD. The risk factors for donor cell count inadequacy, based on binary logistic regression analyses were advanced age [65–74 years yielded an odds ratio of 17.8; confidence interval (CI), 10.6–29.8; P < 0.001; and 75–99 years yielded an odds ratio of 24.6 (CI, 14.5–41.61; P < 0.001) when compared with 20–34 years], cataract surgery (odds ratio, 4.3; CI, 4.0–4.8; P < 0.001), and DM (odds ratio, 1.2; CI, 1.1–1.3; P = 0.001). Conclusions: Age, race, ocular surgery (cataract and refractive), and DM seem to significantly affect donor corneal ECD. Of these variables, age, a history of cataract surgery, and DM were found to be the greatest risk factors for inadequate donor cell density (less than 2000/mm2).

Purpose: To perform an age-stratified analysis of the effect of diabetes and pseudophakia on corneal endothelial cell density (ECD). Methods: This is a comparative analysis of donor characteristics from data supplied by the Lions Eye Institute for Transplant and Research on tissue harvested from July 1, 2007, through May 23, 2014. The mixed-effects model was used to compare age-adjusted mean corneal ECD between donors with and without diabetes. Results: A total of 20,026 nondiabetic donor eyes and 13,617 diabetic donor eyes were included in this study. ECD was 2604 cells per square millimeter in nondiabetic corneas and 2576 cells per square millimeter in diabetic corneas (P < 0.001). Among phakic patients, diabetic ECD was significantly less in the middle-age subgroups: −33 cells per square millimeter in the 21-to-40-year-old subgroup (P = 0.048) and −25 cells per square millimeter in the 41-to-60-year-old subgroup (P = 0.009). Among pseudophakic patients, diabetic ECD was significantly less only in the subgroup 61 years or older: −56 cells per square millimeter (P = 0.026). The magnitude of difference in ECD between phakic and pseudophakic donors was greater in patients with diabetes in the subgroup 61 years or older (P < 0.001). Conclusions: Donor eyes with a history of diabetes had a slightly lower ECD (−29 cells/mm2) than eyes without a history of diabetes. Although this statistical relationship is consistent with our pathophysiologic understanding of diabetes and the corneal endothelium, such a minor difference in ECD would be expected to have minimal clinical impact on overall corneal endothelial function.