Purpose To identify areas of consensus among global experts for the management of Fuchs endothelial corneal dystrophy (FECD) in clinical practice, including its diagnosis, evaluation, decision-making principles with respect to intervention, and recommendations for performing cataract surgery in patients with FECD, including when to combine with keratoplasty. Design Modified Delphi-based global consensus. Participants Thirty-seven ophthalmologists from around the world with significant expertise in the management and mechanisms of FECD. Methods A series of consensus statements about FECD were developed from three iterative rounds of structured questions and statements posed to the panel of experts. Two rounds were asynchronous electronic questionnaires, and the third round was a live virtual meeting. Experts responded anonymously to statements assessing consensus and to open-ended questions that invited diverse input. Main Outcome Measures Consensus was defined as 70% agreement among experts. Results Consensus was reached for 90 of 91 statements after three rounds. Experts agreed that FECD is defined by the presence of central or paracentral scattered or confluent guttae with or without edema. There was strong consensus that a chronic state of subclinical edema precedes the onset of clinically detectable edema that may or may not cause symptoms. With near-unanimous consensus, disease evaluation recommendations included assessing for findings that implicate the cornea as a source of decreased vision to separate it from the effect of comorbid conditions, as this would inform whether corneal intervention is appropriate. These findings include diurnal variation in vision, clinical or subclinical (tomographic) edema, and changes or differences in central corneal thickness. Based on current evidence, experts agreed that there are no effective medical therapies for FECD, and that Descemet membrane endothelial keratoplasty is the surgical treatment of choice when indicated. Conclusions The consensus statements provide current globally endorsed recommendations for the diagnosis and management of FECD. The guidelines are important and relevant for general ophthalmologists, who typically first diagnose and evaluate FECD, and for cornea specialists, by allowing them to benchmark their current practice patterns against expert recommendations. This could help improve patient outcomes and establish a framework adaptable to future advances and evolving technologies in the management of FECD.
Purpose: To identify areas of consensus among experts on the performance of endothelial keratoplasty by using a modified Delphi approach, to help create a framework for novice surgeons to adopt these procedures. Methods: Thirty-one international experts in endothelial keratoplasty participated. Two rounds of electronic survey were followed by a hybrid, virtual meeting. Consensus was set at 75%, and results with agreement between 70% and 75% were deemed as achieving near consensus. Results: A consensus was reached for 98 statements covering the preoperative, intraoperative, and postoperative aspects of Descemet membrane endothelial keratoplasty (DMEK) and Descemet stripping endothelial keratoplasty/Descemet stripping automated endothelial keratoplasty. Four statements achieved near consensus, and consensus could not be achieved for 11 statements. For DMEK, the panel supported a peel technique to prepare tissue for endothelium out DMEK, implanted via an injector and supported by a near full air/gas fill as a baseline procedure onto which more advanced techniques can be built. DMEK tissue should be marked to ensure correct orientation. An inferior peripheral iridotomy should be used to prevent pupil block when a near full air/gas fill in used in endothelial keratoplasty (EK). Descemet stripping automated endothelial keratoplasty was considered preferable to Descemet stripping endothelial keratoplasty where access to microkeratome preparation was available. Conclusions: The Delphi process allowed areas of consensus on the performance of EK to be established by a group of international experts. The statements generated are a helpful framework for novice surgeons learning EK. Further research is needed to help determine what specific tomographic features indicate EK, when guttae are considered visually significant and how to approach combined aphakia and endothelial dysfunction.
Importance:The effect of cornea donor diabetes on endothelial cell density (ECD) and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known. Objective:To determine whether endothelial cell loss (ECL) and morphometric changes 1 year after successful DMEK are related to cornea donor's diabetes status. Design, Setting, and Participants:This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2024 at 28 US clinical sites (46 surgeons) and 13 eye banks. Included in the trial were the eyes of recipients (some of whom received tissue from donors without diabetes and others who received tissue from donors with diabetes) who underwent successful DMEK, primarily for Fuchs endothelial corneal dystrophy, and had at least 1 analyzable postoperative endothelial image. Intervention:DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure to achieve an approximate 2:1 distribution. Main Outcomes and Measures:ECD, ECL, coefficient of variation in cell area (CV), and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images. Results:A total 1274 eyes of 982 recipients (mean [SD] age, 70 [8] years; 569 female [57.9%]; 816 [64.1%] with tissue from donors without diabetes and 458 [35.9%] with tissue from donors with diabetes) were included in the study. Preoperatively, mean (SD) central ECD in tissue from donors without diabetes and with diabetes were 2676 (290) cells/mm2 and 2671 (286) cells/mm2, respectively. At 1 year, mean (SD) ECL was 28.3% (16.1%) and 28.0% (17.0%), in the donor groups without and with diabetes, respectively (adjusted mean difference = -0.4%; 95% CI, -2.3% to 1.4%), resulting in a mean (SD) 1-year ECD of 1927 (498) cells/mm2 and 1920 (496) cells/mm2, respectively (adjusted mean difference = 10 cells/mm2; 95% CI, -36 to 56; P = .95). No difference in ECD at 1 year associated with diabetes severity was noted (P = .97). Mean (SD) CV did not differ at 1 year between the 2 groups of eyes (31.5% [4.1%] vs 31.4% [4.1%]; adjusted mean difference = -0.4%; 95% CI, -0.9% to 0.1%; P = .51), and mean (SD) HEX did not differ at 1 year between the 2 groups of eyes (57.7% [5.8%] vs 57.2% [5.8%]; adjusted mean difference = 0.1%, 95% CI, -0.8% to 0.9%; P = .33). Conclusions and Relevance:This randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes status. With comparable 1-year graft success with tissue from donors with and without diabetes demonstrated in this trial, these findings support the use of corneas from donors with diabetes for endothelial keratoplasty procedures. Trial Registration:ClinicalTrials.gov Identifier: NCT05134480.
This randomized clinical trial investigates if endothelial cell loss and morphometric changes 1 year after successful Descemet membrane endothelial keratoplasty (DMEK) are associated with the presence of diabetes in a cornea donor. QuestionAre endothelial cell loss (ECL) and morphometric changes 1 year after successful Descemet membrane endothelial keratoplasty (DMEK) associated with the presence of diabetes in a cornea donor?FindingsIn this randomized clinical trial including 1274 eyes of 982 recipients with graft success at 1 year and at least 1 analyzable postoperative image, there was no difference observed in ECL based on donor diabetes severity. Morphometric parameters also did not differ at 1 year.MeaningThis study found that ECL and morphometry 1 year after DMEK were not affected by diabetes status of the cornea donor. ImportanceThe effect of cornea donor diabetes on endothelial cell density (ECD) and morphometry after Descemet membrane endothelial keratoplasty (DMEK) is not known.ObjectiveTo determine whether endothelial cell loss (ECL) and morphometric changes 1 year after successful DMEK are related to cornea donor's diabetes status.Design, Setting, and ParticipantsThis was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2024 at 28 US clinical sites (46 surgeons) and 13 eye banks. Included in the trial were the eyes of recipients (some of whom received tissue from donors without diabetes and others who received tissue from donors with diabetes) who underwent successful DMEK, primarily for Fuchs endothelial corneal dystrophy, and had at least 1 analyzable postoperative endothelial image.InterventionDMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure to achieve an approximate 2:1 distribution.Main Outcomes and MeasuresECD, ECL, coefficient of variation in cell area (CV), and percentage of hexagonal cells (HEX) at 1 year from eye bank and postoperative specular central endothelial images.ResultsA total 1274 eyes of 982 recipients (mean [SD] age, 70 [8] years; 569 female [57.9%]; 816 [64.1%] with tissue from donors without diabetes and 458 [35.9%] with tissue from donors with diabetes) were included in the study. Preoperatively, mean (SD) central ECD in tissue from donors without diabetes and with diabetes were 2676 (290) cells/mm2 and 2671 (286) cells/mm2, respectively. At 1 year, mean (SD) ECL was 28.3% (16.1%) and 28.0% (17.0%), in the donor groups without and with diabetes, respectively (adjusted mean difference = -0.4%; 95% CI, -2.3% to 1.4%), resulting in a mean (SD) 1-year ECD of 1927 (498) cells/mm2 and 1920 (496) cells/mm2, respectively (adjusted mean difference = 10 cells/mm2; 95% CI, -36 to 56; P = .95). No difference in ECD at 1 year associated with diabetes severity was noted (P = .97). Mean (SD) CV did not differ at 1 year between the 2 groups of eyes (31.5% [4.1%] vs 31.4% [4.1%]; adjusted mean difference = -0.4%; 95% CI, -0.9% to 0.1%; P = .51), and mean (SD) HEX did not differ at 1 year between the 2 groups of eyes (57.7% [5.8%] vs 57.2% [5.8%]; adjusted mean difference = 0.1%, 95% CI, -0.8% to 0.9%; P = .33).Conclusions and RelevanceThis randomized clinical trial found that ECL and morphometry 1 year after DMEK were not affected by cornea donor diabetes status. With comparable 1-year graft success with tissue from donors with and without diabetes demonstrated in this trial, these findings support the use of corneas from donors with diabetes for endothelial keratoplasty procedures.Trial RegistrationClinicalTrials.gov Identifier: NCT05134480
PURPOSE:To compare long-term outcomes of Descemet membrane endothelial keratoplasty (DMEK) versus Descemet stripping automated endothelial keratoplasty (DSAEK) under a failed penetrating keratoplasty (PKP) graft. METHODS:We retrospectively reviewed consecutive surgeries (Febuary 2007-September 2023) that received a DSAEK graft (n = 52) or DMEK graft (n = 51) under a failed PKP. Postoperative complication rates of primary graft failure (PGF), late endothelial graft failure, graft rejection, rebubble, and steroid response were recorded. Endothelial cell loss (ECL) at 6-month, 2-year, and 5-year postoperative visits were calculated. Graft survival time and survival probability at 5 years was determined using a Kaplan-Meier analysis. Twelve DMEK and 17 DSAEK eyes had 5-year follow-up. Eyes with a glaucoma filtration tube, trabeculectomy, or anterior chamber intraocular lens were excluded. RESULTS:Rebubble rate was significant between DSAEK and DMEK cohorts (5.8%, 29.4%, P = 0.0017*). Rate of rejection, late endothelial graft failure, steroid response, 6-month ECL, 2-year ECL, 5-year ECL, survival probability, and 5-year mean survival time were not significant between DSAEK and DMEK cohorts [(9.6%, 5.9%, P = 0.7155), (13.5%, 9.8%, P = 0.7602), (9.6%, 11.8%, P = 0.7602), (32.0% ± 21.0%, 41.65% ± 25.6%, P = 0.1949), (55.8% ± 21.6%, 62.5% ± 19.8%, P = 0.4463), (59.5% ± 35.0%, 72.5% ± 5.7%, P = 0.3468), (88.5%, 84.3%, P = 0.483), (53.9 ± 2.4 confidence interval, 49.1-58.6 months, 52.7 ± 2.9 confidence interval, 47.0-58.5 months)]. PGF occurred in 0/52 (0%) and 3/51 (5.9%) eyes in the DSAEK and DMEK cohorts with nonsignificant trends favoring DSAEK ( P = 0.1178). CONCLUSIONS:The only significant difference between DSAEK and DMEK cohorts was rebubble rate. However, nonsignificant trends favored PGF and ECL in the DSAEK cohort. Further investigation is warranted to determine if DSAEK provides better short-term and similar long-term outcomes compared with DMEK under a failed PKP.
Importance:If the success of Descemet membrane endothelial keratoplasty (DMEK) is not affected by whether the donor has diabetes, then the donor pool should expand. Objective:To determine whether the 1-year DMEK success rate is affected by the presence of diabetes in the donor. Design, Setting, and Participants:This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2025 at 28 clinical sites (46 surgeons), with donor corneas provided by 13 eye banks in the US. Included in the study were individuals undergoing low to moderate risk DMEK (95% for Fuchs endothelial corneal dystrophy). Study data were analyzed from April to September 2025. Intervention:DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure (comparable with randomization) to achieve an approximate 2:1 distribution, respectively. Main Outcomes and Measures:Graft success at 1 year. Results:A total of 1097 individuals (1421 study eyes; median [IQR] age, 71 [66-76] years; 631 female [57.5%]) were included in the study. The 1-year cumulative probability of graft success was 96.3% (95% CI, 95.0%-97.5%) among 912 study eyes (64.2%) receiving tissue from donors without diabetes and 97.1% (95% CI, 95.5%-98.4%) among 509 study eyes (35.8%) receiving tissue from donors with diabetes (difference between groups = 0.7 percentage points; 95% CI, -1.2 to 2.6; P = .63). The 1-year cumulative probability of graft success was 96.5% (95% CI, 93.6%-98.9%) in the mild donor diabetes severity subgroup (n = 173) and 97.3% (95% CI, 95.4%-98.8%) in the moderate to severe donor diabetes severity subgroup (n = 336), using a diabetes severity rating scale based on medical history. The rates of primary donor failure, early failure related to surgical complications, and subsequent failure were as follows: 2.5% (23 of 912), 0.7% (6 of 912), and 0.3% (3 of 912), respectively, in recipients of tissue from a donor without diabetes, and 2.6% (13 of 509), 0.4% (2 of 509), and 0%, respectively, among recipients of tissue from a donor with diabetes. There were no failures due to graft rejection. Conclusions and Relevance:The 1-year success rate in eyes undergoing DMEK with successfully prepared tissue was very high regardless of donor diabetes status. These results, supported by the separately reported finding that endothelial cell loss and cornea morphometry after 1 year were not affected by donor diabetes status, provide strong support for having no restrictions on the use of tissue from donors with diabetes for DMEK. Trial Registration:ClinicalTrials.gov Identifier: NCT05134480.
This randomized clinical trial investigates if the presence of diabetes in a cornea donor affects the success of Descemet membrane endothelial keratoplasty (DMEK) at 1 year postoperatively. QuestionDoes the presence of diabetes in a cornea donor affect the success of Descemet membrane endothelial keratoplasty (DMEK) 1 year postoperatively?FindingsIn this randomized clinical trial including 1097 individuals and 1421 eyes, DMEK was successful at 1 year using corneas from donors with or without diabetes. The success rate among trial recipients did not appear to be influenced by donor diabetes severity.MeaningDMEK is a highly effective procedure, and the 1-year success rate did not appear to be influenced by the presence of diabetes in the donor. ImportanceIf the success of Descemet membrane endothelial keratoplasty (DMEK) is not affected by whether the donor has diabetes, then the donor pool should expand.ObjectiveTo determine whether the 1-year DMEK success rate is affected by the presence of diabetes in the donor.Design, Setting, and ParticipantsThis was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2025 at 28 clinical sites (46 surgeons), with donor corneas provided by 13 eye banks in the US. Included in the study were individuals undergoing low to moderate risk DMEK (95% for Fuchs endothelial corneal dystrophy). Study data were analyzed from April to September 2025.InterventionDMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure (comparable with randomization) to achieve an approximate 2:1 distribution, respectively.Main Outcomes and MeasuresGraft success at 1 yearResultsA total of 1097 individuals (1421 study eyes; median [IQR] age, 71 [66-76] years; 631 female [57.5%]) were included in the study. The 1-year cumulative probability of graft success was 96.3% (95% CI, 95.0%-97.5%) among 912 study eyes (64.2%) receiving tissue from donors without diabetes and 97.1% (95% CI, 95.5%-98.4%) among 509 study eyes (35.8%) receiving tissue from donors with diabetes (difference between groups = 0.7 percentage points; 95% CI, -1.2 to 2.6; P = .63). The 1-year cumulative probability of graft success was 96.5% (95% CI, 93.6%-98.9%) in the mild donor diabetes severity subgroup (n = 173) and 97.3% (95% CI, 95.4%-98.8%) in the moderate to severe donor diabetes severity subgroup (n = 336), using a diabetes severity rating scale based on medical history. The rates of primary donor failure, early failure related to surgical complications, and subsequent failure were as follows: 2.5% (23 of 912), 0.7% (6 of 912), and 0.3% (3 of 912), respectively, in recipients of tissue from a donor without diabetes, and 2.6% (13 of 509), 0.4% (2 of 509), and 0%, respectively, among recipients of tissue from a donor with diabetes. There were no failures due to graft rejection.Conclusions and RelevanceThe 1-year success rate in eyes undergoing DMEK with successfully prepared tissue was very high regardless of donor diabetes status. These results, supported by the separately reported finding that endothelial cell loss and cornea morphometry after 1 year were not affected by donor diabetes status, provide strong support for having no restrictions on the use of tissue from donors with diabetes for DMEK.Trial RegistrationClinicalTrials.gov Identifier: NCT05134480
Purpose: We aimed to compare the rate of 6-month endothelial cell loss (ECL) and 6-month graft survival in eyes that did not require a postoperative rebubble with eyes that did require a postoperative rebubble after Descemet membrane endothelial keratoplasty (DMEK) surgery. Methods: A consecutive series of DMEK surgeries performed from September 2013 to March 2020 was retrospectively analyzed. Eyes that did not require a rebubble for graft detachment were compared with eyes with 1 rebubble and eyes with 2 or more rebubbles for 6-month ECL and graft survival. A subanalysis of the rebubble rate for different indications for transplantation was also performed. Results: One thousand two hundred ninety-eight eyes were included in this study. The 6-month ECL for eyes with no rebubbles, 1 rebubble, and ≥2 rebubbles was 29.3% ± 16.2% (n = 793), 36.4% ± 18.6% (n = 97, P = 0.001), and 50.1% ± 19.6% (n = 28, P < 0.001), respectively. The 6-month graft survival rate for eyes with no rebubbles, 1 rebubble, and ≥2 rebubbles was 99.5%, 97.8% (P = 0.035), and 81.8% (P < 0.001), respectively. When compared to the rebubble rate for DMEK for Fuchs dystrophy (156/1165 eyes = 13.4%), the rebubble rates were statistically higher for DMEK for failed penetrating keratoplasty (28.5%, P = 0.021) and pseudophakic bullous keratopathy (28.0%, P = 0.036). Conclusions: Eyes undergoing any rebubble procedure in the postoperative period after DMEK have an increased risk of endothelial cell loss and graft failure at 6 months postoperative. DMEK in eyes for failed penetrating keratoplasty and failed DMEK had the highest rebubble rate, with the former reaching statistical significance.
Purpose: The aim of this study was to determine whether loading a Descemet membrane endothelial keratoplasty (DMEK) graft using a drop-in procedure results in more endothelial cell loss (ECL) than the standard suction procedure. Methods: Pairs of donor corneas with equivalent preprocessing endothelium were prepared using the standard protocol of our eye bank. One member of each pair was loaded into an injector using the standard suction protocol. The mate graft was loaded using a drop-in protocol, in which the edge of the graft was gently grasped with a forceps, lifted to the edge of the injector, and dropped inside. Grafts were evaluated for ECL and examined for grab marks or other loading-associated damage. Results: There was no difference in mean ECL of grafts prepared for DMEK using the standard protocol (20.6% ± 4.5%) compared with that of mate grafts prepared using the drop-in loading protocol (19.5% ± 4.8%, P = 0.59). There was no consistent pattern of damage in the drop-in–loaded grafts, as grab marks or other tissue damage associated with the drop-in loading protocol were not consistently identified by a trained corneal surgeon. Conclusions: ECL was not significantly different in grafts prepared using a drop-in loading procedure compared with grafts prepared using the standard suction protocol. The drop-in loading protocol may be particularly useful to surgeons who load their own grafts and eye bank processing technicians who encounter a “flat” DMEK graft that does not scroll or a loosely scrolled DMEK graft.
Purpose: The purpose of this study was to determine whether controlled balanced salt solution (BSS) bursts during graft preparation can safely promote formation of a double-scrolled Descemet membrane endothelial keratoplasty (DMEK) graft in younger donor tissue. Methods: DMEK grafts prepared from young donor tissue (average age, 55 years; range, 39-66 years) were floated in BSS to spontaneously form scrolls (N = 10 pairs). Controlled BSS bursts were used to promote double-scroll (DS) formation in 1 member of each pair. Grafts were stained, preloaded, and shipped before cell viability analysis. After appropriate training, a less experienced technician performed this technique on 10 additional corneas. Outcomes measured for both technicians include the success rate for obtaining a DS, scroll conformation after shipping, and endothelial cell loss (ECL). Results: There was no difference in ECL between grafts subjected to additional manipulation compared with unmanipulated mate grafts (observer 1: 15.2% +/- 3.3% vs. 15.2% +/- 4.4%, P = 0.99; observer 2: 16.3% +/- 2.9% vs. 15.9% +/- 4.5%, P = 0.8). A technician experienced with this technique had a 90% success rate, whereas a less experienced technician had a 70% success rate. The mean ECL of the 10 grafts manipulated by the less experienced technician was not significantly different from results obtained from the experienced technician (observer 1: 18.5% +/- 6.0% vs. 15.2% +/- 3.3%, P = 0.15; observer 2: 18.1% +/- 5.6% vs. 16.3% +/- 2.9%, P = 0.34). Scrolls maintained their conformation during shipping events. Conclusions: Double-scroll graft formation using controlled BSS bursts is a reliable technique that can be performed without causing additional damage to DMEK grafts. This technique may make graft unscrolling easier and can promote the use of younger donor tissue for DMEK.
PURPOSE:To describe Descemet membrane endothelial keratoplasty (DMEK) cases complicated by spontaneous intraoperative fibrin formation.METHODS:DMEK surgeries performed at two centers using a standardized technique were reviewed retrospectively for the occurrence of intraoperative fibrin formation. Cases were assessed for recipient medical history, donor age, best spectacle-corrected visual acuity (BSCVA), intraoperative unscrolling time, 6-month endothelial cell loss (ECL), and the course of the mate donor cornea.RESULTS:In this review of 868 cases of standardized DMEK surgery with surgical peripheral iridotomy, 32 eyes of 29 patients (3.7%) were complicated by the formation of intraoperative fibrin formation, including 3 patients that developed fibrin in both eyes. Three of the 32 grafts failed (9.4%). None of the mate corneas transplanted (n = 27) developed complications related to fibrin. The donor age ranged from 51 to 75 years and recipient age ranged from 49 to 82 years (median, 66 years). Unscrolling time ranged from 1 to 105 min (median, 15 min). Nine eyes required one rebubble procedure. No eyes had vision-limiting comorbidities, and the 6-month BSCVA was ≥20/40 in all eyes. Six-month ECL ranged from 19% to 73% (median, 44%).CONCLUSIONS:We conclude that fibrin formation during DMEK surgery is an uncommon but important complication that can make graft manipulation more difficult, and may have deleterious effects on endothelial cell density and graft survival.
PURPOSE:The purpose of this study was to compare the clinical outcomes from using eye bank-prepared, endothelium-out preloaded Descemet membrane endothelial keratoplasty (DMEK) tissue with those obtained with endothelium-out surgeon-loaded DMEK tissue using the same surgical technique at 1 site.METHODS:This study retrospectively reviewed 400 consecutive cases of DMEK from March 2016 to April 2018. The last 200 cases using surgeon-loaded tissue were compared with the first 200 cases using preloaded tissue. Statistical analysis was performed using the Wilcoxon signed-rank test, binomial logistic regression, Kruskal-Wallis 1-way analysis of variance, Student t test, or Pearson χ tests.RESULTS:Comparing surgeon-loaded versus preloaded DMEK tissue, respectively, no statistical difference was found in the mean 6-month postoperative values for endothelial cell loss (32.9% ± 18.5% vs. 29.9% ± 16.4%, P = 0.31), best corrected visual acuity (20/26 vs. 20/25, P = 0.54), or change in central corneal thickness (-14.4% ± 8.9% vs. -15.6% ± 11.7%, P = 0.43). The mean 1-year endothelial cell loss was also not significantly different (37.6% ± 17.2% vs. 33.2% ± 14.8%, P = 0.07). Overall, the rebubble rate for surgeon-loaded tissue was 17.5% and 12.5% for preloaded tissue, a statistically nonsignificant difference. Operative outcomes for mean tissue scroll tightness (1-4) and tissue unscroll time (minutes) for surgeon-loaded and preloaded tissue were similar between groups (2.4 vs. 2.2, P = 0.12 and 3.5 vs. 3.3 minutes, P = 0.50).CONCLUSIONS:Tissue that is trephinated, stained, and loaded into an injector by the eye bank and then shipped to the surgeon had no difference in clinical outcomes compared with tissue where the surgeon performs these steps. The safety and speed of using preloaded tissue should be considered by DMEK surgeons.