Bowman Layer Onlay Grafting as a Minimally Invasive Treatment for the Most Challenging Cases in Keratoconus.

PURPOSE: To analyze the clinical outcomes after Bowman layer (BL) onlay grafting for the treatment of progressive, advanced keratoconus. DESIGN: Prospective, interventional case series. METHODS: Twenty-one eyes underwent BL onlay grafting. After removing the epithelium, a single or double BL graft was "stretched" onto the corneal surface, allowed to dry-in, and a soft bandage lens was placed until the graft was re-epithelialized. Best spectacle- and/or best contact lens-corrected visual acuity (BSCVA/BCLVA), corneal tomography, and postoperative complication rates were analyzed for the total group and 2 subgroups (group 1: preoperative maximum keratometry [Kmax] <69 diopters [D; n = 7); group 2: preoperative Kmax ≥69 D [n = 14]). Follow-up ranged from 6 to 36 months (mean 21 ± 11 months). RESULTS: All 21 surgeries were uneventful. Overall, Kmax changed from 76 ± 12 D preoperatively to 72 ± 9 D at 6 to 36 months postoperatively (P = .015). Kmax decreased by 6 D in group 2 (P = .002) but did not change in group 1. Average BSCVA remained stable for group 1 and improved from preoperatively 0.8 ± 0.4 to 0.4 ± 0.2 logarithm of the minimum angle of resolution postoperatively in group 2 (P = .032); BCLVA remained stable (P > .05). Within the first postoperative weeks, 2 eyes required BL graft repositioning after inadvertent bandage lens removal and 4 eyes underwent BL retransplantation for incomplete re-epithelialization. One eye underwent BL regrafting 12 months postoperatively after traumatic corneal erosion. All eyes showed a completely re-epithelialized graft at the last available follow-up. CONCLUSIONS: BL onlay grafting is a completely extraocular, minimally invasive surgical technique, providing up to -6 D of corneal flattening in eyes with advanced progressive keratoconus, allowing for continued (scleral) contact lens wear and therefore preserving the BCLVA.

Long-Term Outcome After Bilateral DMEK for Fuchs Endothelial Corneal Dystrophy.

PURPOSE: The aim of this study was to assess the long-term clinical outcome, complications, and graft survival of bilateral Descemet membrane endothelial keratoplasty (DMEK) in patients with Fuchs endothelial corneal dystrophy. METHODS: This was a retrospective cohort study of 181 patients (362 eyes) with sequential bilateral DMEK for Fuchs endothelial corneal dystrophy. Clinical outcomes were assessed up to 5 years postoperatively. Outcome measures were best-corrected visual acuity, pachymetry, endothelial cell density, graft survival, and complication rates. RESULTS: Contralateral DMEK was performed on average 15 ± 11 months (range: 2-60 months) after the first eye. From 1 until 5 years after DMEK, best-corrected visual acuity, pachymetry, endothelial cell density, and graft survival did not differ between the first and second eyes (all P > 0.05). Graft detachment occurred in 67 eyes (19% [18% first eyes, 19% second eyes], 6% bilateral), graft rejection in 9 eyes (3% [3% first eyes, 2% second eyes], 1% bilateral), glaucoma in 25 eyes (7% [8% first eyes, 6% second eyes], 2% bilateral), and graft failure in 22 eyes (6% [4% first eye, 8% second eye], 2% bilateral). All differences were not significant (all P > 0.05). Five-year graft survival rates were comparable for first and second eyes (0.95 and 0.92, respectively; P = 0.15). CONCLUSIONS: Clinical outcomes after bilateral DMEK are similar in both eyes and sustainable in the longer term. Within the first 5 years, the same complication may rarely occur in the contralateral eye.

Long-Term Outcomes of Descemet Membrane Endothelial Keratoplasty: Effect of Surgical Indication and Disease Severity.

PURPOSE: The aim of this study was to evaluate clinical outcomes and graft survival in a large patient cohort up to 10 years after Descemet membrane endothelial keratoplasty (DMEK) based on surgical indication and Fuchs endothelial corneal dystrophy (FECD) severity. METHODS: The cohort in this retrospective study included 750 eyes that underwent DMEK for FECD (86%), bullous keratopathy (BK, 9%), and other indications (5%). Based on the modified Krachmer grading, 186 eyes (29%) had moderate FECD (Krachmer grade 3-4) and 440 eyes (68%) had advanced FECD (Krachmer grade 5-6). Main outcome measures were best-corrected visual acuity (BCVA), central corneal thickness, endothelial cell density (ECD), endothelial cell loss (ECL), postoperative complication rate, and graft survival. RESULTS: The mean 10-year BCVA was 0.08 ± 0.28 logMAR (n = 96), and the BCVA remained stable between 5 and 10 years postoperatively (all P > 0.05). The mean ECL at 5 and 10 years was 56% ± 17% (n = 460) and 66% ± 14% (n = 96), respectively ( P < 0.05). The 10-year graft survival rate for the total cohort was 0.85 (95% confidence interval, 0.82-0.89). BCVA and ECD differed at 1 to 5 years between eyes with different surgical indications (all P < 0.05), and FECD eyes had higher graft survival compared with BK eyes (0.90 vs. 0.60, P = 0.001). Moderate FECD eyes had better BCVA, ECD, and graft survival outcomes than advanced FECD eyes (all P < 0.05). Minor graft detachment ( P = 0.04) and lower donor ECD ( P = 0.01) were related to lower 10-year ECD. CONCLUSIONS: Long-term outcomes and graft survival after DMEK were better in FECD eyes than BK eyes and were also related to FECD disease severity. Eyes operated for moderate FECD showed the highest graft survival probability and excellent long-term outcomes.

Impact of Fuchs Endothelial Corneal Dystrophy Severity on Scheimpflug-Derived Parameters After Descemet Membrane Endothelial Keratoplasty.

PURPOSE: The aim of this study was to evaluate how Scheimpflug-derived parameters of eyes with Fuchs endothelial corneal dystrophy (FECD) are influenced by Descemet membrane endothelial keratoplasty (DMEK) depending on FECD severity and the presence of subclinical edema. METHODS: A retrospective cohort study including 115 eyes (115 patients) that underwent DMEK for FECD and a control group of 27 eyes with nonpathological corneas was conducted. Preoperative and 6 months postoperative Scheimpflug imaging was used to analyze pachymetry, presence of tomographic features (loss of isopachs/displacement of the thinnest point/focal posterior depression), and corneal backscatter. FECD severity was based on the modified Krachmer scale and the absence/presence of subclinical edema. RESULTS: Scheimpflug-derived pachymetry, tomographic, and corneal backscatter parameters were correlated with FECD severity, and all changed from preoperatively to postoperatively (all P < 0.05). Postoperative central corneal thickness, anterior and posterior corneal backscatter, and presence of focal posterior depression remained different from the control group (all P < 0.05). Of eyes without preoperative clinical edema (n = 75), 18.7% showed 0 or 1 tomographic feature (no edema group) and 82.4% had 2 or 3 features (subclinical edema group). Compared with the control group, postoperative best-corrected visual acuity for the "no edema" group did not differ (0.03 ± 0.12 vs. -0.02 ± 0.08 logarithm of the minimum angle of resolution, P = 0.150) but was worse for the subclinical edema group (0.06 ± 0.08 vs. -0.02 ± 0.08 logarithm of the minimum angle of resolution, P = 0.001). CONCLUSIONS: For eyes without preoperative edema, more parameters reversed back to 'normal' levels than for eyes with (sub)clinical edema. Although most analyzed parameters correlated with FECD severity, corneal tomography might be best suited for objective grading of disease severity to aid in surgical decision-making.

Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus.

PURPOSE: To report long-term clinical outcomes and estimated success rates after Bowman layer (BL) inlay transplantation in eyes treated for progressive keratoconus (KC). METHODS: Thirty-five eyes (29 patients) with progressive KC underwent BL inlay transplantation. Best-corrected spectacle and contact lens visual acuity, Scheimpflug-based corneal tomography [simulated and maximum keratometry (Kmax)], central corneal thickness, thinnest point thickness, complications, and success rate were evaluated up to 8 years postoperatively for the total group and 2 subgroups [group 1: preoperative Kmax > 69 diopter (D) (n = 26); group 2: preoperative Kmax < 69D (n = 9)]. RESULTS: Mean logarithm of the minimum angle of resolution best contact lens-corrected visual acuity for the total group and the 2 subgroups did not change from preoperative up to the last available follow-up (all P > 0.05), whereas best spectacle-corrected visual acuity improved for group 1 ( P = 0.03). Group 1 showed an average Kmax reduction of 7D in the first month ( P < 0.001) with no further changes up to 8 years postoperatively ( P > 0.05), whereas no significant changes were observed in group 2 (all P > 0.05). Postoperative KC progression occurred in 4 eyes (n = 3 group 1, n = 1 group 2) and 1 eye (group 2) underwent retransplantation for unsatisfactory visual performance. Kaplan-Meier analysis showed an estimated success rate of 85% at the 5 to 8 years follow-up in group 1 and of 75% at the 5 to 7 years follow-up for group 2. CONCLUSIONS: BL inlay transplantation stabilized KC in most eyes along with preservation of contact lens tolerance up to 8 years postoperatively and may be a successful treatment option, in particular for eyes with progressive advanced KC (Kmax > 69D).

37†Descemet membrane endothelial keratoplasty (DMEK): 10-year clinical outcomes and graft survival.

PURPOSE: To evaluate graft survival and clinical outcomes up to 10 years after Descemet membrane endothelial keratoplasty (DMEK). SETTING/VENUE: Retrospective cohort study conducted at the Netherlands Institute for Innovative Ocular Surgery. METHODS: 750 consecutive DMEK eyes, not including the very first 25 DMEK eyes that constitute the technique learning curve, were included. Main outcome parameters (survival, best-corrected visual acuity (BCVA), central endothelial cell density (ECD)) was evaluated up to 10-years postoperatively and postoperative complications were documented. Outcomes were analyzed for the entire study group and separately for the subgroup of the first 100 DMEK eyes. RESULTS: For the subgroup of 100 DMEK eyes, 82% and 89% reached a BCVA of ≥20/25 (Decimal VA ≥0.8) at 5- and 10 years postoperatively, respectively, and preoperative donor ECD decreased by 59% at 5 years and 68% at 10 years postoperatively. Graft survival probability for the first 100 DMEK eyes was 0.83 [95% Confidence Interval (CI), 0.75-0.92] and 0.79 [95% CI, 0.70 -0.88] at 5- and 10-years postoperatively, respectively. For the total study group, clinical outcome in terms of BCVA and ECD were comparable, but graft survival probability was significantly higher at 5- and 10-year postoperatively. CONCLUSIONS: Most eyes operated in the pioneering phase of DMEK showed excellent and stable clinical outcomes with a promising graft longevity over the first decade after surgery. The increase in DMEK experience resulted in a lower graft failure rate and positively affected longer-term graft survival probability.

Effect of Six-Month Postoperative Endothelial Cell Density on Graft Survival after Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To analyze if 6-month endothelial cell density (ECD) affects long-term ECD outcome and graft survival 5 years after Descemet membrane endothelial keratoplasty (DMEK) in eyes with Fuchs endothelial corneal dystrophy (FECD). DESIGN: Retrospective cohort study. PARTICIPANTS: A total of 585 DMEK eyes were included. The study group was divided into 4 groups based on 6-month ECD quartiles: group 1 (n = 146) with 313 to 1245 cells/mm2, group 2 (n = 148) with 1246 to 1610 cells/mm2, group 3 (n = 145) with 1611 to 1938 cells/mm2, and group 4 (n = 146) with 1939 to 2760 cells/mm2. Group 1 was further split into subgroups 1a (n = 36) with 6-month ECD of ≤828 cells/mm2, 1b (n = 37) with 829 to 1023 cells/mm2, 1c (n = 37) with 1024 to 1140 cells/mm2, and 1d (n = 36) 1141 to 1245 cells/mm2. METHODS: Descemet membrane endothelial keratoplasty. MAIN OUTCOME MEASURES: Long-term ECD, graft survival, and postoperative complication rates. RESULTS: For group 1, 6-month ECD decreased from 951 (±233) cells/mm2 (n = 146) to 735 (±216) cells/mm2 (n = 99) at 5 years postoperatively. Group 1 graft survival probability was 0.95 (95% confidence interval [CI], 0.91-0.99] at 5 years postoperatively, which was lower than for groups 2 to 4 (P = 0.001). Five-year graft survival in subgroup 1a was 0.79 (95% CI, 0.67-0.94), which was lower than in subgroups 1b to 1d (P = 0.001). Preoperative ECD did not influence graft survival (P = 0.400), and higher 6-month ECD values were associated with lower graft failure rates (hazard ratio, 0.994; 95% CI, 0.99-1.00; P = 0.001). CONCLUSIONS: Six-month ECD is associated with DMEK graft survival. High early cell loss after DMEK negatively affects long-term ECD outcome and graft survival. Grafts in the lowest 6-month ECD subgroup (≤828 cells/mm2) are at higher risk of failure within 5 years after DMEK. To ensure sufficiently high 6-month ECD, preoperative graft quality assessment should be optimized, and cellular stress induced to the graft should be minimized. Additionally, developing therapeutic options for the treatment of low postoperative ECD could further improve DMEK graft longevity.

Phacoemulsification After Descemet Membrane Endothelial Keratoplasty: Incidence and Influence on Endothelial Cell Density.

PURPOSE: To analyze the incidence of cataract extraction after Descemet membrane endothelial keratoplasty (DMEK) in phakic eyes and to evaluate the effect of phacoemulsification after DMEK on the donor endothelial cell density (ECD). METHODS: The clinical data of phakic patients with DMEK were examined. From this cohort, all patients who subsequently underwent phacoemulsification after DMEK were reviewed. Data from a prospectively collected dataset were analyzed, including demographic profile, ECD, corrected distance visual acuity (CDVA), central corneal thickness (CCT), and complications. RESULTS: From a series of 261 phakic patients with DMEK, 35 eyes (13.4%) required cataract surgery within the mean follow-up period of 54.2 ± 28 months. The mean time from DMEK to phacoemulsification was 18 ± 13 months (range: 3 to 69 months). The probability of cataract extraction after DMEK was 0.06 (95% CI: 0.03 to 0.09) at 1 year and 0.17 (95% CI: 0.12 to 0.22) at 10 years, respectively. ECD decreased from 1,314 ± 524 cells/mm2 before phacoemulsification to 1,167 ± 443 cells/mm2 (-11%) at 1 to 6 months postoperatively (P = .333). CDVA improved from 0.27 ± 0.13 logMAR preoperatively to 0.07 ± 0.12 logMAR at 1 to 6 months postoperatively. CCT before phacoemulsification was 532 ± 46 µm and remained stable at 539 ± 56 µm at 1 to 6 months after phacoemulsification. Phacoemulsification did not elicit DMEK graft detachment in any of the eyes studied. CONCLUSIONS: The incidence and 10-year projection of cataract extraction in phakic eyes with DMEK was relatively low. Phacoemulsification after DMEK provided excellent CDVA outcomes, did not induce graft detachment, and was associated with an acceptable decrease in ECD. [J Refract Surg. 2021;37(2):119-125.].

Use of Corneas From Septic Donors for Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To evaluate the suitability of corneas from septic donors for transplantation by analyzing the discard rate in the eye bank and the clinical outcome of Descemet membrane endothelial keratoplasty (DMEK) using organ-cultured corneal grafts from septic versus nonseptic donors. METHODS: This retrospective study included 1554 corneas of which 456 corneas (29%) were from septic and 1072 corneas (69%) from nonseptic donors [for 26 corneas (2%) sepsis status was unknown]. The clinical outcome at 6 months after DMEK was evaluated for 82 grafts (26 from septic and 56 from nonseptic donors). Outcome measures were endothelial cell density, central corneal thickness, and postoperative complications. RESULTS: Primary discard rates were higher for corneas from septic than from nonseptic donors (32.9% vs. 24.5%, P = 0.001). The main discard reason was poor endothelial cell quality for both septic (13.8%) and nonseptic (11.8%) donor corneas. Eye bank contamination rates for septic and nonseptic donor corneas were 1.1% and 1.7%, respectively (P = 0.102). After DMEK, donor endothelial cell density at 6m postoperatively was comparable between grafts from septic and nonseptic donors (1410 ± 422 cells/mm vs. 1590 ± 519 cells/mm, P = 0.140). No differences in 6m central corneal thickness and in the rebubbling rate were observed between the 2 groups (P = 0.780 and P = 0.396, respectively). None of the cases had graft rejection nor endophthalmitis in both groups. CONCLUSIONS: Provided strict adherence to donor screening and evaluation protocols, the use of organ-cultured corneas from septic donors for DMEK does not seem to increase the risk for recipients and allows for expansion of the donor pool for corneal tissue.

Donor diabetes mellitus is a risk factor for diminished outcome after liver transplantation: a nationwide retrospective cohort study.

With the growing incidence of diabetes mellitus (DM), an increasing number of organ donors with DM can be expected. We sought to investigate the association between donor DM with early post-transplant outcomes. From a national cohort of adult liver transplant recipients (1996-2016), all recipients transplanted with a liver from a DM donor (n = 69) were matched 1:2 with recipients of livers from non-DM donors (n = 138). The primary end-point included early post-transplant outcome, such as the incidence of primary nonfunction (PNF), hepatic artery thrombosis (HAT), and 90-day graft survival. Cox regression analysis was used to analyze the impact of donor DM on graft failure. PNF was observed in 5.8% of grafts from DM donors versus 2.9% of non-DM donor grafts (P = 0.31). Recipients of grafts derived from DM donors had a higher incidence of HAT (8.7% vs. 2.2%, P = 0.03) and decreased 90-day graft survival (88.4% [70.9-91.1] vs. 96.4% [89.6-97.8], P = 0.03) compared to recipients of grafts from non-DM donors. The adjusted hazard ratio for donor DM on graft survival was 2.21 (1.08-4.53, P = 0.03). In conclusion, donor DM is associated with diminished outcome early after liver transplantation. The increased incidence of HAT after transplantation of livers from DM donors requires further research.

Descemet Membrane Endothelial Keratoplasty: Ten-Year Graft Survival and Clinical Outcomes.

PURPOSE: To evaluate the 10-year graft survival and clinical outcomes of the first case series after Descemet membrane endothelial keratoplasty (DMEK). DESIGN: Retrospective, interventional case series. METHODS: After excluding the very first 25 DMEK eyes that constitute the technique learning curve, the following 100 consecutive primary DMEK eyes (88 patients) were included. Main outcome parameters (survival, best-corrected visual acuity [BCVA], central endothelial cell density [ECD], and central corneal thickness [CCT]) were evaluated up to 10 years postoperatively, and postoperative complications were documented. RESULTS: At 5 and 10 years after DMEK, 68 and 57 of 100 eyes, respectively, were still available for analysis. Of those eyes, 82% and 89% reached a BCVA of ≥20/25 (decimal VA ≥0.8) at 5- and 10 years postoperatively, respectively. Preoperative donor ECD decreased by 59% at 5 years and 68% at 10 years postoperatively. CCT averaged 668 ±74 µm preoperatively and 540 ± 33 µm and 553 ± 43 µm at 5 and 10 years, respectively, after surgery. Within 10 years, 4% of eyes developed allograft rejection, no primary graft failures occurred, and 6% of the eyes developed secondary graft failure. Graft survival probability was 0.83 (95% confidence interval [CI], 0.75-0.92) and 0.79 (95% CI, 0.70-0.88) at 5 and 10 years postoperatively, respectively. CONCLUSIONS: Most eyes that underwent surgery in the pioneering phase of DMEK showed excellent and stable clinical outcomes with low postoperative complication rates and promising graft longevity over the first decade after surgery. This suggests that DMEK may be a safe long-term treatment option for corneal endothelial diseases.

Endothelial Cell Density Changes in the Corneal Center Versus Paracentral Areas After Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To analyze whether endothelial cell density (ECD) differs between central and paracentral areas after Descemet membrane endothelial keratoplasty (DMEK) and to identify the locations of the highest and lowest ECD. METHODS: In this retrospective cohort study, central and paracentral ECDs of 30 eyes of 30 patients who underwent DMEK for Fuchs endothelial corneal dystrophy were evaluated. Central, superonasal, superotemporal, and inferior specular microscopic images were analyzed at 1, 3, 6, 9, and 12 months after DMEK. Changes in ECD by location and over time and changes in location for the highest and lowest ECD were evaluated. RESULTS: When compared with the preoperative donor ECD, the central ECD decreased by 32 (±11)% at 12 months postoperatively. ECD decline between 1 and 12 months postoperatively in the central, inferior, superonasal, and superotemporal location were 7%, 12%, 16%, and 13%, respectively (P < 0.0001 for all locations). Mean ECD was the highest in the center between the 3- to 12-month follow-up, whereas mean ECD was the lowest in the paracentral superonasal area at all time points (P < 0.001). Mean ECD of the highest and lowest density locations differed at all follow-up time points (P < 0.003). CONCLUSIONS: Postoperative ECD was not found to be uniform across the graft. Contrary to the density distribution in the normal endothelium, paracentral area ECDs were found to be consistently lower than in the central area. These differences were most prominent in the superonasal area and persisted 12 months postoperatively. Central ECD after DMEK might, thus, not represent an accurate proxy for cell density of the entire graft.