Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty A Multicenter Randomized Controlled Clinical Trial

Purpose: To compare best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). Design: Prospective, multicenter randomized controlled trial. Participants: Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands. Methods: Participants were allocated to DMEK (n = 29) or UT-DSAEK (n = 25) using minimization randomization based on preoperative BSCVA, recipient central corneal thickness, gender, age, and institution. Donor corneas were prestripped and precut for DMEK and UT-DSAEK, respectively. Six corneal surgeons participated in this study. Main Outcome Measures: The primary outcome measure was BSCVA at 12 months after surgery. Results: Central graft thickness of UT-DSAEK lamellae measured 101 mu m (95% confidence interval [CI], 90-112 mu m). Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR] [95% CI 0.08-0.22 logMAR] vs. 0.22 logMAR [95% CI 0.16-0.27 logMAR]; P = 0.15), 6 months (0.11 logMAR [95% CI 0.05-0.17 logMAR] vs. 0.16 logMAR [95% CI 0.12-0.21 logMAR]; P = 0.20), and 12 months (0.08 logMAR [95% CI 0.03-0.14 logMAR] vs. 0.15 logMAR [95% CI 0.10-0.19 logMAR]; P = 0.06). Twelve months after surgery, the percentage of eyes reaching 20/25 Snellen BSCVA was higher in DMEK compared with UT-DSAEK (66% vs. 33%; P = 0.02). Endothelial cell density did not differ significantly 12 months after DMEK and UT-DSAEK (1870 cells/mm 2 [95% CI 1670-2069 cells/mm(2)] vs. 1612 cells/mm(2) [95% CI 1326-1898 cells/mm(2)]; P = 0.12). Both techniques induced a mild hyperopic shift (12 months: +0.22 diopter [D; 95% CI -0.23 to 0.68 D] for DMEK vs. +0.58 D [95% CI 0.13-1.03 D] for UT-DSAEK; P = 0.34). Conclusions: Descemet membrane endothelial keratoplasty and UT-DSAEK did not differ significantly in mean BSCVA, but the percentage of eyes achieving 20/25 Snellen vision was significantly higher with DMEK. Endothelial cell loss did not differ significantly between the treatment groups, and both techniques induced a minimal hyperopic shift. (C) 2020 by the American Academy of Ophthalmolog

Quality of vision and vision-related quality of life after Descemet membrane endothelial keratoplasty:a randomized clinical trial

PURPOSE: To compare quality of vision and vision‐related quality of life (QOL) in patients undergoing Descemet membrane endothelial keratoplasty (DMEK) or ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK). METHODS: Fifty‐four eyes of 54 patients with Fuchs' dystrophy from six corneal clinics in the Netherlands were randomized to DMEK or ultrathin DSAEK and examined preoperatively, and 3, 6 and 12 months postoperatively. Main outcome measures were corneal higher‐order aberrations (HOAs), contrast sensitivity, straylight and vision‐related QOL. RESULTS: Posterior corneal HOAs decreased after DMEK and increased after ultrathin DSAEK (p ≤ 0.001) 3 months after surgery and correlated positively with best spectacle‐corrected visual acuity (12 months: r = 0.29, p = 0.04). Anterior and total corneal HOAs did not differ significantly between both techniques at any time point. Contrast sensitivity was better (p = 0.01), and straylight was lower (p = 0.01) 3 months after DMEK compared with ultrathin DSAEK; 95% confidence interval [CI] of log(cs) 1.10–1.35 versus 95% CI: 0.84 to 1.12, and 95% CI: log(s) 1.18 to 1.43 versus 95% CI: 1.41 to 1.66, respectively. Both were comparable at later time points. Vision‐related QOL (scale 0–100) did not differ significantly between both groups at any time point and improved significantly at 3 months (β = 12 [95% CI: 7 to 16]; p < 0.001), and subsequently between 3 and 12 months (β = 5 [95% CI: 0 to 9]; p = 0.06). CONCLUSIONS: Descemet membrane endothelial keratoplasty (DMEK) results in lower posterior corneal HOAs compared with ultrathin DSAEK. Contrast sensitivity and straylight recover faster after DMEK but reach similar levels with both techniques at 1 year. Vision‐related QOL improved significantly after surgery, but did not differ between both techniques

Long-term outcomes of repeated Corneal Transplantations: a prospective Dutch registry study

\u3cp\u3ePurpose: To compare long-term outcomes of repeated corneal transplantations (CT), based on primary indication (Fuchs endothelial dystrophy [FED] vs pseudophakic bullous keratoplasty [PBK]), surgical technique (penetrating keratoplasty [PK] vs endothelial keratoplasty [EK]), and indication for repeated grafting. Methods: In this nonrandomized treatment comparison with national registry data (Netherlands Organ Transplantation Registry, NOTR), data on all consecutive repeated CT following primary PK or EK for FED and PBK between 1994 and 2015 were analyzed, with a maximal follow-up of 5 years. Regraft survival was analyzed using Kaplan-Meier survival curves and univariable and multivariable Cox regression analysis. Secondary outcomes best-corrected visual acuity, spherical equivalent, and refractive astigmatism were compared using linear mixed-model analysis. Results: A total of 332 repeated CT were analyzed. The number of regrafts increased significantly between 2007 and 2015 (P =.001). Overall 5-year regraft survival was 60% and was higher for FED vs PBK (77% vs 45%, HR = 0.40, P =.001), and re-EK vs re-PK (81% vs 55%, HR = 0.51, P =.041). However, multivariable analysis showed no significant difference in survival based on primary indication, surgical technique, and indication for regrafting. Corrected for baseline, secondary outcomes also did not differ between groups. Conclusions: We found a significant increase in repeated CT, coinciding with the introduction of EK in the Netherlands. While univariable analysis suggested better overall regraft survival for FED and (re-)EK, multivariable analysis showed no such difference. This may be owing to allocation of favorable cases to undergo (re-)EK. Similarly, secondary outcomes were determined by the primary CT technique.\u3c/p\u3

Long-term Outcomes of Repeated Corneal Transplantations: A Prospective Dutch Registry Study

Purpose: To compare long-term outcomes of repeated corneal transplantations (CT), based on primary indication (Fuchs endothelial dystrophy [FED] vs pseudophakic bullous keratoplasty [PBK]), surgical technique (penetrating keratoplasty [PK] vs endothelial keratoplasty [EK]), and indication for repeated grafting. Methods: In this nonrandomized treatment comparison with national registry data (Netherlands Organ Transplantation Registry, NOTR), data on all consecutive repeated CT following primary PK or EK for FED and PBK between 1994 and 2015 were analyzed, with a maximal follow-up of 5 years. Regraft survival was analyzed using Kaplan-Meier survival curves and univariable and multivariable Cox regression analysis. Secondary outcomes best-corrected visual acuity, spherical equivalent, and refractive astigmatism were compared using linear mixed-model analysis. Results: A total of 332 repeated CT were analyzed. The number of regrafts increased significantly between 2007 and 2015 (P =.001). Overall 5-year regraft survival was 60% and was higher for FED vs PBK (77% vs 45%, HR = 0.40, P =.001), and re-EK vs re-PK (81% vs 55%, HR = 0.51, P =.041). However, multivariable analysis showed no significant difference in survival based on primary indication, surgical technique, and indication for regrafting. Corrected for baseline, secondary outcomes also did not differ between groups. Conclusions: We found a significant increase in repeated CT, coinciding with the introduction of EK in the Netherlands. While univariable analysis suggested better overall regraft survival for FED and (re-)EK, multivariable analysis showed no such difference. This may be owing to allocation of favorable cases to undergo (re-)EK. Similarly, secondary outcomes were determined by the primary CT technique

Preliminary results of a multicenter randomized clinical trial comparing Descemet Membrane Endothelial Keratoplasty (DMEK) with ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)

Purpose : To compare best corrected visual acuity, endothelial cell density, and complications after Descemet Membrane Endothelial Keratoplasty (DMEK) and ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK). Methods : Multicenter prospective randomized clinical trial (RCT). 55 eyes of 55 patients suffering from irreversible corneal endothelial dysfunction due to Fuchs' endothelial corneal dystrophy were randozmized to receive DMEK or UT-DSAEK in six tertiary and secondary eye clinics in the Netherlands. Donor grafts were centrally prepared by the Beverwijk Euro Cornea bank. Patients underwent ophthalmic examinations preoperatively and 3 months postoperatively. Results : Preoperative BCVA did not differ between both groups (DMEK:0.38±0.18 logMAR vs. UT-DSAEK:0.33±0.21 logMAR, P=0.32). Three months after the operation, BCVA improved significantly (P<0.001). However, there was no statistically significant difference in BCVA between both groups (DMEK: 0.16±0.16 vs. UT-DSAEK: 0.19±0.11 logMAR, P=0.59). One graft in each group was damaged during preparation. Donor endothelial cell density (ECD) did not differ between both groups (DMEK:2668±168 vs. UT-DSAEK:2638±193 cells/mm^2). Three months after the operation, ECD was significantly higher after DMEK (1868±478 vs. 1295±673 cells/mm^2, P= 0.01). Rebubbling was required in 17% of cases after DMEK, and was not reuquired after UT-DSAEK. Primary graft failure requiring repeated transplantation occurred in 7% of cases after DMEK, but not after UT-DSAEK. Conclusions : The preliminary results of this multicenter RCT indicate that DMEK and UT-DSAEK achieve a similar improvement in BCVA three months after the operation. However, DMEK was associated with a significantly higher complication rate. To the best of our knowlegde, this is the first report from a RCT comparing both transplantation techniques. This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018

Corneal Transplantation for Infectious Keratitis:A Prospective Dutch Registry Study

PURPOSE: The aim of this study was to analyze real-world practice patterns and graft survival after corneal transplantation for infectious keratitis in the Netherlands. METHODS: All consecutive keratoplasties for infectious keratitis registered in the Netherlands Organ Transplant Registry were included. Graft survival was analyzed using Kaplan-Meier survival curves with Cox regression to compare the 3 most common pathogens with subgroup analysis for type and reason of transplantation, sex, and graft size. Multivariable analysis was performed using the same explanatory factors. RESULTS: Between 2007 and 2017, 1111 keratoplasties for infectious keratitis were registered in the Netherlands Organ Transplant Registry. The most common pathogens were viruses (n = 437), bacteria (n = 271), and Acanthamoeba (n = 121). Human leukocyte antigen (HLA) matching did not provide a significant survival benefit, whereas emergency procedures showed worse graft survival [hazard ratio (HR) = 0.40, P = 0.120; HR = 2.73, P &lt; 0.001, respectively]. Graft size &gt;8.5 mm was significantly worse than graft size 8.5 mm (HR = 2.062, P = 0.010). In therapeutic keratoplasty, graft survival was significantly worse for Acanthamoeba than viral keratitis (HR = 2.36, P = 0.008). In the multivariable model, adjusting for graft size, type, and reason for transplantation, viral and bacterial keratitis did not differ significantly in graft survival, and Acanthamoeba showed a significantly worse prognosis (vs. viral keratitis, HR = 2.30, P &lt; 0.001; bacterial keratitis, HR = 2.65, P &lt; 0.001). CONCLUSIONS: Viral keratitis was the most common indication for transplantation, followed by bacterial and Acanthamoeba keratitis. HLA matching did not offer protection over elective non-HLA-matched procedures, whereas emergency procedures and grafts sized &gt;8.5 mm showed poor survival. In optical keratoplasty, survival is high for all pathogens, whereas in therapeutic keratoplasty Acanthamoeba shows poor outcome