DSAEK surgery allows rapid, excellent BSCVA visual recovery. The rate of visual recovery is more rapid than usually found with penetrating keratoplasty.

Purpose-To assess outcomes 1 year after Descemet's stripping automated endothelial keratoplasty (DSAEK) in comparison with penetrating keratoplasty (PKP) from the Specular Microscopy Ancillary Study (SMAS) of the Cornea Donor Study. Design-Multicenter, prospective, nonrandomized clinical trial.Participants-A total of 173 subjects undergoing DSAEK for a moderate risk condition (principally Fuchs' dystrophy or pseudophakic/aphakic corneal edema) compared with 410 subjects undergoing PKP from the SMAS who had clear grafts with at least 1 postoperative specular image within a 15-month follow-up period.Methods-The DSAEK procedures were performed by 2 experienced surgeons per their individual techniques, using the same donor and similar recipient criteria as for the PKP procedures in the SMAS performed by 68 surgeons at 45 sites, with donors provided from 31 eye banks. Graft success and complications for the DSAEK group were assessed and compared with the SMAS group. Endothelial cell density (ECD) was determined from baseline donor, 6-month (range, 5-7 months), and 12-month (range, 9-15 months) postoperative central endothelial images by the same reading center used in the SMAS. Main Outcome Measures-Endothelial cell density and graft survival at 1 year.Results-Although the DSAEK recipient group criteria were similar to the PKP group, Fuchs' dystrophy was more prevalent in the DSAEK group (85% vs. 64%) and pseudophakic corneal edema was less prevalent (13% vs. 32%, P<0.001). The regraft rate within 15 months was 2.3% (DSAEK group) and 1.3% (PKP group) (P = 0.50). Percent endothelial cell loss was 34±22% versus 11±20% NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript (6 months) and 38±22% versus 20±23% (12 months) in the DSAEK and PKP groups, respectively (both P<0.001). Preoperative diagnosis affected endothelial cell loss over time; in the PKP group, the subjects with pseudophakic/aphakic corneal edema experienced significantly higher 12-month cell loss than the subjects with Fuchs' dystrophy (28% vs. 16%, P = 0.01), whereas in the DSAEK group, the 12-month cell loss was comparable for the 2 diagnoses (41% vs. 37%, P = 0.59). A number of studies suggest that 6-month cell loss is significantly higher after endothelial keratoplasty than PKP. [5][6][7][8] Only 2 published DSAEK studies have reported cell loss to 2 years. In both, the cell loss increased by only 6% to 7%, relative to the baseline donor ECD, between 6 months and 2 years. 5,8 These were relatively modest increases compared with the 25% increase in cell loss seen in a comparable time period in the SMAS PKP eyes. 1 Limited data have been reported on relative graft survivals for endothelial keratoplasty versus PKP. Conclusions-OneThe ideal approach to determine any statistically and, more important, clinically significant differences in endothelial cell loss and graft success after DSAEK and PKP would be with a prospective, randomized study using the same donor pair and a central reading center to determine ECD on the donor an...

Objective To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age. Design Multi-center, prospective, double-masked clinical trial Participants 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs’ dystrophy (62%), pseudophakic/aphakic corneal edema (34%) or another corneal endothelial disorder (4%) and followed for up to 12 years. Methods Forty-three eye banks provided corneas from donors 12 to 75 years old, using a randomized approach to assign donor corneas to study participants, without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons’ usual routines. Main Outcome Measure Graft failure defined as a regraft or in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months. Results In the primary analysis, the 10-year success rate was 77% for 707 corneas from donors 12 to 65 years old compared with 71% for 383 donors 66 to 75 years old (difference = +6%, 95% confidence interval = −1% to +12%, P=0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success after the first 5 years (P<0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors 34 to 71 years old (75%). The success rate was higher for 80 donors 12 to 33 (96%) and lower for 130 donors 72 to 75 years old (62%). The relative drop in the success rate with donor ages 72 to 75 years was not observed until after year 6. Conclusions Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Since we observed a fairly constant 10-year success rate for donors age 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease.

Purpose To assess 3-year outcomes of Descemet stripping automated endothelial keratoplasty (DSAEK) in comparison with penetrating keratoplasty (PKP) from the Cornea Donor Study (CDS). Design Prospective, multicenter, nonrandomized clinical trial. Participants A total of 173 subjects undergoing DSAEK for a moderate risk condition (principally Fuchs’ dystrophy or pseudophakic corneal edema) compared with 1101 subjects undergoing PKP from the CDS. Methods The DSAEK procedures were performed by two experienced surgeons using the same donor and similar recipient criteria as for the CDS PKP procedures, performed by 68 surgeons. Graft success was assessed by Kaplan Meier survival analysis. Central endothelial cell density (ECD) was determined from baseline donor and postoperative central endothelial images by the reading center used in the CDS Specular Microscopy Ancillary Study. Main Outcome Measures Graft clarity and endothelial cell density Results The donor and recipient demographics were comparable in the DSAEK and PKP groups, except the proportion of Fuchs’ dystrophy cases was higher in the DSAEK cohort. The 3-year survival rate did not differ significantly between DSAEK and PKP procedures performed for either Fuchs’ dystrophy (96% for both, P=0.81) or non-Fuchs cases (86% vs. 84%, respectively, P=0.41). Principal causes of graft failure/regraft within 3 years after DSAEK and PKP were immunologic graft rejection (0.6% vs. 3.1%), endothelial decompensation in the absence of documented rejection (1.7% vs 2.1%), unsatisfactory visual or refractive outcome (1.7% vs. 0.5%), and infection (0% vs. 1.1%), respectively. The 3-year predicted probability of a rejection episode was 9% with DSAEK vs. 20% with PKP (P=0.0005). The median 3-year cell loss for DSAEK and PKP was 46% and 51%, respectively (P=0.33) in Fuchs’s dystrophy cases, and 59% and 61%, respectively (P=0.70), in the non-Fuchs’ cases. At 3 years, use of a smaller DSAEK insertion incision was associated with significantly higher cell loss (60% vs. 33% for 3.2- and 5.0-mm incisions, respectively, P=0.0007) but not a significant difference in graft survival (P=0.45). Conclusions The graft success rate and endothelial cell loss were comparable at 3 years for DSAEK and PKP procedures. A 5-mm DSAEK incision width was associated with significantly less cell loss than a 3.2-mm incision.

Long-term results of DSAEK were excellent. Grafts were clear despite lower than normal endothelial cell counts. To our knowledge, this is the longest running study of DSAEK outcomes to date.