DescePrep Significantly Increases Descemet Membrane Endothelial Keratoplasty Processing Efficiency and Success Rate in Diabetic Human Donor Corneas in Comparison With Manual Dissection.

PURPOSE: The purpose of this study was to compare the safety, efficacy, and efficiency of a Descemet membrane endothelial keratoplasty (DMEK) graft processing device, DescePrep, with a manual dissection technique through the measurement of tissue yield, processing time, and graft viability in nondiabetic and diabetic donor corneas. METHODS: Nondiabetic (n = 20) and diabetic (n = 20) donor corneas were processed using DescePrep, which standardizes the liquid bubble technique. Nondiabetic (n = 20) and diabetic (n = 24) donor corneas were also processed through manual dissection. Corneas were stained, processed, and then evaluated for processing success rate and time. Randomly selected corneas (n = 5, each) were evaluated for cell viability using live/dead staining. RESULTS: One hundred percent of nondiabetic and 95% of diabetic corneas were processed successfully with DescePrep in an average of 3.37 minutes. Ninety percent of nondiabetic and 50% of diabetic corneas were processed successfully with manual dissection in an average of 9.87 minutes. DescePrep had a significantly lower processing time ( P < 0.0001) and significantly higher success rate in comparison with manual dissection. DescePrep grafts had an average cell viability of 91.1% ± 3.3% in nondiabetic and 91.5% ± 2.4% in diabetic corneas. Grafts prepared with manual dissection had an average cell viability of 89.5% ± 5.8% in nondiabetic and 88.1% ± 4.3% in diabetic corneas. CONCLUSIONS: DescePrep provides a more effective and efficient method of cornea preparation in comparison with the current standard, particularly in diabetic corneas, while providing comparable cell viability. Thus, DescePrep offers standardized DMEK processing that produces high-quality grafts at high yields, with the potential to expand access and improve the quality of DMEK graft preparation in a larger pool of donors.

Risk Factors for Repeat Keratoplasty After Endothelial Keratoplasty-An IRIS Registry Analysis.

PURPOSE: To assess risk factors for repeat keratoplasty after endothelial keratoplasty (EK). DESIGN: Retrospective cohort study. METHODS: EK procedures performed between 2013 and 2018 in the IRIS Registry (Intelligent Research in Sight) were identified. STUDY POPULATION: Patients aged 18 years and older who underwent EK. MAIN OUTCOME MEASURES: (1) Risk factors for repeat keratoplasty and (2) complication rates after EK. A Kaplan-Meier survival analysis was used to determine the probability of repeat keratoplasty. A multivariable shared frailty survival model was used to assess risk factors. RESULTS: A total of 59 344 procedures were identified in the registry, of which 30 600 EK procedures met the inclusion criteria for the analysis. The probability of repeat keratoplasty was 17.4% (95% CI 16.7-18.0) at 5 years. Risk factors for repeat keratoplasty include postoperative rebubbling procedure (HR 2.24, 95% CI 2.05-2.45), prior failed graft (HR 2.07, 95% CI 1.84-2.32) or bullous keratopathy (HR 1.47, 95% CI 1.33-1.61) vs Fuchs dystrophy as surgical indication; subsequent routine cataract surgery (HR 1.61, 95% CI 1.45-1.79), as well as subsequent (HR 1.53, 95% CI 1.39-1.69) and prior/concurrent (HR 1.23, 95% CI 1.11-1.36) glaucoma surgery or history of glaucoma (HR 1.24, 95% CI 1.14-1.35). Medicaid (HR 1.47, 95% CI 1.13-1.92), military/government (HR 1.29, 95% CI 1.03-1.60), Medicare Fee-for-Service (HR 1.17, 95% CI 1.05-1.31) or Medicare Managed (HR 1.17, 95% CI 1.01-1.36) insurances vs private insurance, as well as Black vs White race (HR 1.25, 95% CI 1.11-1.40) and smoking (HR 1.16, 95% CI 1.05-1.27) were also associated with an increased risk of undergoing repeat keratoplasty. CONCLUSIONS: Black race, government-based insurance plans, and smoking were identified as independent factors associated with repeat keratoplasty in addition to history of glaucoma, glaucoma surgery, and prior graft failure or bullous keratopathy as surgical indication.

Disparities in Visual Acuity Outcomes after Endothelial Keratoplasty: An Intelligent Research in Sight Registry Analysis.

PURPOSE: To assess risk factors for lack of vision improvement after endothelial keratoplasty (EK). DESIGN: Retrospective cohort study. PARTICIPANTS: Patients aged 18 years and older in the Intelligent Research in Sight (IRIS®) Registry who underwent EK surgery in the United States between 2013 and 2018. METHODS: Change in visual acuity (VA) relative to baseline were determined at 6 months and 1 year. A multivariable population-average marginal model estimated using generalized estimating equations adjusting for sociodemographic factors, baseline vision, surgical indication, ocular comorbidities, and postoperative complications was used to identify factors associated with worse VA outcomes. MAIN OUTCOME MEASURES: Visual acuity and lack of VA improvement at 1 year compared with preoperative status. RESULTS: A total of 30 600 EK procedures (N = 25 666 unique patients) were included in the analysis. Overall, VA improved from median logarithm of the minimum angle of resolution (logMAR) 0.54 (Snellen 20/69) (interquartile range [IQR] ± 0.70) preoperatively to median logMAR 0.40 (20/50) (IQR ± 0.36) at 6 months and median logMAR 0.30 (20/40) (IQR ± 0.36) at 1 year postoperatively. A total of 30.3% of the overall cohort, 29.8% of Fuchs' endothelial corneal dystrophy (FECD) subgroup, and 27.4% of the bullous keratopathy (BK) subgroup did not show visual improvement at 1 year postoperatively. In the FECD subgroup, older age (risk ratio [RR], 1.05 per 5-year increase, 95% confidence interval [CI], 1.03-1.07) and female sex (RR, 1.10, 95% CI, 1.04-1.16) were associated with VA worse than or equal to baseline at 1 year postoperatively. In both FECD and BK subgroups, eyes with higher baseline logMAR VA (per 0.1 unit increase in logMAR) were more likely to have visual improvement postoperatively (FECD: RR, 0.82, 95% CI, 0.81-0.84; BK: RR, 0.91, 95% CI, 0.91-0.92), whereas postoperative rebubbling (FECD: RR, 1.10, 95% CI, 1.02-1.19; BK: RR, 1.31, 95% CI, 1.17-1.48) and repeat keratoplasties (FECD: RR, 1.41, 95% CI, 1.32-1.52; BK: RR, 1.42, 95% CI, 1.28-1.57) were associated with higher risk of no VA improvement. CONCLUSIONS: In this large national cohort, postoperative rebubblings and repeat keratoplasties were identified as independent factors associated with worse VA outcomes after EK for both FECD and BK subgroups. Older age and female gender were associated with worse VA outcomes after EK in the FECD subgroup.

Evaluation of Efficacy, Efficiency, and Cell Viability of a Novel Descemet Membrane Endothelial Keratoplasty Graft Preparation Device, DescePrep, in Nondiabetic and Diabetic Human Donor Corneas.

PURPOSE: The purpose of this study was to evaluate the safety, efficacy, and efficiency of a Descemet membrane endothelial keratoplasty (DMEK) graft preparation device, DescePrep, through measurement of graft viability, yield, and preparation time in both healthy and diabetic (high-risk) donor eyes. METHODS: Twenty nondiabetic and 10 diabetic donor corneas were processed using DescePrep, which standardizes the liquid bubble technique. Corneas were stained with trypan blue and then processed. Cell counts through specular microscopy, optical coherence tomography imaging, and slit-lamp analysis were used for the evaluation of graft separation and viability in 5 nondiabetic corneas. The remaining 25 corneas (15 nondiabetic and 10 diabetic) were evaluated for preparation success rate and processing time. Ten corneas (5 nondiabetic and 5 diabetic) were randomly selected for further evaluation of global cell loss through staining. RESULTS: Ninety-seven percent of corneas (29 of 30) were prepared successfully with DescePrep. The average preparation time was 2.83 ± 1.8 minutes. There was no significant difference in the time of preparation between the nondiabetic and diabetic groups (P = 0.077). The overall average cell death after processing was 7.9% ± 3.7% for all corneas. There was no significant difference in cell viability between diabetic and nondiabetic tissues after DescePrep processing (P = 0.769). CONCLUSIONS: DescePrep is a new DMEK preparation technique that can process both nondiabetic and diabetic donor corneas at high yields in minutes. High-yield preparation of diabetic corneas may offer eye banks access to a larger donor pool, which is important because the demand for DMEK grafts continues to rise worldwide.

Factors Associated With Graft Rejection in the Cornea Preservation Time Study.

PURPOSE: To identify factors related to graft rejection following Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS). DESIGN: Cohort study within a multicenter randomized clinical trial. METHODS: A total of 1330 eyes of 1090 subjects undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (n = 675) or 8-14 days (n = 655) and followed for 3 years. Central endothelial cell density (ECD) was determined by a central image analysis reading center. Multivariable Cox models adjusted for PT, recipient diagnosis, and surgeon effect were used to identify factors associated with rejection. RESULTS: Cumulative probability of definite graft rejection was 3.6% (99% confidence interval 2.5%-5.3%). Younger recipient age was associated with graft rejection (P < .001; hazard ratio: 0.53 [0.33, 0.83] per decade). PT, donor-recipient sex mismatch, recipient diagnosis, recipient race, graft size, discontinuation of topical corticosteroids and immune-modulators, prior immunizations within 3 months, and prior glaucoma surgery were not associated with rejection (P > .01). Among clear grafts with an ECD measurement at baseline and 3 years (n = 913), endothelial cell loss (ECL) was greater in eyes that experienced a rejection episode (n = 27) than in those that did not (n = 886) (48% vs 38%, P = .03). Twelve of 44 eyes (27%) with definite graft rejection subsequently failed, comprising 15% of the 79 failures in the CPTS. CONCLUSIONS: Graft rejection is uncommon after DSAEK and more likely with younger age, in a study cohort mostly > 50 years old. Rejection increases ECL, but it is not a leading cause of DSAEK failure.

Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study.

PURPOSE: To associate donor, recipient, and operative factors with graft success 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS). DESIGN: Cohort study within a multicenter, double-masked, randomized clinical trial. PARTICIPANTS: One thousand ninety individuals (1330 study eyes) with a median age of 70 years undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE; 6% of eyes). METHODS: Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (n = 675) or 8 to 14 days (n = 655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as regraft for any reason, a graft that failed to clear by 8 weeks after surgery, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was classified further as primary donor failure or early failure, in the absence or presence of operative complications, respectively. Proportional hazards and logistic regression models were used to estimate risk ratios (RR) and 99% confidence intervals (CIs) for graft failure. MAIN OUTCOME MEASURES: Graft success at 3 years. RESULTS: One thousand two hundred fifty-one of 1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR, 2.35; 99% CI, 1.03-5.33) and operative complications (RR, 4.21; 99% CI, 1.42-12.47) were associated with increased risk for primary or early failure. Preoperative diagnosis of PACE (RR, 3.59; 99% CI, 1.05-12.24) was associated with increased risk for late failure by 3 years after surgery compared with Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR, 1.19 per decade; 99% CI, 0.91-1.56 per decade), preoperative donor endothelial cell density (RR, 1.10 per 500 cells; 99% CI, 0.74-1.63 per 500 cells), graft diameter (RR, 1.22 per 1 mm; 99% CI, 0.39-3.76 per 1 mm), and injector use for graft insertion (RR, 0.92; 99% CI, 0.40-2.10). CONCLUSIONS: Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study.

Incidence and Outcomes of Positive Donor Rim Cultures and Infections in the Cornea Preservation Time Study.

PURPOSE: To assess donor rim culture results and outcomes of ocular infections in the Cornea Preservation Time Study (CPTS). METHODS: Donor corneal rim cultures were optional. Donor characteristics were assessed for association with positive cultures using the Fisher exact test and Poisson regression analyses. Incidence rates of ocular infections were estimated, and 95% confidence intervals were calculated. RESULTS: Cultures were performed in 784 (58.9%) of the 1330 cases. For the 0 to 7-day versus 8 to 14-day preservation time groups, respectively, positive fungal growth occurred in 10 of 397 (2.5%) versus 5 of 387 (1.3%) corneas (P = 0.30), whereas positive bacterial cultures occurred in 6 of 397 (1.5%) versus 4 of 387 (1.0%) corneas (P = 0.75). Surgeon-prepared tissue remained a significant risk for positive fungal cultures [relative risk (RR) of surgeon- versus eye-bank-prepared, 2.85; 95% CI (1.02-7.98)], whereas younger donors [RR per year of age, 0.96; 95% CI (0.93-1.00)] and accidental death donors [RR of accident versus disease, 3.71; 95% CI (1.36-10.13)] were at a greater risk for positive bacterial cultures. Fungal infection (Candida glabrata) developed in 1 (6.7%) of 15 recipients with a positive fungal culture, and no recipient infections occurred with positive bacterial culture. With one additional fungal keratitis (Candida albicans) and one bacterial endophthalmitis (E. coli) with no rim culture performed, a total of 2 of 1330 eyes (0.15%) developed fungal and 1/1330 eyes (0.08%) developed bacterial postkeratoplasty infections. CONCLUSIONS: A longer preservation time was not associated with a higher rate of positive donor rim cultures. The overall rate of infection across the entire cohort was low.

Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial.

Importance: Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. Objective: To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. Design, Setting, and Participants: A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy). Interventions: Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). Main Outcomes and Measures: Graft success at 3 years. Results: Of the 1090 participants (1330 study eyes; 60.2% women and 39.8% men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3% (95% CI, 93.6%-96.9%) in the 0-7d PT group and 92.1% (95% CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95% CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4% in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95% CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5% (95% CI, 92.3%-98.4%) for PT of 4 days or less, 94.9% (95% CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95% CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3% (95% CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). Conclusions and Relevance: The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.

Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial.

Importance: Demonstrating that endothelial cell loss following Descemet stripping automated endothelial keratoplasty (DSAEK) is independent of donor cornea preservation time (PT) could increase the pool of corneal tissue available for keratoplasty. Objective: To determine whether endothelial cell loss 3 years after successful DSAEK is related to PT. Design, Setting, and Participants: A multicenter, double-masked, randomized clinical trial included 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 945 eyes of 769 participants were included in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK, performed primarily for Fuchs endothelial corneal dystrophy (96% of the cohort). The study was conducted from April 16, 2012, to June 5, 2017. Interventions: DSAEK with random assignment of a donor cornea with PT of 0 to 7 days (0-7d PT) or 8 to 14 days (8-14d PT). Main Outcomes and Measures: Endothelial cell density (ECD) at 3 years determined by a central image analysis reading center from clinical specular or confocal central endothelial images. Results: Nine hundred forty-five eyes of 769 participants (median age, 70 years [range, 42-90 years], 60.8% women, 93.0% white) in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK were included. At the initial eye bank tissue screening, mean (SD) central ECD was 2746 (297) cells/mm2 in the 0-7d PT group (n = 485) and 2723 (284) cells/mm2 in the 8-14d PT group (n = 460). At 3 years, the mean (SD) ECD decreased from baseline by 37% (21%) in the 0-7d PT group and 40% (22%) in the 8-14d PT group to 1722 (626) cells/mm2 and 1642 (631) cells/mm2, respectively (mean difference, 73 cells/mm2; 95% CI, 8-138 cells/mm2; P = .03). When analyzed as a continuous variable (days), longer PT was associated with lower ECD (mean difference by days, 15 cells/mm2; 95% CI, 4-26 cells/mm2; P = .006). Endothelial cell loss (ECL) was comparable from 4 to 13 days' PT (n = 878; 36%-43% when tabulated by day). Available extension study ECD results at 4 years mirrored those at 3 years in the 203 eyes in the 0-7d PT group (mean [SD] ECD, 1620 [673] cells/mm2 and mean [SD] ECL, 41% [23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm2 and mean [SD] ECL, 44% [23%]) (mean difference, 112 cells/mm2; 95% CI, 5-219 cells/mm2; P = .04). Conclusions and Relevance: Although ECL 3 years after Descemet stripping automated endothelial keratoplasty is greater with longer PT, the effect of PT on ECL is comparable from 4 to 13 days' PT.

Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States.

PURPOSE: The aim of this study was to describe the aims, methods, donor and recipient cohort characteristics, and potential impact of the Cornea Preservation Time Study (CPTS). METHODS: The CPTS is a randomized clinical trial conducted at 40 clinical sites (70 surgeons) designed to assess the effect of donor cornea preservation time (PT) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK). Eyes undergoing surgery for Fuchs endothelial corneal dystrophy or pseudophakic/aphakic corneal edema were randomized to receive donor corneas stored ≤7 days or 8 to 14 days. Donor and patient characteristics, tissue preparation and surgical parameters, recipient and donor corneal stroma clarity, central corneal thickness, intraocular pressure, complications, and a reading center-determined central endothelial cell density were collected. Surveys were conducted to evaluate pre-CPTS PT practices. RESULTS: The 1330 CPTS donors were: 49% >60 years old, 27% diabetic, had a median eye bank-determined screening endothelial cell density of 2688 cells/mm, and 74% eye bank prepared for DSAEK. A total of 1090 recipients (1330 eyes including 240 bilateral cases) had: median age of 70 years, were 60% female, 90% white, 18% diabetic, 52% phakic, and 94% had Fuchs endothelial corneal dystrophy. Before the CPTS, 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010 to 2011; 96% were preserved ≤7 days. Of 305 American Academy of Ophthalmology members responding to a pre-CPTS survey, 233 (76%) set their maximum PT preference at 8 days or less. CONCLUSIONS: The CPTS will increase understanding of factors related to DSAEK success and, if noninferiority of longer PT is shown, will have great potential to extend the available pool of endothelial keratoplasty donors.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01537393.

Escalation of glaucoma therapy after deep lamellar endothelial keratoplasty.

PURPOSE: To determine the prevalence and risk factors for escalation of glaucoma therapy after deep lamellar endothelial keratoplasty (DLEK). METHODS: Retrospective review of every case of DLEK performed at a tertiary care facility between December 1, 2003 and January 31, 2006. RESULTS: Eighty eyes met the inclusion criteria. Escalation of glaucoma therapy occurred in 13 eyes (16.3%) during a mean follow-up period of 27.1 months. Ten eyes required additional topical medical therapy, and 3 eyes required surgical intervention. Glaucoma therapy escalation was significantly associated with preexisting glaucoma (42.9% vs. 10.6%; P = 0.008). CONCLUSION: Escalation of glaucoma therapy is not uncommon after DLEK, especially in eyes with preexisting glaucoma.

Extended long-term outcomes of penetrating keratoplasty for keratoconus.

OBJECTIVE: To report graft survival results for initial penetrating keratoplasty (PK) performed more than 20 years ago for keratoconus. Secondary outcome measures included recurrent keratoconus, best spectacle-corrected visual acuity (BSCVA), and rates of glaucoma. DESIGN: Retrospective, consecutive, noncomparative case series. PARTICIPANTS: All patients with clinical and histopathological keratoconus who underwent initial PK at the University of Iowa Hospitals and Clinics from 1970 to 1983. Patients with pellucid marginal degeneration were excluded. METHODS: At baseline, age, preoperative BSCVA, keratometric astigmatism, and host/donor graft sizes for each eye were recorded. Visual acuity and intraocular pressure were followed until the eyes reached 1 of 4 end points: graft failure, recurrent keratoconus, loss to follow-up, or death. Kaplan-Meier survival analysis was performed to estimate the long-term probability of graft failure and recurrent keratoconus. RESULTS: Among the 112 eyes of 84 patients who met entry criteria, there was a mean age at transplant of 33.7 years and preoperative BSCVA of 20/193. With a mean follow-up of 13.8 years (range, 0.5-30.4), 7 eyes (6.3%) experienced graft failure. Recurrent keratoconus was confirmed clinically or histologically in 6 eyes (5.4%), with a mean time to recurrence of 17.9 years (range, 11-27). Kaplan-Meier analysis estimated a graft survival rate of 85.4% and a rate of recurrent keratoconus of 11.7% at 25 years after initial transplantation. Six eyes (5.4%) developed open-angle glaucoma, and 2 eyes required trabeculectomy. At the last follow-up visit, 82 eyes (73.2%) had BSCVA of 20/40 or better. CONCLUSION: Penetrating keratoplasty offers good long-term visual rehabilitation for keratoconus. Relative to other indications for PK, there is a low rate of graft failure. Late recurrence of disease occurs with increasing frequency over time. Given the younger age at which keratoconus patients undergo corneal transplantation, these long-term findings should be incorporated into preoperative counseling.