The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial: PHMB 0.08% (Polihexanide) and Placebo versus PHMB 0.02% and Propamidine 0.1.

PURPOSE: To compare topical PHMB (polihexanide) 0.02% (0.2 mg/ml)+ propamidine 0.1% (1 mg/ml) with PHMB 0.08% (0.8 mg/ml)+ placebo (PHMB 0.08%) for Acanthamoeba keratitis (AK) treatment. DESIGN: Prospective, randomized, double-masked, active-controlled, multicenter phase 3 study (ClinicalTrials.gov identifier, NCT03274895). PARTICIPANTS: One hundred thirty-five patients treated at 6 European centers. METHODS: Principal inclusion criteria were 12 years of age or older and in vivo confocal microscopy with clinical findings consistent with AK. Also included were participants with concurrent bacterial keratitis who were using topical steroids and antiviral and antifungal drugs before randomization. Principal exclusion criteria were concurrent herpes or fungal keratitis and use of antiamebic therapy (AAT). Patients were randomized 1:1 using a computer-generated block size of 4. This was a superiority trial having a predefined noninferiority margin. The sample size of 130 participants gave approximately 80% power to detect 20-percentage point superiority for PHMB 0.08% for the primary outcome of the medical cure rate (MCR; without surgery or change of AAT) within 12 months, cure defined by clinical criteria 90 days after discontinuing anti-inflammatory agents and AAT. A prespecified multivariable analysis adjusted for baseline imbalances in risk factors affecting outcomes. MAIN OUTCOME MEASURES: The main outcome measure was MCR within 12 months, with secondary outcomes including best-corrected visual acuity and treatment failure rates. Safety outcomes included adverse event rates. RESULTS: One hundred thirty-five participants were randomized, providing 127 in the full-analysis subset (61 receiving PHMB 0.02%+ propamidine and 66 receiving PHMB 0.08%) and 134 in the safety analysis subset. The adjusted MCR within 12 months was 86.6% (unadjusted, 88.5%) for PHMB 0.02%+ propamidine and 86.7% (unadjusted, 84.9%) for PHMB 0.08%; the noninferiority requirement for PHMB 0.08% was met (adjusted difference, 0.1 percentage points; lower one-sided 95% confidence limit, -8.3 percentage points). Secondary outcomes were similar for both treatments and were not analyzed statistically: median best-corrected visual acuity of 20/20 and an overall treatment failure rate of 17 of 127 patients (13.4%), of whom 8 of 127 patients (6.3%) required therapeutic keratoplasty. No serious drug-related adverse events occurred. CONCLUSIONS: PHMB 0.08% monotherapy may be as effective (or at worse only 8 percentage points less effective) as dual therapy with PHMB 0.02%+ propamidine (a widely used therapy) with medical cure rates of more than 86%, when used with the trial treatment delivery protocol in populations with AK with similar disease severity. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Sterile Corneal Infiltrates following Cataract Surgery: Case Series.

We report a case series of 26 eyes of 26 patients undergoing planned cataract surgery from December 2021 to March 2022, who were diagnosed as having whitish round infiltrates in the surgical corneal incisions. The infiltrates were detected at the first check after 5-8 days from cataract surgery and were located either within the main corneal incision and/or in the smaller incisions. Corneal infiltrates (CIs) were single or multiple, without epithelial defects, and painless. All infiltrates were initially treated with full topical antibiotic coverage, in order to control eventual and serious postsurgical infection. However, at daily checks, the clinical course of CIs suggested a sterile etiology. For this reason, steroidal topical treatment was maintained for a long time with slow tapering until complete remission of the CIs. All infiltrates resolved completely in around 30-40 days. The surgical instruments and the sterilization process were scrutinized. A white amorphous material was found mainly on non-disposable anterior chamber cannulas and on irrigation/aspiration tips. Disposable cannulas were adopted, and machinery for cleaning and sterilization procedures were reviewed, with specific reference to water softener renewal. Thanks to these precautions, CIs never occurred again. Finally, our hypothesis was an immune corneal reaction to amorphous deposit on cannula tips. This case series describes a previously unknown complication of cataract surgery and our experience might be useful for other surgeons.

Hemi-Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (Hemi-UT-DSAEK) Using Pediatric Donor Corneas: A Case Series.

OBJECTIVE: We sought to evaluate the clinical outcomes of hemi-UT-DSAEK grafts from the pediatric donor corneas of patients affected by Fuchs Endothelial Corneal Dystrophy (FECD). METHODS: A prospective, interventional case series was conducted at the Ophthalmology Department of Venice Civil Hospital and the Veneto Eye Bank Foundation (Venice, Italy). Six eyes of six patients affected by FECD received large-diameter, semicircular hemi-UT-DSAEK grafts obtained from three pediatric donor corneas using the standard pull-through method. Endothelial cell density (ECD), central corneal thickness (CCT), best-corrected visual acuity (BCVA) and intraoperative and postoperative complications were recorded at different time intervals up to 12 months. RESULTS: The average donor age was 64.6 ± 8.6 years, and the pre-operative ECD was 3266 ± 225 cells/mm2. At 12 months postoperatively, the average ECD was 1376 ± 509 cells/mm2 with a mean decrease of 56.8 ± 19.1% from the preoperative donor count. At 12 months, four out of six eyes had significantly improved and reached a BCVA of ≥20/25 (Snellen equivalent). The mean CCT significantly decreased from 788 ± 138 µm before surgery to 576 ± 30 µm at 12 months postoperatively (p < 0.01). CONCLUSIONS: Hemi-UT-DSAEK grafts using pediatric donor corneas are surgically feasible and can provide similar clinical outcomes compared to conventional UT-DSAEK. Transplanting pediatric donor tissues with high ECD into two patients could potentially increase the donor tissue pool to treat endothelial disease.

Recurrent keratoconus: an analysis of breaks in Bowman's layer in corneal grafts.

OBJECTIVE: To study in a masked fashion whether an objective histological feature associated with keratoconus (KCN) occurs in donor corneas in eyes originally receiving a corneal graft for KCN. METHODS: Two ocular pathologists performed a retrospective masked histological analysis of slides from donor buttons recovered from 21 eyes with a history of KCN undergoing repeat penetrating keratoplasty (failed-PK-KCN), 11 eyes that underwent their first PK due to KCN (primary KCN), and 11 eyes without history of KCN which underwent PK for other conditions (failed-PK-non-KCN). Breaks/gaps in Bowman's layer served as the pathological feature indicative of recurrent KCN. RESULTS: Breaks in Bowman's layer were present in 18/21 (86%) of the failed-PK-KCN group, 10/11 (91%) of the primary KCN group, and in 3/11 (27%) of the failed-PK-non-KCN group. Pathological evidence suggests that the prevalence of breaks is significantly higher in grafted patients with a history of KCN than non-KCN controls (OR: 16.0, 95% CI 2.63 to 97.2, Fisher's exact test p=0.0018) with a conservative Bonferroni criterion of p <0.017 to account for multiple group comparisons. There was no statistically significant difference found between the failed-PK-KCN and primary KCN groups. CONCLUSIONS: This study provides histological evidence that breaks and gaps in Bowman's layer, consistent with those found in primary KCN, may develop within the donor tissue in eyes with a history of KCN.

Recurrent Keratoconus: Corneal Transplants for Keratoconus Develop Tomographic Ectatic Changes.

PURPOSE: The purpose of this study was to evaluate postoperative Scheimpflug imaging changes during the first 5 years after penetrating keratoplasty (PK) in patients with keratoconus (KC). METHODS: This retrospective, interventional case series includes 31 eyes of 31 patients who underwent their first PK with a history of KC. Postoperative Scheimpflug imaging was performed 3 months after the removal of the last suture (baseline) and then repeated 3 and 5 years after the PK. Demographic data, donor and host trephination diameter, and Scheimpflug imaging (Pentacam HR, Oculus, Germany) parameters indicative of ectasia were analyzed to evaluate postoperative graft changes that occur after PK. RESULTS: The maximal keratometry (Kmax) progressed significantly between baseline (53.5 ± 6.1 D) and postoperative year 3 and year 5 [56.5 ± 6.1 diopter (D) and 58.8 ± 7.9 D, P < 0.001]. Significant changes were also observed for the anterior best fit sphere and posterior best fit sphere ( P < 0.001 for 3 and 5 years compared with baseline). Kmax increased by at least 2 Ds for 74.2% of patients and up to 7 Ds or more for 25.8% of the patients. A significant inverse correlation was observed for host trephine size and progression of Kmax (r = -0.52, P = 0.01), which indicated that larger host trephination size was associated with a smaller increase in postoperative Kmax. CONCLUSIONS: Tomographic graft changes indicative of ectasia were observed within 3 to 5 years after PK in patients with KC. These changes were observed more frequently and sooner after corneal transplants than previously reported.

Factors Affecting the Success Rate of Preloaded Descemet Membrane Endothelial Keratoplasty With Endothelium-Inward Technique: A Multicenter Clinical Study.

PURPOSE: To evaluate factors affecting the outcomes of preloaded Descemet membrane endothelial keratoplasty (pl-DMEK) with endothelium-inward. DESIGN: Retrospective clinical case series and a comparative tissue preparation study. METHODS: Participants: Fifty-five donor tissues for ex vivo study and 147 eyes of 147 patients indicated with Fuchs endothelial dystrophy or pseudophakic bullous keratopathy with or without cataract. INTERVENTION: Standardized DMEK peeling was performed with 9.5-mm-diameter trephination followed by second trephination for loading the graft (8.0-9.5 mm diameter). The tissues were manually preloaded with endothelium-inward and preserved for 4 days or shipped for transplantation. Live and dead assay and immunostaining was performed on ex vivo tissues. For the clinical study, the tissues were delivered using bimanual pull-through technique followed by air tamponade at all the centers. MAIN OUTCOME MEASURES: Tissue characteristics, donor and recipient factors, rebubbling rate, endothelial cell loss (ECL), and corrected distance visual acuity (CDVA) at 3, 6, and 12 months. RESULTS: At day 4, significant cell loss (P = .04) was observed in pl-DMEK with loss of biomarker expression seen in prestripped and pl-DMEK tissues. Rebubbling was observed in 40.24% cases. Average ECL at 3, 6, and 12 months was 45.87%, 40.98%, and 47.54%, respectively. CDVA improved significantly at 3 months postoperation (0.23 ± 0.37 logMAR) (P < .01) compared to the baseline (0.79 ± 0.61 logMAR). A significant association (P < .05) between graft diameter, preservation time, recipient gender, gender mismatch, and recipient age to rebubbling rate was observed. CONCLUSION: Graft loading to delivery time of pl-DMEK tissues in endothelium-inward fashion must be limited to 4 days after processing. Rebubbling rate and overall surgical outcomes following preloaded DMEK can be multifactorial and center-specific.

Cost-effectiveness analysis of preloaded versus non-preloaded Descemet membrane endothelial keratoplasty for the treatment of Fuchs endothelial corneal dystrophy in an academic centre.

AIMS: To determine the cost-effectiveness of preloaded Descemet membrane endothelial keratoplasty (pDMEK) versus non-preloaded DMEK (n-pDMEK) for the treatment of Fuchs endothelial corneal dystrophy (FECD). METHODS: From a societal and healthcare perspective, this retrospective cost-effectiveness analysis analysed a cohort of 58 patients with FECD receiving pDMEK (n=38) or n-pDMEK (n=30) from 2016 to 2018 in the Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, USA. Exclusion criteria were previous ocular surgeries (other than uncomplicated cataract surgery), including other keratoplasty procedures, ocular pathological conditions as glaucoma, amblyopia, laser treatments, or any retinal or corneal disease. The main outcome parameters were the incremental cost-utility ratio (ICUR) and net monetary benefit (NMB). RESULTS: pDMEK was less costly compared with n-pDMEK (healthcare: $13 886 vs $15 329; societal: $20 805 vs $22 262), with a slighter greater utility (QALY 0.6682 vs QALY 0.6640) over a time horizon of 15 years. pDMEK offered a slightly higher clinical effectiveness (+0.0042 QALY/patient) at a lower cost (healthcare: -$1444 per patient; societal: -$1457 per patient) in improving visual acuity in this cohort of patients with FECD. pDMEK achieved a favourable ICUR and NMB compared with n-pDMEK. Based on sensitivity analyses performed, the economic model was robust. CONCLUSIONS: From the societal and healthcare perspective, pDMEK was less costly and generated comparable utility values relative to n-pDMEK. Therefore, pDMEK appears to be cost-effective and cost saving with respect to n-pDMEK. Further long-term follow-up data are needed to confirm these findings.

Gender Matching Did Not Affect 2-year Rejection or Failure Rates Following DSAEK for Fuchs Endothelial Corneal Dystrophy.

PURPOSE: To investigate whether donor to recipient gender or H-Y mismatching was associated with graft rejection or failure following Descemet stripping automated endothelial keratoplasty (DSAEK) in patients with Fuchs endothelial corneal dystrophy (FECD). DESIGN: Clinical cohort study. METHODS: This study used a multi-center registry including patients aged >18 years who had undergone their first DSAEK for FECD between January 2008 and March 2018. The impact of donor and recipient gender incompatibility (including H-Y mismatches) on corneal graft rejection and failure was evaluated using Kaplan-Meier curves and univariable and multivariable Cox models. RESULTS: Outcome data from 4341 eyes (3915 from the UK and 426 from Italy) were analyzed. Graft failure at 2-year follow-up occurred in 477 (11.0%) cases. Graft rejection at 2-year follow-up occurred in 175 cases (4.0%), 58 (1.3%) of whom developed graft failure. There was no significant effect of gender or H-Y mismatching on either rejection (P = .12, P = .06) or failure (P = .28, P = .14), respectively. CONCLUSIONS: In patients with FECD undergoing DSAEK, no significant influence of gender and or H-Y mismatch on graft rejection or failure was found.

Corneal transplantation during the COVID-19 pandemic: An operational guide.

PURPOSE: To provide an operational guide for corneal transplantation during the COVID-19 pandemic aimed to maintain surgery and avoid spreading of SARS-CoV-2. METHODS: Prospective observational case series study in patients requiring corneal graft manage toward separate free and restricted pathways for those COVID-19 negative or positive, respectively. RESULTS: During the national lockdown, 30 consecutive patients underwent endothelial (n = 16), penetrating (n = 9), and anterior lamellar keratoplasty (n = 5). Two patients followed the COVID-19 restricted pathway, as they were considered positive while waiting for test results. Nine patients were hospitalized one night in the hospital. On admission to the hospital before surgery, at surgery, the day after surgery and at 7 and 30 days all patients and health-care personnel showed no symptoms and resulted negative at risks factors/exposure to the SARS-CoV-2 infection and occurrence of COVID-19. Nucleic acid testing resulted not detectable in all patients and SARS-CoV-2 antibodies quantification showed IgG and IgM below the positive predicted value in 29 patients. One patient showed IgM above the cut-off of significance (1.21 and 1.03 preoperative and 1-month postoperative, respectively) that were considered irrelevant because of the absence of symptoms and exposure risks. CONCLUSIONS: The concept of donor emergency (i.e. short-term availability of transplant tissues), makes corneal transplantation an always-urgent activity because it is related to the availability of the corneal tissue from a donor. Modest adjustments to ophthalmic clinic and eye surgery organization are required to maintain surgery and care of eye patients in a safe environment.

One-Year Clinical Outcomes of Preloaded Descemet Membrane Endothelial Keratoplasty Versus Non-Preloaded Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To compare the one-year outcomes of preloaded Descemet membrane endothelial keratoplasty (pDMEK) and non-preloaded DMEK (n-pDMEK) in patients with Fuchs endothelial corneal dystrophy (FECD). METHODS: This retrospective comparative cohort study consecutively included 68 eyes with Fuchs endothelial corneal dystrophy who underwent either pDMEK (n = 38) or n-pDMEK (n = 30) performed by cornea fellows with an experienced surgeon between 2016 and 2018 at the Massachusetts Eye and Ear Infirmary. Exclusion criteria were previous surgery (other than uncomplicated cataract surgery) and any documented evidence of macular or other corneal diseases. Corrected distance visual acuity (CDVA), central corneal thickness, intraocular pressure, patient characteristics, postprocessing endothelial cell count, donor graft data, and complications were compared. RESULTS: CDVA showed similar results for pDMEK (0.12 ± 0.11 logarithm of the minimal angle of resolution [LogMAR]) and n-pDMEK (0.13 ± 0.13 LogMAR) (P = 0.827). Sixty-six percent of the pDMEK eyes and 57% of the n-pDMEK eyes achieved a VA of ≥0.1 LogMAR, and 95% and 97%, respectively, achieved a CDVA ≥0.3 LogMAR. The preoperative central corneal thickness of pDMEK and n-pDMEK (644 ± 62.2 µm, 660.5 ± 56.2 µm) decreased significantly after surgery (525.1 ± 43.6 µm, 526.5 ± 45.2 µm, P < 0.001), with no difference between groups (P = 0.840). The postprocessing endothelial cell count did not differ between pDMEK (2959.2 ± 182.9 cells/mm2) and n-pDMEK (2939.3 ± 278.7 cells/mm2) (P = 0.484). Complication rates were comparable with just the rebubbling performed in a minor procedure room showing a lower rate for pDMEK (13.16%) compared with n-pDMEK (33.33%) (P < 0.045). CONCLUSIONS: One-year clinical outcomes were similar between pDMEK and n-pDMEK procedures, rendering eye bank-prepared pDMEK tissues a useful tool in the treatment of endothelial dysfunction.

Shotgun sequencing to determine corneal infection.

PURPOSE: To investigate if shotgun-sequencing method could be useful in detailed diagnosis of herpes simplex virus (HSV) infection and compare it with the conventional diagnostic method. OBSERVATIONS: Using a sterile scraper, the infectious part of the ocular surface was scraped gently and placed on a glass slide for conventional diagnosis using PCR and histology and in RNA stabilizing reagent for shotgun sequencing respectively. Concentration of the DNA was determined using a sensitive fluorescence dye-based Qubit dsDNA HS Assay Kit. Shotgun-sequencing libraries were generated using the NEBNext DNA ultra II protocol. The samples were sequenced on the Illumina NextSeq 500 in high output mode with 2X150 bp paired-end sequencing. Taxonomic and functional profiles were generated.Conventional diagnostic method suspected herpetic keratitis. The results indicated presence of an amplified product of 92 bp positive HSV-DNA. Conventional diagnostic method detected the presence of Herpes Simplex Virus DNA (type 1). Shotgun sequencing confirmed the diagnosis of HSV along with the taxonomical profiling of the virus. These results were achieved using 1.9 ng/µL of DNA concentration (114 ng in 60 µL) of the total sample volume. CONCLUSIONS AND IMPORTANCE: Shotgun sequencing is a hypothesis-free approach that identifies full taxonomic and functional profile of an organism. This technology is advantageous as it requires smaller sample size compared to conventional diagnostic methods.

Five-Year Outcomes of Ultrathin Descemet Stripping Automated Endothelial Keratoplasty.

PURPOSE: To report 5-year outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) with a central graft thickness intended to be <100 µm. METHODS: This retrospective, consecutive, interventional case series included 354 eyes with endothelial decompensation due to various causes (Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed previous graft, herpetic endothelitis, or buphthalmos). Donor tissue was prepared using the microkeratome-assisted double-pass technique aiming at a graft thickness <100 µm. The Descemet membrane was stripped under air. The graft was delivered into the anterior chamber using the pull-through technique through a 3.2-mm clear corneal incision using a modified Busin glide. The best spectacle-corrected visual acuity (BSCVA), endothelial cell loss, graft survival rates, and immunologic rejection rates were evaluated. RESULTS: Follow-up data at 1, 2, 3, and 5 years after UT-DSAEK were collected from 214, 172, 147, and 105 eyes, respectively. After excluding eyes with comorbidities, BSCVA better than or equal to 20/20 was recorded in 36.3%, 37.4%, 46.4%, and 53.4% of eyes, respectively, whereas BSCVA better than or equal to 20/40 was documented in 95.5%, 95.3%, 96.0%, and 96.6% of eyes, respectively. The mean endothelial cell loss was 35.4%, 42.3%, 43.3%, and 52.3%; Kaplan-Meier graft survival probability was 99.1%, 96.2%, 94.2%, and 94.2%, and Kaplan-Meier cumulative probability of a rejection episode was 3.4%, 4.3%, 5%, and 6.9% at 1, 2, 3, and 5 years, respectively. CONCLUSIONS: UT-DSAEK grafts allow excellent 5-year outcomes, including BSCVA, endothelial cell density, and survival rates comparable with those recorded post-Descemet membrane endothelial keratoplasty, but with a higher immunologic rejection rate.

Deep Trephination Allows High Rates of Successful Pneumatic Dissection for DALK Independent of Surgical Experience.

PURPOSE: To evaluate the relationship between surgical experience and the success rate of pneumatic dissection for deep anterior lamellar keratoplasty (DALK) using deep trephination. METHODS: A noncomparative case series evaluating the first 10 consecutive keratoconic eyes without deep stromal scarring, operated by 8 surgeons of 3 different experience levels, was conducted; there were a total of 80 patients. Standardized DALK was performed, including deep trephination 450 to 550 µm in depth and 9 mm in diameter, pneumatic dissection, removal of the stroma, and transplantation of a 9-mm partial-thickness anterior lamellar graft. The success rate of pneumatic dissection correlated with surgical experience. RESULTS: Pneumatic dissection succeeded in 7, 7, 8, and 9 cases of 10 cases in the first group of 4 inexperienced surgeons (under 10 previous keratoplasties of any kind); in 9 and 10 of 10 cases in the second group of 2 relatively experienced surgeons (under 100 keratoplasties); and in 10 and 8 of 10 cases in the third group of 2 very experienced surgeons (more than 1000 previous keratoplasties). No difference between the groups was found to be statistically significant with the χ test (P > 0.05). CONCLUSIONS: The standardized DALK technique using a deep trephination allows high success rates of pneumatic dissection even for surgeons inexperienced in keratoplasty.

Outcomes of a Modified Technique for Successful Pneumatic Dissection in Pediatric Eyes With Corneal Scars.

PURPOSE: To report the outcomes of a modified deep anterior lamellar keratoplasty (DALK) procedure for the treatment of scarred corneas in otherwise healthy pediatric eyes. METHODS: All pediatric eyes undergoing DALK by the same surgeon (M.B.) between July 2013 and June 2017 were enrolled. The standard DALK procedure was modified by including a large (9 mm) and deep (150 µm from the thinnest pachymetric measurement) trephination, a minimal cannula advancement from the base of the trephination, and a clearing of a central 6 mm optical zone. The success rates of pneumatic dissection, visual and refractive outcomes, and complications were reported. A complete ophthalmologic examination was performed preoperatively and a few days after suture removal (6-months post-DALK) for all patients as well as 12, 24, and 36 months postoperatively for available patients. RESULTS: Fourteen eyes of 13 patients with various indications were included in this study. The mean age at the time of surgery was 11.7 ± 2.5 years. Pneumatic dissection succeeded in all but one case (13/14 eyes = 92.8%), which was completed by hand dissection. All sutures were removed within 6 months of surgery. With a minimum postoperative follow-up of 6 months, best spectacle-corrected visual acuity improved from ≤20/50 to ≥20/40 in all but one eye, which was known to be amblyopic. CONCLUSIONS: Despite impaired corneal transparency and increased tissue consistency, a modified DALK technique allows successful pneumatic dissection in an extremely high percentage of scarred pediatric eyes. Visual results compare favorably with those obtained in children after penetrating keratoplasty, while vision threatening complications are minimized.

Clinical Outcomes of Preloaded Descemet Membrane Endothelial Keratoplasty Grafts With Endothelium Tri-Folded Inwards.

PURPOSE: To evaluate the initial outcomes and complications of Descemet membrane endothelial keratoplasty (DMEK) using donor tissues tri-folded with the endothelium inwards, preloaded at the Eye Bank, and delivered with bimanual pull-through technique. DESIGN: Prospective, noncomparative, interventional case series. METHODS: Setting: Eye bank and tertiary care eye department. PATIENT POPULATION: Forty-six consecutive eyes of 41 patients with Fuchs endothelial dystrophy with or without cataract operated between November 2016 and March 2017. INTERVENTION: DMEK tissues prepared with SCUBA technique and punched to a diameter of 8.25 mm were preloaded with the endothelium tri-folded inwards in an intraocular lens (IOL) cartridge with a 2.2-mm opening filled with the same tissue culture medium contained in the vial used for shipment to the surgeon. Standardized DMEK was performed as a single procedure (n = 15) or in combination with phacoemulsification and IOL implantation (n = 31) within 48 hours from preparation using a bimanual pull-through technique. MAIN OUTCOME MEASURES: Preparation and surgical times, intraoperative and postoperative complications, best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), and graft detachment rate. RESULTS: Preparation time averaged 26.2 ± 4.1 minutes (range 17-36 minutes), while the surgical time from opening of the stoppers to air fill of the anterior chamber never exceeded 9 minutes (range 3-9 minutes). Surgery was uneventful in all cases. Postoperative complications included graft detachment in 9 of 46 cases (19.6%), successfully managed in all cases by single rebubbling within 6 days from surgery, and glaucoma irresponsive to conservative treatment in 1 of 46 cases (2.1%). In all eyes without comorbidities (35 of 40 eyes) BSCVA was 20/25 (0.097 logMAR) or better as early as 3 months after surgery. Six months postoperatively, ECD was available in 24 of 25 eyes with an endothelial cell loss calculated as a percentage of the preoperative value determined at the eye bank (ranging from 2500 to 2800 cells/mm2) of 29.5% ± 14.8% (range 8.3%-52.1%). CONCLUSIONS: Delivering a preloaded DMEK tissue, tri-folded with the endothelium inwards, minimizes surgical time and costs without negatively affecting the outcomes of the procedure.

Anterior Segment Optical Coherence Tomography of Post-Descemet Stripping Automated Endothelial Keratoplasty Eyes to Evaluate Graft Morphology and Its Association With Visual Outcome.

PURPOSE: To evaluate the relationship between graft thickness/regularity and visual outcomes of Descemet stripping automated endothelial keratoplasty (DSAEK). METHODS: Records of post-DSAEK patients who were examined by anterior segment optical coherence tomography at "Villa Igea" Private Hospital (Forlì, Italy) since April 2015 were reviewed. Pachymetric and elevation maps of both host cornea and graft were analyzed. Graft regularity was determined based on the root mean square error (RMSE) of the graft pachymetric measurements taken 3 and 6 mm from the center and the RMSE of the corneal elevation measurements at its posterior and interface surfaces. These parameters were correlated with best-spectacle-corrected visual acuity (BSCVA) (expressed in logarithm of the minimum angle of resolution) and compared between eyes with central graft thickness (CGT) ≥100 µm (group 1) and eyes with CGT <100 µm (group 2). RESULTS: Eighty-nine post-DSAEK eyes of 89 patients with Fuchs endothelial dystrophy or bullous keratopathy and no significant comorbidities were included. There were 40 eyes (CGT = 138.2 ± 31.7 µm) in group 1 and 49 eyes (CGT = 73.3 ± 15.5 µm) in group 2. The RMSEs of graft pachymetry and the RMSEs of the interface and posterior surface elevation maps at 3 and 6 mm differed significantly between both groups (P < 0.05). When only eyes with Fuchs endothelial dystrophy (n = 54) were considered in both groups, there was a statistically significant correlation (r = 0.44; P = 0.001) between BSCVA and CGT. CONCLUSIONS: DSAEK grafts thinner than 100 µm are more regular than thicker ones. In eyes with Fuchs endothelial dystrophy that are otherwise healthy, thinner grafts yield significantly better BSCVA.

Outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) performed in eyes with failure of primary Descemet membrane endothelial keratoplasty (DMEK).

AIM: To evaluate the outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) performed in eyes after failure of primary Descemet membrane endothelial keratoplasty (DMEK). METHODS: This was a retrospective, non-comparative interventional case series done in a tertiary care hospital. The study group included 21 eyes of patients which underwent UT-DSAEK following the failure of primary DMEK. Outcome measures included best spectacle-corrected visual acuity (BSCVA) and endothelial cell density (ECD) both recorded 6 and 12 months postoperatively as well as central graft thickness (CGT) measured 6 months after UT-DSAEK. RESULTS: When considering only eyes without comorbidities (17 of 21), 12 months after UT-DSAEK, BSCVA was ≥20/25 in 12/13 (92%) eyes and ≥20/20 in 4/13 (30%) eyes. Mean ECD loss rate was 38.9% at 12 months postoperatively (range 8%-57%). Six months postoperatively, CGT averaged at 81±34 µm (range 34-131 µm). No intraoperative complications were recorded. Postoperatively, one patient (no. 8) had graft wrinkles that were fixed 2 days following UT-DSAEK. Four patients have developed intraocular lens (IOL) opacification, and two of them underwent IOL exchange. No other postoperative complications were recorded. CONCLUSIONS: UT-DSAEK is instrumental in the management of primary DMEK graft failure, allowing visual rehabilitation which is comparable with that of repeat DMEK.

Factors Associated With Early Graft Detachment in Primary Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To evaluate the risk factors for early graft detachment in Descemet membrane endothelial keratoplasty (DMEK). DESIGN: Case-control study. METHODS: Participants: A total of 173 donor corneas and 173 eyes of the patients following DMEK or DMEK in combination with phacoemulsification and intraocular lens implantation were included. INTERVENTION: Pre-stripped DMEK grafts were transplanted using pull-through technique. At the end of surgery, the anterior chamber was filled with air, which was removed 3 hours later only if pupillary block was suspected. Rebubbling was performed in all cases with graft detachment, independently of its extension, as documented by means of anterior segment optical coherence tomography. The donor characteristics were collected from the eye bank database and matched with the recipient database. MAIN OUTCOME MEASURES: Donor and recipient characteristics affecting graft detachment using univariate and multivariate analysis. RESULTS: The combination of DMEK with cataract removal and IOL implantation (odds ratio [OR] = 5.31, 95% confidence interval [CI] 2.03-13.86, P < .002) and air fill of ≤75% of anterior chamber height at 2-3 hours postoperatively (OR = 2.66, 95% CI 1.12-6.34, P = .027) were found to be independent risk factors for postoperative graft detachment. CONCLUSIONS: Cataract removal at the time of DMEK is a risk factor for early graft detachment and therefore sequential surgery may be preferred over combined surgery in an attempt at minimizing rebubbling. Air level in the anterior chamber should be monitored and maintained above 75% in the early hours following surgery.