Efficacy and Safety of Preoperative Prophylaxis in Cataract Surgery with Combined Topical Antiseptics: A Microbiological Study.

INTRODUCTION: To evaluate the antimicrobial efficacy of an ophthalmic formulation containing hexamidine diisethionate (HD) 0.05%, polyhexamethylene biguanide (PHMB) 0.0001%, and edetate disodium (EDTA) 0.01% (Keratosept®, Bruschettini, Genova, Italy) on the microbial flora of a healthy ocular surface. METHODS: Patients were enrolled consecutively. Each patient applied two drops of Keratosept® in the eye scheduled for cataract surgery (study eye) three times daily in the 2 days prior to surgery and one time in the morning of surgery. The contralateral eyes were considered as control (control eye). Bilateral conjunctival swabs were collected before the first administration (T0) and the morning of surgery (T1). The swabs were processed within 3 h from sampling for the automated detection of the presence of replicating microorganisms (colony-forming units, CFU/mL) and the provision of real-time growth curves. RESULTS: Conjunctival swabs of 32 patients (n = 128) were examined. Six patients were excluded from the efficacy analysis because of microbial load < 50 CFU/mL at T0 in the study eye. No difference between study and control eyes was observed at T0 (p = 0.40). Compared with T0, 20 (76.9%) study eyes and 10 (38.5%) control eyes showed a ≥ 1 log reduction of the microbial load at T1, with a significant difference between groups (p = 0.005). Keratosept® showed good tolerability, and no adverse events or eye discomfort were recorded. CONCLUSIONS: This study showed that the low-dose combination of antiseptic agents in the Keratosept® ophthalmic solution effectively reduces the bacterial load of healthy flora on the ocular surface.

Deep Anterior Lamellar Keratoplasty Using Dehydrated versus Standard Organ Culture-Stored Donor Corneas: Prospective Randomized Trial.

PURPOSE: To compare the outcomes of deep anterior lamellar keratoplasty (DALK) using dehydrated versus standard organ culture-stored donor corneas for eyes with keratoconus. DESIGN: Prospective, randomized, single-center trial conducted in Italy. PARTICIPANTS: Adult patients (age ≥ 18 years) with keratoconus scheduled for elective DALK. METHODS: Patients undergoing successful type 1 bubble pneumatic dissection using a standard DALK technique were randomized during surgery to receive either dehydrated (n = 30) or standard organ culture-stored (n = 30) donor corneas. MAIN OUTCOME MEASURES: The primary study outcome was best spectacle-corrected visual acuity (BSCVA) 12 months after surgery. Secondary outcomes were refractive astigmatism (RA), endothelial cell density (ECD), and complication rates. RESULTS: Postoperative BSCVA did not significantly differ between groups at both time points: mean difference at 6 months was 0.030 logarithm of the minimum angle of resolution (logMAR; 95% confidence interval [CI], -0.53 to 0.10 logMAR; P = 0.471) and at 12 months was -0.013 logMAR (95% CI, -0.10 to 0.08 logMAR; P = 0.764). No significant differences between groups were observed in terms of postoperative RA and ECD at all time points. In the first 3 days after DALK, an epithelial defect was present in 10 patients (33%) in the organ culture cornea group and in 29 patients (97%) in the dehydrated cornea group. Complete re-epithelialization was achieved by day 7 in all patients (100%) in both groups. CONCLUSIONS: The study provides evidence that the use of dehydrated corneas is noninferior to the use of standard organ culture donor corneas for DALK. Corneal tissue dehydration represents a viable solution that can allow long-term cornea preservation and avoid wastage of unused corneas. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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.

Effect of Liposomal-Lactoferrin-Based Eye Drops on the Conjunctival Microflora of Patients Undergoing Cataract Surgery.

INTRODUCTION: Postoperative endophthalmitis is typically caused by the patient's conjunctival bacterial flora. Povidone iodine solution (5%) is used perioperatively to obtain periocular and ocular antisepsis. However, an adjunctive prophylaxis procedure could further help control the conjunctival microbial load. Considering the increase in antibiotic resistance, a progressive shift toward alternative methods would be desirable. Somilux® eye drops (Alfa Intes, lactoferrin-based eye drops) are medical devices containing liposomal lactoferrin (LF). This study evaluates the effects on conjunctival microflora of LF-based eye drops used in the preoperative phase in patients scheduled for cataract surgery. METHODS: LF-based eye drops or a vehicle solution (water solution) were instilled 4 times a day starting 3 days before cataract surgery. Before the therapy (T0) and at the time of surgery (T1), a conjunctival swab was performed in both eyes and processed to detect microbial growth, microbiological isolation, and species identification. The outcome was the quantification and characterization of the local microbial flora before and after using LF-based or vehicle-based eye drops. Safety of the treatments was also evaluated. RESULTS: 88 eyes of 44 patients (mean [± SD] age 75 [± 12.6] years) were enrolled. At baseline, 54 conjunctival swabs showed only saprophytic flora, 27 showed only potential pathogenic flora, and seven showed both of them. LF-based eye drops reduced the proportion of potentially pathogenic bacteria (36% at T0 vs. 9% at T1, p = 0.008) compared with the vehicle (41% at T0 vs. 55% at T1, p = 0.302) without altering the physiological ocular microbial composition. No adverse events have been reported. CONCLUSION: Our findings provide a novel contribution to the scientific knowledge on the role of LF in the ophthalmic field, supporting the use of LF-based eye drops as a safe and selective treatment to improve the ocular surface physiological defenses and control the bacterial ocular surface contamination prior to cataract surgery.

Results of ultrathin Descemet stripping automated endothelial keratoplasty with donor corneas preserved in synthetic organ culture media.

PURPOSE: To evaluate outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) with donor corneas preserved at 31°C in Cornea Syn®, a medium formulated with recombinant human serum albumin (rHSA) to replace foetal calf serum, and deswelled-transported in the xeno-free medium Cornea Trans®. METHODS: Prospective, multicentre, open-label study. We evaluated the endothelial cell loss (ECL) as the percentage variation of the endothelial cell density (ECD, cells/mm2) between 6 and 12 months after surgery, corneal transparency and thickness at 12 months, and adverse events within 12 months. Endothelial lenticules of mean 89 µm, ECD ≥ 2300 cells/mm2, minimum signs of cell mortality or morphology alterations, were dissected by microkeratome in the eye bank, and grafted in patients ≥ 18 years without corneal neovascularisation, conjunctivalization, or blinking impairment. RESULTS: Thirty-five patients underwent UT-DSAEK, 3 showed primary failure, 1 late failure, and 2 skipped the 6-month visit. We analysed data from 29 patients, 27 with Fuchs endothelial corneal dystrophy (FECD) and 2 with pseudophakic bullous keratopathy (PBK). The median ECL between 6 and 12 months was 2.6% (p = .054, CI 0 to 12.5) and the absolute mean (SD) was 158.4 (364.1) cells/mm2. After 12 months, 96.5% of corneas were clear, with mean pachymetry of 585.9 (50.4) µm. CONCLUSIONS: The ECL rate after UT-DSAEK match overall that observed in DSAEK or UT-DSAEK models of endothelial survival and the overall safety compared that reported for similar follow-up. Corneas maintained in Cornea Syn® and Cornea Trans® did not affect the ECD and functional outcomes of UT-DSAEK up to 12 months.

23†Cryopreservation of human amniotic membrane (HAM) for ocular surface reconstruction: a comparison beetween protocols.

PURPOSE: In the past decades, the human amniotic membrane has been largely applied for several surgical and non-surgical procedures. It has been farther demonstrated that both hAM and cornea share similar patterns of expression of structural components of the basement membrane (like laminin 5 and collagen IV) making hAM an useful tissue for ocular surface reconstruction. Since 1996 in fact, amniotic membrane transplantation has been applied to a large number of ocular surface diseases including Stevens-Johnson syndrome, pterygium, corneal ulceration, ocular surface reconstruction after chemical/thermal burns and in the reconstruction after excision of ocular surface neoplasia. During the previous decades, hAM has achieved a pivotal role in regenerative medicine too.The possibility to preserve human amniotic membrane, without affecting membrane's features, has become pivotal, allowing virological and microbiological analyses to be carried out before grafting. The purpose of the present study is to investigate an easier and cheaper protocol for human amniotic membrane preservation without affecting its properties and structure, ensuring the safety profile of the tissue. We compared the effects on adhesive and structural properties of newer preservation conditions to those obtained with an established, standardized protocol (dimethyl sulfoxide at -160°C). In attempt to simplify and enhance the safety of the procedure, we tested dextran-based freezing medium and a dry condition (no medium) at temperatures of -80°C. METHODS: Five patches of human amniotic membrane were obtained from three different donors. For each donor, five preservation condition were tested: dimethyl sulfoxide at -160°C, dimethyl sulfoxide at -80°C, dextran-based medium at -160°C, dextran-based medium at -80°C and dry freezing at -80°C (no medium). At the end of four months storage period, adhesive properties and structure were analyzed. RESULTS: None of the newer preservation protocols showed differences in adhesive and structural properties of the tissues. The stromal layer always kept its adhesiveness, while both structure and basement membrane were not altered by any the preservation protocol. CONCLUSIONS: Switching from liquid nitrogen cryopreservation to -80°C would reduce manipulation, simplify the procedure, making it also cheaper. The use of dextran-based freezing medium or no medium at all (dry condition) would avoid the potential toxicity of the dimethyl sulfoxide-based freezing media.

Efficacy of a New Commercial Ocular Spray Containing Oftasecur Citrus Extract for Reducing Microbial Load in the Conjunctiva of Patients Receiving Intravitreal Injections.

INTRODUCTION: The control of conjunctival microbial load is crucial for patients receiving intravitreal injections (IVTs) in order to reduce the risk of endophthalmitis. The purpose of this work was to assess the antimicrobial activity of a new commercial ocular spray containing Biosecur citrus extract (Oftasecur®, Off Health, Florence, Italy). METHODS: This prospective cross-sectional pilot study included patients receiving IVTs who were instructed to apply Oftasecur spray onto the eye to be injected four times daily starting 4 days before surgery. The contralateral eye was considered the control. A conjunctival swab for microbiological analysis was performed in both eyes before starting study treatment and at the time of the injection. The Brief Ocular Discomfort Inventory (BODI) questionnaire was administered to patients based on an 11-point scale (0 for no discomfort and 10 for maximum discomfort). RESULTS: Thirty patients (15 male, 15 female; mean age 64.7 ± 11.6 [standard deviation, SD] years) were included. Before starting treatment, 53.3% of the total eyes tested positive during the microbiological analysis. After the treatment period, only 20% of the eyes tested positive at the time of injection, showing a significant reduction in the microbial load (p < 0.01). Moreover, in the treated arm, the positive swabs before and after the prophylactic treatment with Oftasecur ocular spray showed a significant reduction (from 70.4% to 29.6%; p = 0.003, McNemar's test). Oftasecur ocular spray was well tolerated, with an average BODI score of 1.2 (± 0.70 SD). CONCLUSION: Oftasecur ocular spray showed antimicrobial activity that significantly reduced the microbial load in patients receiving intravitreal injections. Therefore, it may have a role in the prophylaxis of infection in the setting of IVTs.

Asymptomatic Infection in Decompensated Full-Thickness Corneal Grafts Referred for Repeat Penetrating Keratoplasty.

PURPOSE: We report a case series of asymptomatic infections affecting failed corneal grafts in patients referred for repeat penetrating keratoplasty (PK). METHODS: In this retrospective, noncomparative, interventional case series, we reviewed the medical records of all repeat PK procedures performed at Villa Serena-Villa Igea private Hospitals (Forlì, Italy) between January 2011 and March 2016. Specifically, preoperative and postoperative slit-lamp examinations, and the results of histological and bacteriological examinations, were noted. RESULTS: Fifty-three repeat PKs were performed in the study period. All patients were referred because of long-standing graft decompensation with stromal scars or surface irregularities, thus unsuitable for endothelial keratoplasty. None was referred because of presumed infection. Histological examination of the explanted buttons showed the presence of microorganisms of various types in 7 eyes. Cultures were positive in 4 of these cases and in one additional case Staphylococcus aureus was grown in culture, but was not seen in the histology specimen. None of the patients presented with unusual pain, tearing, or discomfort. Preoperative abnormal clinical findings included epithelial defect (n = 6), focal whitening of corneal stroma (n = 5), crystalline keratopathy (n = 1), and an elevated pigmented lesion (n = 1). After repeat PK, recurrence of the infection was seen in 5 of 7 (71%) cases, 2 of which required a third PK procedure. CONCLUSIONS: Apparently quiet eyes with failed PK can harbor slow-growing asymptomatic infection. An epithelial defect in a failed PK graft should raise suspicion of infection. Routine cultures and histological examination of the excised corneal buttons are instrumental in the diagnosis of these infections and can guide further treatment.

Transplantation failure due to inadvertent reversal of human donor corneas.

PURPOSE: To emphasize and create awareness of the possibility of inadvertently grafting an inverted corneal button and describe 4 cases that showed this phenomenon on human donor corneas during preservation and transportation from an eye bank. METHODS: Three out of 4 tissues showed inadvertent inversion during transportation and 1 was identified as inverted during preservation in the eye bank. Out of the 3 tissues that were shipped, 2 tissues were transplanted and 1 was identified as inverted prior to transplantation and shipped back to the eye bank. RESULTS: Four tissues showed inversion at different time points. The anatomy was clearly visible with a naked eye that showed the presence of trabecular meshwork on its outside along with some residual choroid. The endothelial cell count was in the range of transplantation without any mortality even after inversion. The inverted corneas showed a mountain-like shape with grooves as compared to the normal cornea. CONCLUSIONS: Previous reports have identified tissue inversion post-transplantation. We describe inadvertent inversion of donor tissues during preservation and transportation from an eye bank. It is recommended to check the presence of corneo-scleral rim, trabecular meshwork, grooves, and residues of choroid if present inside or outside before transplantation to ensure accurate grafting and avoid transplantation failures.