Use of Cenegermin in the Presence of Bandage Contact Lenses.

PURPOSE: The aim of this study was to characterize the outcomes of eyes with neurotrophic keratitis (NK) treated with a course of cenegermin-bkbj in the presence of a bandage contact lens (BCL). METHODS: A retrospective chart review of all eyes with a clinical diagnosis of NK treated with cenegermin-bkbj was performed between 2018 and 2020. Inclusion criteria included cenegermin-bkbj treatment with a BCL in place. Demographics, etiology, visual acuity, pretreatment and posttreatment corneal sensation, and treatment outcomes were assessed. RESULTS: There were 18 eyes of 16 patients (69% female) with NK treated with cenegermin-bkbj while having a BCL in place. After cenegermin-bkbj treatment, presence of corneal sensation significantly increased from 7% of eyes to 79% of eyes (P < 0.0001). There was also a significant increase in the number of quadrants with corneal sensation (mean of 0.1 quadrants increased to 1.6 quadrants, P =0.0005). Six of 10 eyes (67%; P = 0.004) with a persistent epithelial defect (PED) experienced complete resolution at the conclusion of treatment, while 3 additional eyes experienced a decrease in the defect size. Despite all 18 eyes necessitating a chronic BCL before cenegermin-bkbj treatment, 4 were able to maintain their epithelium without a BCL after treatment for at least some period. CONCLUSIONS: Cenegermin-bkbj treatment for NK with a BCL in place demonstrated improvement in corneal sensation, epithelial defect size, and fluorescein staining. In eyes demonstrating previous ocular surface decompensation with discontinuation of a BCL, maintenance of BCL use during treatment with cenegermin-bkbj may be considered.

Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery.

PURPOSE: To assess the efficacy and safety of a sustained-release intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery. SETTING: Twenty-one United States sites. DESIGN: Prospective multicenter randomized parallel-arm double-masked vehicle-controlled phase 3 study. METHODS: Patients with planned clear corneal cataract surgery were randomized (1:1) to receive dexamethasone insert or placebo, and the treatment was placed in the canaliculus of the eye immediately after surgery (Day 1). The primary efficacy endpoints were complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day 8. RESULTS: The study comprised 438 adult patients (216 in the treatment arm and 222 in the placebo arm). At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P < .0001). At Day 8, significantly more patients had an absence of ocular pain in the dexamethasone insert arm compared with placebo (79.6% versus 61.3%; P < .0001). The dexamethasone insert arm showed no increase compared with placebo in incidence of all adverse events or ocular adverse events. Twice as many placebo patients required rescue therapy, compared with treated patients at Day 14. CONCLUSIONS: Both primary endpoints were successfully met. In addition, patients receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as Day 4 through Day 45, and a decrease in pain as early as one day after surgery (Day 2) through Day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo.

Prelamellar Dissection Donor Corneal Thickness Is Associated With Descemet Stripping Automated Endothelial Keratoplasty Operative Complications in the Cornea Preservation Time Study.

PURPOSE: To identify donor and recipient factors, including eye bank tissue observations, predictive of operative complications in the Cornea Preservation Time Study. METHODS: One thousand three hundred thirty study eyes undergoing Descemet stripping automated endothelial keratoplasty for Fuchs dystrophy or pseudophakic/aphakic corneal edema 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 factors included demographics, prelamellar corneal and postlamellar lenticule dissection thickness, central endothelial cell density, and tissue processing time. Recipient factors included demographics, intraocular pressure, and glaucoma medications or surgery (trabeculectomy, laser trabeculoplasty). Eye bank observations included donor tissue folds, pleomorphism/polymegethism, and endothelial cell abnormalities. Possible tissue-related operative complications were recorded including difficult donor lenticule unfolding and positioning. Multivariable logistic regression with backward selection was used to identify statistically significant (P < 0.01) associations between factors and operative complications. RESULTS: The only factor predictive of operative complications [58 (4.4%) of 1330 surgeries] was prelamellar dissection donor corneal thickness (P = 0.002). For every 50 µm of donor corneal thickness prior to lamellar dissection, operative complication odds increased by 40% (odds ratio [99% confidence interval (CI)]: 1.40 [1.06-1.83]) adjusting for PT and whether the epithelium was on or off. The estimated mean prelamellar dissection donor corneal thickness for PT 0 to 7 days was 537 µm (99% CI: 516 µm-558 µm) compared with 567 µm (99% CI: 546 µm-588 µm) for PT 8 to 14 days (P < 0.001). CONCLUSIONS: Thicker donor tissue (prelamellar dissection) is associated with operative complications and should be considered in tissue selection for Descemet stripping automated endothelial keratoplasty lenticule preparation.

Tomographic changes in eyes with hyperopic shift after triple Descemet membrane endothelial keratoplasty.

PURPOSE: To describe the tomographic changes in eyes with a hyperopic shift after triple Descemet membrane endothelial keratoplasty (DMEK). SETTING: Private cornea practice, Blue Ash, Ohio, USA. DESIGN: Retrospective case series. METHODS: Patients who had previous triple DMEK with preoperative and postoperative Scheimpflug corneal tomography (Pentacam) measurements and corresponding manifest refraction measurements were reviewed. Eyes with and without a hyperopic postoperative shift were compared at either the 1-month or 3- to 6-month follow-ups. Assessed parameters included demographics, cataract testing, visual acuity, manifest refraction, and Scheimpflug tomography data. RESULTS: Sixty-two eyes of 47 patients (21 men, 26 women) with Fuchs endothelial corneal dystrophy were included. Preoperative posterior flat keratometry (K), posterior steep K, posterior average K, central pachymetry, and asphericity (Q value) of the posterior cornea were significantly different when comparing the hyperopic and non-hyperopic group. At the postoperative 1-month and 3- to 6-month follow-ups, there was a significant between-group difference in change in postoperative anterior K (average), posterior K (average), central pachymetry, and posterior Q values compared with preoperative values. The combined preoperative criteria of posterior flat K (≥-5.25), central pachymetry (≥670 µm), and posterior Q value (≥0.5) had a sensitivity of 58% (11/19 correctly identified hyperopic shifts) and specificity of 81% (8/43 incorrectly identified). CONCLUSIONS: Eyes with a hyperopic surprise after triple DMEK demonstrated a significant change in posterior and anterior corneal curvature compared with eyes without a hyperopic surprise. This might be secondary to corneal edema because these eyes also demonstrated greater preoperative corneal pachymetry.

Comparison of Visual Acuity Outcomes Between Nanothin Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty.

PURPOSE: To compare the visual outcomes and complications between nanothin Descemet stripping automated endothelial keratoplasty (NT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). METHODS: A prospective comparative case series of 28 consecutive cases of NT-DSAEK (less than or equal to 50 µm) and DMEK was undertaken. Inclusion criteria were a diagnosis of Fuchs dystrophy, presence of pseudophakia, or planned combined cataract surgery/endothelial keratoplasty, with a minimum of 6-month follow-up. Exclusion criteria were any concurrent ocular comorbidities. Primary outcomes measures were best spectacle-corrected visual acuity (BSCVA) and complications. RESULTS: Mean thickness of NT-DSAEK grafts was 41.0 ± 7.5 µm (range 26-50 µm). At 1 month postoperatively, the DMEK group had significantly better mean BSCVA of 0.18 ± 0.20 logarithm of the minimum angle of resolution (logMAR) (20/33) compared with 0.28 ± 0.16 logMAR (20/40) for NT-NSAEK (P = 0.049). At 3, 6, and 12 months postoperatively, mean BSCVA was comparable between both groups [3 months: NT-DSAEK 0.17 ± 0.12 logMAR (20/30) versus DMEK 0.13 ± 0.17 (20/27), P = 0.31; 6 months: NT-DSAEK 0.11 ± 0.10 logMAR (20/26) versus DMEK 0.09 ± 0.10 (20/25), P = 0.63; 12 months: NT-DSAEK 0.07 ± 0.09 logMAR (20/24) versus DMEK 0.07 ± 0.11 logMAR (20/24), P = 0.95]. Other than 1 NT-DSAEK graft that was successfully rebubbled, no other complications were encountered in either group. CONCLUSIONS: Compared with DMEK, NT-DSAEK provides comparable visual outcomes and complications rates.

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.

Incidence, Risk Factors, and Surgical Management of Boston Type 1 Keratoprothesis Corneal Melts, Leaks, and Extrusions.

PURPOSE: To determine the rate of Boston type 1 keratoprosthesis (Kpro)-related corneal melts, leaks, and extrusions requiring surgical repair and to analyze possible risk factors and visual outcomes. METHODS: Retrospective chart review of 110 patients (128 eyes) who received a Kpro between November 2004 and December 2010 (average follow-up of 29 mo). The rate of corneal complications, risk factors for melts, and postmelt repair visual outcomes were evaluated. RESULTS: Twenty eyes from 18 patients developed Kpro-related melts requiring surgical repair. The incidence of melt-related complications was 16%. In total, there were 33 episodes of melt-related complications. Surgical repair included lamellar patch grafts (15), Kpro removal with penetrating keratoplasty (7), reassembly of Kpro onto a new cornea (4), replacement of Kpro (3), suturing of a leak (3), and enucleation (1). The majority of eyes (18/20) did not regain their best post-Kpro vision at final follow-up (average 10 mo and range, 1-36 mo after melt repair). Significant risk factors for melt included previous infectious keratitis [P < 0.0001, odds ratio (OR) = 12.50, 95% confidence interval (CI), 4.02-38.9] and conjunctival deficiency (ie, a diagnosis of Stevens-Johnson syndrome, mucous membrane pemphigoid, or chemical injury, P = 0.043, OR = 2.66, CI, 1.01-7.02). CONCLUSIONS: Patients who undergo Kpro with severe ocular surface disease are at greater risk for corneal melts, leaks, and extrusions. Patients with infectious keratitis and conjunctival deficiency are at an increased risk of developing corneal melts. Visual outcomes are poor after surgical repair of these complications.

Pressure-induced interface keratitis: a late complication following LASIK.

PURPOSE: Interface inflammation is a common complication of laser in situ keratomileusis (LASIK). The most well-described presentation is diffuse lamellar keratitis (DLK), which typically develops early after LASIK and responds quickly to topical steroids. In this report, we describe a novel presentation of interface inflammation that resembles DLK in appearance but presents late in the postoperative period, is associated with increased intraocular pressure, and is exacerbated by steroid treatment. METHODS: A retrospective case series and chart review of all patients treated in our tertiary care private practice for late-onset interface inflammation associated with elevated intraocular pressure. RESULTS: Ten eyes in 6 patients with late-onset interface inflammation and increased intraocular pressure were identified. At presentation, all patients were presumed to have classic DLK and were treated initially with aggressive topical steroids. Eight of the 10 eyes were receiving topical steroids at the time of presentation. The average time of presentation was 17 days after LASIK (range, 7-34). Elevated intraocular pressure was noted on average 28 days after presentation (range, 8-69). Lamellar inflammation was exacerbated by topical steroids. Resolution of the interface inflammation did not occur until intraocular pressure was controlled. CONCLUSIONS: This case series describes a clinically distinct form of interface inflammation that presents late and is associated with elevated intraocular pressure. The lamellar inflammation was refractory to topical steroids and only resolved when pressure was controlled. These findings suggest that elevated intraocular pressure can contribute to interface inflammation. Postoperative assessment of intraocular pressure is essential in patients presenting with flap inflammation.

Recurrence of Fuchs marginal keratitis within a lamellar graft.

We report a case of Fuchs marginal keratitis with a recurrence and spontaneous perforation on the lamellar graft. A constellation of marginal corneal infiltrates and stromal thinning under a pseudopterygium characterize this condition. Two years after an initial lamellar keratoplasty, the pathology recurred within the graft. A repeat lamellar keratoplasty was performed, this time combined with a conjunctival autograft.

Concentrations of levofloxacin, ofloxacin, and ciprofloxacin in human corneal stromal tissue and aqueous humor after topical administration.

OBJECTIVE: To evaluate the penetration of commercially available levofloxacin 0.5%, ofloxacin 0.3%, and ciprofloxacin 0.3% topical ophthalmic solutions in human corneal stromal and aqueous humor tissues. METHODS: A total of 67 patients scheduled to undergo penetrating keratoplasty for treatment of stromal scar or dystrophy, keratoconus, pellucid marginal degeneration, or endothelial disease were enrolled in this prospective, double-blind, 3-center study. To be considered for inclusion, patients had to have an intact corneal epithelium and minimal or no corneal edema (pachymetry < 650 microm). After informed consent was obtained, patients were randomized to receive 1 drop of levofloxacin 0.5%, ofloxacin 0.3%, or ciprofloxacin 0.3% topical ophthalmic solution at approximately 15 and 10 minutes before surgery. Approximately 0.1 mL of aqueous fluid was aspirated by paracentesis through the trephination wound at the onset of surgery, followed by excision of the affected cornea and removal of its epithelium. Specimens were stored frozen at -70 degrees C until assayed by high-performance liquid chromatography. RESULTS: All 3 fluoroquinolones were well tolerated. A total of 65 corneas and 59 aqueous fluid samples were obtained and assayed. The mean +/- standard deviation corneal concentrations of ciprofloxacin, ofloxacin, and levofloxacin following a 2-drop administration were 9.92 +/- 10.99 microg/g (n = 18), 10.77 +/- 5.90 microg/g (n = 23), and 18.23 +/- 20.51 microg/g (n = 24), respectively. Although corneal stromal levels were highest in the levofloxacin group, the high degree of interpatient variability prevented demonstration of statistically significant differences when compared with ofloxacin (P = 0.377). In contrast, levofloxacin concentrations were approximately twice as high as ciprofloxacin, and this difference reached statistical significance (P = 0.014). The corresponding aqueous humor concentrations of ciprofloxacin, ofloxacin, and levofloxacin were 0.135 +/- 0.231 microg/mL (n = 15), 0.135 +/- 0.111 microg/mL (n = 20), and 0.372 +/- 0.546 microg/mL (n = 24, P < 0.001 versus ciprofloxacin and ofloxacin). CONCLUSION: The topical administration of all 3 agents was well tolerated in patients undergoing penetrating keratoplasty. Two drops of levofloxacin 0.5% solution results in a 1.7- to 2.7-fold greater penetration into human corneal stromal and aqueous humor tissues than ofloxacin 0.3% or ciprofloxacin 0.3%. The mean intracorneal concentrations of all three agents following 2 drops exceeds the MIC90 for the majority of pathogens causing bacterial keratitis. Topical levofloxacin appears to offer pharmacokinetic and pharmacodynamic advantages over ofloxacin and ciprofloxacin in terms of enhanced transcorneal penetration; however, clinical comparative trials are needed to confirm these relative advantages.

Keratopathy in congenital aniridia.

Although the most apparent clinical finding in aniridia is the absence of iris tissue, additional ocular structures are often affected. Mutations of the Pax 6 gene, which is important for eye development, have been identified in families with members affected by aniridia. Poor vision in aniridic eyes may be the result of macular hypoplasia, nystagmus, amblyopia, cataracts, glaucoma, and corneal disease, termed aniridic keratopathy. Advances in surgical techniques have improved management of some of the visually disabling manifestations of aniridia, but aniridic keratopathy remains a significant source of visual loss. We have conducted a large, retrospective study of patients with aniridia to gain information about the natural course of aniridic keratopathy. In this paper, we report the results of our study, as well as findings reported in the literature. Penetrating keratoplasty alone has not been a successful treatment for severe stromal scarring, as it does not treat the underlying epithelial causes of corneal disease. However, it has been successful in corneas that have achieved stable epithelium following limbal stem cell transplantation.

Report of the Eye Bank Association of America medical advisory board subcommittee on fungal infection after corneal transplantation.

PURPOSE: To investigate the incidence of fungal infections after corneal transplantation to determine whether storage media supplementation with an antifungal should be considered. METHODS: Adverse reactions reported to the Eye Bank Association of America through the online adverse reaction reporting system between January 1, 2007, and December 31, 2010, were reviewed to identify cases of recipient fungal infection. Data were collected regarding the donor, the donor cornea, recovery and processing, and mate culture and clinical course of the recipients. RESULTS: Thirty-one cases of culture-proven fungal keratitis (n = 14) and endophthalmitis (n = 17) were reported out of 221,664 corneal transplants performed using corneal tissue distributed by domestic eye banks (1.4 cases per 10,000 transplants performed). Although the annual incidence of postkeratoplasty fungal infection has not increased significantly since 2005, a trend toward an increasing rate of fungal infection has been observed. Fungal infections were more commonly reported after endothelial keratoplasty procedures (0.022%) than penetrating keratoplasty procedures (0.012%), but the difference was not statistically significant (P = 0.076). Additionally, no association was found between fungal infection after endothelial keratoplasty and whether the lamellar tissue cut was performed by the surgeon or the eye bank technician. Seventy-three percent (16 of 22) of the fungal cultures performed on the mate corneas were positive, with infection developing in 67% (10 of 15) of recipient eyes (endophthalmitis in 6 eyes and keratitis in 4 eyes). CONCLUSIONS: Although a nonsignificant increasing trend in the rate of fungal infection has been observed over the past 6 years, it is not sufficiently compelling to pursue antifungal supplementation of donor storage media.

Traumatic wound rupture after Boston type 1 keratoprosthesis implantation.

OBJECTIVE: To describe the incidence, characteristics, causes, treatment, and outcomes of traumatic wound rupture in patients with Boston type 1 keratoprosthesis (KPro). DESIGN: Retrospective case series. PARTICIPANTS: We studied 136 eyes of 122 patients who underwent KPro implantation at a single institute between November 2004 and May 2011. METHODS: A chart review was performed to determine the incidence, characteristics, causes, treatments, and outcomes of traumatic wound rupture. RESULTS: The 4 eyes of 4 patients that sustained traumatic wound rupture resulted in an incidence of traumatic wound rupture of 2.9% (4/136). This complication occurred, on average, at 4.2 months (range, 1-9 months) after the KPro was implanted. All ruptures occurred at the graft-host junction. The 2 eyes that had complete keratoprosthesis extrusion experienced decreased vision postrupture, from hand motions to no light perception, and 20/300 to count-fingers vision, respectively. One eye that had 4 clock hours of superior wound rupture recovered vision postrupture from light perception to 20/40. One eye that had 2 clock hours of superior wound rupture maintained a stable vision of 20/125 after repair. CONCLUSIONS: The incidence of traumatic wound rupture after keratoprosthesis is comparable to that after penetrating keratoplasty. Patients should be aware that traumatic rupture is a lifelong concern and should use protective measures to prevent this complication from occurring.

Visual outcome comparison of unilateral versus bilateral implantation of apodized diffractive multifocal intraocular lenses after cataract extraction: prospective 6-month study.

PURPOSE: To evaluate the visual outcomes and patient satisfaction after unilateral implantation or stepwise bilateral implantation of an apodized diftractive multifocal intraocular lens (IOL). SETTING: Private practice, Cincinnati, Ohio, USA. METHODS: Patients requiring cataract surgery in 1 eye were recruited. AcrySof ReSTOR IOLs were implanted in 1 eye of patients with phakic contralateral eyes, patients with contralateral monofocal IOLs, and patients with a contralateral multifocal IOL of the same model. Six months postoperatively, patients were assessed for visual acuity (31.0 cm, 50.0 cm, 4.0 m), contrast sensitivity, and stereopsis. Patients were surveyed for visual disturbances and lifestyle visual quality. RESULTS: Of unilateral multifocal IOL patients, 75% were satisfied with their vision (score 7.3 out of 10) and a majority (56% multifocal-phakic, 65% multifocal-monofocal) achieved spectacle independence. These values were slightly lower than values for bilateral multifocal patients (92% satisfied, 77% spectacle independent), but not at a statistically significant level. Mean overall patient satisfaction was statistically significantly different: 8.9 for bilateral patients versus 7.3 for unilateral patients. Objectively, significant differences favored bilateral implantation over unilateral implantation for stereopsis, uncorrected near visual acuity, and best corrected near and intermediate visual acuities. Contrast sensitivity was similar between groups in most cases. The incidence of halos was lower in unilateral patients (57%) than in bilateral patients (77%), although the difference did not reach statistical significance. CONCLUSION: Although unilateral implantation of a multifocal IOL provided patients with high levels of spectacle freedom and good visual acuity without compromising contrast sensitivity, overall clinical results favored bilateral implantation.

Techniques for managing common complications of cataract surgery.

Cataract surgery has evolved dramatically over the last two decades, largely as a result of technological advances. As a result, visual outcomes and patient convalescence have improved significantly. A second consequence of increased instrumentation and technology, however, is increased complexity of cataract surgery and the advent of complications unique to these advances. Cataract surgeons must be aware and capable of managing the many possible adverse events that can occur during cataract surgery. This review identifies many of the common complications of cataract surgery, describes methods to avoid these complications and discusses techniques to address complications that do occur. It is the ability to avoid, quickly identify, and properly manage complications that defines the accomplished cataract surgeon.