A Phase 3b Study for Management of Ocular Side Effects in Patients with Epidermal Growth Factor Receptor-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin.

INTRODUCTION: The Understanding New Interventions with GBM ThErapy (UNITE) study was designed to assess the effect of prophylaxis for ocular side effects (OSEs) in patients with glioblastoma receiving the antibody-drug conjugate (ADC) depatuxizumab mafodotin. UNITE (NCT03419403) was a phase 3b, open-label, randomized, exploratory study performed at 18 research sites in 5 countries. METHODS: The study enrolled adult patients with epidermal growth factor receptor-amplified, histologically confirmed, newly diagnosed supratentorial glioblastoma or grade IV gliosarcoma, and a Karnofsky Performance Status ≥70, receiving depatuxizumab mafodotin. All patients were administered depatuxizumab mafodotin during concurrent radiotherapy and temozolomide and with adjuvant temozolomide. Ninety patients were to be randomized (1:1:1) to OSE prophylactic treatments with each depatuxizumab mafodotin infusion: (a) standard steroid eye drops, (b) standard steroid eye drops plus vasoconstrictor eye drops and cold compress, or (c) enhanced steroids plus vasoconstrictor eye drops and cold compress. A Corneal Epitheliopathy Adverse Event (CEAE) scale was devised to capture symptoms, grade OSEs (scale of 0-5), and inform ADC dose modifications. The primary endpoint was the frequency of a required change in OSE management due to inadequate control of OSEs, defined as decline from baseline in visual acuity (using logarithm of the minimum angle of resolution [LogMAR] scale) or a Grade ≥3 CEAE event, in the worst eye in the first 8 weeks of treatment; unless otherwise specified, the treatment period refers to both the chemoradiation and adjuvant phases. RESULTS: The UNITE study was stopped early after interim analysis of separate phase III trial showed no difference in survival from depatuxizumab mafodotin. Forty patients were randomized (38 received depatuxizumab mafodotin). Overall, 23 patients experienced inadequate control of OSEs that required change in OSE management within 8 weeks of treatment, with 21 (70.0%) experiencing ≥+0.3 change on LogMAR scale in baseline-adjusted visual acuity and 12 reporting a grade ≥3 CEAE. There were no definitive differences among prophylactic treatments. CONCLUSIONS: The premature cessation of the study precludes definitive conclusions regarding the OSE prophylaxis strategies. No new clinically significant safety findings were noted. Despite these limitations, this study highlights the need for novel assessment tools to better understand and mitigate OSEs associated with ADCs.

Depatuxizumab mafodotin in EGFR-amplified newly diagnosed glioblastoma: A phase III randomized clinical trial.

BACKGROUND: Approximately 50% of newly diagnosed glioblastomas (GBMs) harbor epidermal growth factor receptor gene amplification (EGFR-amp). Preclinical and early-phase clinical data suggested efficacy of depatuxizumab mafodotin (depatux-m), an antibody-drug conjugate comprised of a monoclonal antibody that binds activated EGFR (overexpressed wild-type and EGFRvIII-mutant) linked to a microtubule-inhibitor toxin in EGFR-amp GBMs. METHODS: In this phase III trial, adults with centrally confirmed, EGFR-amp newly diagnosed GBM were randomized 1:1 to radiotherapy, temozolomide, and depatux-m/placebo. Corneal epitheliopathy was treated with a combination of protocol-specified prophylactic and supportive measures. There was 85% power to detect a hazard ratio (HR) ≤0.75 for overall survival (OS) at a 2.5% 1-sided significance level (ie traditional two-sided p ≤ 0.05) by log-rank testing. RESULTS: There were 639 randomized patients (median age 60, range 22-84; 62% men). Prespecified interim analysis found no improvement in OS for depatux-m over placebo (median 18.9 vs. 18.7 months, HR 1.02, 95% CI 0.82-1.26, 1-sided p = 0.63). Progression-free survival was longer for depatux-m than placebo (median 8.0 vs. 6.3 months; HR 0.84, 95% confidence interval [CI] 0.70-1.01, p = 0.029), particularly among those with EGFRvIII-mutant (median 8.3 vs. 5.9 months, HR 0.72, 95% CI 0.56-0.93, 1-sided p = 0.002) or MGMT unmethylated (HR 0.77, 95% CI 0.61-0.97; 1-sided p = 0.012) tumors but without an OS improvement. Corneal epitheliopathy occurred in 94% of depatux-m-treated patients (61% grade 3-4), causing 12% to discontinue. CONCLUSIONS: Interim analysis demonstrated no OS benefit for depatux-m in treating EGFR-amp newly diagnosed GBM. No new important safety risks were identified.

Standard management options for rosacea: The 2019 update by the National Rosacea Society Expert Committee.

In 2017, a National Rosacea Society Expert Committee developed and published an updated classification of rosacea to reflect current insights into rosacea pathogenesis, pathophysiology, and management. These developments suggest that a multivariate disease process underlies the various clinical manifestations of the disorder. The new system is consequently based on phenotypes that link to this process, providing clear parameters for research and diagnosis as well as encouraging clinicians to assess and treat the disorder as it may occur in each individual. Meanwhile, a range of therapies has become available for rosacea, and their roles have been increasingly defined in clinical practice as the disorder has become more widely recognized. This update is intended to provide a comprehensive summary of management options, including expert evaluations, to serve as a guide for tailoring treatment and care on an individual basis to achieve optimal patient outcomes.

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.

Use of Topical Rho Kinase Inhibitors in the Treatment of Fuchs Dystrophy After Descemet Stripping Only.

PURPOSE: Fuchs corneal dystrophy (FD) is a common cause of endothelial keratoplasty. Recently, a series of FD cases treated with Descemet stripping only (DSO) demonstrated recovery of the central endothelium without transplantation of donor cells. Ripasudil, a rho kinase inhibitor, has been shown to promote corneal endothelial wound healing in animal models. This study prospectively evaluated the use of ripasudil in patients undergoing DSO for FD. METHODS: Enrolled patients underwent DSO with or without cataract surgery, performed by 1 surgeon. On the first postoperative day, patients were assigned to topical ripasudil 0.4% (Glanatec) 4 times a day for 2 months or no ripasudil and followed up monthly for the first 6 months and then at 9 and 12 months after surgery. Endothelial cell density (ECD) and pachymetry were evaluated at each postoperative visit. RESULTS: Eighteen patients were enrolled, including 8 women and 1 man in each group. Overall, patients who underwent DSO with ripasudil recovered vision more quickly (4.6 vs. 6.5 weeks, P < 0.01). In addition, the ripasudil group had a statistically significantly higher average ECD at 3, 6, and 12 months. The patients in the DSO observation group had a 10% decrease in peripheral ECD when comparing counts before surgery with counts 12 months after surgery (P < 0.05). In the DSO ripasudil group, there was no significant difference between peripheral ECD at preoperative baseline versus 12 months after surgery. CONCLUSIONS: DSO with topical rho kinase inhibitors may be an alternative treatment for patients with FD and a peripheral ECD greater than 1000 cells/mm.

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.

Eye banking and corneal transplantation communicable adverse incidents: current status and project NOTIFY.

PURPOSE: Evidence of the transmission of disease via donor ocular tissue has been demonstrated for adenocarcinoma, rabies, hepatitis B virus, cytomegalovirus, herpes simplex virus, Creutzfeldt-Jakob disease, and a variety of bacterial and fungal infections. METHODS: Although there is no evidence to date of disease transmission for HIV infection, syphilis, hepatitis C, hepatitis A, tuberculosis, HTLV-1 and -2 infection, active leprosy, active typhoid, smallpox, and active malaria, these entities remain contraindications for transplantation for all eye banks nationally and internationally. The potential sources of contamination include infected donors, during the process of removing tissue from cadaveric donors, the processing environment, and contaminated supplies and reagents used during processing. The transmissions of Herpes simplex virus and HSV via corneal graft have been shown to be responsible for primary graft failure. HSV-1 may also be an important cause of PFG. RESULTS: The long latency period of some diseases, the emergence of new infectious disease, and the reemergence of others emphasize the need for long-term record maintenance and effective tracing capabilities. CONCLUSIONS: The standardization of definitions for adverse events and reactions will be necessary to support the prevention and transmission of disease. International classification of a unique identification system for donors will be increasingly important for vigilance and traceability in cross-national exportation of human cells, tissues, and cellular- and tissue-based products. Opportunities for continuous improvement exist as does the need for constant vigilance and surveillance.

Incidence of presumed iatrogenic graft failure in Descemet stripping automated endothelial keratoplasty.

PURPOSE: To evaluate presumed iatrogenic graft failure (PIGF) in Descemet stripping automated endothelial keratoplasty (DSAEK). METHODS: Deidentified data were collected retrospectively from the Illinois Eye Bank between April 2007 and May 2010. PIGF was defined as cases in which a repeat corneal transplant was performed <8 weeks after an initial DSAEK. Data collected for each case included days between initial DSAEK and regraft, regraft type (DSAEK vs. penetrating keratoplasty), precut versus surgeon-cut tissue, and number of DSAEKs distributed to individual surgeons. Ninety-three cases of PIGF were identified for a group of 46 surgeons who received 2504 corneas. Nine PIGF cases from 4 surgeons in cornea fellowships were analyzed separately. Individual surgeon failure rate and overall failure rate were calculated. Analysis of the overall failure rate was conducted without cases performed by surgeons who train fellows. Effect of surgical experience on PIGF was analyzed. RESULTS: Overall presumed iatrogenic DSAEK failure rate was 3.66% (84 PIGF cases divided by 2294 corneas). Within the group of 4 surgeons that trained fellows, the failure rate was 4.29% (9 cases PIGF divided by 210 corneas). Average time to regraft was 27.5 ± 17.4 days. Initial diagnoses included Fuchs dystrophy, pseudophakic bullous keratopathy, edema, and other disease states. Average donor and recipient ages were 54.3 ± 13.0 and 71.7 ± 11.3 years, respectively. Use of precut versus surgeon-cut tissue did not affect overall failure rates. Failure rates of less experienced surgeons (21.8% ± 10.8%) were higher than more experienced surgeons (1.5% ± 1.4%). CONCLUSIONS: Overall, DSAEK failure rates improve as surgeons gain experience. Failure rates in cornea fellowship programs are not excessive.

Standard management options for rosacea, part 2: options according to subtype.

The standard management options were developed by a consensus committee and review panel of 26 experts to assist in providing optimal patient care based on the standard classification and grading systems for rosacea that were developed to perform research; analyze results and compare data from different sources; and provide a common terminology and reference for the diagnosis, treatment, and assessment of results in clinical practice. We discuss the standard management options for rosacea in 2 parts: (1) overview and broad spectrum of care, and (2) management options according to subtype. The menu of options is considered provisional and may be expanded and updated as appropriate. Managing the various potential signs and symptoms of rosacea calls for consideration of a broad spectrum of care, and a more precise selection of therapeutic options may become increasingly possible as the mechanisms of action of therapies are more definitively established.

Standard management options for rosacea, part 1: overview and broad spectrum of care.

The standard management options were developed by a consensus committee and review panel of 26 experts to assist in providing optimal patient care based on the standard classification and grading systems for rosacea that were developed to perform research; analyze results and compare data from different sources; and provide a common terminology and reference for the diagnosis, treatment, and assessment of results in clinical practice. We discuss standard management options for rosacea in 2 parts: (1) overview and broad spectrum of care, and (2) options according to subtype. The options are considered provisional and may be expanded and updated as appropriate. Managing the various potential signs and symptoms of rosacea calls for consideration of a broad spectrum of care, and a more precise selection of therapeutic options may become increasingly possible as the mechanism of action of therapies are more definitively established.

Eye bank survey of surgeons using precut donor tissue for descemet stripping automated endothelial keratoplasty.

PURPOSE: To assess surgeon satisfaction with precut corneal tissue from 1 eye bank for Descemet stripping automated endothelial keratoplasty (DSAEK). Surgical techniques and predictors of procedural success were also examined. METHODS: A 19-question survey was completed by 53 surgeons around the United States for 197 DSAEK cases using prepared corneal allograft tissue from the Iowa Lions Eye Bank. Surgeries were performed between April 1 and December 31, 2006; surveys were completed retrospectively within a few weeks of surgery. RESULTS: Tissue was found to be acceptable in 98% of DSAEK cases reported. Difficulties with precut tissue (eg, lack of anterior cap adherence to the posterior lamella, not visible or decentered central dot, anterior edge undermining) were reported in approximately 10% of cases. A rebubbling procedure was performed in 23% of cases for donor dislocations. The donor lenticule adhered, with resulting corneal deturgescence, in 86% of cases. Surgeons declared a successful procedure in 92% of cases. Of the 14 unsuccessful cases, donor tissue quality was the underlying etiology in only 1 case. Procedural success rates were related to surgeon experience (P = 0.002), lenticule adherence after only 1 anterior chamber air bubble (P = 0.005), no small perforations to release fluid (P = 0.005), and the presence of corneal deturgescence (P = 0.002). CONCLUSIONS: The use of precut tissue for DSAEK is not associated with increased risk of complications related to tissue preparation. With standardization of precutting donor tissue, safety of DSAEK surgery may be improved while increasing surgeon efficiency.

Refractive enhancement following presbyopia-correcting intraocular lens implantation.

PURPOSE OF REVIEW: Presbyopia-correcting intraocular lenses are widely available. Residual ametropia is one of the most common issues that can result in patient dissatisfaction. Options for correcting refractive surprises include piggyback intraocular lens implantation, corneal incisional surgery and laser correction. Excimer laser surgery is a safe and predictable method to correct residual amounts of ametropia in pseudophakic patients with monofocal intraocular lenses; however, there is scant published literature regarding this technique. RECENT FINDINGS: Presbyopia-correcting intraocular lenses require emmetropia for the best visual outcome, as small amounts of astigmatism or residual refractive errors can limit their visual performance. Laser-assisted in-situ keratomileusis and photorefractive keratectomy are safe and effective results in pseudophakic patients. Surgeons can refine the refractive outcome after intraocular lens implantation with the excimer laser to achieve better results and higher patient satisfaction. SUMMARY: Excimer laser corneal surgery for fine-tuning residual ametropia after presbyopia-correcting intraocular lenses is a safe adjunct treatment to increase patient satisfaction. Which technique (photorefractive keratectomy or laser-assisted in-situ keratomileusis) to use depends on surgeon preference and patient characteristics, as both demonstrate similar results in published literature. Knowledge of all available refractive methods and technologies are crucial for improving outcomes in these patients.

Suture technique for Descemet stripping and endothelial keratoplasty.

PURPOSE: To describe a suture technique for Descemet stripping and endothelial keratoplasty (DSEK). METHODS: The technique was performed in 2 eyes of 2 patients with Fuchs endothelial corneal dystrophy. A double-armed 10-0 prolene suture on a CIF-4 needle was used to pull the donor corneal button into the recipient's anterior chamber without the use of forceps to hold the button. The suture was also used to unfold the lenticule in the eye without marking the stroma with gentian violet, to center the lenticule and to secure that in place. RESULTS: No intraoperative problems occurred in either case. The suture technique was successfully used to pull the donor button into the host's eye and to unfold and center the button. Both lenticules were well centered and had minimal corneal edema. At 6 months, the central endothelial loss was 8% in the first case and 10% in the second. CONCLUSION: This suture technique for DSEK avoids the use of forceps and allows less traumatic donor button manipulation. It may be an effective alternative with low endothelial damage; further follow-up will determine the long-term effect on the central endothelial cell count.

Corneal ectasia after scleral buckling surgery.

PURPOSE: To describe a case of corneal ectasia with marked asymmetric progression attributable to encircling buckle surgery for retinal detachment. METHODS: Case report. RESULTS: A 72-year-old man developed clinical signs of pellucid marginal degeneration in 1 eye after placement of an encircling scleral buckle. The fellow eye showed normal slit-lamp examination, with topographic signs of forme-fruste pellucid marginal degeneration. CONCLUSION: Patients with forme-fruste pellucid marginal degeneration may show progression and clinical manifestations after encircling scleral buckle, probably by changes in ocular physiology and corneal biomechanics.

Visual outcomes after accommodating intraocular lens implantation.

PURPOSE: To evaluate and compare the visual outcomes and accommodative amplitude in cataract patients after implantation of the Crystalens intraocular lens (IOL) (Eyeonics) versus standard monofocal IOLs. SETTING: Ten clinics in a nationwide multicenter study in the United States. METHODS: A multicenter comparative interventional case series with masked randomized postoperative examination of 224 eyes of 112 patients was performed by a single observer. Patients were divided into 2 groups (56 patients; 112 eyes each) depending on which IOL was implanted (Crystalens or monofocal). Accommodation was measured using 1 objective (dynamic retinoscopy) and 2 subjective methods (defocus and near point of accommodation). Visual acuity measurements were performed under the same conditions with standard visual acuity charts. RESULTS: Uncorrected monocular near vision was significantly better in the Crystalens group than in the standard monofocal group, with 101 of 112 eyes (90%) and 17 of 112 (15%), respectfully, reading J3 or better postoperatively. All 56 Crystalens patients had a binocular uncorrected near visual acuity of J3 or better compared with 16 of 56 (29%) standard monofocal patients. The mean postoperative monocular (0.85 +/- 0.30 [SD] versus 0.70 +/- 0.19, P<.01) and binocular (1.16 +/- 0.17 versus 1.01 +/- 0.14, P<.01) distance uncorrected visual acuities were also better in the Crystalens group than in the control group. All patients in the study achieved a corrected distance visual acuity of 20/20 or better. Measures of accommodation were significantly higher in Crystalens patients than in the monofocal IOL patients (dynamic retinoscopy 2.42 +/- 0.39 diopters [D] versus 0.91 +/- 0.24 D, P<.01; monocular defocus 1.74 +/- 0.48 D versus 0.75 +/- 0.25 D, P<.01; monocular near point of accommodation 9.5 +/- 3.1 inches versus 34.7 +/- 9.8 inches, P<.01). Perceived accommodation (5.79 D) was significantly greater than the measured accommodation (1.96 to 2.42 D) in Crystalens patients (paired t test, P<.01). CONCLUSIONS: The Crystalens IOL provided better uncorrected near and distance visual outcomes than standard monofocal IOLs in all analyses performed. Patients perceived a greater accommodation than measured. Understanding why this occurred could lead to valuable advances in accommodating IOL technology.

Effect of expanding the treatment zone of the Nidek EC-5000 laser on laser in situ keratomileusis outcomes.

PURPOSE: To evaluate the effect of expanding the treatment zone of the Nidek EC-5000 laser on postoperative visual acuity as well as night glare and halos after laser in situ keratomileusis (LASIK) using 4 ablation zone diameters. SETTING: Division of Ophthalmology, Evanston Northwestern Healthcare and Northwestern University Medical School, Glenview, Illinois, USA. METHODS: This prospective study comprised 301 eyes of 154 consecutive patients who had LASIK in 1 or both eyes using the Nidek EC-5000 laser by 1 surgeon with experience in keratomileusis and excimer laser refractive surgery. A 6.5 mm optical zone was used with a transition zone 1.0 mm larger than the pupil under scotopic conditions (7.5, 8.0, 8.5, or 9.0 mm). Targeted correction was calculated according to a customized clinical nomogram. All patients were queried about glare and halos preoperatively and 3 months postoperatively using a questionnaire assigning numeric values to the degree of perceived visual disturbance (0 = no glare or halos, 1 = minimal, 2 = moderate, 3 = severe). RESULTS: The baseline uncorrected visual acuity (UCVA) was 20/200 or worse in 293 eyes. The baseline best spectacle-corrected visual acuity was 20/20 or better. The mean preoperative refractive sphere was -6.33 diopters (D) +/- 2.80 (SD) (range -1.00 to -16.25 D) and the mean preoperative refractive cylinder, 0.86 +/- 0.83 D (range 0 to +3.25 D). Three months postoperatively, 78% of eyes had a UCVA of 20/20 and 99%, of 20/40 or better. Preoperatively, 94 eyes (31%) had glare and halos. At 3 months, glare, halos, or both were present in 19 eyes of 11 patients (6.3%) (P<.0001); in 14 eyes, patients reported less severe glare and halos postoperatively than preoperatively. CONCLUSIONS: The use of a peripheral transition zone 1.0 mm larger than the pupil under scotopic conditions resulted in a low incidence of glare and halos postoperatively and did not adversely affect visual acuity. There was no increase in postoperative complications including corneal ectasia.

Ocular rosacea can mimic trachoma: a case of cicatrizing conjunctivitis.

PURPOSE: To report the case of a patient with upper eyelid chronic cicatrizing conjunctivitis and entropion, presumably secondary to ocular rosacea. METHODS: Case report and review of medical literature. RESULTS: The patient has a history of chronic cicatrizing conjunctivitis since 1999. Despite an extensive workup for other possible causes, the patient's known history of acne rosacea is the most substantive explanation for her ocular disease. CONCLUSION: The presence of chronic cicatrizing conjunctivitis affecting mainly the upper eyelids, previously thought to be unique to trachoma, can be associated with ocular rosacea.

Ocular surface squamous neoplasia: a review.

Even though ocular surface squamous neoplasia (OSSN) has been recognized for well over a century, the past decade has witnessed advances that have helped rewrite many of the paradigms for the diagnosis and management of these lesions. OSSN occurs predominantly in the elderly for whom they are the third most common oculoorbital tumors after melanoma and lymphoma. In addition to advanced age and male sex, other major risk factors linked to its pathogenesis are ultraviolet light, cigarette smoking, and the human papilloma virus. Although the latter has been linked to OSSN for nearly 4 decades, its identification and role in the pathogenesis of these tumors has been elucidated recently and is addressed in detail in this review. Newer techniques of impression cytology represent a noninvasive and reliable method of diagnosing OSSN and monitoring treated cases. The efficacy of chemotherapeutic agents such as mitomycin C and 5-fluorouracil have been proven in the recent past, making them a clear alternative to the time-tested treatment of surgical excision and cryotherapy. Early reports on the efficacy of topical Iterferon alpha 2b indicate significant promise in providing another alternative for the treatment of some of these neoplasms. These advances thus represent a minimally invasive and highly successful approach to the diagnosis and treatment of OSSN.