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Glaucoma is a multifactorial progressive and degenerative optic neuropathy representing one of the world's leading cause of irreversible blindness. Currently, reduction of intraocular pressure remains the only universally approved therapy, yet a wealth of studies has identified significant vascular contributions to the disease process in certain individuals. Population-based studies have identified important racial disparities and differential risk factors in glaucoma prevalence, incidence, and progression. A more significant vascular component has been identified in persons of African descent. Elucidating risk modifiers, including genetic and racial influence, is important when considering individually tailored clinical management of glaucoma. The application of artificial intelligence and mathematical modeling inclusive of demographic considerations, vascular health, and clinical biomarkers may help reduce disease disparities, advance personalized medicine, and provide a comprehensive model of glaucoma.

ObjectiveTo identify temporal and geographic trends in private equity (PE) backed acquisitions of ophthalmology and optometry practices in the United States from 2012 to 2021.DesignCross-sectional time series analysis using acquisition data from 10/21/2019 to 9/1/2021 compared to previously published data from 1/1/2012-10/20/2019. Acquisition data was compiled from 6 financial databases, 5 industry news outlets, and publicly available press releases. Linear regression models were used to compare rates of acquisition.Subjects245 PE acquisitions of ophthalmology and optometry practices in the United States between 10/21/2019 and 9/1/2021.MeasuresNumber of total acquisitions, practice type, locations, provider details, and geographic footprint.Results245 practices associated with 614 clinical locations and 948 ophthalmologists or optometrists were acquired by 30 PE-backed platform companies. 18 of 30 platform companies were new compared to our prior study. Of these acquisitions from 10/21/2019 - 9/1/2021, 127, 29, and 89 were comprehensive, retina, and optometry practices, respectively. From 2012 to 2021, monthly acquisitions increased by 0.947 acquisitions per year (pConclusionPE acquisitions increased from 2012-2021 as companies continue to utilize both regionally focused and multi-state models of add-on acquisitions.

Telehealth has become a viable option for glaucoma screening and glaucoma monitoring due to advances in technology. The ability to measure intraocular pressure without an anesthetic and to take optic nerve photographs without pharmacologic pupillary dilation using portable equipment have allowed glaucoma screening programs to generate enough data for assessment. At home, patients can perform visual acuity testing, web-based visual field testing, rebound tonometry, and video visits with the physician to monitor for glaucomatous progression. Artificial intelligence will enhance the accuracy of data interpretation and inspire confidence in popularizing telehealth for glaucoma.

Purpose This study evaluated US resident and fellow glaucoma surgical experience over a 7- and 8-year period, respectively. Methods US ophthalmology resident glaucoma case logs from 2009 to 2016 and glaucoma fellow case logs from 2008 to 2016 were reviewed. The number of total, average, median, and minimum cases, along with percentile data for filtering surgery, shunting surgery, and novel procedures were analyzed for year-to-year trends. Results Among residents training from 2009 to 2016, there was a decline in the average number of primary filtering surgeries by 20%, from 6.0±5.0 to 4.8±4.0 cases, with a concurrent increase in average primary glaucoma drainage implant (GDI) surgeries by 40%, from 4.5±4.0 to 6.3±5.0 cases, which represented an increase of 6.5% per year, P

PRECIS We retrospectively reviewed records of patients prescribed latanoprostene bunod 0.024% (LBN) to assess its efficacy and safety in a real-world clinical setting. LBN was efficacious in lowering intraocular pressure (IOP) and had a favorable safety profile. PURPOSE The aim of this study was to evaluate the usage of LBN, the first topical nitric oxide-donating prostaglandin analog (PGA) for reducing IOP, in clinical practice. PATIENTS AND METHODS Retrospective review identified patients prescribed LBN by 5 glaucoma specialists at an academic center from January 2018 to November 2019. Fifty-six patients (102 eyes) met inclusion criteria of an IOP measured at the visit LBN was prescribed and at 2 visits ≥7 days after beginning treatment, with no surgeries, lasers or medication changes during follow-up. Main outcome measures were IOP, number of ocular medications, and adverse effects. RESULTS IOP (mean±SD, mm Hg) at the visit LBN was prescribed was 16.2±4.3 on 3.2±1.5 glaucoma medications. IOP at most recent visit was 13.7±3.8 on 3.2±1.6 medications. Mean IOP reduction was 2.1±3.5 (P

Purpose To discuss the effects of the severe acute respiratory syndrome coronavirus 2 betacoronavirus on ambulatory ophthalmology practices, the value proposition of telemedicine, teleophthalmology implementation methodologies, and the accelerated future of telemedicine. Design Review of the current telehealth landscape including usage, policies, and techniques for ambulatory practice integration. Methods We provide author-initiated review of recent trends in telehealth, governmental recommendations for health care delivery during the COVID-19 pandemic, and a PubMed Central query for telemedicine in ophthalmology or teleophthalmology. In addition, the authors' comprehensive experience in telemedicine design and implementation is provided. Results We provide a summary describing the present state of telehealth, teleophthalmology modeling, care delivery, and the proposed impact of telehealth surges on the future of ophthalmology practice. Conclusion Recent patient and provider interest in telemedicine, the relaxation of regulatory restrictions, increased remote care reimbursement, and ongoing social distancing practices compel many ophthalmologists to consider virtualizing services.

PRE[COMBINING ACUTE ACCENT]CIS:: Cortical response to low-contrast stimuli, as measured by isolated-check visual evoked potential (icVEP) technology, has the potential to provide functional assessment that may complement standard achromatic perimetry in assessing glaucomatous change. PURPOSE To evaluate the utility of modified icVEP testing in detecting functional glaucomatous damage. MATERIALS AND METHODS Subjects who met predetermined criteria of controls, glaucoma suspects, preperimetric glaucoma, or glaucoma were enrolled in this prospective cross-sectional study from a single tertiary care center. Glaucoma patients were further categorized as early, moderate, advanced, or severe on the basis of Hodapp-Anderson-Parrish criteria. icVEP testing was performed with ten 2-second runs per qualified eye using the EvokeDx testing software. Multivariate statistics were used to calculate signal-to-noise ratios (SNR) and perform outlier analysis. RESULTS In total, 140 eyes met criteria (mean±SD; age of 63±14 y; 49% male; logMAR visual acuity, 0.11±0.089). There was no significant difference in age, sex, or logMAR visual acuity among the groups. Controls had a significantly higher SNR than all other groups (P

Purpose As American health care evolves, an increasing number of doctors are pursuing MBAs. However, relatively little is known about how business training translates into their future careers. This study characterizes ophthalmologists who have completed MBAs and identifies opportunities for physician leadership in the field. Design Cross-sectional study. Methods We identified 120 ophthalmologists who hold MBAs. We searched each individual's online profiles to collect information on demographics, training, and professional activities. Results Physician-MBAs in ophthalmology are 80% male; 80% are fellowship trained; and 28% are in primarily nonclinical roles and 55% participate in significant nonclinical activity. Hospital administration is most common (31%), followed by pharmaceutical administration (7%) and consulting (5%). Older ophthalmologist-MBAs were more likely to work in nonclinical roles, with 79% of those who completed residency before 2000 engaged in significant nonclinical activity compared to 30% of those who completed residency after 2000. The most common employers of physician-MBAs in ophthalmology are academic medical centers (43%), large group practices (30%), and private practices (13%). Conclusions The majority of ophthalmologist-MBAs work in primarily clinical roles, although a sizable proportion hold nonclinical positions. Moving forward, we anticipate an increased role for physician leaders in health care administration, policy, and entrepreneurship. While formal management training is not necessary for these roles, a growing number of physicians have sought out MBAs to support their nonclinical interests.

Aim: Conventional eyedropper-delivered volumes (25–50 µl) exceed the eye's usual tear-film volume (7 µl) and precorneal reservoir capacity, risking overflow and ocular/systemic complications. Piezoelectric high-precision microdosing may circumvent these limitations. Results & methodology: In this masked, nonrandomized, cross-over study, subjects (n = 12) underwent pupil dilation with topical phenylephrine (PE) administered by 32-µl eyedropper (2.5% or 10% formulation) and 8-µl electronic microdosing (10% formulation). Microdosing with PE-10% achieved comparable peak dilation as 10% eyedropper-delivery and superior dilation to 2.5% eyedropper-delivery (p = 0.009) at 75 min. Microdosing significantly reduced 20-min plasma PE levels versus PE10% eyedropper; neither treatment altered heart rate/blood pressure. Eye irritation occurred significantly less frequently with microdosing than PE10% eyedrops. Conclusion: Piezo-ejection PE microdosing achieves comparable biological effect as eyedropper dosing; reduced systemic absorption may decrease risk of systemic side effects.

Purpose 5-Fluorouracil (5-FU) has been well described for a failing trabeculectomy bleb, but not for aqueous shunts. We sought to determine whether subconjunctival 5-FU prolongs the intraocular pressure (IOP) efficacy of Ahmed shunts.

To determine the relative efficacy of the Ahmed-FP7 and Baerveldt BG101-350 implants.Pooled analysis of 2 multicenter, randomized clinical trials.A total of 514 patients aged 18 or older with uncontrolled glaucoma that had failed or were at high risk of failing trabeculectomy were randomized to receive an Ahmed implant (n = 267) or Baerveldt implant (n = 247). Cumulative failure rates (using an intraocular pressure [IOP] target of 6-18 mm Hg inclusive), de novo glaucoma surgery rates, mean IOP, mean glaucoma medication use, and visual acuity were compared.Baseline characteristics were similar between groups. Mean preoperative IOP of the study population was 31.5 ± 11.3 mm Hg on an average of 3.3 ± 1.1 glaucoma medications. At 5 years, mean IOP was 15.8 ± 5.2 mm Hg in the Ahmed group and 13.2 ± 4.7 mm Hg in the Baerveldt group (P.001). Mean glaucoma medication use was 1.9 ± 1.5 in the Ahmed group and 1.5 ± 1.4 in the Baerveldt group (P = .007). The cumulative failure rate at 5 years was 49% in the Ahmed group and 37% in the Baerveldt group (P = .007). High IOP was the most common reason for failure in both groups, and de novo glaucoma surgery was required in 16% of the Ahmed group and 8% of the Baerveldt group (P = .006). Failure owing to hypotony occurred in 0.4% of the Ahmed group and 4.5% of the Baerveldt group (P = .002). Visual outcomes were similar between groups (P = .90).The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and lower mean IOP on fewer medications than the Ahmed group. Baerveldt implantation carried a higher risk of hypotony.

Purpose To compare 2 frequently used aqueous shunts for the treatment of glaucoma. Design International, multicenter, randomized trial. Participants Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. Methods Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. Main Outcome Measures The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5–18 mmHg) or reduced Results A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group ( P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group ( P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group ( P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. Conclusions Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group.

Louis R Pasquale,1 Shan Lin,2 Robert N Weinreb,3 James C Tsai,4 Robert L Kramm,5 Tsontcho Ianchulev5,6 1Department of Ophthalmology, Harvard Medical School, Cambridge, MA, USA; 2Department of Ophthalmology, University of California San Francisco, San Francisco, CA, USA; 3Department of Ophthalmology, University of California San Diego, San Diego, CA, USA; 4Department of Ophthalmology, Mount Sinai School of Medicine, New York, NY, USA; 5Eyenovia Incorporated, New York, NY, USA; 6Department of Ophthalmology, New York Eye and Ear Infirmary, Mount Sinai Medical School, New York, NY, USA Background: Topical high-precision piezo-print delivery of microdoses of latanoprost achieved significant IOP reduction consistent with the eyedropper effect but with a 75% reduced exposure to drugs and preservatives. Prostaglandin analogs are a mainstay glaucoma therapy. However, conventional eyedroppers deliver 30–50 μL drops that greatly exceed the physiologic 7-μL ocular tear film capacity. Eyedropper overdosing floods the eye with excess drug compounds and preservatives, resulting in ocular surface toxicity, periorbitopathy, and other well-characterized ocular side effects. Piezoelectric high-precision microdosing provides targeted delivery that can reduce exposure to both drug and preservatives compared to conventional eyedropper delivery, with the potential to deliver similar biologic effect. Methods: Both eyes (N=60) of 30 healthy volunteers received single 8-μL microdoses of 0.005% latanoprost (0.4 μg; μRx-latanoprost) on the morning of Days 1 and 2 using a high-precision, piezo-print horizontal delivery system. Diurnal IOP was measured before and 2 days after microdosing. Main efficacy outcomes were diurnal IOP change after μRx-latanoprost microdosing and accurate microdosing success rates, and the primary safety outcome was adverse event (AE) incidence. Results: μRx-latanoprost reduced baseline IOP by 26% and 30% at 1 and 2 days postadministration, respectively. Successful topical dosing was achieved in 100% of technician-assisted deliveries. All patients successfully self-administered microdoses after receiving training. Microdose administration was well tolerated and did not result in any AEs. Conclusion: Microdosing of 0.4 μg of μRx-latanoprost achieved significant IOP reduction. Lower ocular exposure with topical prostaglandin analog microdosing can enable new therapeutic opportunities for optimizing glaucoma treatment. Microdosing may also be beneficial in reducing ocular side effects associated with excessive drug product and preservatives often used to treat chronic ocular diseases such as glaucoma. Keywords: microdosing, piezo-ejection system, latanoprost, IOP, IOP lowering, glaucoma, ocular drug delivery, Optejet, self-administration, usability

Purpose To consider the American Journal of Ophthalmology's (AJO's) role not only as a forum to describe clinical and scientific advances but also as a record of institutional histories. We used the New York Eye and Ear Infirmary of Mount Sinai, the Massachusetts Eye and Ear Infirmary, and the Wills Eye Hospital as case studies on the Journal's role in documenting the people and organizations that have moved ophthalmology forward. Design Perspective. Methods Using the ScienceDirect database, we conducted a literature search to gather all mentions of the 3 eye hospitals in the Journal's archives from 1918 to 2018. We evaluated those search results to identify a few of the individuals and articles that highlight how the history of eye institutions are reflected in the AJO. Results Searches for the aforementioned 3 hospitals yielded over 3400 results in Journal archives. These included articles on their histories, proceedings from clinical case conferences, profiles of prominent surgeons, and information about educational offerings, among others. Many of those articles were written by physicians from those institutions who also served on the AJO's editorial board or had a long history of publishing in the Journal. Conclusions The AJO has played a crucial role in the last 100 years as a register of ophthalmic history. The New York Eye and Ear Infirmary of Mount Sinai, Massachusetts Eye and Ear Infirmary, and Wills Eye Hospital provide 3 examples of how that role manifests.

To calculate the association between Medicare payment and service volume for 6 commonly performed glaucoma procedures.Retrospective, longitudinal database study.A 100% dataset of all glaucoma procedures performed on Medicare Part B beneficiaries within the United States from 2005 to 2009.Fixed-effects regression model using Medicare Part B carrier data for all 50 states and the District of Columbia, controlling for time-invariant carrier-specific characteristics, national trends in glaucoma service volume, Medicare beneficiary population, number of ophthalmologists, and income per capita.Payment-volume elasticities, defined as the percent change in service volume per 1% change in Medicare payment, for laser trabeculoplasty (Current Procedural Terminology [CPT] code 65855), trabeculectomy without previous surgery (CPT code 66170), trabeculectomy with previous surgery (CPT code 66172), aqueous shunt to reservoir (CPT code 66180), laser iridotomy (CPT code 66761), and scleral reinforcement with graft (CPT code 67255).The payment-volume elasticity was nonsignificant for 4 of 6 procedures studied: laser trabeculoplasty (elasticity, -0.27; 95% confidence interval [CI], -1.31 to 0.77; P = 0.61), trabeculectomy without previous surgery (elasticity, -0.42; 95% CI, -0.85 to 0.01; P = 0.053), trabeculectomy with previous surgery (elasticity, -0.28; 95% CI, -0.83 to 0.28; P = 0.32), and aqueous shunt to reservoir (elasticity, -0.47; 95% CI, -3.32 to 2.37; P = 0.74). Two procedures yielded significant associations between Medicare payment and service volume. For laser iridotomy, the payment-volume elasticity was -1.06 (95% CI, -1.39 to -0.72; P0.001): for every 1% decrease in CPT code 66761 payment, laser iridotomy service volume increased by 1.06%. For scleral reinforcement with graft, the payment-volume elasticity was -2.92 (95% CI, -5.72 to -0.12; P = 0.041): for every 1% decrease in CPT code 67255 payment, scleral reinforcement with graft service volume increased by 2.92%.This study calculated the association between Medicare payment and service volume for 6 commonly performed glaucoma procedures and found varying magnitudes of payment-volume elasticities, suggesting that the volume response to changes in Medicare payments, if present, is not uniform across all Medicare procedures.

Purpose Glaucoma is a major cause of vision loss due to retinal ganglion cell (RGC) degeneration. Therapeutic intervention controls increased IOP, but neuroprotection is unavailable. NogoReceptor1 (NgR1) limits adult central nervous system (CNS) axonal sprouting and regeneration. We examined NgR1 blocking decoy as a potential therapy by defining the pharmacokinetics of intravitreal NgR(310)-Fc, its promotion of RGC axonal regeneration following nerve crush, and its neuroprotective effect in a microbead glaucoma model. Methods Human NgR1(310)-Fc was administered intravitreally, and levels were monitored in rat vitreal humor and retina. Axonal regeneration after optic nerve crush was assessed by cholera toxin β anterograde labeling. In a microbead model of glaucoma with increased IOP, the number of surviving and actively transporting RGCs was determined after 4 weeks by retrograde tracing with Fluro-Gold (FG) from the superior colliculus. Results After intravitreal bolus administration, the terminal half-life of NgR1(310)-Fc between 1 and 7 days was approximately 24 hours. Injection of 5 μg protein once per week after optic nerve crush injury significantly increased RGCs with regenerating axons. Microbeads delivered to the anterior chamber increased pressure, and caused 15% reduction in FG-labeled RGCs of control rats, with a 40% reduction in large diameter RGCs. Intravitreal treatment with NgR1(310)-Fc did not reduce IOP, but maintained large diameter RGC density at control levels. Conclusions Human NgR1(310)-Fc has favorable pharmacokinetics in the vitreal space and rescues large diameter RGC counts from increased IOP. Thus, the NgR1 blocking decoy protein may have efficacy as a disease-modifying therapy for glaucoma.

The aim was to investigate the impact of antihypertensive medication on the onset of glaucoma. Data from the complete Danish population between 40 and 95 years of age were used in the period from 1996 to 2012, covering >2.6 million individuals. The National Danish Registry of Medicinal Products Statistics was used to identify all claimed prescriptions for glaucoma medication and antihypertensive drugs. We first investigated basic correlations in the data and found that patients treated with antihypertensive medication, at any time during the study period, had a significantly higher overall relative risk (RR) of glaucoma, even when controlling for age and sex (with a RR of 1.31 and P

To determine if receiving a prescheduled appointment is associated with an increased likelihood of complying with follow-up eye care among individuals identified as at risk for glaucoma during community-based glaucoma screening in an urban underserved population. This study sampled 362 individuals aged ≥30 years without known glaucoma from low-income, predominantly black/Hispanic neighborhoods in New Haven, Connecticut presenting to one of twelve community-based glaucoma screening events from May 2010 to October 2012. A quasi-experimental design systematically assigned 63 individuals identified as at risk for glaucoma into either intervention or control group with a 1:2 ratio. Individuals in the control group (n = 41) received counseling on glaucoma and a recommendation for obtaining a follow-up appointment at the eye department of a local community health center, which offers affordable health services with income-adjusted fee discounts to uninsured, low-income patients. Those in the intervention group (n = 22) received the same counseling and a prescheduled appointment at the community health center. The overall rate of follow-up compliance within 3 months of screening was 30 % (41 % in the intervention group; 24 % in the control group). Multivariate logistic regression analysis adjusting for sex, age, ethnicity, health insurance status, car access, living situation, and smoking status found that follow-up compliance was significantly associated with intervention (adjusted odds ratio 4.8; 95 % confidence interval 1.1-20.9). Providing prescheduled appointments can improve follow-up compliance after community-based glaucoma screening. This finding may be potentially applicable to community-based health screening for other preventable diseases.

To compare 24 h intraocular pressure (IOP) control obtained with preservative free (PF) tafluprost 0.0015% versus branded preservative containing latanoprost 0.005% administered as first choice monotherapy in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT).This prospective, observer-masked, crossover study included consecutive newly diagnosed patients with POAG or OHT, and baseline IOP between 24 and 33 mm Hg. Qualifying patients underwent baseline untreated 24 h IOP monitoring in habitual positions, with Goldmann tonometry at times 10:00, 14:00, 18:00 and 22:00, and Perkins supine tonometry at times 02:00 and 06:00. They were then randomised to either latanoprost or tafluprost, administered in the evening, for 3 months and then switched to the opposite therapy for another 3 months. 24 h monitoring was repeated at the end of each treatment period.38 patients completed the study. Mean untreated 24 h IOP (24.9 mm Hg) was significantly reduced with both prostaglandins (p0.001). Tafluprost demonstrated similar mean 24 h efficacy compared with latanoprost (17.8 vs 17.7 mm Hg; p=0.417). Latanoprost demonstrated significantly better 24 h trough IOP (15.9 vs 16.3 mm Hg; p=0.041) whereas tafluprost provided significantly lower 24 h IOP fluctuation (3.2 vs 3.8 mm Hg; p=0.008). No significant difference existed between the two prostaglandins for any adverse event.PF tafluprost achieved similar 24 h IOP reduction to branded latanoprost. The current study highlights the importance of complete assessment of efficacy over 24 h.NCT01162603.

OBJECTIVE To calculate the associations between Medicare payment and service volume for complex and noncomplex cataract surgeries. DATA SOURCES The 2005-2009 CMS Part B National Summary Data Files, CMS Part B Carrier Summary Data Files, and the Medicare Physician Fee Schedule. STUDY DESIGN Conducting a retrospective, longitudinal analysis using a fixed-effects model of Medicare Part B carriers representing all 50 states and the District of Columbia from 2005 to 2009, we calculated the Medicare payment-service volume elasticities for noncomplex (CPT 66984) and complex (CPT 66982) cataract surgeries. DATA EXTRACTION Service volume data were extracted from the CMS Part B National Summary and Carrier Summary Data Files. Payment data were extracted from the Medicare Physician Fee Schedule. PRINCIPAL FINDINGS From 2005 to 2009, the proportion of total cataract services billed as complex increased from 3.2 to 6.7 percent. Every 1 percent decrease in Medicare payment was associated with a nonsignificant change in noncomplex cataract service volume (elasticity = 0.15, 95 percent CI [-0.09, 0.38]) but a statistically significant increase in complex cataract service volume (elasticity = -1.12, 95 percent CI [-1.60, -0.63]). CONCLUSIONS Reduced Medicare payment was associated with a significant increase in complex cataract service volume but not in noncomplex cataract service volume, resulting in a shift toward performing a greater proportion of complex cataract surgeries from 2005 to 2009.

The prostanoids are commonly used in the treatment of glaucoma. They have been shown to effectively reduce intraocular pressure with a relatively benign side-effect profile. Tafluprost is the newest member of the prostanoid family used in the treatment of glaucoma, and it is also the first prostanoid to be released in a preservative-free formulation. Early data suggest that it is as effective as the other prostanoids. The objective of this article is to detail the development and subsequent early testing of tafluprost.

Primary angle closure glaucoma (PACG) is a significant cause of visual disability worldwide. It predominantly affects the Eastern and South Asian population of the world. Early detection of anatomically narrow angles is important, and the subsequent prevention of visual loss from PACG depends on an accurate assessment of the anterior chamber angle (ACA). Gonioscopy has given way to modern day imaging technologies such as ultrasound biomicroscopy (UBM) and more recently, anterior segment optical coherence tomography (AS-OCT). Ultrasound biomicroscopy provides objective, high-resolution images of anterior segment anatomy, including the cornea, iris, anterior chamber, anterior chamber angle, and ciliary body. Optical coherence tomography (OCT) is a noncontact optical signal acquisition and processing device that provides magnified, high-resolution cross-sectional images of ocular tissues. Recent technological advances towards three-dimensional visualization broadened the scope of AS-OCT in ophthalmologic evaluation. Optical coherence tomography systems use low-coherence, near-infrared light to provide detailed images of anterior segment structures at resolutions exceeding that of UBM. This paper summarizes the clinical application of UBM and OCT for assessment of anterior segment in glaucoma.

Objective To report the design, baseline patient characteristics, and intraoperative complications of the Ahmed Versus Baerveldt (AVB) Study. Design Multicenter, randomized, clinical trial. Participants Patients were recruited from 7 international clinical sites and treated by 10 surgeons between 2005 and 2009. Inclusion criteria required that patients be at least 18 years of age and have uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy. Methods Eligible patients were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using standardized surgical technique, to be followed for 5 years. Main Outcome Measures The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (5–18 mmHg with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions. Results A total of 238 patients were enrolled in the study; 124 received the Ahmed-FP7 valve implant and 114 received the Baerveldt-350 implant. The 2 treatment groups did not differ in any baseline characteristics with the exception of sex. The mean age of the study group was 66±16 years, and 55% were women, with a greater proportion in the Baerveldt group ( P =0.01). The mean baseline IOP of the study group was 31.4±10.8 on a mean of 3.1±1.0 glaucoma medications. The median Snellen visual acuity was 20/100, mean number of previous laser therapies was 0.9±1.1, and mean number of previous surgeries was 1.7±1.2. Five (4%) patients in the Ahmed group and 4 (4%) patients in the Baerveldt group experienced significant intraoperative complications. Conclusions Aqueous drainage devices are being increasingly used for glaucoma refractory to conventional treatment, and the AVB Study compares the 2 most commonly implanted devices. The 2 groups had similar baseline characteristics, and there were a similar number of intraoperative complications for both devices. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

Promoting nerve regeneration involves not only modulating the post-injury microenvironment but also ensuring survival of injured neurons. Sustained delivery of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) has been shown to promote the survival and regeneration of neurons, but systemic administration is associated with significant side effects. We fabricated poly(lactic-co-glycolic acid) (PLGA) microspheres and nanospheres containing the EGFR TKI 4-(3-chloroanilino)-6,7-dimethoxyquinazoline (AG1478) for intravitreal administration in a rat optic nerve crush injury model. Upon administration, less backflow from the injection site was observed when injecting nanospheres compared to microspheres. Two weeks after intravitreal delivery, we were able to detect microspheres and nanospheres in the vitreous using coumarin-6 fluorescence, but fewer microspheres were observed compared to the nanospheres. At four weeks only nanospheres could be detected. AG1478 microspheres and nanospheres promoted optic nerve regeneration at two weeks, and at four weeks evidence of regeneration was found only in the nanosphere-injected animals. This observation could be attributed to the ease of administration of the nanospheres versus the microspheres, which in turn led to an increased amount of spheres delivered to the vitreous in the nanosphere group compared to the microsphere group. These data provide evidence for use of PLGA nanospheres to deliver AG1478 intravitreally in a single administration to promote nerve regeneration.

Topic Risk factors for poor adherence or nonadherence to topical glaucoma medication regimens. Clinical Relevance Poor adherence to glaucoma medication regimens may be associated with subsequent visual loss and irreversible optic nerve damage. Methods A literature search was performed using the words “ glaucoma AND adherence AND risk ” and “ glaucoma AND compliance AND risk ,” limited to those studies in English and focused on care in the United States. Publications from well-regarded journals in this field were reviewed, and a focused summary of the literature is presented. Results There are a myriad of adherence barriers inherent to the glaucoma patient population. Although most of these obstacles are common in the elderly (e.g., reduced cognition, musculoskeletal problems, and transportation difficulties), older age has not been shown to be a consistent risk factor for poor adherence to glaucoma medication regimens. Other expected barriers, such as medication cost, limited health insurance, disease severity, and role of complicated dosing regimens, have varied effects based on the patient population studied and the definition of adherence. Poor medication adherence also is associated with decreased adherence to follow-up medical visit schedules. A systematic taxonomy of adherence barriers has been formulated. In addition, subanalyses from the Glaucoma Adherence and Persistency Study identified 8 variables that affect adherence to glaucoma medication regimens as well as several characteristics that support the importance of and associations between doctor-patient communications. Conclusions Recent studies have provided valuable insights into the many factors that increase the risk(s) for poor adherence in patients prescribed glaucoma medications. Four major types of barriers to effective patient adherence (medication regimen, patient factors, provider factors, and situational or environmental factors) have been identified. Addressing these specific barriers will require a tailored, patient-centered approach. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

Purpose To introduce a rapid and objective electrophysiological technique that can assess visual function in the magnocellular pathway, which is thought to be affected in early-stage glaucoma. Methods Low-contrast bright or dark isolated-checks were luminance-modulated against a static background at 10 Hz in order to drive preferentially the magnocellular ON or OFF pathway. Visual evoked potentials were recorded during 1-s epochs of stimulation and responses at the stimulus frequency were measured. Artifact rejection features ensured that eight valid runs were obtained per eye. Signal-to-noise ratios (SNR) were derived based on a multivariate statistic. In order to demonstrate its functionality, a small group of patients with glaucoma (N = 18, Snellen acuity of 20/30 or better) and control observers (N = 16) were tested. A participant failed the test if either eye yielded an SNR ≤ 1. Receiver-operating-characteristic curve analysis was used to estimate the accuracy of group classification. Results The instrument was found to elicit reliable responses from control observers. For the 15% bright condition, all control observers yielded significant isolated-check VEPs (icVEPs), whereas the majority of patients failed to do so, indicating significant losses in central visual function. This condition produced the highest classification accuracy (94%), followed by the 10% dark condition (91%). Conclusions Both ON and OFF divisions of the magnocellular pathway can be assessed rapidly through the application of the icVEP technique. This measure of central visual function may be of value in the detection of glaucomatous deficits and may complement tests of peripheral function.

Glaucoma is a progressive optic neuropathy that is the leading cause of irreversible blindness in the world. Although methods to lower intraocular pressure are the mainstay of glaucoma therapy, there are currently no available treatment modalities targeted at neuroprotection. Erythropoietin is a hematopoietic cytokine that has been shown to possess remarkable tissue-protective properties in preclinical models of neurodegeneration. As a result, there is a growing interest to explore the neuroprotective properties of erythropoietin as a possible therapeutic agent in neuropathic diseases of the eye such as glaucoma. Initial results in animal models have been promising, but further studies are needed to fully evaluate the safety and efficacy of this candidate neuroprotective agent in clinical trials.

Purpose To calculate the relationship between Medicare payment and service volume for the 3 highest-volume retina procedures: intravitreal injection (Current Procedural Terminology [CPT] code 67028), laser treatment for retinal edema (CPT code 67210), and laser treatment for proliferative retinopathy (CPT code 67228). Design Retrospective, longitudinal database study. Participants One hundred percent dataset of all retina procedures performed on Medicare Part B beneficiaries within the United States from 2005 through 2009. Methods Fixed-effects regression model using Medicare Part B carrier data for all 50 states and the District of Columbia, controlling for time-invariant carrier-specific characteristics, national trends in service volume, Medicare beneficiary population, number of ophthalmologists, and income per capita. Main Outcome Measures Medicare payment-service volume elasticities, defined as the percent change in service volume per 1% change in Medicare payment, for intravitreal injection, laser treatment for retinal edema, and laser treatment for proliferative retinopathy. Results For all 3 retina procedures, the regression coefficients representing the Medicare payment-service volume elasticity were nonsignificant: intravitreal injection elasticity, −0.75 (95% confidence interval [CI], −1.62 to 0.13; P = 0.09); laser treatment for retinal edema elasticity, 0.14 (95% CI, −0.38 to 0.65; P = 0.59); and laser treatment for proliferative retinopathy elasticity, 0.05 (95% CI, −0.26 to 0.35; P = 0.77). Conclusions This study found no evidence suggesting that there is an association between Medicare payment and service volume for the 3 highest-volume retina procedures from 2005 through 2009.

Normal tension glaucoma is a progressive optic neuropathy that poses technical complexity in management to prevent vision loss. Surgical intervention is necessary when visual field progression is noted or imminent. Trabeculectomy with adjunct use of the anti-scarring agent mitomycin-C is the treatment of choice in achieving a target intraocular pressure to preserve vision in normal tension glaucoma patients. This subset of patients is at a relatively higher risk for dense visual field defects and postoperative surgical management is key to success for the patient and the surgeon. Other surgical interventions can be of aid in combination with each other or with traditional trabeculectomy and antimetabolite treatment to prevent fibrosis; however, these surgeries have not definitively resulted in intraocular pressures low enough to reach a desired target in normal tension glaucoma patients.

Objective To analyze the longer-term surgical outcomes of Ahmed and Baerveldt shunt implants in the treatment of refractory glaucoma. Design Retrospective, nonrandomized, comparative trial. Participants Consecutive patients who underwent glaucoma shunt implantation (70 Baerveldt, 48 Ahmed) by a single surgeon. Methods Follow-up retrospective analysis of 118 consecutive cases of refractory glaucoma that required placement of either Ahmed or Baerveldt shunt implants for intraocular pressure (IOP) control. The longer term clinical course (survival curve analysis up to 48 months) was reviewed. Main Outcome Measures The primary outcome measure was surgical success (6 mmHg ≤ IOP ≤ 21 mmHg without additional glaucoma surgery or devastating complication). Secondary outcome measures included mean IOP and number of medications used at the following postoperative visits: day 1, 1 week, 1 month, 3 months, 6 months, and every 6 months thereafter (up to 48 months). In unsuccessful cases, the median time to failure was determined. Results No significant differences in success rates were noted at 1, 2, 3, or 4 years after surgery, with 4-year success rates of 62% for the Ahmed group and 64% for the Baerveldt group ( P = 0.843). Mean IOPs were comparable from 1 to 48 months ( P >0.05). However, patients in the Ahmed group required more glaucoma medications at 18, 24, 30, and 36 months ( P P = 0.009). Conclusions No differences were observed in longer term survival rates and IOP profiles between Ahmed and Baerveldt shunt implants up to 48 months following surgery. Patients in the Baerveldt group were more likely to develop early postoperative hypotony-related complications and failure, whereas patients undergoing Ahmed implants were more likely to be on additional glaucoma medications (starting at 18 months postsurgery) and develop later onset failure.

To measure the peripapillary retinal nerve fiber layer (RNFL) thickness in normal children.Observational cross-sectional study.Ninety-two eyes of 92 normal children ages 4 to 17 years presenting to the Ophthalmology Clinic at the Harkness Eye Institute, Department of Ophthalmology, Columbia University.Retinal nerve fiber layer thickness was measured with optical coherence tomography (OCT). Patient cooperation and signal strength of the OCT scans were assessed. Optic disc photographs were evaluated by a glaucoma specialist in a masked fashion. Eyes with abnormal optic discs were excluded. One eye of each subject was randomly selected for statistical analysis. The effect of several factors on RNFL thickness was investigated statistically.Retinal nerve fiber layer thickness.Ninety-one percent of the study subjects were Hispanic; 8%, African American; and 1%, Caucasian. Optical coherence tomography measurements were obtained in 117 of 121 (96.7%) subjects, and disc photographs were available for 92 of them. Mean age (+/-standard deviation [SD]) was 9.7+/-2.7 years. Mean global RNFL thickness (+/-SD) was 107.0+/-11.1 microm (range, 78.1-134.6). The RNFL was thickest inferiorly (136.9+/-16.9 microm) and superiorly (135.4+/-19.3 microm), thinner nasally (83.0+/-18.0 microm), and thinnest temporally (72.5+/-13.4 microm). In univariate regression analysis, age (P = 0.013) and refraction (P0.001) had a significant effect on RNFL thickness; age had a significant effect on refraction (P0.001). When controlling for refraction, age no longer had a significant effect.Optical coherence tomography can be used to measure RNFL thickness in children. Refraction had an effect on RNFL thickness. In normal children, variation in RNFL thickness is large. The normative data provided by this study may assist in identifying changes in RNFL thickness in children.

As with many diseases, glaucoma increases in frequency in older populations, and is very often encountered in patients taking multiple medications. While the exact mechanism of glaucomatous optic neuropathy (GON) is not known, intraocular pressure (IOP) is thought to be central to the process, and reducing IOP is the only known effective treatment. The newer definition of glaucoma is an IOP-sensitive optic neuropathy. While large, controlled studies have indicated that reducing IOP will slow the progression of disease, the contributions of other conditions and medications have not been adequately studied. As the adverse effect profiles of medical therapies for glaucoma have improved, use of these agents has increased greatly. This has resulted in a large number of older patients taking glaucoma medications. Since topical medications can easily be overlooked in a medical history, and are for the most part well tolerated, systemic complications from these agents can be missed. In addition to being a common disease requiring treatment, glaucoma is also a model system for other degenerative diseases, and many of the concepts originally developed in relation to neurodegenerative diseases such as Alzheimer's disease are under investigation for glaucoma. These include approaches targeted towards neuroprotection and excitotoxicity.

The aim of this pilot study was to evaluate the potential neuroprotective effect of an intravitreal injection of erythropoietin (EPO) on retinal ganglion cell (RGC) preservation in an episcleral vessel cautery-induced rat model of glaucoma.The animals were randomly assigned into an unoperated control group (n = 11) and three experimental groups: episcleral vessel cautery only (EVC: n = 4), episcleral vessel cautery with intravitreal normal saline injection (EVC-NS; n = 5), and episcleral vessel cautery with intravitreal EPO treatment (EVC-EPO; n = 9). The intravitreal injections were limited to 5 mul containing either normal saline alone or 200 ng of EPO in normal saline administered immediately after the cautery procedure. RGCs were labeled retrogradely by FluoroGold neuron tracer 5 to 7 days prior to the collection of eyes at day 21 and counted in whole flat-mounted retinas with fluorescence microscopy.Compared to the RGC counts in retinal specimens from unoperated control rats (12,619 +/- 310), the corresponding RGC counts were significantly decreased in both the EVC (9116 +/- 273; p0.005) and EVC-NS (9489 +/- 293; p0.005) groups but not significantly decreased in the EVC-EPO (11,212 +/- 414; p = 0.051) treated retinas.A single intravitreal 200 ng dose of EPO appears to have a protective effect on RGC viability in an in vivo rat model of glaucoma. Further experimental studies are needed to confirm these preliminary results and to optimize the appropriate dose and frequency of EPO delivery in animal models of glaucoma.

Purpose To systematically identify and describe common obstacles to medication adherence (i.e., compliance) for patients with glaucoma. Methods A prospective case series of structured interviews were conducted with 48 patients with glaucoma. The subjects' responses were recorded verbatim on interview forms as well as recorded on audiotapes. Situational obstacles to medication adherence were elicited. Using hierarchical cluster analysis, the situational descriptions were stratified, grouped, and analyzed by frequency distribution. Results Seventy-one unique situational obstacles were reported. These were then grouped into 4 defined and separate categories: situational/environmental factors (35 of 71 situations; 49%), medication regimen (23 of 71; 32%), patient factors (11 of 71; 16%), and provider factors (2 of 71; 3%). Conclusion Significant barriers to compliance exist for patients with glaucoma in addition to those cited by previous ophthalmic studies. A systematic classification (i.e., taxonomy) of these barriers was formulated to assist in optimizing patient education and problem-solving regarding prescribed therapeutic regimens.

Purpose To compare the surgical outcome of Baerveldt and Ahmed shunt implants in the treatment of refractory glaucoma. Design Retrospective, nonrandomized, comparative trial. Methods and participants Medical records of 118 consecutive patients who underwent glaucoma shunt implantation (70 Baerveldt, 48 Ahmed) by a single surgeon were reviewed. Main outcome measures The primary outcome measure was surgical success (6 mmHg ≤ intraocular pressure [IOP] ≤ 21 mmHg without additional glaucoma surgery or devastating complication) at 12 months after surgery. Secondary outcome measures included mean IOP and number of medications used at the following postoperative visits: day 1, 1 week, 1 month, 3 months, 6 months, and every 6 months thereafter. Additional outcome measures evaluated include visual acuities, prevalence and timing of postoperative choroidal detachment, and clinical bleb encapsulation. Results Survival curve analysis showed success rates of 82.9% of the Ahmed group and 72.9% of the Baerveldt group at 12 months after surgery ( P = 0.257). Patients in the Ahmed group exhibited lower IOPs at 1 day ( P P P P P P = 0.001). Conclusions The Ahmed shunt implant exhibited better control of IOP in the early postoperative period (1 day and 1 week) with patients requiring fewer glaucoma medications at 1 week and 1 month after surgery. There was both a higher prevalence and earlier onset of bleb encapsulation observed with the Ahmed shunt implant.

To assess the outcome of supplemental transscleral diode laser cyclophotocoagulation after aqueous tube shunt placement to obtain effective intraocular pressure (IOP) control.Retrospective non-comparative case series.Twenty-one eyes in 21 subjects with uncontrolled IOP despite the presence of an aqueous tube shunt and maximally tolerated glaucoma medications.Supplemental transscleral diode laser cyclophotocoagulation was performed.Reduction of intraocular pressure and reduction of glaucoma medications.Twelve adults and nine children underwent supplemental transscleral diode cyclophotocoagulation and were followed postoperatively for a mean of 26.9 +/- 13.4 (standard deviation [SD]) months (range, 7-58 months). Average IOP was significantly reduced from a preoperative level of 35.7 +/- 14.7 (SD) mmHg to a postoperative level of 13.6 +/- 7.1 (SD) mmHg (P0.001) with the mean number of medications significantly reduced to 1.5 +/- 1.3 (SD) (P0.001). Seven subjects (33%) had additional laser treatment to achieve IOP control. Six subjects who were therapy failures included three who developed no light perception in the setting of proliferative diabetic retinopathy, one subject with chronic angle-closure glaucoma who gradually developed no light perception after refusing further treatment or medication, and two subjects who developed retinal detachments. One child who was a qualified success underwent enucleation and debulking of an enlarging neurofibroma that caused significant proptosis and disfigurement.In cases of glaucoma that are uncontrolled despite a glaucoma aqueous tube shunt and multiple medications, adjunctive transscleral diode cyclophotocoagulation treatment(s) is a viable option to lower IOP.