Defining the role of ab externo Xen gel stent in glaucomatous eyes with prior failed surgical intervention.

PURPOSE: To evaluate the safety and efficacy of Xen45 Gel stent (Xen; Allergan) in eyes that have failed prior surgical intervention, compared to traditional glaucoma drainage device (GDD) or continuous-wave cyclophotocoagulation (CPC). Since this population has low expected success rates with additional surgery, it is vital to compare to standard-of-care surgical options. METHODS: Retrospective, single-center, case-control study of ab externo transconjunctival Xen shunt in eyes that have previously undergone trabeculectomy and/or GDD surgery. Postoperative data were collected for 18 months. Failure was defined as no light perception, additional glaucoma surgery required, or intraocular pressure (IOP) of < 6 mmHg after 6 weeks postoperatively. RESULTS: Eighteen Xen eyes and 36 control eyes matched on both glaucoma type and previous glaucoma surgeries were included. Seventy-two percent had primary open angle glaucoma, 11% uveitic, 6% primary angle closure, 6% pseudoexfoliation, and 6% pigmentary glaucoma. Fifty-six percent of eyes in each group had prior trabeculectomy, 28% of Xen and 31% of control eyes had prior GDD, and 17% of Xen and 14% of control eyes had both. Baseline medicated IOP was lower in the Xen group (21.8 ± 7.2) compared to controls (27.5 ± 9.4, P = 0.043). The cumulative failure rate at year 1 was 17% for Xen and 20% for controls (P = 0.57). Mean survival time was 14.1 (± 1.5) months and 11.4 (± 0.6) months for controls. There was no difference in minor complication rates between groups (P = 0.65), but the Xen group had a significantly lower rate of serious complications (P = 0.043) defined as vision threatening or requiring surgical intervention in the operating room. When censored for additional glaucoma procedures, there were no differences at year 1 in IOP, change in IOP, number of IOP-lowering medications, or number of medications reduced from baseline. CONCLUSIONS: The Xen shunt provides a reasonable alternative to current standard of care, with a similar failure rate at year 1, with a noninferior IOP reduction compared to GDD and CPC, and a preferred safety profile.

Comparison between the CASIA SS-1000 and Pentacam in measuring corneal curvatures and corneal thickness maps.

PURPOSE: To compare the intra-device repeatability and inter-device reproducibility between two anterior segment imaging instruments, the CASIA SS-1000 (Tomey Corp., Nagoya, Japan) and Pentacam (OCULUS, Arlington, WA) in measuring anterior segment parameters. METHODS: Single-center, prospective clinical trial. Participants ≥20 years of age were included. One eye was randomly selected, each imaged by three CASIA SS-1000 devices and three Pentacam devices by three different examiners. Each photographer operated a pair of devices, one CASIA SS-1000 and one Pentacam. The image order for each participant was determined by a random permutation table. Three images were taken from each device. A total of 18 images were taken for each eye. Ratios of the standard deviations, referenced as (CASIA/Pentacam), were calculated to compare the repeatability and reproducibility of the two imaging instruments. RESULTS: In all, 66 participants with a mean age of 46.4 years (±21.7) were enrolled in the study. All repeatability ratios and intra-device variability were less than 1 (anterior corneal curvature: flat = 0.86, steep = 0.85; posterior corneal curvature: flat = 0.43, steep = 0.61; and map: thinnest = 0.22; central = 0.24, 2 mm = 0.26, 4 mm = 0.27, and 6 mm = 0.30). All reproducibility ratios, which measure the inter-device variability, were less than 1 (anterior corneal curvature: flat = 0.58, steep = 0.73; posterior corneal curvature: flat = 0.25, steep = 0.31; and pachymetry map: thinnest = 0.20; central = 0.20; 2 mm = 0.20; 4 mm = 0.19; and 6 mm = 0.22). A ratio of less than 1 indicates that the CASIA SS-1000 has more consistent measurements. CONCLUSIONS: The CASIA SS-1000 was found to have better repeatability and reproducibility compared to the Pentacam for both corneal curvature and pachymetry maps. This greater consistency may require further study to determine whether the decreased variability can be translated into improved clinical results.

Genetic Architecture of Primary Open-Angle Glaucoma in Individuals of African Descent: The African Descent and Glaucoma Evaluation Study III.

PURPOSE: To find genetic contributions to glaucoma in African Americans. DESIGN: Cross-sectional, case-control study. PARTICIPANTS: One thousand eight hundred seventy-five primary open-angle glaucoma (POAG) patients and 1709 controls, self-identified as being of African descent (AD), from the African Descent and Glaucoma Evaluation Study (ADAGES) III and Wake Forest School of Medicine. METHODS: MegaChip genotypes were imputed to Thousand Genomes data. Association of single nucleotide polymorphisms (SNPs) with POAG and advanced POAG was tested by linear mixed model correcting for relatedness and population stratification. Genetic risk scores were tested by receiver operator characteristic curves (ROC-AUCs). MAIN OUTCOME MEASURES: Primary open-angle glaucoma defined by visual field loss without other nonocular conditions (n = 1875). Advanced POAG was defined by age-based mean deviation of visual field (n = 946). RESULTS: Eighteen million two hundred eighty-one thousand nine hundred twenty SNPs met imputation quality of r2 > 0.7 and minor allele frequency > 0.005. Association of a novel locus, EN04, was observed for advanced POAG (rs185815146 ß, 0.36; standard error, 0.065; P < 3×10-8). For POAG, an AD signal was observed at the 9p21 European descent (ED) POAG signal (rs79721419; P < 6.5×10-5) independent of the previously observed 9p21 ED signal (rs2383204; P < 2.3×10-5) by conditional analyses. An association with POAG in FNDC3B (rs111698934; P < 3.9×10-5) was observed, not in linkage disequilibrium (LD) with the previously reported ED SNP. Additional previously identified loci associated with POAG in persons of AD were: 8q22, AFAP1, and TMC01. An AUC of 0.62 was observed with an unweighted genetic risk score comprising 11 SNPs in candidate genes. Two additional risk scores were studied by using a penalized matrix decomposition with cross-validation; risk scores of 50 and 400 SNPs were identified with ROC of AUC = 0.74 and AUC = 0.94, respectively. CONCLUSIONS: A novel association with advanced POAG in the EN04 locus was identified putatively in persons of AD. In addition to this finding, this genome-wide association study in POAG patients of AD contributes to POAG genetics by identification of novel signals in prior loci (9p21), as well as advancing the fine mapping of regions because of shorter average LD (FNDC3B). Although not useful without confirmation and clinical trials, the use of genetic risk scores demonstrated that considerable AD-specific genetic information remains in these data.

Association of Genetic Variants With Primary Open-Angle Glaucoma Among Individuals With African Ancestry.

Importance: Primary open-angle glaucoma presents with increased prevalence and a higher degree of clinical severity in populations of African ancestry compared with European or Asian ancestry. Despite this, individuals of African ancestry remain understudied in genomic research for blinding disorders. Objectives: To perform a genome-wide association study (GWAS) of African ancestry populations and evaluate potential mechanisms of pathogenesis for loci associated with primary open-angle glaucoma. Design, Settings, and Participants: A 2-stage GWAS with a discovery data set of 2320 individuals with primary open-angle glaucoma and 2121 control individuals without primary open-angle glaucoma. The validation stage included an additional 6937 affected individuals and 14 917 unaffected individuals using multicenter clinic- and population-based participant recruitment approaches. Study participants were recruited from Ghana, Nigeria, South Africa, the United States, Tanzania, Britain, Cameroon, Saudi Arabia, Brazil, the Democratic Republic of the Congo, Morocco, Peru, and Mali from 2003 to 2018. Individuals with primary open-angle glaucoma had open iridocorneal angles and displayed glaucomatous optic neuropathy with visual field defects. Elevated intraocular pressure was not included in the case definition. Control individuals had no elevated intraocular pressure and no signs of glaucoma. Exposures: Genetic variants associated with primary open-angle glaucoma. Main Outcomes and Measures: Presence of primary open-angle glaucoma. Genome-wide significance was defined as P < 5 × 10-8 in the discovery stage and in the meta-analysis of combined discovery and validation data. Results: A total of 2320 individuals with primary open-angle glaucoma (mean [interquartile range] age, 64.6 [56-74] years; 1055 [45.5%] women) and 2121 individuals without primary open-angle glaucoma (mean [interquartile range] age, 63.4 [55-71] years; 1025 [48.3%] women) were included in the discovery GWAS. The GWAS discovery meta-analysis demonstrated association of variants at amyloid-ß A4 precursor protein-binding family B member 2 (APBB2; chromosome 4, rs59892895T>C) with primary open-angle glaucoma (odds ratio [OR], 1.32 [95% CI, 1.20-1.46]; P = 2 × 10-8). The association was validated in an analysis of an additional 6937 affected individuals and 14 917 unaffected individuals (OR, 1.15 [95% CI, 1.09-1.21]; P < .001). Each copy of the rs59892895*C risk allele was associated with increased risk of primary open-angle glaucoma when all data were included in a meta-analysis (OR, 1.19 [95% CI, 1.14-1.25]; P = 4 × 10-13). The rs59892895*C risk allele was present at appreciable frequency only in African ancestry populations. In contrast, the rs59892895*C risk allele had a frequency of less than 0.1% in individuals of European or Asian ancestry. Conclusions and Relevance: In this genome-wide association study, variants at the APBB2 locus demonstrated differential association with primary open-angle glaucoma by ancestry. If validated in additional populations this finding may have implications for risk assessment and therapeutic strategies.

Characterizing Anterior Segment OCT Angle Landmarks of the Trabecular Meshwork Complex.

PURPOSE: To identify the presence or absence of 3 identifiable landmarks: trabecular meshwork (TM), Schlemm's canal (SC), and a novel landmark termed the band of extracanalicular limbal lamina (BELL), which is a landmark adjacent to SC visible on anterior segment (AS) OCT. These landmarks also were analyzed pathologically to identify all 3 landmarks. DESIGN: Retrospective review. PARTICIPANTS: One eye per participant from prior institutional review board-approved studies in which AS OCT imaging was performed. METHODS: Horizontal images from 2-dimensional angle analysis scans using a CASIA SS-1000 (Tomey, Nagoya, Japan) AS OCT were evaluated by masked readers. Logistic regression was used to analyze the potential factors of age, gender, race, intraocular pressure, gonioscopy grade, angle location, and history or presence of surgery on the visibility of these structures. Pathologic correlation on 5 previously enucleated eyes also was performed. MAIN OUTCOME MEASURES: Presence or absence of angle landmarks-TM, SC, and BELL-using Anterior Chamber Analysis and Interpretation software (ACAI, Houston, TX). RESULTS: Three hundred three angles of 153 horizontal images were included in this study. The mean age was 51.5±16.0 years, with 98 women (64%) and 100 white persons (66%). The outer border of the BELL was observed in 288 angles (95%), TM was found in 220 angles (73%), and SC was seen in 120 angles (40%). The outer border of the BELL was more visible in white persons (P = 0.02) than Asians and in eyes with a Spaeth gonioscopy grade of E than those with a grade of A (P = 0.02). Both TM (P = 0.001) and SC (P = 0.001) were more visible in temporal angles (81% for TM, 49% for SC) than in nasal angles (64% for TM, 30% for SC). Additionally, SC was more visible in open angles (43%) than in narrow angles (27%; P = 0.02). These 3 structures were verified in a pathologic study. CONCLUSIONS: We identified a novel AS OCT landmark adjacent to SC. This structure also was identified on pathologic samples from enucleated eyes. Further study is needed to determine the pathophysiologic relevance of these findings.

Postoperative Complications of True Dropless Cataract Surgery versus Standard Topical Drops.

Purpose Compare postoperative outcomes in cataract surgery between eyes with standard drop regimen versus dropless protocol by residents. Design Retrospective cohort study between April 1, 2018 and March 31, 2020. Methods The study was performed at Lyndon B. Johnson General Hospital in Houston, Harris County, Texas. A total of 547 eyes (234 dropless vs. 313 standard) with phacoemulsification cataract surgery and minimum of 1-month follow-up with best-corrected visual acuity (BCVA) were included. Dropless received 40 mg sub-Tenon's triamcinolone and intracameral moxifloxacin. Patients were followed at postoperative day 1 (POD1), week 1 (POW1), and month 1 (POM1). Postoperative rate of BCVA better than 20/40 (Good vision) and rate of complications were compared between groups. Results Good vision on POM1 in dropless (77.8%) was noninferior to standard (75.1%, p = 0.80). Complication rate in dropless (28.6%) was noninferior to standard (24.0%, p = 0.13). Intraocular pressure (IOP) elevation on POD1 ( p = 0.041) and anterior chamber (AC) cells on POW1 and POM1 ( p < 0.001) were more frequent in dropless. Mean spherical equivalent at POM1 was better in dropless (-0.37 D [±0.81 D]) compared with standard (-0.61D [±0.77 D], p = 0.001). Early posterior capsular opacification (early PCO) was more frequent in dropless ( p = 0.042). Conclusions Postoperative rate of BCVA better than 20/40 and rate of postoperative complications were noninferior, although dropless had higher rates of AC inflammation, IOP elevation, and early PCO.

Direct Costs of Second Aqueous Shunt Implant Versus Transscleral Cyclophotocoagulation (The Assists Trial).

PRCIS: The cost of cyclophotocoagulation is less than the cost of a second glaucoma drainage device. PURPOSE: To compare the total direct costs of implantation of a second glaucoma drainage device (SGDD) with transscleral cyclophotocoagulation (CPC) for patients with inadequately controlled intraocular pressure (IOP) reduction, despite the presence of a preexisting glaucoma drainage device in the ASSISTS clinical trial. METHODS: We compared the total direct cost per patient, including the initial study procedure, medications, additional procedures, and clinic visits during the study period. The relative costs for each procedure during the 90-day global period and the entire study period were compared. The cost of the procedure, including facility fees and anesthesia costs, were determined using the 2021 Medicare fee schedule. Average wholesale prices for self-administered medications were obtained from AmerisourceBergen.com. The Wilcoxon rank sum test was used to compare costs between procedures. RESULTS: Forty-two eyes of 42 participants were randomized to SGDD (n=22) or CPC (n=20). One CPC eye was lost to follow-up after initial treatment and was excluded. The mean (±SD, median) duration of follow-up was 17.1 (±12.8, 11.7) months and 20.3 (±11.4, 15.1) months for SGDD and CPC, respectively ( P =0.42, 2 sample t test). The mean total direct costs (±SD, median) per patient during the study period were $8790 (±$3421, $6805 for the SGDD group) and $4090 (±$1424, $3566) for the CPC group ( P <0.001). Similarly, the global period cost was higher in the SGDD group than in the CPC group [$6173 (±$830, $5861) vs. $2569 (±$652, $2628); P <0.001]. The monthly cost after the 90-day global period was $215 (±$314, $100) for SGDD and $103 (±$74, $86) for CPC ( P =0.31). The cost of IOP-lowering medications was not significantly different between groups during the global period ( P =0.19) or after the global period ( P =0.23). CONCLUSION: The total direct cost in the SGDD group was more than double that in the CPC group, driven largely by the cost of the study procedure. The costs of IOP-lowering medications were not significantly different between groups. When considering treatment options for patients with a failed primary GDD, clinicians should be aware of differences in costs between these treatment strategies.

Glaucoma Progression Analysis software compared with expert consensus opinion in the detection of visual field progression in glaucoma.

PURPOSE: To compare the results of Glaucoma Progression Analysis (GPA, Carl Zeiss Meditec, Dublin, CA) to subjective expert consensus in the detection of glaucomatous visual field progression. DESIGN: Retrospective, observational case series. PARTICIPANTS: We included 100 eyes of 83 glaucoma patients. METHODS: Five serial Humphrey visual fields from 100 eyes of 83 glaucoma patients were evaluated by 5 masked glaucoma subspecialists for determination of progression. Four months later, with a randomly reordered patient sequence, the same visual field series were reevaluated by the same graders, at which time they had access to the Glaucoma Progression Analysis (GPA) printout. MAIN OUTCOME MEASURES: The level of agreement between majority expert consensus and GPA, both before and after access to GPA data, was assessed using kappa statistics. RESULTS: On initial review and on reevaluation with access to the GPA printout, the level of agreement between majority expert consensus and GPA was fair (kappa = 0.52, 95% confidence interval [CI], 0.35-0.69 and kappa = 0.62; 95% CI, 0.46-0.78, respectively). Expert consensus was more likely to classify a series of fields as showing progression than was GPA (P ≤ 0.002). There was good agreement between expert consensus on initial review and reevaluation 4 months later (kappa = 0.77; 95% CI, 0.65-0.90). CONCLUSIONS: The level of agreement between majority expert consensus of subjective determination of visual field progression and GPA is fair. In cases of disagreement with GPA, the expert consensus classification was usually progression. Access to the results of GPA did not significantly change the level of agreement between expert consensus and the GPA result; however, expert consensus did change in 11 of 100 cases.

Outcomes of the Second Aqueous Shunt Implant Versus Transscleral Cyclophotocoagulation Treatment Study: A Randomized Comparative Trial.

PRCIS: Short-term overall success rates were high with either SGDD or CPC. However, SGDD was associated with more clinic visits and an increased risk of additional glaucoma surgery. Both treatments were reasonable options for eyes with inadequately controlled IOP after a single GDD. PURPOSE: The purpose of this study is to compare the implantation of a second glaucoma drainage device (SGDD) and transscleral cyclophotocoagulation (CPC) in eyes with inadequately controlled intraocular pressure (IOP), despite the presence of a preexisting glaucoma drainage device. METHODS: Patients with inadequately controlled IOP, despite the medical therapy and a preexisting glaucoma drainage device, were enrolled at 14 clinical centers and randomly assigned to treatment with a SGDD or CPC. MAIN OUTCOME MEASURES: Surgical failure was defined as: (1) IOP ≤5 mm Hg or >18 mm Hg or <20% reduction below baseline on maximum tolerated topical ocular hypotensive therapy, (2) reoperation for glaucoma, or (3) loss of light perception. The primary outcome measure was overall success with or without adjunctive medical therapy. RESULTS: Forty-two eyes of 42 participants were randomized to SGDD (n=22) or CPC (n=20). Mean duration of follow-up was 18.6 (±12.1; range: 1.1-38.6) months. The cumulative success rate was 79% for SGDD and 88% for CPC at 1 year ( P =0.63). Although the study was underpowered, no significant differences in IOP, postoperative number of IOP-lowering medications, or adverse events were observed. The number of additional glaucoma surgeries ( P =0.003), office visits during the first 3 months ( P <0.001), and office visits per month after month 3 ( P <0.001) were greater in the SGDD group. CONCLUSIONS: Short-term overall success rates were high with either SGDD or CPC. However, SGDD was associated with more clinic visits and an increased risk of additional glaucoma surgery.

Interobserver agreement and intraobserver reproducibility of the subjective determination of glaucomatous visual field progression.

PURPOSE: To determine the extent of interobserver agreement and intraobserver reproducibility of the subjective determination of visual field progression with achromatic automated static perimetry in eyes with glaucoma, and to determine the impact of access to Glaucoma Progression Analysis (GPA) data on interobserver agreement. DESIGN: Retrospective, observational case series. PARTICIPANTS: Five glaucoma subspecialists from 5 different academic medical centers. METHODS: Five visual field tests from each of 100 eyes of 83 patients being monitored for glaucoma were retrospectively identified and subjectively and independently evaluated by the 5 glaucoma subspecialists. Each set of visual fields was classified regarding progression as "none," "questionable," "probable," or "definite." More than 1 month later, the same expert observers reevaluated the same sets of visual field tests to allow determination of intraobserver reproducibility. A final subjective evaluation regarding progression was performed 3 months later, at which time the expert observers had access to the GPA printout. MAIN OUTCOME MEASURES: The level of interobserver agreement and intraobserver reproducibility was estimated using kappa statistics on the raw classification data and also on dichotomized data in which "none" and "questionable" progression were reclassified together as nonprogressed and " probable" and "definite" were reclassified as progressed. RESULTS: Intraobserver reproducibility was good to excellent (kappa = 0.62-0.78) for the raw data and moderate to good (kappa = 0.58-0.71) for the dichotomized data. Interobserver agreement was moderate (kappa = 0.45; 95% confidence interval [CI], 0.35-0.55) for the raw classification data and also for dichotomized data (kappa = 0.55; 95% CI, 0.46-0.64). Access to the GPA printout did not significantly change the level of interobserver agreement. CONCLUSIONS: Five glaucoma experts had good to excellent reproducibility of the determination of visual field progression compared with earlier evaluation of the same field sets. Agreement among the experts with each other was only moderate, and did not improve when each had access to GPA results. .

Comparing the Effect of Lens Extraction With Endocycloplasty to Lens Extraction Alone in Eyes With Plateau Iris Configuration: Pilot Study.

PRECIS: Lens extraction with endocycloplasty (LE/ECPL) results in greater angle deepening than LE alone in plateau iris eyes. This study directly compares an LE/ECPL treatment group with a control group. PURPOSE: Quantitatively determine the effect of LE/ECPL versus LE alone for eyes with plateau iris configuration/plateau iris syndrome (PIC/PIS) on angle parameters. METHODS: Patients with PIC/PIS who underwent LE/ECPL or LE alone were reviewed. Eyes with ultrasound biomicroscopy-documented PIC that underwent anterior segment optical coherence tomography examination before and after treatment were included. Angle parameters, angle opening distance (AOD), trabecular-iris space area (TISA), and trabecular-iris circumference volume (TICV) were calculated. Angle parameters were compared between treatments using a 2-sample t test. P-values were adjusted by the false discovery rate method (P*). A paired t test was used to compare treated (nasal) and untreated (temporal) angles in LE/ECPL-treated eyes. RESULTS: Twenty-three eyes of 14 participants were included. Ten eyes (43%) eyes of 7 participants were treated with LE/ECPL, and 13 eyes (57%) of 7 participants were treated with LE alone. Angles were deepened in both groups (P<0.001). Changes in AOD, TISA, and TICV showed that the magnitude of deepening in treated (nasal) quadrants was greater in LE/ECPL eyes than in LE alone eyes (P<0.05). ECPL-treated angles deepened more than the untreated angles by AOD, TISA, and TICV (P<0.002). CONCLUSION: Our study suggests that LE/ECPL is more effective than LE alone in opening the anterior chamber angle and that ECPL deepens treated angles more than untreated angles. This study directly compares an LE/ECPL treatment group with a control group, LE alone, allowing for separation of the effect of ECPL from LE.

Determining Risk Factors That Affect Progression in Patients with Nonproliferative Diabetic Retinopathy.

PURPOSE: To determine risk factors that affect nonproliferative diabetic retinopathy (NPDR) progression and establish a predictive model to estimate the probability of and time to progression in NPDR. Patients and Methods. Charts of diabetic patients who received an initial eye exam between 2010 and 2017 at our county hospital were included. Patients with proliferative diabetic retinopathy (PDR), fewer than 2 years of follow-up, or fewer than 3 clinic visits were excluded. Demographics and baseline systemic and ocular characteristics were recorded. Follow-up mean annual HbA1c and blood pressure, best-corrected visual acuity, and the number of antivascular endothelial growth factor treatments were recorded. Stage and date of progression were recorded. A 5-state nonhomogeneous continuous-time Markov chain with a backward elimination model was used to identify risk factors and estimate their effects on progression. RESULTS: Two hundred thirty patients were included. Initially, 65 eyes (28.3%) had no retinopathy; 73 (31.7%) mild NPDR; 60 (26.1%) moderate NPDR; and 32 (13.9%) severe NPDR. Patients were followed for a mean of 5.8 years (±2.0 years; range 2.1-9.4 years). 164 (71.3%) eyes progressed during the follow-up. Time-independent risk factors affecting progression rate were age (hazard ratio (HR) = 0.99, P=0.047), duration of diabetes (HR = 1.02, P=0.018), and Hispanic ethnicity (HR = 1.31, P=0.068). Mean sojourn times at mean age, duration of diabetes, and annual HbA1c for a non-Hispanic patient were estimated to be 3.03 (±0.97), 4.63 (±1.21), 6.18 (±1.45), and 4.85 (±1.25) years for no retinopathy, mild NPDR, moderate NPDR, and severe NPDR, respectively. Each 1% increase in HbA1c annually diminished sojourn times by 15%, 10%, 7%, and 10% for no retinopathy, mild NPDR, moderate NPDR, and severe NPDR, respectively. CONCLUSION: HbA1c level is a significant modifiable risk factor in controlling the progression of DR. The proposed model could be used to predict the time and rate of progression based on an individual's risk factors. A prospective multicenter study should be conducted to further validate our model.

Current Knowledge and Attitudes Concerning Cost-Effectiveness in Glaucoma Pharmacotherapy: A Glaucoma Specialists Focus Group Study.

BACKGROUND: Rising healthcare costs motivate continued cost-reduction efforts. To help lower costs associated with open-angle glaucoma (OAG), a prevalent, progressive disease with substantial direct and indirect costs, clinicians need to understand the cost-effectiveness of intraocular pressure (IOP)-lowering pharmacotherapies. There is little published information on clinicians' knowledge and attitudes about cost-effectiveness in glaucoma treatment. PURPOSE: This pilot focus group study aimed to explore clinician attitudes and perspectives around the costs and cost drivers of glaucoma therapy; the implementation of cost-effectiveness decisions; the clinical utility of cost-effectiveness studies; and the cost-effectiveness of available treatments. METHODS: Six US glaucoma specialists participated in two separate teleconferencing sessions (three participants each), managed by an independent, skilled moderator (also a glaucoma specialist) using a discussion guide. Participants reviewed recent publications (n=25) on health economics outcomes research in glaucoma prior to the sessions. RESULTS: Participants demonstrated a clear understanding of the economic burden of glaucoma therapy and identified medications, diagnostics, office visits, and treatment changes as key cost drivers. They considered cost-effectiveness an appropriate component of treatment decision-making but identified the need for additional data to inform these decisions. Participants indicated that there were only a few recent studies on health economics outcomes in glaucoma which evaluate parameters important to patient care, such as quality of life and medication adherence, and that longitudinal data were scant. In addition to efficacy, participants felt patient adherence and side-effect profile should be included in economic evaluations of glaucoma pharmacotherapy. Recently approved medications were evaluated in this context. CONCLUSION: Clinicians deem treatment decisions based on cost-effectiveness data as clinically appropriate. Newer IOP-lowering therapies with potentially greater efficacy and favorable side-effect and adherence profiles may help optimize cost-effectiveness. Future studies should include: clinicians' perspectives; lack of commercial bias; analysis of long-term outcomes/costs; more comprehensive parameters; real-world (including quality-of-life) data; and a robust Markov model.

Using Anterior Segment Optical Coherence Tomography (ASOCT) Parameters to Determine Pupillary Block Versus Plateau Iris Configuration.

PRéCIS:: The potential parameters for differentiating pupillary block (PB) from plateau iris configuration (PIC) on anterior segment optical coherence tomography (ASOCT) are lens/pupil size parameters and angles. Further study is needed to determine a landmark peripheral to the centroid of the iris. PURPOSE: Investigate anterior segment parameters to distinguish between 2 mechanisms of angle closure, PB and PIC, using swept-source Fourier domain ASOCT. PATIENTS AND METHODS: Retrospective ASOCT images from narrow angle eyes were reviewed. PIC was defined either by ultrasound biomicroscopy and/or clinically when an iridoplasty was performed. Images were read by a masked reader using Anterior Chamber Analysis and Interpretation software to identify scleral spur landmarks and calculate anterior chamber, peripheral angle, iris size, iris shape, and lens/pupil size parameters. ASOCT parameters were summarized and compared using the 2-sample t test. Thresholds and area under receiver operating characteristic curve were calculated using logistic regression analysis. RESULTS: One hundred eyes (66 PB and 34 PIC) of 100 participants were reviewed. Of all ASOCT parameters, iris length in each quadrant, pupil arc, lens/pupil parameters (pupil arc, lens vault, and pupil diameter), all pupillary margin-center point-scleral spur landmark (PM-C-SSL) parameters, and all except superior central iris vault parameters were significantly different between PB and PIC. On threshold evaluation, lens/pupil parameters had the greatest area under receiver operating characteristic curve values (0.77 to 0.80), followed by PM-C-SSL angles (0.71 to 0.75). CONCLUSIONS: We propose that the pupil size parameters and PM-C-SSL angle are the most reliable novel ASOCT parameters to distinguish between PB and PIC eyes. These parameters do not rely on the visibility of the posterior iris surface, which is difficult to identify with ASOCT, but may be ambient lighting dependent.

New technology for examining the anterior segment by ultrasonic biomicroscopy.

PURPOSE: To compare the comfort levels and measurement accuracy of the open-shell technique and a bag/balloon technology (ClearScan, ESI) in anterior segment ultrasound biomicroscopy. SETTING: Department of Ophthalmology and Visual Science, Robert Cizik Eye Clinic, University of Texas Medical School at Houston, Houston, Texas, USA. METHODS: In this prospective investigation, 20 subjects stated their preference and rated comfort (0 best to 5 worst) for the open-shell technique versus the bag/balloon technology. Three anterior chamber depth and sulcus-to-sulcus measurements were obtained, and the mean for each structure was taken as datum for each subject. Order presentation between the 2 methods was randomized. Pairwise t tests and linear regression analysis were used to determine statistical differences. RESULTS: One hundred percent of the cohort preferred the bag/balloon technology to the traditional open-shell technique. The mean comfort score was 0.40 +/- 0.53 (SD) and 2.95 +/- 0.90, respectively (P<.0001). Anterior chamber depth measurements did not differ clinically (0.056 mm) nor did sulcus-to-sulcus determinations (0.039 mm). CONCLUSION: Biometry, patient comfort, and ease of use were better with the ClearScan bag/balloon technology than with the traditional open-shell technique.

Comparison of the ocular hypotensive efficacy of adjunctive brimonidine 0.15% or brinzolamide 1% in combination with travoprost 0.004%.

PURPOSE: To compare efficacies of adjunctive therapy with brimonidine 0.15% and adjunctive therapy with brinzolamide 1% in combination with travoprost 0.004%. DESIGN: Three-month randomized, parallel-group, double-masked, multicenter clinical trial. PARTICIPANTS: Patients with primary open-angle glaucoma, exfoliation glaucoma, or ocular hypertension with intraocular pressure (IOP) > 18 mmHg on monotherapy with travoprost (N = 163). METHODS: Patients were randomized to receive adjunctive therapy with twice-daily brimonidine (N = 79) or twice-daily brinzolamide (N = 84). Treatment efficacy was assessed after 1 and 3 months of combination therapy. Intraocular pressure was measured at 8 am, noon, and 4 pm at baseline (on travoprost monotherapy) and after 3 months of combination therapy. Mean diurnal IOP was defined as the average of the IOP measurements at these 3 time points. Adverse events were recorded at each visit. MAIN OUTCOME MEASURE: Difference between treatment groups in mean diurnal IOP at month 3, adjusted for difference in baseline IOP, using analysis of covariance. RESULTS: Mean diurnal IOPs (+/- standard error of the mean) at baseline were 21.7+/-0.33 mmHg in the brimonidine group and 21.1+/-0.29 mmHg in the brinzolamide group (P = 0.16). Mean diurnal IOPs at month 3 were 19.6+/-0.41 mmHg in the brimonidine group and 18.4+/-0.33 mm Hg in the brinzolamide group (P = 0.019). At month 3, mean diurnal IOPs, adjusted for difference in baseline IOP, were 19.3+/-0.27 in the brimonidine group and 18.6+/-0.25 in the brinzolamide group (P = 0.035). CONCLUSIONS: The combination of travoprost and brinzolamide was statistically significantly more efficacious than the combination of travoprost and brimonidine in lowering IOP. The clinical significance of this difference is uncertain.

Examiner Handedness and the Effects on Intraocular Pressure Readings Using the Tono-Pen XL.

PURPOSE: To assess the effect of examiner handedness on intraocular pressure (IOP) readings using the Tono-Pen XL in eyes without corneal pathology or previous ocular surgeries. PATIENTS AND METHODS: Patients 18 years of age or older were included in this prospective study. Participants who had a history of corneal conditions or other characteristics that would prevent reliable IOP measurements were excluded. Five experienced examiners, 2 right-hand dominant and 3 left-hand dominant, took bilateral IOP measurements with a Tono-Pen XL. Each participant was tested by 2 examiners, 1 left-handed and 1 right-handed, in a random order. The time between each examiner's measurements was 15 minutes. A paired t test was used to compare IOP differences between "near" (right eye for right-hand or left eye for left-hand dominant examiner) and "far" (right eye by left-hand or left eye by right-hand dominant examiner) measurements for each eye. RESULTS: Forty-six participants with a mean age of 33.8 years (±12.8) were enrolled. No significant difference in IOP between near and far eyes was found (IOP difference=IOPfar-IOPnear=-0.11 [±2.74] mm Hg; P=0.70). Right-hand dominant examiners consistently measured significantly higher IOP (0.83±2.03 mm Hg; P=0.008) compared with left-hand dominant examiners, regardless of the relative position of the eye with respect to the examiner. CONCLUSIONS: The results suggest that IOP readings are not influenced by the positioning of the patient relative to the dominant hand of the examiner.

Long-term Outcome of Argon Laser Peripheral Iridoplasty in the Management of Plateau Iris Syndrome Eyes.

PURPOSE: To report long-term (>5 y) outcomes of plateau iris syndrome patients treated with argon laser peripheral iridoplasty (ALPI). PATIENTS AND METHODS: A retrospective chart review was performed on all patients with plateau iris syndrome treated with ALPI from 1996 to 2007. The study included 22 eyes from 22 patients with plateau iris after peripheral iridotomy that were followed for at least 1 year after ALPI. The primary outcome was incidence of needing any intraocular pressure (IOP)-lowering medications or surgery (either a filtering procedure or phacoemulsification). Demographic and baseline clinical data were summarized by mean (±SD) or frequency (percentage). Snellen best-corrected visual acuity was converted to logMAR. The paired t test was used to compare IOP changes, number of IOP-lowering medications, and best-corrected visual acuity from baseline to annual follow-up. RESULTS: Mean follow-up was 76 months. Only 2 (9%) eyes maintained an IOP<21 mm Hg without requiring medication or surgery. Seventeen (77%) eyes underwent surgery at an average of 49.1±7.9 months after ALPI. Eight (36%) eyes underwent filtering surgery, and 9 (41%) eyes underwent phacoemulsification. Three months after cataract extraction, no eyes required IOP-lowering medication. CONCLUSIONS: The beneficial effects of ALPI last for <4 years, with the majority of patients (77%) requiring surgery. Phacoemulsification alone was a successful treatment for plateau iris in our patient population.

Surgical repair of large cyclodialysis clefts.

PURPOSE: To describe a new surgical technique to effectively close large (>180 degrees) cyclodialysis clefts. METHODS: Our method involves the use of procedures commonly associated with repair of retinal detachment and complex cataract extraction: phacoemulsification with placement of a capsular tension ring followed by pars plana vitrectomy and gas tamponade with light cryotherapy. We also used anterior segment optical coherence tomography (OCT) as a noninvasive mechanism to determine the extent of the clefts and compared those results with ultrasound biomicroscopy (UBM) and gonioscopy. RESULTS: This technique was used to repair large cyclodialysis clefts in 4 eyes. All 4 eyes had resolution of hypotony and improvement of visual acuity. One patient had an intraocular pressure spike requiring further surgical intervention. Anterior segment OCT imaging in all 4 patients showed a more extensive cleft than UBM or gonioscopy. CONCLUSIONS: This technique is effective in repairing large cyclodialysis clefts. Anterior segment OCT more accurately predicted the extent of each cleft, while UBM and gonioscopy both underestimated the size of the cleft.

Comparison of Efficacy and Complications of Cyclophotocoagulation and Second Glaucoma Drainage Device After Initial Glaucoma Drainage Device Failure.

PURPOSE: Compare intraocular pressure (IOP) control and complication rates of a second glaucoma drainage device (GDD) to diode transscleral cyclophotocoagulation (TSCPC) following failure of an initial GDD. PATIENTS AND METHODS: Eyes with 1 GDD that required a second GDD or TSCPC for glaucoma control were included. Exclusion criteria were a cyclodestructive procedure before initial GDD, no light perception vision, or follow-up <1 year. Failure was defined as ≥1 of (1) reoperation for lowering IOP; (2) explantation of second GDD; (3) persistent hypotony; (4) use of oral carbonic anhydrase inhibitor for lowering IOP in the study eye; or (5) loss of light perception. Reoperation for lowering IOP included additional GDD implantation or additional cyclodestruction, except if additional cyclodestruction was within 6 months of the initial session. RESULTS: A total of 75 eyes (35 in second GDD; 40 in TSCPC) were included (mean follow-up, 25.5 mo). Both procedures lowered IOP [-11.4 mm Hg (±13.6) for second GDD and -7.8 mm Hg (±11.8) for TSCPC groups] and decreased the number of IOP-lowering medications at the last visit. The second GDD group had significantly greater mean survival time [45.0 mo (±4.2)] than the TSCPC group [26.5 mo (±2.8)] but significantly more postoperative complications (60% of eyes) and non-IOP-related procedures (40% of eyes) than the TSCPC group (20% for postoperative complications and 18% for non-IOP-related procedures). CONCLUSIONS: Although both second procedures are efficacious in lowering IOP and number of IOP-lowering medications, TSCPC failed earlier, whereas a second GDD had significantly more complications.