Minimally Invasive Bleb Surgery for Glaucoma: A Health Technology Assessment.

Background: Glaucoma is the term for a group of eye disorders that causes progressive damage to the optic nerve, which can lead to visual impairment and, potentially, irreversible blindness. Minimally invasive bleb surgery (MIBS) reduces eye pressure through the implantation of a device that creates a new subconjunctival outflow pathway for eye fluid drainage. MIBS is a less invasive alternative to conventional/incisional glaucoma surgery (e.g., trabeculectomy). We conducted a health technology assessment of MIBS for people with glaucoma, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MIBS, and patient preferences and values. Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias 1.0 tool for randomized controlled trials (RCTs) and the Risk of Bias Assessment tool for Nonrandomized Studies (RoBANS) for comparative observational studies, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We conducted an economic literature search and we estimated the budget impact of publicly funding MIBS in Ontario. We did not conduct a primary economic evaluation due to the limited long-term effectiveness data. We summarized the preferences and values evidence from previous health technology assessments to understand the perspectives and experiences of patients with glaucoma. Results: We included 41 studies (2 RCTs and 39 comparative observational studies) in the clinical evidence review. MIBS may reduce intraocular pressure and the number of medications used, but we are uncertain if MIBS results in outcomes similar to trabeculectomy (GRADE: Moderate to Very low). Compared with trabeculectomy, MIBS may result in fewer follow-up visits and interventions, and adverse events (GRADE: Moderate to Very Low). MIBS may also reduce intraocular pressure and the number of antiglaucoma medications used, compared with other glaucoma treatments, but the evidence is uncertain (GRADE: Very low). Our economic evidence review identified two directly applicable studies. The results of these studies indicate that the cost-effectiveness of MIBS is highly uncertain, and the cost of glaucoma interventions are likely to vary across provinces. The annual budget impact of publicly funding MIBS in Ontario ranged from $0.11 million in year 1 to $0.67 million in year 5, for a total 5-year budget impact estimate of $1.93 million. Preferences and values evidence suggests that fear of ultimate blindness and difficulty managing medication for glaucoma led patients to explore other treatment options such as MIBS. Glaucoma patients found minimally invasive glaucoma surgery (MIGS) procedure beneficial, with minimal side effects and recovery time. Conclusions: Minimally invasive bleb surgery reduces intraocular eye pressure and the number of antiglaucoma medications needed, but we are uncertain if the outcomes are similar to trabeculectomy (GRADE: Moderate to Very low). However, MIBS may be safer than trabeculectomy (GRADE: Moderate to Very low) and result in fewer follow-ups (GRADE: Moderate to Very low). MIBS may also improve glaucoma symptoms compared with other glaucoma treatments, but the evidence is very uncertain (GRADE: Very low).We estimate that publicly funding MIBS would result in an additional cost of $1.93 million over 5 years. Patients who underwent MIGS procedures found them to be generally successful and beneficial, with minimal side effects and recovery time. We could not draw conclusions about specific MIBS procedures or long-term outcomes.

Impact of the Coronavirus Disease 2019 Pandemic on Surgical Volumes Among Fellowship-Trained Glaucoma Subspecialists.

PRCIS: The change in glaucoma surgical volumes due to the coronavirus disease 2019 pandemic was not uniform across procedure types and was unequal between rural and urban practice locations. PURPOSE: To quantify the impact of the coronavirus disease 2019 pandemic on surgical volumes performed by fellowship-trained glaucoma subspecialists. MATERIALS AND METHODS: This retrospective cohort analysis of the Centers for Medicare and Medicaid Services Medicare Public Use File extracted all glaucoma surgeries, including microinvasive glaucoma surgeries (MIGSs), trabeculectomy, goniotomy, lasers, and cataract surgery, performed by fellowship-trained glaucoma surgeons in rural and urban areas between 2016 and 2020. Predicted estimates of 2020 surgical volumes were created utilizing linear squares regression. Percentage change between predicted and observed 2020 surgical volume estimates was analyzed. Statistical significance was achieved at P <0.05. RESULTS: In 2020, fellowship-trained glaucoma surgeons operated mostly in urban areas (N = 810, 95%). A 29% and 31% decrease in predicted cataract surgery volumes in urban and rural areas, respectively, was observed. Glaucoma surgeries experienced a 36% decrease from predicted estimates (N = 56,781). MIGS experienced an 86% and 75% decrease in rural and urban areas, respectively. Trabeculectomy in rural areas experienced a 16% increase relative to predicted estimates while urban areas experienced a decrease of 3% ( P > 0.05). The number of goniotomies decreased by 10% more in rural areas than in urban areas (-22% and -12%, respectively). Laser procedures decreased by 8% more in urban areas than in rural areas (-18% and -10%, respectively). CONCLUSIONS: Among glaucoma-trained surgeons, glaucoma surgeries experienced a greater volume loss than cataract surgeries. In urban US areas, relative reductions in MIGS and goniotomy volumes in urban areas may have been compensated by greater laser and trabeculectomy volumes. Trabeculectomies in rural areas were the only group exceeding predicted estimates. Glaucoma subspecialists may utilize these findings when planning for future events and in overcoming any remaining unmet need in terms of glaucoma care.

Aqueous Shunts with Extraocular Reservoir for Open-Angle Adult Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To evaluate the recently published literature on the efficacy and safety of the use of aqueous shunts with extraocular reservoir for the management of adult open-angle glaucomas (OAGs). METHODS: A search of peer-reviewed literature was last conducted in April 2023 of the PubMed database and included only articles published since the last aqueous shunt Ophthalmic Technology Assessment, which assessed articles published before 2008. The abstracts of these 419 articles were examined, and 58 studies were selected for full-text analysis. After inclusion and exclusion criteria were applied, 28 articles were selected and assigned ratings by the panel methodologist according to the level of evidence. Twenty-five articles were rated level I and 3 articles were rated level II. There were no level III articles. RESULTS: Implantation of aqueous shunts with extraocular reservoir can lower intraocular pressure (IOP) by between one-third and one-half of baseline IOP, depending on whether it is undertaken as the primary or secondary glaucoma surgery. Success rates for aqueous shunts were found to be better than for trabeculectomies in eyes with prior incisional surgery. Conversely, in eyes without prior incisional surgery, implantation of aqueous shunts was found to have an overall lower success rate as the primary glaucoma procedure compared with trabeculectomy. Although both valved and nonvalved aqueous shunts with extraocular reservoir were effective, the nonvalved device generally achieved slightly lower long-term IOPs with fewer glaucoma medications and less need for additional glaucoma surgery. Both devices slow the rates of visual field progression with efficacy comparable with that of trabeculectomy. Early aqueous humor suppression after aqueous shunt implantation is recommended for the management of the postoperative hypertensive phase and long-term IOP control. No strong evidence supports the routine use of mitomycin C with aqueous shunt implantation for OAG. CONCLUSIONS: Implantation of aqueous shunts with extraocular reservoir, including valved or nonvalved devices, has been shown to be an effective strategy to lower IOP. Strong level I evidence supports the use of aqueous shunts with extraocular reservoir by clinicians for the management of adult OAG. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Selective Laser Trabeculoplasty for the Treatment of Glaucoma: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the current published literature for high-quality studies on the use of selective laser trabeculoplasty (SLT) for the treatment of glaucoma. This is an update of the Ophthalmic Technology Assessment titled, "Laser Trabeculoplasty for Open-Angle Glaucoma," published in November 2011. METHODS: Literature searches in the PubMed database in March 2020, September 2021, August 2022, and March 2023 yielded 110 articles. The abstracts of these articles were examined to include those written since November 2011 and to exclude reviews and non-English articles. The panel reviewed 47 articles in full text, and 30 were found to fit the inclusion criteria. The panel methodologist assigned a level I rating to 19 studies and a level II rating to 11 studies. RESULTS: Data in the level I studies support the long-term effectiveness of SLT as primary treatment or as a supplemental therapy to glaucoma medications for patients with open-angle glaucoma. Several level I studies also found that SLT and argon laser trabeculoplasty (ALT) are equivalent in terms of safety and long-term efficacy. Level I evidence indicates that perioperative corticosteroid and nonsteroidal anti-inflammatory drug eye drops do not hinder the intraocular pressure (IOP)-lowering effect of SLT treatment. The impact of these eye drops on lowering IOP differed in various studies. No level I or II studies exist that determine the ideal power settings for SLT. CONCLUSIONS: Based on level I evidence, SLT is an effective long-term option for the treatment of open-angle glaucoma and is equivalent to ALT. It can be used as either a primary intervention, a replacement for medication, or an additional therapy with glaucoma medications. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Cost-utility analysis of commonly used anti-glaucoma interventions for mild-to-moderate primary open-angle glaucoma patients in rural and urban China.

OBJECTIVE: An increasing number of studies have explored the clinical effects of antiglaucoma surgical procedures; however, economic evidence was scarce. We aimed to compare the cost-effectiveness between maximal medical treatment (MMT) and commonly used surgical procedures (trabeculectomy, Ahmed glaucoma valve implantation, gonioscopy-assisted transluminal trabeculotomy and ab interno canaloplasty). DESIGN AND SETTING: A Markov model study. PARTICIPANTS: A hypothetical cohort of 100 000 patients with mild-to-moderate primary open-angle glaucoma (POAG). OUTCOMES: Data were obtained from public sources. The main outcomes were incremental cost-utility ratios (ICURs) using quality-adjusted life-years (QALYs). Sensitivity analyses were conducted to verify the robustness and sensitivity of base-case results. MAIN RESULTS: Both cumulative costs and QALYs gained from surgical procedures (US$6045-US$13 598, 3.33-6.05 QALYs) were higher than those from MMT (US$3117-US$6458, 3.14-5.66 QALYs). Compared with MMT, all surgical procedures satisfied the cost-effectiveness threshold (lower than US$30 501 and US$41 568 per QALY gained in rural and urban settings, respectively). During the 5-year period, trabeculectomy produced the lowest ICUR (US$21 462 and US$15 242 per QALY gained in rural and urban settings, respectively). During the 10-year-follow-up, trabeculectomy still produced the lowest ICUR (US$13 379 per QALY gained) in urban setting; however, gonioscopy-assisted transluminal trabeculotomy (US$19 619 per QALY gained) and ab interno canaloplasty (US$18 003 per QALY gained) produced lower ICURs than trabeculectomy (US$19 675 per QALY gained) in rural areas. Base-case results were most sensitive to the utilities and costs of initial treatment and maintenance. CONCLUSIONS: The long-term cost-effectiveness of commonly used surgical procedures could be better than the short-term cost-effectiveness for mild-to-moderate POAG patients in China. Health economic studies, supported by more rigorous structured real-world data, are needed to assess their everyday cost-effectiveness.

Multi-Quantitative Assessment of AS-OCTA Complemented AS-OCT for Monitoring Filtering Bleb Function After Trabeculectomy.

Purpose: The purpose of this study was to explore a quantitative grading system of the filtering bleb combined anterior segment optical coherence tomography angiography (AS-OCTA) vascular features and optical coherence tomography (OCT) morphological features. Methods: One hundred three eyes of 103 patients diagnosed with primary open-angle glaucoma and undergone trabeculectomy over 6 months were divided into success and failure groups according to postoperative intraocular pressure (IOP) level. Vessel density (VD) and vessel diameter index (VDI) were examined by AS-OCTA. Bleb's morphology, including bleb height (BH), and microcyst-structure (MCS) were detected by AS-OCT. Multi-vascular model score (MVMS) was calculated by comprehensive factor analysis, and the comprehensive grading system (MVMS-MCS-BH) was analyzed by linear regression. The efficiency our method was verified by receiver operating characteristic (ROC) analysis. Results: The VD and VDI were higher in the failure group and closely related to post-trabeculectomy IOP (all P = 0.000). The MVMS was mostly consisted of VD in all regions, and VDIs of nasal, central, and temporal positions in sequence. MVMS ≥0, BH <1.33, and non-MCS were significantly associated with IOP increasing (coefficient = -3.23, -3.69, and 8.10, all P = 0.000). MVMS-BH-MCS got a higher area under curve (AUC), sensitivity, and specificity (0.92, 100%, and 80.30%) than the slit-lamp method (0.62, 72.20%, and 46.43%, respectively). Conclusions: The quantitative vascular characteristics detected by AS-OCTA were significant for the bleb monitor. The MVMS-BH-MCS grading system had achieved outstanding accuracy in reflecting the surgical results. Translational Relevance: The multi-vascular biomarker and comprehensive evaluation combined vascular and morphological parameters yield useful information on surgical outcomes, and help ophthalmologists to monitor patients effectively.

Practice patterns and costs of glaucoma treatment in Japan.

PURPOSE: Understanding the practice patterns and costs of glaucoma care in real-world clinical settings is important for optimizing medical expenses. However, glaucoma treatment trends and associated costs in Japan are unknown. We aimed to unveil glaucoma treatment trends and costs using a large administrative claims database in Japan. STUDY DESIGN: Retrospective cohort study. METHODS: We included patients diagnosed with glaucoma between April 2014 and March 2021 using the DeSC database. We calculated the frequencies and costs of antiglaucoma eyedrops, incisional or laser procedures, and ophthalmic examinations stratified by fiscal year and age. In the year-by-year analyses, the age distribution was standardized based on the 2020 distribution. RESULTS: A total of 841,747 patient-years (429,051 patients) were included. The number of prescribed eyedrops significantly increased and the fixed-combination eyedrops proportion decreased with age. Trabeculectomy frequency decreased, and that of laser trabeculoplasty increased during the observation period. The frequencies of both incisional and laser procedures peaked in the 75-79 age group. In 2020, 16.1 bottles of eyedrops per patient-year were prescribed, and 15.9 incisional surgeries and 11.3 laser therapies were performed per 1000 patient-years. Intraocular pressure measurement and visual field testing were performed 6.5 times and 2.0 times per patient-year, respectively. The total direct cost of glaucoma treatment was 55,139 yen (US $399.5) per patient-year, of which medications accounted for 44.2%, ophthalmic examinations for 47.4%, and incisional or laser procedures for 8.4%. CONCLUSION: These results may be useful for understanding glaucoma treatment trends and costs in Japan.

The budget impact of introducing the OMNI® surgical system to a United States health plan for managing mild-to-moderate primary open-angle glaucoma.

OBJECTIVES: Minimally invasive glaucoma surgery devices fill an unmet need in the treatment paradigm between topical intraocular pressure medicines and more invasive filtration procedures. This study evaluated the adoption of The OMNI® Surgical System with or without cataract surgery in primary open-angle glaucoma patients. METHODS: A budget impact analysis estimated costs before and after adoption of OMNI® to a hypothetical US health plan with 1 million Medicare-covered lives over two years. Model input data were derived from published sources and development of the model included primary research with key opinion leaders and payers. The model compared total annual direct costs for OMNI® versus other treatment options (medications, other minimally invasive surgical procedures, selective laser trabeculoplasty) to calculate budget impact. A one-way sensitivity analysis was conducted to assess parameter uncertainty. RESULTS: Increased adoption of OMNI® resulted in budget neutrality over the two years with a decrease in total costs of $35,362. Per member per month incremental costs were $0.00 when used without cataract surgery and yielded cost savings of -$0.01 when used with cataract surgery. Sensitivity analysis confirmed model robustness and identified surgical center fee variability as a key driver of costs. CONCLUSION: OMNI® is budgetary efficient from a US payer perspective.

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial.

BACKGROUND: Trabeculectomy is the "gold standard" initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. METHODS: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. DISCUSSION: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019.

Budget impact analysis of the XEN®63 for the treatment of primary openangle glaucoma in Spain.

BACKGROUND AND OBJECTIVE: To evaluate the economic impact in Spain derived from the introduction of the XEN®63 implant as a surgical alternative in the management of primary open angle glaucoma (POAG) with or without cataract in refractory patients. MATERIALS AND METHODS: A budget impact analysis was designed to estimate the costs of surgical treatment of POAG from the perspective of the Spanish National Health System (NHS), over a time horizon of 1 year. The comparators considered (trabeculectomy, deep non-penetrating sclerectomy, Ahmed valve, iStent inject, Preserflo® microshunt and XEN®45) correspond to those used in Spanish public clinical practice. For the calculation of the target population, market shares and resource use in terms of follow-up visits, additional procedures and post-surgery complications, data from the literature were used and validated with a panel of 4 experts. Unit costs (€ 2021) were obtained from the ESALUD database. RESULTS: The inclusion of XEN®63 could generate savings of €2,569,737 after one year since its introduction, derived from savings in the cost of the implant and procedure (-€423,120; -0.7%), follow-up visits (-€777,407; -4.5%), additional procedures (-€1,048,145; -20.6%) and post-surgery complications (-€321,065; -14.2%). CONCLUSIONS: The incorporation of XEN63®in the surgical arsenal for the treatment of refractory POAG with and without cataracts could generate savings for the NHS.

Impact of Fellowship Training on Practice Patterns of Glaucoma Surgeons Treating Medicare fee-for-service Beneficiaries.

PURPOSE: Analyze practice patterns of glaucoma surgeons with and without fellowship training. MATERIALS AND METHODS: Physician-specific 2017 Medicare data were obtained from the Centers for Medicare & Medicaid Services website. Current Procedural Terminology codes identified procedures including iStent, tube shunts, trabeculectomy, complicated trabeculectomy, endoscopic cyclophotocoagulation, internal Xen Implant, external Xen or Express shunt, Gonioscopy-Assisted Transluminal Trabeculotomy, and Kahook Dual Blade Goniotomy. Physicians with fellowship training were identified via the American Glaucoma Society website. RESULTS: A total of 1547 glaucoma surgeons were identified, of which 319 had completed fellowship training. Overall, fellowship-trained glaucoma surgeons performed more services (50.4 ± 47.0 vs 40.5 ± 35.3, P < .001) with a larger variety of procedures (1.8 ± 1.0 vs 1.3 ± 0.6, P < .001) than those without fellowship training. Surgeons without fellowship training were more likely to perform iStent and endoscopic cyclophotocoagulation and less likely to perform the remaining procedures than their fellowship-trained counterparts. Medicare payments did not differ between groups and the number of Medicare beneficiaries only differed for internal Xen implant (P = .03). Patient comorbidity burden was similar between groups with about one-third of patients being diagnosed with ischemic heart disease. CONCLUSIONS: Surgeons without fellowship training can treat a similar volume of glaucoma patients as those with fellowship training. However, based on surgical procedures employed, their practices are skewed towards mild and moderate glaucoma and they are more limited in their breadth of procedures. In addition, ischemic heart disease was prevalent in the glaucoma patient population.

Comparative Cost-effectiveness of Trabeculectomy versus MicroShunt in the US Medicare System.

PURPOSE: To assess the societal cost-utility of the MicroShunt compared with trabeculectomy for the surgical management of glaucoma in the US Medicare system. DESIGN: Cost-utility analysis using efficacy and safety results of a randomized controlled trial and other pivotal clinical trials. PARTICIPANTS: Markov model cohort of patients with open-angle glaucoma. METHODS: Open-angle glaucoma treatment costs and effects were analyzed with a deterministic model over a 1-year horizon using TreeAge software. Health states included the Hodapp-Parrish-Anderson glaucoma stages (mild, moderate, advanced, blind) and death. Both treatment arms received additional ocular hypotensive agents to control intraocular pressure (IOP). Treatment effect was measured as mean number of ocular hypotensive medications and reduction in IOP, which had a direct impact on transition probabilities between health states. Analyses of scenarios were performed with longer time horizons. One-way sensitivity and probabilistic sensitivity analyses were conducted to assess the impact of alternative model inputs. Both treatment arms were subject to reported complication rates, which were factored in the model. MAIN OUTCOME MEASURES: Incremental cost per quality-adjusted life-year (QALY) gained. RESULTS: At 1 year, the MicroShunt had an expected cost of US dollars (USD) 6318 compared with USD 4260 for trabeculectomy. MicroShunt patients gained 0.85 QALYs compared with 0.86 QALYs for trabeculectomy, resulting in a dominated incremental cost-utility ratio of USD 187 680. Dominance is a health economic term used to describe a treatment option that is both more costly and less effective than the alternative. The MicroShunt remained dominant in 1-way sensitivity analyses using best-case input parameters (including a device fee of USD 0). At a willingness-to-pay threshold of USD 50 000, the likelihood of the MicroShunt being cost-effective was 6.4%. Dominance continued in longer time horizons, up to 20 years. CONCLUSIONS: Trabeculectomy appears to be a dominant treatment strategy over the MicroShunt in the surgical management of glaucoma. More independent, long-term studies are required for the MicroShunt and other subconjunctival microstent devices to evaluate their use in clinical practice.

Assessment of angiogenesis-related parameters in juvenile idiopathic arthritis-associated uveitis.

PURPOSE: Juvenile idiopathic arthritis-associated uveitis (JIAU) may run a chronic and treatment-resistant course, and occasionally, alterations of the iris vasculature may be observed clinically. METHODS: Iris tissue (IT), aqueous humor (AH) and serum samples from patients with clinically inactive JIAU (n = 30), acute anterior uveitis (AAU; n = 18), and primary open angle glaucoma (POAG; n = 20) were obtained during trabeculectomy or cataract surgery. Samples were analyzed by RNA-Seq, qRT-PCR, LC-IMS, Western-Blot, and LEGENDplex™ analysis. Pattern of iris vasculature in JIAU patients was assessed qualitatively via fluorescein and indocyanine green angiography (FLA/ICGA). RESULTS: RNA-Seq of IT showed significantly differential expression (DE) of 136 genes between JIAU and POAG, of which 15 were associated with angiogenesis. qRT-PCR, performed to validate RNA-Seq results, showed upregulation of the angiogenesis-related genes Kdr, Angpt-1, Tie-1, Tie-2 and Mmrn2 in IT (JIAU vs POAG, p > 0.05). LC-IMS of IT revealed a total number of 56 DE proteins (JIAU vs POAG), of which Angiopoetin, Lumican and Decorin were associated with angiogenesis and showed increased (p > 0.05) expression on Western-Blot analysis. LEGENDplex™ analysis showed upregulation of ANGPT-2 in AH from JIAU compared to AAU and POAG, whereas VEGF was upregulated in AAU. Iris vascular leakage, hypoperfusion and neovascularization were observed by FLA/ICGA in JIA patients with treatment-refractory complicated course of uveitis. CONCLUSION: Angiogenesis-related factors could play a role in long-standing complicated JIAU, leading to clinically visible alterations in selected cases.

Gender Differences in Ophthalmic Procedural Volume: A Study of Male vs. Female Glaucoma Specialists.

PURPOSE: To investigate whether differences in procedural volume exist between practicing male and female glaucoma specialists. DESIGN: A cross-sectional analysis. SUBJECTS: A total of 213 female and 666 male glaucoma specialists who performed ≥ 11 traditional, incisional glaucoma procedures for Medicare beneficiaries between 2014 and 2018. METHODS: The 2014 to 2018 Medicare Provider Utilization and Payment Data database was queried using Current Procedural Terminology and Evaluation and Management codes to identify clinic visits and cataract, glaucoma drainage implant (GDI), trabeculectomy, minimally invasive glaucoma surgery (MIGS), and office-based glaucoma laser procedures. The number of procedures performed per provider was averaged and compared between genders. The univariate ordinary least squares linear regression analysis was used to investigate the effects of gender on procedural volume. The multivariate ordinary least squares linear regression analysis was used to examine the effects of gender, the number of group practice members, and the number of years after medical school graduation on cataract, GDI, trabeculectomy, MIGS, and glaucoma laser procedural volumes. MAIN OUTCOME MEASURES: Mean difference in the number of procedures by gender and predictors of procedural volume. RESULTS: In the univariate analysis, men performed an estimated 7.8 more MIGSs (95% confidence interval [CI], 2.7-12.9; P = 0.003), 138.9 more cataract procedures (95% CI, 59.6-218.3; P = 0.0006), and 1.99 more GDI procedures (95% CI, 0.03-3.95; P = 0.046) than women. This relationship remained true for MIGS and cataract procedures in the multivariate analysis after controlling for clinical volume, the number of group practice members, and the number of years after medical school graduation (MIGS, ß = 6.1 [95% CI, 0.5-11.8; P = 0.03]; cataract, ß = 110.2 [95% CI, 16.9-203.5; P = 0.02]). Glaucoma drainage implant procedures were no longer associated with the gender of the surgeon in the multivariate analysis (ß = 2.1, 95% CI, -0.1 to 4.2; P = 0.06). The volumes of trabeculectomy and office-based glaucoma laser procedures did not differ between the genders in both the univariate (glaucoma laser, ß = 7.0 [95% CI, -4.4 to 18.5; P = 0.23]; trabeculectomy, ß = 2.7 [95% CI, -0.8 to 6.2; P = 0.13]) and multivariate analyses (glaucoma laser, ß = -7.3 [95% CI, -18.7 to 4.1; P = 0.21]; trabeculectomy, ß = 1.7 [95% CI, -5.6 to 2.1; P = 0.38]). CONCLUSIONS: Women performed fewer MIGS and cataract procedures than men, even after controlling for clinical volume, the number of years after medical school graduation, and the number of group practice members. After controlling for these factors, there was no difference in the incisional glaucoma or glaucoma laser procedural volume between genders. Further research is needed to understand factors contributing to these differences.

Trends in prescriptions for glaucoma and ocular hypertension in France between 2014 and 2019.

PURPOSE: To explore the national trend in prescriptions for glaucoma and ocular hypertension (OHT) in France between 2014 and 2019. METHODS: This is a retrospective descriptive study based on prescription data from the Primary Health Insurance Fund databases. All patients with a social security number who received one or more glaucoma/OHT prescriptions between 2014 and 2019 were identified. Figures for 2020 are not yet available as of the date of submission of this article. Demographic characteristics from Common Classification of Medical Acts information and from National Institute of Statistics and Economic Studies were analyzed. The data analysis was carried out using the R version 3.6.2.software from the available databases of the Information Systems Medicalization Program. RESULTS: Our results suggest an increase in the number of patients treated with glaucoma drugs, which cannot be explained simply by demographic growth. There is also a change in drug prescription habits, both in the class of medication used and in the use of fixed combinations. We also note the increasing use of SLT (Selective Laser Trabeculoplasty), a relatively newer tool in the therapeutic arsenal. Over the same time period, demographic characteristics remained stable; age and sex distribution for each year remained constant. In addition, the phenomenon of poor therapeutic compliance, which we attempted to explore, remained stable. DISCUSSION: This study updates the French epidemiologic data available on prescriptions for glaucoma and ocular hypertension, a true public health concern. CONCLUSION: On the one hand, prescribing practices have evolved over the study period. On the other hand, the number of patients treated has increased faster than the growth of the French population over the same period. These findings are consistent with trends observed in previous studies.

Augmented trabeculectomy-outcomes of first hundred versus second hundred surgeries of a fellowship-trained glaucoma surgeon.

PURPOSE: We aim to compare the outcomes of trabeculectomy with mitomycin-C by a fellowship-trained glaucoma surgeon in the first hundred compared to second hundred surgeries. PATIENTS AND METHODS: Retrospective review of 200 consecutive surgeries from May 2015 to January 2017. Primary outcomes were intraocular pressure (IOP) control and use of IOP-lowering medications. Success between first hundred (Group 1) and second hundred (Group 2) patients were reported using World Glaucoma Association guidelines. Kaplan-Meier survival demonstrated complete success and qualified success. Secondary outcome measures were postoperative complications, bleb interventions and additional procedures. RESULTS: We found no statistical difference between the first hundred and second hundred patient's postoperative IOP at week 4 (p = 0.17), 3 months (p = 0.74), 6 months (p = 0.46), 12 months (p = 0.47), 18 months (p = 0.13) or at final follow up (p = 0.53). The mean final follow up period was 3.6 ± 0.7 years. Mean IOP reduction in Group 1 was from 27.1 ± 10.8 to 12.6 ± 7.1 (p < 0.0001) and Group 2 from 22.8 ± 8.4 to 11.3 ± 4.2 (p < 0.0001). Kaplan-Meier graphs showed no significant difference in complete success (p = 0.0693) or qualified success (p = 0.0866) between Group 1 and Group 2. Bleb interventions were not statistically significant between two groups. There was a significantly higher rate of complications with the first hundred patients (p < 0.0001). CONCLUSION: Both first hundred and second hundred patient groups achieved statistically similar outcomes in long term IOP control. Significant reduction of complications was achieved in the second group of patients.

Updates on the utility of anterior segment optical coherence tomography in the assessment of filtration blebs after glaucoma surgery.

The formation of filtration blebs is the main drainage mechanism for reducing intraocular pressure after traditional incisional glaucoma surgery such as trabeculectomy and non-penetrating deep sclerotomy. Early and short-lasting blebs may also occur after canaloplasty. Bleb formation also plays an important role after the implantation of glaucoma drainage devices, including Minimally Invasive Glaucoma Surgery devices. Anterior segment optical coherence tomography (AS-OCT) is a rapid and non-invasive high-resolution imaging technique that has evolved in recent years to become a routine examination. Anterior segment optical coherence tomography (AS-OCT) provides key information in the assessment and follow-up of glaucoma surgery, especially in the assessment of filtration blebs. Thus, bleb morphology can be qualitatively classified into diffuse, cystic, encapsulated and flattened, and AS-OCT imaging can also provide several quantitative parameters of the bleb, such as total bleb height, bleb fluid-filled cavity height, bleb wall thickness, number of microcysts and trabeculectomy opening size. These parameters could have an impact on clinical management during follow-up because they may predict the success or failure of the surgery in the early and late postoperative periods. Additionally, they may also guide the procedures used to increase filtration and reduce intraocular pressure, such as bleb needling and laser suture lysis.

Burden of Trabeculectomy and Glaucoma Drainage Implantation after Laser Trabeculoplasty: A Two-Year Follow-up Study.

PURPOSE: To evaluate the burden of incisional glaucoma surgery (trabeculectomy and glaucoma drainage device implantation) after laser trabeculoplasty (LTP) in the United States. DESIGN: Retrospective, matched, case-comparison study. PARTICIPANTS: Medicare beneficiaries who underwent LTP between January 2012 and December 2014 were identified using the 5% Medicare Current Beneficiary Survey. METHODS: Subjects aged 35 years or older at the time of LTP with ocular hypertension, suspected glaucoma, or mild open-angle glaucoma (OAG) were matched to a comparison group without LTP on the basis of age, gender, race, geographic region, and glaucoma diagnosis codes. Survival analysis and Cox proportional hazard analysis were performed. MAIN OUTCOME MEASURES: Primary analysis included risk of incisional glaucoma surgery. Secondary analysis included risk of conversion to moderate or severe OAG based on billing data. RESULTS: The mean age of study participants was 75.0 ± 8.9 years. After 2 years, 40 of 2435 eyes required incisional glaucoma surgery after LTP, and 51 of 2435 eyes required glaucoma surgery in the comparison group (P = 0.27, adjusted for covariates). Regardless of intervention, Black Americans were more likely to require glaucoma surgery (hazard ratio [HR], 1.89; 95% confidence interval [CI], 1.13-3.17). Patients with a diagnosis of OAG were more likely to require surgery than glaucoma suspects (HR, 2.03; 95% CI, 1.12-3.69). Black Americans were also more likely to require surgery or convert to more severe glaucoma (HR, 3.21; 95% CI, 1.92-5.37) versus White Americans. CONCLUSIONS: Laser trabeculoplasty did not alter the need for subsequent incisional glaucoma surgery among glaucoma suspects or patients with mild OAG. Regardless of treatment with LTP, African heritage and OAG diagnosis status were risk factors for requiring glaucoma surgery.

A Brazilian cost-utility analysis of trabecular micro-bypass with iStent inject® for the treatment of open-angle glaucoma / Análise de custo-utilidade do implante trabecular iStent inject® para o tratamento do glaucoma de ângulo aberto no Brasil

ABSTRACT Purpose To evaluate the cost-utility of the iStent inject® for the treatment of mild-to-moderate open-angle glaucoma (OAG) within the Brazilian Unified Health System (SUS). Methods A Markov model was developed, in which the effectiveness outcome measure was the incremental cost-effectiveness ratio (ICER: R$ / QALY quality-adjusted life-year). Direct medical costs were obtained from the SUS perspective. The base case comprised of a hypothetical cohort of patients with OAG using topical medication and being managed according to the Clinical Protocol and Therapeutic Guidelines (PCDT) and a real-world setting based on data from Datasus. The model's robustness through sensitivity analyses was tested. Results In the PCDT base case setting, the trabecular micro-bypass implant provided gains of 0.47 QALYs and an ICER of R$7,996.66/QALY compared to treatment with topical medication. In the real-world setting based on data from Datasus, the trabecular micro-bypass implant, provided gains of 0.47 QALYs and an ICER of R$4,485.68/QALY compared to treatment with topical medication. The results were robust to sensitivity analyses. Conclusion Incorporating iStent inject® to SUS provides an improvement in the patient's quality of life with an additional cost that warrants the benefit provided to patients. Results may be considered cost-effective compared to topical medication.

RESUMO Objetivo Avaliar a relação custo-utilidade do iStent inject® para o tratamento do glaucoma de ângulo aberto leve a moderado no Sistema Único de Saúde. Métodos Foi desenvolvido um modelo de Markov, no qual a medida de resultado de efetividade foi a razão custo-efetividade incremental (razão de custo-efetividade incremental: R$/ano de vida ajustado pela qualidade). Os custos médicos diretos foram obtidos por meio da perspectiva do Sistema Único de Saúde. O caso base foi composto de uma coorte hipotética de pacientes com glaucoma de ângulo aberto em uso de medicação tópica tratados de acordo com o Protocolo Clínico e Diretrizes Terapêuticas e um cenário do mundo real baseado em dados do Departamento de Informática do Sistema Único de Saúde. Foi testada a robustez do modelo por meio de análises de sensibilidade. Resultados No cenário base do Protocolo Clínico e Diretrizes Terapêuticas, o implante trabecular micro-bypass proporcionou ganhos de 0,47 ano de vida ajustado pela qualidade e razão de custo-efetividade incremental de R$7.996,66/ano de vida ajustado pela qualidade em relação ao tratamento com medicação tópica. No cenário real baseado em dados do Departamento de Informática do Sistema Único de Saúde, o implante trabecular proporcionou ganhos de 0,47 ano de vida ajustado pela qualidade e razão de custo-efetividade incremental de R$ 4.485,68/ano de vida ajustado pela qualidade em relação ao tratamento com medicação tópica. Os resultados foram robustos para análises de sensibilidade. Conclusão A incorporação do iStent inject® ao Sistema Único de Saúde proporciona melhora na qualidade de vida do paciente com um custo adicional que garante o benefício proporcionado a eles. Os resultados podem ser considerados custo-efetivos em comparação com a medicação tópica.