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.

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.

Social Vulnerability, Prevalence of Glaucoma, and Incidence of Glaucoma Surgery in the California Medicare Population.

PURPOSE: To examine associations of Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry Social Vulnerability Index (SVI) scores with prevalence of glaucoma and incidence of glaucoma surgery in 2019 California Medicare beneficiaries. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: 2019 California Medicare beneficiaries ≥ 65 years old with part A and part B coverage. METHODS: The exposure of interest was SVI score, which was assessed overall and by themes. Outcomes included prevalence of glaucoma in the study population and incidence of glaucoma surgery in beneficiaries with glaucoma. Logistic regression modeling was performed to assess associations between quartiles of each type of SVI score, prevalence of glaucoma, and incidence of glaucoma surgery, controlling for age, sex, race/ethnicity, Charlson Comorbidity Index score, pseudophakia, and age-related macular degeneration. MAIN OUTCOME MEASURES: Prevalence of any glaucoma, primary open angle glaucoma (POAG), secondary open angle glaucoma (SOAG), and angle closure glaucoma in all beneficiaries. Incidence of any glaucoma surgery, trabeculectomy, tube shunt, minimally invasive glaucoma surgery (MIGS), and cyclophotocoagulation (CPC) in beneficiaries with glaucoma. RESULTS: Of 5 725 245 beneficiaries in the total study population, there were 215 814 (3.8%) with any glaucoma, and of those with glaucoma, 10 135/215 814 (4.7%) underwent glaucoma surgery. In adjusted analyses for overall SVI score, where higher levels of SVI refer to higher levels of social vulnerability, there were decreased odds of any glaucoma (adjusted odds ratio [aOR] = 0.83; 95% confidence interval [CI] = 0.82, 0.84 for Q4 vs. Q1), POAG (aOR = 0.85; 95% CI = 0.84, 0.87 for Q4 vs. Q1), and SOAG (aOR = 0.59; 95% CI = 0.55, 0.63 for Q4 vs. Q1) in higher (Q4) vs. lower (Q1) SVI quartile. There were increased odds of any glaucoma surgery (aOR = 1.19; 95% CI = 1.12, 1.26 for Q4 vs. Q1), MIGS (aOR = 1.24; 95% CI = 1.15, 1.33 for Q4 vs. Q1), and CPC (aOR = 1.49; 95% CI = 1.29, 1.76 for Q4 vs. Q1) for higher (Q4) vs. lower (Q1) SVI quartile. CONCLUSIONS: In the 2019 California Medicare population, there were variable associations between SVI score, prevalence of glaucoma, and incidence of glaucoma surgery. Further investigation is needed to understand the role of social, economic, and demographic factors in glaucoma care on the individual and structural levels. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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.

An IRIS Registry-Based Assessment of Primary Open-Angle Glaucoma Practice Patterns in Academic Versus Nonacademic Settings.

PURPOSE: To compare patient demographic data; level of severity; and clinical, diagnostic, and surgical practice patterns in patients with primary open-angle glaucoma (POAG) in an academic setting vs nonacademic setting using the American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight). METHODS: A retrospective cohort study of IRIS Registry data that included patients with POAG who were seen between January 2016 and December 2019 and had at least 1 year of follow-up. RESULTS: Of 3 707 084 distinct eyes with POAG, 3% (109 920) were included in the academic subcohort and 97% (3 597 164) were included in the nonacademic subcohort. Among the findings of greatest note (P < .0001 for all comparisons) were a higher proportion of eyes of Black patients, a higher proportion of eyes with level 3 severity, and a higher mean cup-to-disc ratio in eyes in the academic setting. The relative frequency of gonioscopy, pachymetry, and visual field testing in conjunction with new patient visits was also notably higher in the academic setting. For glaucoma surgical procedures, the greatest proportional differences in relative frequency were seen for tube shunt procedures (2.55-fold higher in the academic setting), iStent and Hydrus procedures (2.52-fold higher in the nonacademic setting), and endoscopic cyclophotocoagulation (5.80-fold higher in the nonacademic setting). CONCLUSIONS: Based on IRIS Registry data, notable differences appear to exist with regard to ethnoracial groups, glaucoma severity, and diagnostic and surgical practice patterns in academic vs nonacademic settings. By understanding these differences, potential opportunities exist in the development of educational programs related to clinical and surgical glaucoma care.

Cost Utility of Schlemm's Canal Microstent Injection With Cataract Surgery for Open-angle Glaucoma in the US Medicare System.

PRCIS: Hydrus microstent (HMS) implantation at the time of cataract surgery appears to be cost-effective in mild-to-moderate glaucoma. However, long-term follow-up is essential for a full assessment of device performance, safety and cost-effectiveness. PURPOSE: The aim was to assess the societal cost-utility to the US Medicare system of implanting HMS with cataract surgery versus cataract surgery alone in patients with open-angle glaucoma. PATIENTS: Markov model cohort of patients with mild-to-moderate open-angle glaucoma and visually significant cataract. METHODS: Patients received HMS during cataract surgery versus cataract surgery alone, in a deterministic model over a 2-year horizon using TreeAge software. Both arms received additional ocular hypotensive agents to control intraocular pressure. Treatment effect of HMS was measured as mean number of ocular hypotensive medications and intraocular pressure, which directly impacted transition probabilities. Health states included the Hodapp-Parrish-Anderson glaucoma stages (mild, moderate, advanced, blind) and death. One-way sensitivity and probabilistic sensitivity analyses were conducted on device efficacy and longer time horizons. RESULTS: At 2 years, HMS with cataract surgery in mild glaucoma had an incremental cost-utility ratio of USD 38,346.43 per utility gained, compared with cataract surgery alone. Probabilistic sensitivity analysis was cost-effective in 61.4% of iterations for HMS+cataract surgery. The probability of side-effects with eye drops, utility decrement with side-effects, cost of the HMS and real-world efficacy rate had the greatest impact on model outcomes. HMS must be 85.60% as effective as published data to maintain cost-effectiveness at a willingness-to-pay threshold of USD 50,000. The incremental cost-utility ratio of HMS with cataract surgery in moderate glaucoma was USD 42,895.38. CONCLUSIONS: HMS implantation during cataract surgery appears to be cost-effective for patients with mild-to-moderate glaucoma. Nevertheless, more long-term safety and efficacy data are required.

Cost-Effectiveness Analysis of Minimally Invasive Trabecular Meshwork Stents with Phacoemulsification.

PURPOSE: To investigate the costs and effects of implanting trabecular meshwork bypass stents during cataract surgery from a societal perspective in the United States. DESIGN: Cost-utility analysis using Markov models and efficacy/safety data from published pivotal or randomized control trials (RCTs) of devices investigated. PARTICIPANTS: Patients aged 65 years and older with mild to moderate primary open-angle glaucoma with or without visually significant cataract. METHODS: With the use of Markov models, glaucoma progression through 4 glaucoma states (mild, moderate, advanced, severe/blind) and death were simulated over 35 years. The cohort with cataract entered the model and received cataract surgery with or without device implantation. We included a medication management only reference group to calculate total costs and outcomes for those without cataract. Intraocular pressure (IOP) reductions from RCTs were converted to glaucoma state transition probabilities using visual field (VF) mean deviation (MD) decline rates from the Early Manifest Glaucoma Trial. Progressive thinning of the retinal nerve fiber layer (RNFL) on OCT imaging related to IOP control warranted further intervention, including adding medication, selective laser trabeculoplasty (SLT), or incisional glaucoma surgery. We estimated whole costs at Medicare rates and obtained utility values for glaucoma states from previous studies. Incremental costs per quality-adjusted life-year (QALY) gained were evaluated at a QALY threshold of $50 000. One-way deterministic sensitivity analysis, scenario analyses, and probabilistic sensitivity analyses addressed parameter uncertainty and demonstrated model robustness. MAIN OUTCOME MEASURES: Total costs, QALY, and incremental cost-effectiveness ratio (ICER). RESULTS: Over 35 years in the base case, the Hydrus (Ivantis, Inc.) implanted with cataract surgery arm cost $48 026.13 and gained 12.26 QALYs. The iStent inject (Glaukos Corp.) implanted with cataract surgery arm cost $49 599.86 and gained 12.21 QALYs. Cataract surgery alone cost $54 409.25 and gained 12.04 QALYs. Initial nonsurgical management cost $57 931.22 and gained 11.74 QALY. The device arms dominated or were cost-effective compared with cataract surgery alone within 5 years and throughout sensitivity analyses. The iStent inject arm was cost-effective in 94.19% of iterations in probabilistic sensitivity analyses, whereas the Hydrus arm was cost-effective in 94.69% of iterations. CONCLUSIONS: Implanting the Hydrus Microstent or iStent inject during cataract surgery is cost-effective at a conservative QALY threshold.

Reoperation Rates and Disease Costs for Primary Open-Angle Glaucoma Patients in the United States Treated with Incisional Glaucoma Surgery.

PURPOSE: To evaluate the claims-based 5-year economic and reintervention burden for patients with primary open-angle glaucoma (POAG) after incisional glaucoma surgery in the United States. DESIGN: Retrospective Medicare claims analysis. PARTICIPANTS: One thousand nine hundred forty-five Medicare fee-for-service patients with POAG treated with trabeculectomy, tube shunt, or EX-PRESS shunt procedures from 2010 through 2011. METHODS: Patients with POAG treated with incisional glaucoma surgery (trabeculectomy, tube shunt, or EX-PRESS shunt) from 2010 through 2011 were identified in the Medicare 5% Standard Analytical Files. Ten years of claims data for each patient (2005-2016) were evaluated for prior incisional surgeries and downstream procedures in the treated eye within 5 years of index. Patients' characteristics, downstream procedures, and POAG-related costs were evaluated. Proportions of patients with downstream procedures in the index eye indicating failure of the index surgery, glaucoma reoperations, nonfailure complications, interventions, or cataract surgery were assessed over 5 years of follow-up. MAIN OUTCOME MEASURES: Cumulative rates of index surgery failure and glaucoma reoperations over 5 years after incisional glaucoma surgery. RESULTS: Of 1945 patients, 223 underwent EX-PRESS shunt, 551 underwent tube shunt, and 1171 underwent trabeculectomy at index. Rates of failure, glaucoma reoperations, or nonfailure complications rose over 5 years after index for all patient subgroups. At 1 year, 15.1% of EX-PRESS shunt patients, 11.6% of tube shunt patients, and 8.8% of trabeculectomy patients had experienced failure based on postindex procedures. By 5 years follow-up, these rates were 31.5% of EX-PRESS shunt patients, 27.1% of tube shunt patients, and 23.5% of trabeculectomy patients. Five-year rates of glaucoma reoperations were 18.3%, 14.0%, and 15.1%, respectively. Among tube shunt and trabeculectomy patients with prior incisional surgery, the 5-year failure rates were 32.5% and 32.6%, and reoperations rates were 12.0% and 26.1%, respectively. CONCLUSIONS: More than one-fourth of patients with POAG treated with incisional surgery underwent additional procedures to address index surgery failure within 5 years. Of these, more than half underwent additional incisional glaucoma surgery. These outcomes from clinical practice settings demonstrate that patients with POAG who require incisional surgery continue to need additional safe and effective surgical treatment options to manage their glaucoma.

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.

Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT.

BACKGROUND: Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes. OBJECTIVES: To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness. DESIGN: This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial. SETTING: Secondary care eye services. PARTICIPANTS: Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma. INTERVENTION: Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C. MAIN OUTCOME MEASURES: The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety. RESULTS: A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43; p = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg; p < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11; p = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%. CONCLUSIONS: Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year. FUTURE WORK: Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56878850. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 72. See the NIHR Journals Library website for further project information.

Glaucoma is an eye condition in which the intraocular pressure is too high, causing damage to the optic nerve and loss of vision. Patients with severe vision loss at diagnosis are the most at risk of blindness in their lifetime. Lowering pressure in the eye is the only way to prevent further vision loss. Two treatments to lower pressure are commonly used: using eye drops or having an operation known as a trabeculectomy. In England, Wales and Northern Ireland, the National Institute for Health and Care Excellence recommends surgery as the first treatment. However, we do not know which treatment is best for preventing vision loss or which is safest, has the best patient experience or provides the best value for money for the NHS. Therefore, surgery is not usually carried out in the first instance and patients start with eye drops instead. This study compared whether starting treatment with eye drops affected the quality of life of patients with advanced glaucoma more or less than starting treatment with trabeculectomy. We also investigated if initial treatment with surgery and initial treatment with eye drops were equally good at controlling pressure and were equally safe, and how much each treatment cost the NHS. Every patient had an equal chance of starting treatment with surgery or eye drops and they participated in the study for 2 years. We found that quality of life was similar regardless of treatment. Those starting with surgery had lower pressure and needed far fewer types of eye drops than those starting with eye drops. Thirty-nine patients in the eye drop arm required surgery to control their glaucoma. Initial treatment with eye drops was cheaper over 2 years' follow-up. Our study suggests that, over a 2-year period, having surgery in the first instance lowers intraocular pressure more than eye drops and is equally as safe as eye drops. Although eye drops are a cheaper treatment option for the NHS, if the effects of surgery on intraocular pressure are lasting, then the increased cost may be justified.

Cost-utility analysis of trabecular micro-bypass stents (TBS) in patients with mild-to-moderate open-angle Glaucoma in Italy.

BACKGROUND: Glaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective. METHODS: Simulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. RESULTS: Results of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained. CONCLUSIONS: The results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.

A cost-effectiveness analysis of iStent inject combined with phacoemulsification cataract surgery in patients with mild-to-moderate open-angle glaucoma in France.

OBJECTIVE: To investigate the cost-effectiveness of implementing iStent inject trabecular bypass stent (TBS) in conjunction with cataract surgery (Cat Sx) in patients with mild-to-moderate glaucoma from a societal perspective in France. The secondary objective was to explore the economic impact of iStent inject TBS in patients who comply to different degrees with their anti-glaucoma medications. METHODS: A previously published Markov model was adapted to estimate the cost-effectiveness of treatment with iStent inject TBS + Cat Sx versus Cat Sx alone over a lifetime time horizon in patients with mild-to-moderate open-angle glaucoma in France. Progression was modeled by health states reflecting increasing stages of vision loss. Disease progression was obtained from the two-year randomized clinical trial assessing safety and effectiveness of both interventions. French specific health-state utilities and costs were obtained through a targeted literature review. Model structure and inputs were validated by French ophthalmologists. Outcomes were expressed as incremental cost per quality-adjusted life-year (QALY) gained. The robustness of results was tested through sensitivity analyses. RESULTS: iStent inject TBS + Cat Sx reduced the number of medications needed and risk of blindness. Incremental cost and QALYs were €75 and 0.065 leading to an incremental cost-effectiveness ratio (ICER) of €1,154/QALY gained. ICER ranged from dominating for non-persistent patients to €31,127 patients fully persistent with their medication regime. Results from one-way sensitivity analysis had a maximum ICER of €29,000 when varying input parameters. iStent inject TBS + Cat Sx had an 86% chance of being cost-effective at a willingness-to-pay threshold of €30,000 per QALY gained. CONCLUSION: Results demonstrate that iStent inject TBS + Cat Sx is a cost-effective intervention for intraocular pressure reduction when compared to Cat Sx alone in France.

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS).

OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma. DESIGN: Pragmatic multicentre randomised controlled trial. SETTING: 27 secondary care glaucoma departments in the UK. PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months. SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety. RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare. CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.