Standalone Implantation of 2-3 Trabecular Micro-Bypass Stents (iStent inject ± iStent) as an Alternative to Trabeculectomy for Moderate-to-Severe Glaucoma.

INTRODUCTION: This retrospective consecutive study compared standalone implantation of multiple (2-3) trabecular micro-bypass stents (iStent inject ± iStent) (Multi-Stent group) vs trabeculectomy + mitomycin C (Trab group) in moderate to severe open-angle glaucoma (OAG). METHODS: Eligible patients underwent Multi-Stent or Trab surgery from 2018 to 2020 and had at least 3-month follow-up; visual field mean deviation (VF MD) - 6 dB or worse; inadequate prior response to maximum medications ± laser procedures; and had trabeculectomy as their next planned intervention. Primary effectiveness, safety-adjusted treatment success, was defined as ≥ 20% intraocular pressure (IOP) reduction on the same or fewer medications, without clinically significant safety events (severe complications, secondary surgeries, reinterventions). Secondary effectiveness included mean IOP and medications; qualified and complete attainment of target IOP (≤ 21/18/15/12 mmHg and > 6 mmHg); health-economic and quality-of-life (QoL) measures; and 2-vs-3-stent subgroup analysis. RESULTS: The baseline groups (n = 70 Multi-Stent/40 Trab) were similar: mean IOP (21.1 mmHg/22.3 mmHg); medications (2.87/3.10 medications); disease stage (30%/35% severe); VF MD (- 10.1 dB/- 10.4 dB); and mean last follow-up (LFU, 13.1 months/15.7 months) (all differences non-significant). Primary effectiveness: treatment success at LFU was 62.9% vs 30.0% in Multi-Stent vs Trab eyes, respectively (p = 0.001). Secondary effectiveness: At LFU in Multi-Stent vs Trab groups, respectively: mean IOP decreased by 31% to 14.2 mmHg (p < 0.001) vs by 43% to 12.5 mmHg (p < 0.001); mean medications decreased by 51% to 1.31 medications (p < 0.001) vs by 84% to 0.43 medications (p < 0.001). Multi-Stent eyes, compared to Trab eyes, had fewer visits ± reinterventions within 3 months (3.6 vs 6.1, p < 0.001); longer time to first reintervention (12.2 months vs 4.5 months, p = 0.01); fewer total reinterventions (0.26 vs 0.75, p = 0.006); and earlier lifting of postoperative restrictions (12.6 vs 32.1 days, p < 0.001). In 2-vs-3-stent analysis, there was a trend toward more 3-stent eyes achieving target IOP than 2-stent eyes. Visual fields remained stable in both Multi-Stent and Trab eyes. CONCLUSION: Implanting 2-3 trabecular micro-bypass stents was a viable alternative to trabeculectomy for moderate-to-severe OAG, with clinically appropriate IOP/medication reductions and higher safety-adjusted treatment success vs trabeculectomy.

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.

Two-Year Comparative Outcomes of First- and Second-Generation Trabecular Micro-Bypass Stents with Cataract Surgery.

INTRODUCTION: This retrospective comparative study assessed real-world effectiveness and safety of first-generation (iStent®) and second-generation (iStent inject®) trabecular micro-bypass stents with cataract surgery in patients with open-angle glaucoma (OAG). MATERIAL AND METHODS: Through a 24-month postoperative follow-up, the effectiveness was quantified by intraocular pressure (IOP) reduction; mean glaucoma medication reduction; proportional analysis of eyes meeting IOP cutoffs (<18, <15, <12 mmHg) either with or without medications; and proportional analysis of medication burden. Safety measures included visual acuity, adverse events, and secondary surgery. RESULTS: A total of 82 consecutive eyes (39 iStent, 43 iStent inject) with a 24-month follow-up were analyzed. Most eyes (74.4%) had primary open-angle glaucoma, with the remainder having pseudoexfoliative or pigmentary glaucoma; all eyes had mild-to-moderate disease. At 24 months postoperative, the mean IOP was lower, and the percent reduction from baseline was greater, in iStent inject eyes (26.0% reduction, 17.7mmHg to 13.1mmHg) than in iStent eyes (9.8% reduction, 16.4mmHg to 14.8mmHg) (between-groups comparison, p=0.019). Within each group, the postoperative IOP reduction was greater in eyes with higher baseline IOP (p<0.001). Medication burden decreased significantly in both groups, from 1.74 to 0.51 mean medications for iStent (70.7% reduction, p<0.0001), and 2.19 to 0.65 for iStent inject (70.3% reduction, p<0.0001). Both groups exhibited excellent safety. CONCLUSION: iStent or iStent inject with phacoemulsification produced significant IOP and medication reductions, with effects enduring for two years. IOP reductions were greater for iStent inject than for iStent. Within each group, higher preoperative IOP was associated with greater postoperative IOP reduction.

Preventing glaucoma progression using the trabecular micro-bypass implant iStent inject®. A cost-effectiveness analysis / Prevenindo a progressão do glaucoma por meio do implante de by-pass trabecular iStent inject®. Uma análise de custo-efetividade

ABSTRACT Objective To assess the economic impact of reducing glaucoma progression by using the trabecular micro-bypass implant, iStent inject®, in the Reference Centers for glaucoma treatment within the Brazilian Public Unified Health System (SUS). Methods In a cost-effectiveness analysis, a Markov model was developed, and the costs were obtained from the SUS perspective (medical direct costs). Effectiveness was measured in progression-free life-years. The time horizon was the mean life expectancy of the Brazilian population. The model parameters were obtained through a review and a critical analysis of the literature. The base case comprised a hypothetical cohort of patients with open-angle glaucoma, using anti-glaucoma eye drops and followed up at Reference Centers of SUS. We tested whether the incorporation of iStent inject® as an alternative second-line therapy would be cost-effective. The outcome measure was the incremental cost-effectiveness ratio (R$/progression-free life-years). We tested the robustness of the model by univariate and probabilistic sensitivity analyses. Results The use of iStent inject® led to decreased progression rate of glaucoma, evidenced by the amount of progression-free life-years obtained with each treatment strategy (7.82 progression-free life-years with iStent inject® versus 6.33 progression-free life-years with medical treatment), thereby improving glaucoma control. There was also a reduction in future costs associated with eye drops, filtering surgeries, and treatment complications. Incremental cost-effectiveness ratio ranged from R$ 6,429.30 to R$ 7,550.97/progression-free life-years. The model proved to be robust in the sensitivity analyses. Conclusion This analysis showed that iStent inject®, when used after the failure of the first-line therapy, is able to reduce the rate of glaucoma progression at an acceptable cost.

RESUMO Objetivo Avaliar o impacto econômico da redução da progressão do glaucoma pelo uso do implante de by-pass trabecular iStent inject® no ambiente dos Centros de Referência para tratamento do Sistema Único de Saúde (SUS). Métodos Em uma análise de custo-efetividade, elaborou-se um modelo de Markov, cujos custos foram obtidos a partir da perspectiva do SUS financiador (custos médicos diretos). A efetividade foi medida em anos de vida livres de progressão. O horizonte temporal foi a expectativa de vida média da população brasileira. Os parâmetros do modelo foram obtidos pela revisão e pela análise crítica da literatura. O caso base foi composto de uma coorte hipotética de portadores de glaucoma de ângulo aberto em uso de colírios antiglaucomatosos e em acompanhamento nos Centros de Referência do SUS. Testou-se se a incorporação do iStent inject® como alternativa à segunda linha de tratamento seria custo-efetiva. A medida de desfecho foi a razão de custo-efetividade incremental (R$/anos de vida livres de progressão). A robustez do modelo foi testada por meio de análises de sensibilidade univariada e probabilística. Resultados A utilização do iStent inject® proporcionou uma diminuição da velocidade de progressão do glaucoma, evidenciada pela quantidade de anos de vida livres de progressão obtida com cada estratégia de tratamento (7,82 anos de vida livres de progressão com iStent inject® versus 6,33 anos de vida livres de progressão com tratamento com colírios), melhorando, dessa forma, o controle do glaucoma. Houve ainda redução nos custos futuros associados aos colírios, às cirurgias filtrantes e às complicações do tratamento. A razão de custo-efetividade incremental variou de R$6.429,30 a R$7.550,97/anos de vida livres de progressão. O modelo mostrou-se robusto nas análises de sensibilidade. Conclusão O iStent inject®, quando usado após a falha do primeiro medicamento, é capaz de reduzir a taxa de progressão do glaucoma a um custo aceitável.

Does the type of treatment have an influence on utility values in a glaucoma population?

PURPOSE: To assess the impact of glaucoma therapy on utility values in a glaucoma population. METHODS: A cross-sectional study of consecutive glaucoma patients was conducted. Utility values were obtained using the time trade-off method. Visual function variables (visual acuity and mean deviation in the better eye) and sociodemographic and clinical characteristics (age, sex, race, educational level, type of glaucoma, current and past glaucoma treatments, and comorbidities) were also obtained for statistical analysis. We divided the patients into three groups: medical treatment (group 1), surgical treatment (group 2), and mixed surgical and medical treatment (group 3). RESULTS: Mean age of the study population (n=225) was 65.7 years. After controlling for glaucoma stage (early, moderate, and advanced), the difference among the groups in mean utility values was not statistically significant. Number of medications per patient, type of medication, or type of surgical technique did not have an impact on the utility values. CONCLUSION: Our findings suggest that the type of therapy did not affect the utility values in a glaucoma population.

Utility values for glaucoma in Brazil and their correlation with visual function.

PURPOSE: We sought to identify the utility values in a group of Brazilian patients with primary open-angle glaucoma (POAG), and to assess its impact on visual acuity (VA) and mean deviation index values. MATERIALS AND METHODS: This was a cross-sectional study of consecutive patients with POAG, who were interviewed using three methods for obtaining utility values: time trade-off (TTO), standard gamble anchored at risk of death (SG1), and standard gamble anchored at risk of blindness (SG2). Visual function variables (VA and mean deviation index in the better eye) and sociodemographic characteristics (age, sex, race, and educational level) were also obtained for statistical analysis. RESULTS: The mean age (± standard deviation) of the study population (n=227) was 65.7 (±15.1) years. Mean utility values for the entire population were 0.82 from TTO, 0.90 from SG1, and 0.93 from SG2 (P<0.0001). Age, race, and sex had no influence on the utility values. Higher education tended to predict higher values by TTO, but not by SG1 or SG2. Visual function variables had an influence on utility values. The more advanced the visual loss, whether measured by VA or perimetry, in the better eye, the lower the utility values by all three methods. CONCLUSION: We obtained utility values for Brazilian patients with POAG, as well as specific values for different levels of vision loss.