Trabecular microbypass as replacement therapy in pharmacologically controlled open-angle glaucoma patients / Implante de by-pass trabecular como alternativa aos colírios em portadores de glaucoma de ângulo aberto controlados com tratamento clínico

ABSTRACT Purpose: To assess the outcomes of the trabecular bypass as replacement therapy for medications in pharmacologically controlled vs. pharmacologically uncontrolled open-angle glaucoma patients. Methods: This was a retrospective study of eyes treated with first- (iStent) or second-generation (iStent inject) trabecular bypass. Group 1 consisted of eyes with pharmacologically controlled intraocular pressure <18 mmHg and Group 2 consisted of eyes with pharmacologically controlled intraocular pressure ≥18 mmHg. The main outcomes measured were qualified (with or without medications) and unqualified or complete (without medications) success rates at different target intraocular pressures, mean reduction (%) in medication use, and proportion of medication-free eyes. Results: The mean age was 70.4 years in Group 1 (n=105) and 68.1 years in Group 2 (n=65). Qualified success rates for intraocular pressure <18 mmHg, intraocular pressure <15 mmHg, and intraocular pressure <12 mmHg were similar between the groups (Group 1: 96.2%, 88.6%, and 32.4%, respectively; Group 2: 93.8%, 78.5%, and 21.5%, respectively; all p>0.05). Complete success rates were significantly higher in Group 1 than in Group 2: for intraocular pressure <18 mmHg (76.2% vs. 47.7%), intraocular pressure <15 mmHg (73.3% vs. 40.0%), and intraocular pressure <12 mmHg (14.3% vs. 4.6%). The mean reduction in medication use was higher in Group 1 than in Group 2. At the end of follow-up, 79.0% of eyes in Group 1 and 47.7% of eyes in Group 2 became medication-free. Conclusions: Both groups showed high qualified success rates, but eyes with baseline pharmacologically controlled intraocular pressure <18 mmHg showed higher complete success rates and greater chances of achieving no need for medications.

RESUMO Objetivo: Avaliar os resultados dos implantes de by-pass trabecular como terapia de substituição aos colírios em pacientes com glaucoma de ângulo aberto controlados com medicação vs. não controlados com medicação. Métodos: Este foi um estudo retrospectivo de olhos submetidos a cirurgia de implante de by-pass trabecular de primeira (iStent) ou segunda geração (iStent inject). O Grupo 1 consistiu em olhos com pressão intraocular medicada <18 mmHg e o Grupo 2 consistiu em olhos com pressão intraocular medicada ≥18 mmHg. Os principais desfechos foram as taxas de sucesso relativo (com ou sem medicamentos) e completo (sem medicamentos) em diferentes pressões intraoculares-alvo, redução média (%) no uso de medicamentos e proporção de olhos sem medicamentos. Resultados: A média de idade foi de 70,4 anos no Grupo 1 (n=105) e 68,1 anos no Grupo 2 (n=65). As taxas de sucesso relativo para pressão intraocular <18 mmHg, pressão intraocular <15 mmHg e pressão intraocular <12 mmHg foram semelhantes entre os grupos (Grupo 1: 96,2%, 88,6% e 32,4%, respectivamente; Grupo 2: 93,8%, 78,5% e 21,5%, respectivamente; todos p>0,05). As taxas de sucesso completo foram significativa mente maiores no Grupo 1 do que no Grupo 2: pressão intraocular <18 mmHg (76,2% vs. 47,7%); pressão intraocular <15 mmHg (73,3% vs. 40%); pressão intraocular <12 mmHg (14,3% vs. 4,6%). A redução média no uso de medicamentos foi maior no Grupo 1 do que no Grupo 2. Ao final do acompanhamento, 79,0% dos olhos do Grupo 1 e 47,7% dos olhos do Grupo 2 estavam livres medicamentos. Conclusões: Ambos os grupos mostraram altas taxas de sucesso relativo, mas olhos com pressão intraocular medicada pré-operatória <18 mmHg apresentaram taxas de sucesso completo mais elevadas, bem como maiores chances de se tornarem livres de medicamentos para glaucoma.

Trabecular microbypass as replacement therapy in pharmacologically controlled open-angle glaucoma patients.

PURPOSE: To assess the outcomes of the trabecular bypass as replacement therapy for medications in pharmacologically controlled vs. pharmacologically uncontrolled open-angle glaucoma patients. METHODS: This was a retrospective study of eyes treated with first- (iStent) or second-generation (iStent inject) trabecular bypass. Group 1 consisted of eyes with pharmacologically controlled intraocular pressure <18 mmHg and Group 2 consisted of eyes with pharmacologically controlled intraocular pressure ≥18 mmHg. The main outcomes measured were qualified (with or without medications) and unqualified or complete (without medications) success rates at different target intraocular pressures, mean reduction (%) in medication use, and proportion of medication-free eyes. RESULTS: The mean age was 70.4 years in Group 1 (n=105) and 68.1 years in Group 2 (n=65). Qualified success rates for intraocular pressure <18 mmHg, intraocular pressure <15 mmHg, and intraocular pressure <12 mmHg were similar between the groups (Group 1: 96.2%, 88.6%, and 32.4%, respectively; Group 2: 93.8%, 78.5%, and 21.5%, respectively; all p>0.05). Complete success rates were significantly higher in Group 1 than in Group 2: for intraocular pressure <18 mmHg (76.2% vs. 47.7%), intraocular pressure <15 mmHg (73.3% vs. 40.0%), and intraocular pressure <12 mmHg (14.3% vs. 4.6%). The mean reduction in medication use was higher in Group 1 than in Group 2. At the end of follow-up, 79.0% of eyes in Group 1 and 47.7% of eyes in Group 2 became medication-free. CONCLUSIONS: Both groups showed high qualified success rates, but eyes with baseline pharmacologically controlled intraocular pressure <18 mmHg showed higher complete success rates and greater chances of achieving no need for medications.

Custo-utilidade do tratamento primário não farmacológico do glaucoma de ângulo aberto / Cost-utility of primary non-pharmacological treatment of open-angle glaucoma

RESUMO Objetivo: Avaliar o impacto econômico de iniciar o tratamento do glaucoma primário de ângulo aberto com estratégias não farmacológicas nos centros de referência para o tratamento do glaucoma no Sistema Único de Saúde. Métodos: A população foi oriunda de uma coorte hipotética de pacientes aos 60 anos de idade, portadores de glaucoma primário de ângulo aberto inicial. A estratégia 1 se baseou apenas em uso de colírios. As estratégias 2 e 3 tiveram como tratamento inicial a trabeculoplastia seletiva a laser. Na estratégia 2, após a falência do laser, foi realizado o implante de dispositivo trabecular (iStent inject®), seguido de uso de colírios. A estratégia 3 iniciou-se com o tratamento medicamentoso logo após a falência do laser. O modelo desenvolvido foi o de Markov. Foi usada a razão de custo-utilidade incremental como medida de desfecho. Resultados: As estratégias 2 e 3 geraram ganho de qualidade de vida e foram dominantes em relação à estratégia 1, sendo mais efetivas e baratas. Porém a relação custo-efetividade da estratégia 2 sofreu um impacto significativo, de acordo com a idade de entrada no modelo. Conclusão: As estratégias não farmacológicas do glaucoma primário de ângulo aberto inicial foram custo-efetivas sob a perspectiva do Sistema Único de Saúde em um horizonte da expectativa de vida da população.

ABSTRACT Objective: To evaluate the economic impact of starting the treatment of primary open angle glaucoma with non-pharmacological strategies within the scope of reference centers for the treatment of glaucoma in the Unified Health System. Methods: The population of this study comes from a hypothetical cohort of patients aged 60 years with initial primary open angle glaucoma. The reference strategy (strategy 1) is based only on the use of eye drops, following the guidelines of the clinical protocol of the Brazilian Ministry of Health. Strategies 2 and 3 have the same initial treatment, with selective laser trabeculoplasty. In strategy 2, after laser failure, a trabecular device (iStent inject®) is implanted, followed by the use of eye drops as needed, and in strategy 3, it starts with the drug treatment right after the failure of the laser. The model developed for the cost-utility analysis was the Markov model. The incremental cost-utility ratio was used as an outcome measure. Results: Strategies 2 and 3 generated a gain in quality of life and were dominant over strategy 1, being at the same time more effective and less costly in relation to clinical treatment. The two non-pharmacological strategies (2 and 3) proved to be cost-effective; however, the cost-effectiveness of strategy 2 suffers a significant impact according to the age of entry into the model. Conclusion: It is concluded that the initial non-pharmacological treatment strategies of the initial primary open angle glaucoma are cost-effective from the perspective of the Unified Health System in a horizon of the life expectancy of the population.

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.

Custo-efetividade do uso do dispositivo de by-pass trabecular (iStent® Trabecular MicroBypass) associado a cirurgia de catarata para o tratamento conjunto do glaucoma primário de ângulo aberto e da catarata sob a perspectiva do Sistema de Saúde Suplementar no Brasil / Cost-effectiveness of using the trabecular by-pass device (iStent® Trabecular Micro-Bypass) combined with cataract surgery for the treatment of primary open-angle glaucoma and cataract from the Supplementary Health System perspective in Brazil

Objetivo: Avaliar se a incorporação do implante trabecular iStent® Trabecular Micro-Bypass é custo- -efetiva para o tratamento do glaucoma primário de ângulo aberto (GPAA) em pacientes que serão submetidos a cirurgia de catarata sob a perspectiva do Sistema de Saúde Suplementar no Brasil. Métodos: Foi elaborado um modelo analítico de Markov, cujos custos foram obtidos a partir da perspectiva da saúde suplementar brasileira (custos médicos diretos). A efetividade foi medida em "anos de vida livres de progressão (PFLY)". O horizonte temporal foi a expectativa de vida média da população brasileira. Os dados foram obtidos por meio da revisão e da análise crítica da literatura. O caso base foi: portadores de GPAA e catarata submetidos a cirurgia de catarata isolada e manutenção do uso de colírios antiglaucomatosos. Testou-se se a incorporação do iStent® Trabecular Micro-Bypass nesse cenário seria custo-efetiva. A medida de desfecho foi a razão de custo-efetividade incremental (RCEI: R$/PFLY). Realizou-se análise de sensibilidade univariada e probabilística para testar a robustez do modelo. Resultados: A incorporação do iStent® Trabecular Micro-Bypass gera um aumento dos custos inicialmente, mas melhora o controle da doença, tornando o glaucoma estável por mais tempo e diminuindo os custos futuros relacionados à progressão da doença. A RCEI foi de R$ 5.491,99/PFLY. O modelo mostrou-se robusto nas análises de sensibilidade. Conclusão: Esta análise sugere que a incorporação do implante iStent® Trabecular Micro-Bypass combinado com a cirurgia de catarata seria custo-efetiva para o tratamento conjunto da catarata e do GPAA no cenário da saúde suplementar no Brasil.

Objective: To evaluate whether the incorporation of the iStent® Trabecular Micro-Bypass implant is cost-effective for the treatment of primary open-angle glaucoma (POAG) in patients undergoing cataract surgery from the perspective of the supplementary healthcare system in Brazil. Methods: An analytical Markov model was developed and costs were obtained from the Brazilian supplementary health perspective (direct medical costs). Effectiveness was measured in "progression free life years (PFLY)". The time horizon was the average life expectancy of the Brazilian population. Data were obtained through review and critical analysis of the literature. The base case was: glaucomatous patients with cataract who underwent isolated cataract surgery and continued use of antiglaucomatous eye drops. We tested whether incorporating iStent® Trabecular Micro-Bypass in this scenario would be cost effective. The outcome measure was the incremental cost-effectiveness ratio (ICER: R$/PFLY). We performed univariate and probabilistic sensitivity analyses to test the robustness of the model. Results: Incorporating the iStent® Trabecular Micro-Bypass increases initial costs but improves disease control, making glaucoma stable longer and reducing future costs due to disease progression. The ICER was R$ 5,491.99/PFLY. The model was robust in sensitivity analyses. Conclusion: This analysis suggests that the incorporation of the iStent® Trabecular Micro-Bypass combined with cataract surgery would be cost-effective for joint cataract and POAG treatment in the supplementary health setting in Brazil.

One-Year Comparative Evaluation of iStent or iStent inject Implantation Combined with Cataract Surgery in a Single Center.

INTRODUCTION: This retrospective consecutive case series assessed 12-month effectiveness and safety of iStent® or iStent inject® trabecular micro-bypass implants with cataract surgery in patients with open-angle glaucoma (OAG) in a real-world clinical setting. METHODS: Effectiveness outcomes consisted of intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving IOP < 18, < 15, or < 12 mmHg; and proportional analysis of medication usage. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA). RESULTS: This evaluation included 58 eyes with OAG (35 iStent, 23 iStent inject), with 96.6% of eyes having mild or moderate glaucoma. Diagnoses included primary open-angle glaucoma (the majority; 72.4%), pseudoexfoliative glaucoma, and pigmentary glaucoma. Baseline mean IOP and medications were statistically comparable between groups: 16.1 ± 3.6 mmHg on a mean of 1.8 ± 0.8 medications in the iStent group, and 16.2 ± 3.1 mmHg on a mean of 1.7 ± 0.8 medications in the iStent inject group. Twelve months after stent-cataract surgery, mean IOP was significantly lower in the iStent inject group than in the iStent group (13.1 mmHg vs. 15.4 mmHg, respectively; p < 0.001), and the percent reduction in IOP from baseline was significantly greater in iStent inject eyes than in iStent eyes (19.1% vs. 4.3% reduction, respectively; p < 0.001). At 12 months postoperative, significantly greater proportions of iStent inject eyes than iStent eyes achieved IOP < 18 mmHg (100% vs. 80.0% of eyes, respectively; p = 0.035), IOP < 15 mmHg (73.9% vs. 34.3% of eyes, respectively; p = 0.003), and IOP < 12 mmHg (26.1% vs. 0% of eyes, respectively; p = 0.002). Meanwhile, both groups achieved significant medication reductions at 12 months vs. baseline (94.1% reduction in iStent inject eyes, p < 0.0001; and 72.2% reduction in iStent eyes, p < 0.0001), with the percent reduction being significantly greater in iStent inject eyes than in iStent eyes (p = 0.023). At 12 months, mean number of medications was significantly lower in iStent inject eyes than iStent eyes (0.1 vs. 0.5 medications, respectively; p = 0.021), and significantly more iStent inject eyes (95.7%) than iStent eyes (71.4%) were off medications entirely (p = 0.021). A similarly high safety profile was observed in both groups. CONCLUSION: iStent or iStent inject implantation with cataract surgery resulted in substantial and safe reductions in IOP and medications through 12 months postoperative. Consistent with prior observations, greater efficacy was observed with iStent inject than with iStent. FUNDING: The Rapid Service Fees were funded by Glaukos Corporation.

Avaliação econômica do glaucoma primário de ângulo aberto / Economic evaluation of primary open-angle glaucoma

Resumo Objetivo: Avaliar a relação custo-utilidade do tratamento inicial com laser ou medicamentos do glaucoma primário de ângulo aberto (GPAA) no Brasil, considerando de um lado os custos totais e de outro lado o impacto na qualidade de vida dos pacientes. Métodos: O estudo foi realizado com base em um modelo de Markov, onde uma coorte teórica de portadores de GPAA em estágio inicial foi gerada. Os parâmetros usados no modelo foram obtidos na literatura e incluíram: custos médicos diretos (consultas, exames, tratamento); custos não médicos diretos (gasto com hospedagem, transporte, alimentação, acompanhante); custos indiretos (relacionados à incapacidade para o trabalho); valores de utilidade (qualidade de vida medida em QALY - quality-adjusted life year); e probabilidade de transição entre os estágios de saúde. Três estratégias de tratamento foram testadas no modelo: (1) sem tratamento; (2) tratamento inicial com colírios; (3) tratamento inicial com trabeculoplastia a laser. A medida de desfecho foi a razão de custo-utilidade incremental (RCUI). A robustez do modelo foi testada através de análise de sensibilidade. Resultados: As estratégias (2) e (3) de tratamento inicial do GPAA geraram ganhos em qualidade de vida em relação à (1) no Brasil. Iniciar o tratamento com laser gerou ganho médio de 1 QALY, enquanto que com medicamentos propiciou um ganho de 2 QALYs em média. Dentre as três estratégias testadas, a estratégia (2) foi a custo-efetiva e foi dominante sobre as demais, pois foi ao mesmo tempo a mais barata e a mais efetiva. Conclusão: Tanto a trabeculoplastia a laser quanto os medicamentos como tratamentos primários do GPAA inicial geraram ganhos significativos de qualidade de vida. A estratégia de se iniciar o tratamento com medicações foi custo-efetiva, quando se considera os custos totais. A alternativa de tratamento inicial através de trabeculoplastia a laser não foi custo-efetiva.

Abstract Objective: To evaluate the cost-utility relation of the initial treatment with laser or primary open-angle glaucoma medications (PLA) in Brazil, considering on the one hand the total costs and on the other side the impact on patients' quality of life. Methods: The study was performed based on a Markov model, where a theoretical cohort of early-stage GPAA carriers was generated. The parameters used in the model were obtained in the literature and included: direct medical costs (consultations, examinations, treatment); direct non-medical costs (accommodation, transportation, meals, companions); indirect costs (related to incapacity for work); utility values (quality of life measured in QALY - quality-adjusted life year); and probability of transition between stages of health. Three treatment strategies were tested in the model: (1) without treatment; (2) initial treatment with eye drops; (3) initial treatment with laser trabeculoplasty. The measure of outcome was the incremental cost-utility ratio (RCUI). The robustness of the model was tested through sensitivity analysis. Results: The strategies (2) and (3) of the initial treatment of POAG generated gains in quality of life in relation to (1) in Brazil. Initiating the laser treatment generated an average gain of 1 QALY, whereas with medication it gave a gain of 2 QALYs on average. Among the three strategies tested, strategy (2) was cost-effective and was dominant over the other strategies, since it was at the same time the cheapest and the most effective strategy. Conclusion: Both laser trabeculoplasty and medications as primary treatments of early-stage POAG have generated significant gains in quality of life. The strategy of starting treatment with medications was cost-effective, whereas laser trabeculoplasty strategy was not cost-effective, when non-medical costs (direct and indirect) are included.

Custos não médicos diretos e indiretos relacionados ao glaucoma primário de ângulo aberto no Brasil / Non-medical direct and indirect costs related to primary open-angle glaucoma in Brazil

RESUMO Objetivo: Identificar os custos não médicos diretos e indiretos em uma população de pacientes portadores de glaucoma primário de ângulo aberto (GPAA) em tratamento no Brasil. Métodos: A pesquisa dos custos neste estudo transversal foi realizada através de entrevista a uma população de pacientes portadores de GPAA em acompanhamento em um centro de referência para o tratamento do glaucoma na cidade de Juiz de Fora - MG. Para avaliação dos custos não médicos diretos, as seguintes variáveis foram investigadas: gasto com transporte, hospedagem, alimentação e acompanhante para cada consulta. Já na análise dos custos indiretos, avaliou-se: recebimento ou não de benefício social por causa do glaucoma (aposentadoria ou auxílio-doença) e qual o valor anual e perda de dias trabalhados pelo paciente e/ou pelo acompanhante. Os valores médios anuais foram calculados para todo o grupo e para cada estágio evolutivo do glaucoma. Resultados: Setenta e sete pacientes foram incluídos nesta análise (GPAA inicial: 26,0%; GPAA moderado: 24,7% e GPAA avançado: 49,3%). A média do custo não médico direto foi (em reais): 587,47; 660,52 e 708,54 para os glaucomas iniciais, moderados e avançados, respectivamente. Já a média do custo indireto foi: 20.156,75 (GPAA inicial); 26.988,16 (moderado) e 27.263,82 (avançado). Conclusão: Os custos não médicos diretos e indiretos relacionados ao GPAA no Brasil foram identificados. Os custos indiretos são superiores aos custos não médicos diretos e ambos tendem a aumentar com o avanço da doença.

ABSTRACT Objective: To identify direct and indirect non-medical costs in a population of patients with primary open-angle glaucoma (POAG) receiving treatment in Brazil. Methods: In this cross-sectional study, we obtained the costs through an interview with a population of patients with POAG at a glaucoma referral clinic in the city of Juiz de Fora - MG. In order to assess the direct non-medical costs, we investigated the following variables transportation expenses, lodging expenses, food and companion expenses for each visit. In the indirect costs analysis, we assessed the following variables: whether or not social benefits were received because of glaucoma (retirement or sickness benefit) and the annual value and loss of days worked by the patient and/or the companion. We calculated the mean annual values for the whole group and for each glaucoma stage. Results: Seventy-seven patients were included in this analysis (initial POAG: 26.0%, moderate POAG: 24.7% and advanced POAG 49.3%). The mean non-medical direct cost was (in reais): 587.47; 660.52 and 708.54 for the initial, moderate and advanced glaucomas, respectively. The mean indirect cost was: 20,156.75 (initial POAG); 26,988.16 (moderate POAG) and 27,263.82 (advanced POAG). Conclusion: We identified the direct and indirect non-medical costs related to POAG in Brazil. Indirect costs are higher than non-medical direct costs and both tend to increase with disease progression.

Intermediate Results of iStent or iStent inject Implantation Combined with Cataract Surgery in a Real-World Setting: A Longitudinal Retrospective Study.

INTRODUCTION: In this real-world, retrospective, comparative study we evaluated 6-month performance and safety in consecutive eyes following implantation of the iStent® or iStent inject® trabecular micro-bypass device with concomitant cataract surgery. METHODS: Performance outcomes included intraocular pressure (IOP) reduction; glaucoma medication reduction; proportions of eyes achieving an IOP of < 18, < 16, < 14, or < 12 mmHg; and proportions of eyes on 0, 1, 2, or ≥ 3 medications. Safety outcomes included adverse events, secondary surgeries, and best-corrected visual acuity (BCVA). RESULTS: A total of 73 eyes with open-angle glaucoma and cataract were included in the study; of these, 38 eyes were implanted with the iStent device and 35 were implanted with the iStent inject device. The two groups of patients had similar baseline characteristics, with the exception of mean age and medication burden (both higher in patients receiving the iStent inject device); over 90% of eyes in both groups had early glaucoma. At 6 months after surgery, mean IOP had fallen from 16.5 ± 3.9 to 13.9 ± 2.3 mmHg in eyes with the iStent implant (p < 0.001), and from 17.3 ± 3.0 to 12.7 ± 1.8 mmHg in those with the iStent inject implant (p < 0.001). This reduction was significantly greater in the iStent inject eyes than in the iStent eyes (26.6 vs. 15.8%) (p = 0.005). Significantly more eyes receiving the iStent inject device compared to the iStent device achieved an IOP of < 18 mmHg at 6 months post surgery (100 vs. 86.8%) (p = 0.033). Average medication usage was reduced from 1.8 to 0.4 medications in iStent eyes (p < 0.001) and from 2.3 to 0.4 medications in iStent inject eyes (p < 0.001). Over 70% of eyes in both groups became medication-free by 6 months post implantation. Adverse events in iStent eyes were mild and resulted in no sequelae; two iStent eyes underwent non-penetrating deep sclerectomy during follow-up. No complications or secondary surgeries were noted in iStent inject eyes. All eyes in both groups maintained or showed improved BCVA versus baseline. CONCLUSION: Significant and safe IOP and medication reductions were observed after iStent or iStent inject implantation with concomitant cataract surgery. Trends toward greater effectiveness and fewer adverse events were observed with the iStent inject device compared with the iStent device. FUNDING: Article processing charges were provided by Glaukos Corporation.

Controle da hipertensão arterial sistêmica: uma proposta de intervenção na Estratégia Saúde da família no município de Piraúba - Minas Gerais

A Hipertensão Arterial Sistêmica é um das mais comuns doenças cardiovasculares e por ser de curso assintomático, seu tratamento é feito de forma inadequada pelos indivíduos que possuem a enfermidade. A baixa adesão à terapia medicamentosa para HAS constitui maior desafio terapêutico, com isso, identificar os fatores que contribuem para esta não adesão ao tratamento pode contribuir para a elaboração de estratégias de intervenção bem sucedidas. A hipertensão é um problema de extrema importância na saúde, pois a mortalidade por doença cardiovascular aumenta progressivamente com a elevação e descontrole da pressão arterial, sendo assim, sua detecção, tratamento e controle são fundamentais para reduzir este índice. O presente estudo tem como objetivo elaborar um plano de intervenção visando aumentar a adesão dos usuários ao tratamento da HAS da área de abrangência da ESF IV - Dra. Ana Lúcia Boim de Freitas. Para subsidiar o projeto de intervenção foi feita uma revisão narrativa. O diagnóstico situacional da área foi realizado através do Planejamento Estratégico Situacional, sendo utilizada a metodologia de Estimativa Rápida para se chegar aos problemas enfrentados pela comunidade. Apesar das dificuldades, a implementação do plano de ação proposto apresenta vantagens como um diagnóstico adequado da hipertensão e classificação de risco, auxiliando a prevenção e tratamento precoce das complicações e a priorização das medidas de promoção à saúde.