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.

The outcomes of a low-cost, non-valved glaucoma drainage device using mitomycin-C: 1-year results.

PURPOSE: To evaluate the indications, outcomes, and complications of the usage of Aurolab Aqueous Drainage Implant (AADI) using mitomycin-C. METHODS: A retrospective case series of patients who underwent AADI placement using mitomycin-C between April 2018 and June 2020 at Ain Shams University Hospitals, Cairo, Egypt. The data was extracted from the records of the patients with a minimum of 1 year of follow-up. Complete success was defined as IOP ≥ 5 mmHg and ≤ 21 mmHg or reduction of IOP by ≥ 20% from baseline without antiglaucoma medications (AGMs). Qualified success was defined as reaching the same IOP range with the aid of AGM. RESULTS: A total of 50 eyes of 48 patients were included. Neovascular glaucoma represented the commonest indication (13 patients, 26%). The mean preoperative IOP was 34.0 ± 7.1 mmHg, with a median number of AGM of 3 (mean ± SD = 2.84 ± 1), while the mean IOP after 12 months was 14.3 ± 4 with a median number of AGM of 0. (mean ± SD = 0.52 ± 0.89) (p < 0.001). Complete success was achieved in 33 patients (66%). Qualified success was achieved in 14 patients (28%). Thirteen eyes (26%) had variable postoperative complications; none of them required explantation of the device or affected the visual acuity (except one patient). CONCLUSION: AADI with using mitomycin-C and ripcord during the surgery is an effective and relatively safe method of control of IOP in refractory and advanced cases of glaucoma, with an overall success rate of 94%.

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

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

Management of a recurrent encapsulated bleb with a cost-effective non-valved glaucoma drainage device.

Despite the advancements in the surgical management of glaucoma, childhood glaucoma remains a challenging surgical disease worldwide. An early adolescent boy with primary congenital glaucoma, status after glaucoma drainage device (GDD) implantation, on maximum medical therapy, was presented with a swelling in the superotemporal orbital region. The patient had undergone an uneventful GDD implantation 2 years prior to presentation. A similar swelling, which was diagnosed to be a Tenon's cyst, had been excised on three earlier occasions. Given that the repeat capsular excision would also have the same likelihood of failure, and poor intraocular pressure control, a non-valved, cost-effective Aurolab aqueous drainage implant (AADI, Aurolab, Madurai, India) implantation was done inferonasally. In this patient, AADI proved to be a safe and effective alternative for the known GDDs.

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

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

Assessment of the Role and Timing of Glaucoma Surgery in Boston Keratoprosthesis Type 1 Patients.

PURPOSE: To determine the role and optimal timing of glaucoma surgery in relation to Boston keratoprosthesis type 1 (KPro) implantation. DESIGN: Retrospective, comparative, nonrandomized clinical study. METHODS: Single-center study of a total of 100 eyes (100 patients) implanted with a KPro between 2008 and 2017, and diagnosed with glaucoma before or after KPro. Patients were separated into 2 groups: those with preexisting glaucoma and those who developed de novo glaucoma after KPro. Groups were then divided based on whether patients were medically or surgically managed. Glaucoma surgery included glaucoma drainage device (GDD) implantation, trabeculectomy, and cyclophotocoagulation (CPC). Primary outcomes included best-corrected visual acuity (BCVA), glaucoma progression, and complications. Differences in outcomes were compared using parametric and nonparametric tests, as well as log-rank test to compare time-to-outcome events. RESULTS: Among 72 eyes with preexisting glaucoma, 27 (38%) had glaucoma surgery before KPro (18 GDD), whereas 45 (62%) were medically managed only. Among the latter, 19 (42%) needed glaucoma surgery post-KPro (16 GDD). Among 28 eyes with de novo glaucoma, 12 (43%) had glaucoma surgery post-KPro (9 GDD). For eyes with preexisting glaucoma, glaucoma progression was greater with glaucoma surgery performed post-KPro (100%) compared with pre-KPro (74%, P = .016) and to medical management (54%, P = .002). No increase in complications were observed with glaucoma surgery compared to medications only (P > .05), whereas fewer eyes maintained a BCVA of 20/200 or better over time with medical management (P = .013). Eyes with de novo glaucoma had similar progression, BCVA, and complications between medical and surgical care (P > .05). CONCLUSIONS: Glaucoma surgery should be performed before or at the same time as KPro implantation in eyes with preexisting glaucoma. Complication rates are not increased when glaucoma surgery is performed in KPro eyes with either preexisting or de novo glaucoma. To ensure optimal glaucoma control, glaucoma surgery should be performed as early as possible in KPro eyes with good visual potential.

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.

Implante de drenagem oftalmológico no tratamento do glaucoma primário de ângulo aberto leve a moderado / Ophthalmic drainage implant in the treatment of mild to moderate open angle primary glaucoma

INTRODUÇÃO: O glaucoma é uma neuropatia ótica degenerativa que evolui com perda do campo visual e cegueira. A pressão intraocular superior a 21 mmHg é estratégia diagnóstica padrão-ouro e o controle do quadro clínico é considerado como fator associado a retardo na progressão da doença. O tratamento usual é realizado por colírios ou cirurgia para casos refratários. O produto em saúde que avaliado neste relatório consiste em procedimento cirúrgico microinvasivo com implante de microstent, que tem como objetivo reduzir a pressão intraocular e controlar a progressão da doença. TECNOLOGIA: iStent inject® Trabecular Micro-Bypass System. PERGUNTA: iStent é seguro, eficaz e custo-efetivo em relação ao tratamento com colírios para adultos com glaucoma primário de ângulo aberto após falha de pelo menos um colírio? EVIDÊNCIAS CIENTÍFICAS: O demandante apresentou dois estudos como evidência, no entanto, após análise do material o parecerista externo considerou que a busca por evidências realizada mostrou incoerência entre a estrutura da pergunta de pesquisa proposta, a elaboração da busca e a estratégia de seleção dos estudos. Assim, nova pergunta de pesquisa e busca na literatura foram feitas, onde apenas um estudo de alto risco de viés foi identificado. De acordo com essa evidência, o efeito do dispositivo foi semelhante ao uso de colírios, com a única vantagem de reduzir o número de aplicações, no entanto, o procedimento apresenta riscos de complicações a serem consideradas. AVALIAÇÃO ECONÔMICA: Foi realizado um estudo de custo-efetividade com método de modelagem de Markov, horizonte temporal lifetime e taxa de desconto anual de 5%. Frente a ausência de claro benefício da tecnologia na evidência clínica, não foi elaborado um novo modelo pelo parecerista externo. O modelo do demandante apresenta o pressuposto que o esquecimento de doses leva a redução do campo visual, o que foi considerado inadequado. No cenário base, foi obtida a razão de custo efetividade incremental (RCEI) de R$ 12.595,26 por ano de vida ganho ajustado pela qualidade (QALY) e no cenário alternativo, R$ 9.139,78/QALY. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: Foi estimado um impacto orçamentário incremental de R$ 8.221.464 no primeiro ano, chegando a R$ 78.417.260 em 5 anos, com o uso do dispositivo. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram encontrados dois depósitos patentários relacionados a implantes oftalmológicos para o tratamento de glaucoma. O primeiro trata-se de um depósito patentário internacional que também possui pedido em âmbito nacional. O referido pedido apresenta um dispositivo ocular implantável e seu respectivo procedimento cirúrgico minimamente invasivo para o seu implante. O segundo é um pedido sem depósito nacional e que se trata de um implante de drenagem destinado ao tratamento cirúrgico de glaucoma primário de ângulo aberto, confeccionado em material acrílico hidrofílico na forma de segmento de anel. CONSIDERAÇÕES: O iStent possui moderada qualidade de evidência para redução da PIO, desfecho substituto para perda da visão em pacientes com GPAA. A magnitude de efeito de redução da PIO é semelhante ao obtido com colírios. O uso de iStent associa-se com o benefício da redução da necessidade do uso de colírios ou redução da quantidade de colírios necessários para a redução da PIO. No entanto, o dispositivo necessita de especialistas treinados para sua implementação. O impacto orçamentário em 5 anos foi estimado em cerca de 78 milhões de reais. Não foi elaborado novo modelo de custo-efetividade pois a efetividade do iStent versus colírios foi considerada semelhante e o custo superior. RECOMENDAÇÃO PRELIMINAR DA CONINTEC: Diante do exposto, a Conitec, em sua 99ª reunião ordinária, realizada no dia 30 de junho de 2021, deliberou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar não favorável à incorporação, no SUS, do implante de drenagem oftalmológico para o tratamento de pacientes com glaucoma de ângulo aberto que falharam ao uso de pelo menos um colírio. Justificou-se esta recomendação com base no alto impacto orçamentário calculado e na fragilidade da evidência científica, que não suportou piora na evolução do tratamento clínico devido a uma menor aderência aos colírios, sugerindo semelhança de efeitos desejáveis entre o implante e os colírios. Além disso, foi observado maior risco de complicações e mínimo benefício clínico no uso do implante, se comparado ao uso de colírios. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: A Consulta Pública nº 69/2021 foi realizada entre os dias 23/07/2021 e 11/08/2021. Foram recebidas 72 contribuições, sendo 17 pelo formulário para contribuições técnico-científicas e 55 pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. Assim, o Plenário da Conitec entendeu que houve argumentação suficiente para mudança de entendimento acerca de sua recomendação preliminar. RECOMENDAÇÃO FINAL DA CONITEC: Pelo exposto, o Plenário da Conitec, em sua 101ª Reunião Ordinária, no dia 01 de setembro de 2021, deliberou por unanimidade recomendar a incorporação no SUS do implante de drenagem oftalmológico para o tratamento de pacientes com glaucoma primário de ângulo aberto leve a moderado que falharam ao uso de pelo menos um colírio, conforme Protocolo estabelecido pelo Ministério da Saúde. Assim, foi assinado o Registro de Deliberação nº 659/2021. DECISÃO: Incorporar o implante de drenagem oftalmológico no tratamento do glaucoma primário de ângulo aberto leve a moderado, no âmbito do Sistema Único de Saúde ­ SUS, conforme a Portaria nº 68, publicada no Diário Oficial da União nº 192, seção 1, página 96, em 08 de outubro de 2021.

Impact of iStent Micro-Bypass Shunt on Medicare Part B Glaucoma Surgical Expenditure.

PURPOSE: To examine the impact of the iStent (Glaukos) on the recent glaucoma surgical expenditure for Medicare Part B beneficiaries. DESIGN: Retrospective, observational, population-based analysis. PARTICIPANTS: All applicable cases in the Centers for Medicare and Medicaid Services Part B Summary Data Files. METHODS: The Part B National Summary Data Files from 2007 to 2017 were obtained through the Centers for Medicare and Medicaid Services. Glaucoma surgical procedures, including trabeculectomy, glaucoma drainage implants (GDIs), and select minimally invasive glaucoma surgeries (MIGS) including the iStent, were queried from the database using Current Procedural Terminology (CPT) codes. We used Chow's test to confirm significant changes in expenditure trajectories. We built a mixed-effects regression model to examine the effect of demographic factors on each state's iStent adoption speed. MAIN OUTCOME MEASURES: Proportion of iStent in total glaucoma surgical spending for individual states for each year. RESULTS: Total Medicare part B payment for the selected glaucoma procedures increased from $52.0 million in 2007 to $179.9 million in 2017. The percentage for trabeculectomy and GDIs decreased from 92.3% to 21.2%. Conversely, the iStent, approved by the Food and Drug Administration in 2012, increased to represent 57.9% of total payment by 2017. There were significant changes in the slope of glaucoma surgical Medicare payment (P < 0.00001) and iStent payment (P < 0.0001) trajectories in 2012. Mixed-effect regression analysis showed a wide range among the states' rates of increase in iStent proportion between 2012 and 2017 (range, 5.12%-14.54% per year). Higher male proportion in the population was associated with faster increases in iStent proportions (12.4% per 5% increase in male proportion, 95% confidence interval [CI], 4.3-20.5, P = 0.003). Higher median age of the population was associated with slower increases (-3.6% per 1-year increase in median age, 95% CI, -0.4 to -6.8, P = 0.026). CONCLUSIONS: Increasing payment for the iStent represents the majority of the increase in glaucoma surgical spending in the recent decade. Male gender and age significantly affect the state-wise speed of adoption for the iStent. The impact of the iStent on the comprehensive glaucoma Medicare expenditure in the same time period warrants further study.

Outcome of a low-cost glaucoma drainage device with posterior chamber/pars plana insertion of the tube.

INTRODUCTION: The Aurolab aqueous drainage implant (AADI) is a low-cost glaucoma drainage device that is modelled on the Baerveldt glaucoma implant. Studies on AADI have reported absolute success rates of 41.8-93.1% at 1 year. Most studies report on tube placement in the anterior chamber. We report on results of tube insertion in the sulcus/pars plana. MATERIAL AND METHODS: A retrospective chart review of all patients who had undergone AADI implantation (with insertion of tube in the sulcus/posterior segment) between June 2015 and November 2018 was done. Patients were asked to stop anti-glaucoma medications on the 40th post-operative day. RESULTS: The mean age was 57.4 ± 13.8 years (n = 30). The mean IOP prior to surgery was 34.4 ± 6.1 mmHg which reduced to 15.4 ± 8.6 mmHg on the 45th post-operative day (p < 0.001). The absolute success at last review was 10% and the qualified success was 80%. The complication rate was 26.7%. Three patients had hypotony related complications noted at/after the 45th day review (none before 40th day). The incidence of ocular motility disturbances was 26.7% though none of the patients reported diplopia. One patient had sideways rotation of the scleral patch graft resulting in tube exposure. This complication was not seen after we shifted to using 9-0 nylon sutures to anchor the graft. Six patients had loss of best corrected visual acuity and one patient developed endophthalmitis. The endophthalmitis was preceded by conjunctival retraction and sloughing off of the scleral patch graft. DISCUSSION: AADI implantation results in a substantial drop in IOP. However, many patients continue to require anti-glaucoma medications. Allowing overlap of scleral/corneal patch graft onto the scleral flap may be effective in preventing peritubular leak. It may be advisable to use 9-0 nylon sutures to secure the scleral patch graft anti-glaucoma medications can be temporarily suspended after the 40th post-operative day to minimize hypotony related complications. Melting of the scleral patch graft may be an early sign of endophthalmitis. It would be prudent to specifically look for ocular motility problems in patients undergoing AADI implantation.

Minimally Invasive Glaucoma Surgery: A Critical Appraisal of the Literature.

Micro- or minimally invasive glaucoma surgeries (MIGS) have been the latest addition to the glaucoma surgical treatment paradigm. This term refers not to a single surgery, but rather to a group of distinct procedures and devices that aim to decrease intraocular pressure. Broadly, MIGS can be categorized into surgeries that increase the trabecular outflow [Trabectome, iStent (first and second generations), Hydrus microstent, Kahook Dual Blade and gonioscopy-assisted transluminal trabeculotomy], surgeries that increase suprachoroidal outflow (Cypass microstent and iStent Supra), and conjunctival bleb-forming procedures (Xen gel stent and InnFocus microshunt). Compared to traditional glaucoma surgeries, such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves), MIGS are touted to have less severe complications and shorter surgical time. MIGS represent an evolving field, and the efficacy and complications of each procedure should be considered independently, giving more importance to high-quality and longer-term studies.

Impacto financeiro no tratamento cirúrgico do glaucoma / Financial impact on glaucoma surgical treatment

Resumo Objetivo: Segunda maior causa de cegueira mundial, o glaucoma, ocasionalmente necessita de procedimento cirúrgico para controle. Tendo o Brasil um Sistema Único de Saúde (SUS), e crise político-econômica em 2016, objetiva-se avaliar o impacto financeiro na decisão terapêutica do glaucoma nos últimos 6 anos no Brasil, e considerar atual discussão sobre indicação de procedimentos intervencionistas precocemente no seu algoritmo terapêutico. Métodos: Estudo ecológico da população brasileira, com base no Sistema de Informações Hospitalares do SUS, avaliando comportamento temporal dos procedimentos cirúrgicos do SUS para tratamento do glaucoma, e variação do dólar como influenciador da tendência temporal sobre os procedimentos. Realizada a análise de Regressão Linear Simples, com significância estatística de P<0.05. Resultados: Entre 2013 e 2018 foram internados 24888 indivíduos por glaucoma, prevalência do sexo masculino (51.68%), brancos (32,57%) e idosos (57.84%). Regiões Sudeste (45.61%) e Nordeste (26.36%) com maior número de internações, sendo a Trabeculectomia (84,18%) principal procedimento realizado. Houve associação da Trabeculectomia e Implante de Válvula, individualmente e atrelados, com os valores do dólar nas regiões Centro-Oeste (β= 1,103 com P= 0,007 para Trabeculectomias e β= 1,105 com P=0,012 para ambos os procedimentos) e Sul (β= 16,727 e P= 0,006 para os Implantes), e associação entre aumento de Implantes na região Sul e maior cobertura na atenção básica (β= 0.64 e P= 0.009). Conclusão: Observou-se não interferência do dólar, e aumento dos procedimentos na região Sul e Centro-Oeste. Os resultados corroboram tendência intervencionista, podendo ser representada pelo possível uso dos procedimentos disponibilizados pelo SUS de forma precoce.

Abstract Objective: The second leading cause of blindness worldwide, glaucoma, occasionally requires surgical procedure for control. Given that Brazil has an Unified Health System (SUS) and a political-economic crisis in 2016, we aim to evaluate the financial impact on the therapeutic decision of glaucoma in the last 6 years in Brazil, and to consider the current discussion about early interventionist indication in its therapeutic algorithm. Methods: Ecological study of the Brazilian population, based on the SUS Hospital Information System, evaluating the temporal behavior of SUS surgical procedures on glaucoma treatment, and dollar variation as influencing the temporal trend on the procedures. Simple Linear Regression analysis was performed, with statistical significance of P <0.05. Results: Between 2013 and 2018, 24888 individuals were hospitalized for glaucoma, male prevalence (51.68%), whites (32.57%) and elderly (57.84%). Southeast (45.61%) and Northeast (26.36%) Regions with the largest number of hospitalizations, and Trabeculectomy (84.18%) being the main procedure performed. There was an association of trabeculectomy and valve implantation, individually and linked, with dollar values in the Midwest (β = 1.103 with P = 0.007 for Trabeculectomies and β = 1.105 with P = 0.012 for both procedures) and South (β). = 16,727 and P = 0,006 for Implants), and association between increased Implants in the South region and greater coverage in primary care (β = 0.64 and P = 0.009). Conclusion: Non-dollar interference was observed, and increased procedures in the South and Midwest. The results corroborate an interventionist tendency and may be represented, possible, by the use of procedures provided by the SUS in an early manner.

Automated Gonioscopy Assessment of XEN45 Gel Stent Angle Location After Isolated XEN or Combined Phaco-XEN Procedures: Clinical Implications.

PRéCIS:: Angle location of the XEN implant both in isolated and in combined procedures did not appear to influence long-term outcomes. However, more posterior stent placements seem to be associated with increased early postoperative complications. PURPOSE: The purpose of this study was to assess success and safety outcomes of different levels of insertion of the XEN45 gel stent in the angle in standalone and combined procedures. METHODS: This was a cross-sectional study of patients in whom XEN had been implanted without intraoperative gonioscopy. Automated gonioscopy was used for postoperative analysis of the XEN location, classified as anterior or posterior relative to the scleral spur. Absolute success was defined as ≥20% intraocular pressure decrease from baseline and ranging from 6 to 21 mm Hg without medication and qualified success if medicated. The need for additional drainage surgery was considered failure, but needling was allowed. Clinical data were retrieved from patient files. RESULTS: Gonioscopy-assisted XEN location was performed on 42 eyes of 33 patients (14 isolated and 28 combined procedures) on average 18±9 months after surgery. Absolute (32% vs. 35%; P>0.99) and qualified (44% vs. 65%; P=0.22) success was similar in both anterior and posterior placements, respectively. Kaplan-Meier survival analysis yielded similar median survival times for both groups. The distribution of XEN insertion level in the angle was similar in standalone and combined procedures (P=0.75). Although overall safety outcome measures did not differ significantly, the proportion of intraoperative and early postoperative complications was higher in posterior XEN placements (P=0.03). CONCLUSIONS: Different locations of XEN45 did not seem to significantly impact late success and safety outcomes, although stents inserted more posteriorly may be associated with a higher rate of early complications. Combined implantation of XEN with phacoemulsification does not seem to influence stent location in the iridocorneal angle in a setting without intraoperative gonioscopy.

Two-Year Outcomes of the New Low-cost Nonvalved Aurolab Aqueous Drainage Implant in Refractory Glaucoma.

PURPOSE: This study aimed to report the 2-year surgical outcomes in terms of efficacy and safety of the relatively new, indigenously manufactured, low-cost nonvalved drainage device Aurolab Aqueous Drainage Implant (AADI) in the management of refractory glaucomas in the Indian population. METHODS: A retrospective review of consecutive patients older than 12 years, who underwent nonvalved glaucoma drainage device surgery via AADI, was performed by a single fellowship-trained surgeon, between January 2014 and January 2018, who had at least 12 months of documented postoperative follow-up. OUTCOME MEASURES: Primary-intraocular pressure (IOP).Secondary-number of antiglaucoma medication (AGM), LogMAR best-corrected visual acuity and complications.Complete success was defined as IOP ≥5 and ≤21 mm Hg; qualified success was defined as fulfilling the above criteria with the use of AGM. Failure was defined as the inability to fulfill the IOP criteria, loss of perception of light, explantation, or any additional glaucoma surgery. RESULTS: A total of 48 eyes of 46 patients were included with a median follow-up of 24 months (quartile 1=16, quartile 3=31.25; interquartile range=15.25) (mean=24.9 mo; SD=10.1). The IOP and number of AGM required was significantly lower at every timepoint postoperatively (P<0.001). The median LogMAR best-corrected visual acuity remained unchanged (P=0.307). Complications occurred in 21 patients (43.7%); some eyes had >1 complication. Complete success was seen in 56.3%; overall success was 87.5%. CONCLUSIONS: The safety and efficacy of the new nonvalved glaucoma drainage device, AADI, remain in its second year after implantation. Still further follow-up is recommended, as it has the ability to breach the cost barrier in newly industrialized nations worldwide.

Long-term outcome of low-cost glaucoma drainage device (Aurolab aqueous drainage implant) compared with Ahmed glaucoma valve.

PURPOSE: To compare the long-term outcome of Aurolab aqueous drainage device (AADI) and Ahmed glaucoma valve (AGV). METHOD: Retrospective analysis of patients with refractory glaucoma who underwent AGV (AGV-FP7) and AADI (AADI Model 350) implantation. The outcome measures were intraocular pressure (IOP), requirement of antiglaucoma medications (AGMs) and re-surgery for IOP control. The postoperative complications were classified as early (≤3 months), intermediate (>3 months to ≤1 year) or late (>1 year). RESULTS: 173 patients (189 eyes) underwent AGV implantation (AGV Group) while 201 patients (206 eyes) underwent AADI implantation (AADI group). The IOP in AADI group was significantly lower than AGV group at all time points till 2 years and comparable at 3 years. AADI group had significantly higher number of AGM in preoperative period and significantly lower number in postoperative period till 3 years compared with AGV group. AADI group had more hypotony-related complications but statistically insignificant (p = 0.07). The surgical interventions were significantly higher in AGV (n = 18) compared with AADI group (n = 5) in late postoperative period (p = 0.01). At 3 years, overall success was seen in 58.18% in AGV and 73.08% in AADI group (p = 0.15). Complete success was seen in 7.27% patients in AGV and 25.00% patients in AADI group (p = 0.02). CONCLUSION: Both AADI and AGV implant had comparable mean IOP at 3 years with lesser requirement of AGM in the AADI group. Both procedures appear to be safe with slight preponderance of hypotony-related complications in AADI group.

Intra-Scleral Ciliary Sulcus Suprachoroidal Microtube: Making Supraciliary Glaucoma Surgery Affordable.

PURPOSE: The suprachoroidal space (SCS) has been a successful target to lower intraocular pressure (IOP) in glaucoma patients. We present the results of 4 patients who underwent a novel glaucoma surgical procedure to lower IOP: Intrascleral Ciliary Sulcus-Suprachoroidal Microtube. METHODS: A sterile medical grade silicone microtube (Tube extender, New World Medical) was surgically placed to drain aqueous from the posterior chamber ciliary sulcus of the eye to the SCS. The internal diameter of the tube was 300 um and the length varied from 8-10mm. After informed consent was obtained and witnessed, this procedure was performed in glaucoma patients with pseudophakia. The tube was placed intrasclerally beneath an inferotemporal sclera flap (50% thickness approximately 4mm x 4mm). The anterior end of the tube was inserted into the ciliary sulcus approximately 2mm from the limbus and the posterior end was placed into the SCS approximately 4mm from the limbus. The microtube was sutured to the sclera with a 10-0 nylon suture. 8-0 vicryl sutures were used to close the sclera flap and the conjunctiva inferotemporally. RESULTS: All 4 patients had lower IOP. The average reduction of IOP was 36% at 3 months. The amount of glaucoma medications per patient at 3 months dropped from an average of 3 to 0.25. The risks are similar to traditional glaucoma incisional surgery. CONCLUSION: This new technique of Intrascleral Ciliary Sulcus-Suprachoroidal Microtube in all four patients with mild, moderate, and advanced glaucoma demonstrated a significant lowering of IOP and a decrease in the number of medications. Further research is required to assess long term efficacy and safety.

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database.

Importance: The iStent Trabecular Micro-Bypass (Glaukos Corporation) is a minimally invasive glaucoma implant used in conjunction with cataract surgery to lower intraocular pressure. Objective: To determine whether implantation of the iStent concurrent with cataract surgery is associated with reduced use of ocular antihypertensive medications in a US health care claims database. Design, Setting, and Participants: Retrospective, observational longitudinal cohort study of individuals enrolled in a US managed care network who underwent iStent implantation with cataract surgery (iStent/CEIOL) from 2012 to 2016 (n = 1509 bilateral and n = 1462 unilateral surgery). A control group of individuals who underwent bilateral cataract surgery only (CEIOL) were matched 1:1 to patients undergoing bilateral iStent/CEIOL on baseline demographic and clinical factors. Data were analyzed between November 1, 2017, and January 31, 2018. Main Outcomes and Measures: The number of topical ocular antihypertensive agents used postoperatively by patients undergoing iStent/CEIOL compared with baseline and with matched CEIOL control individuals, and hazard ratios with 95% confidence intervals for sustained reduced use of at least 1 topical ocular antihypertensive agent postoperatively. Results: Of the 2971 eligible enrollees, mean age at first surgery was 74.3 years, and 1659 (55.8%) were women. Patients undergoing iStent/CEIOL had diagnoses that included primary open-angle glaucoma (n = 2329; 78.4%), narrow angles (n = 381; 12.8%), and secondary glaucomas (n = 261; 8.8%). At baseline, 1223 (41.2%) were receiving no topical glaucoma agents; 876 (29.5%), 437 (14.7%), and 435 (14.6%) were receiving 1, 2, or at least 3 agents, respectively. Although only 678 persons (22.8%) completed at least 2 years of postoperative follow-up, the proportion of patients receiving no drops increased postoperatively (64.7%, 20-24 months, P < .001, χ2). Patients receiving at least 1 topical agent at baseline had mean reduction of 1.01 and 0.61 medications used at 20 to 24 months with bilateral or unilateral surgery, respectively (both P < .001, paired t). Sustained reduction in glaucoma medication use was more likely in patients receiving at least 3 vs 1 medication at baseline (hazard ratio, 1.68; 95% CI, 1.36-2.09). Compared with matched control individuals undergoing CEIOL, patients undergoing bilateral iStent/CEIOL had a greater mean reduction in drops used (0.99 vs 0.49; postoperative month 20-24; P < .001; paired t) and a higher proportion receiving no drops postoperatively (73.5% vs 55.3%, postoperative month 20-24; P < .001; χ2). Conclusions and Relevance: Implantation of the iStent trabecular micro-bypass stent concurrent with cataract surgery was associated with moderately reduced use of topical ocular antihypertensive medication. Reduction in the use of glaucoma medications may lessen the burden of medication adverse effects and promote better adherence.

Incidence, management and outcome of raised intraocular pressure in childhood-onset uveitis at a tertiary referral centre.

BACKGROUND/AIMS: To investigate the incidence, management and outcome of uveitis and raised intraocular pressure (IOP) in children treated at the Manchester Uveitis Clinic (MUC). METHODS: This was a retrospective, observational study of patients who presented with uveitis under the age of 16 to the MUC from July 2002 to June 2016. RESULTS: A total of 320 children were included in the study. Out of these, 55 (17.2%) patients (75 eyes) were found to have raised IOP requiring treatment. The mean age at diagnosis of uveitis and at first recorded raised IOP was 8.2±4.3 and 10.8±3.6 years, respectively. The pre-treatment IOP was 32.3±6.6 mm Hg and the IOP at the final visit was 15.5±3.7 mm Hg (median follow-up period, 43.7 months) on a median number of 0 medications. Twenty-eight eyes (37.3%) required glaucoma drainage surgery, and eight eyes (12.5%) had cyclodiode laser before this. Kaplan-Meier analysis showed that 11.5% of eyes required glaucoma surgery at 1 year after diagnosis of raised IOP, increasing to 50.0% by 5 years. The best-corrected visual acuity at diagnosis of uveitis was 0.26±0.42 logMAR, which remained stable at 0.28±0.65 logMAR at final follow-up visit. Four eyes (5.3%) from four patients fulfilled the definition of blindness by the WHO criteria. The mean cup:disc ratio at final follow-up was 0.4. CONCLUSION: Our cohort of children with raised IOP appeared to have a good outcome overall through aggressive medical and surgical management. Regular long-term follow-up is recommended, and early surgical intervention in eyes with uncontrolled IOP can prevent loss of vision.