Prospective evaluation of penetrating deep sclerectomy in advanced open-angle glaucoma: Filtration surgery adapted to resource scarcity in developing countries.

PURPOSE: Two of the hurdles that are facing ophthalmologists in developing countries are scarcity of resources and patient follow-up. Deep sclerectomy (DS) has proven less costly and more effective than topical therapies and has a more favorable safety profile than trabeculectomy. The main factors preventing its use in developing countries are the need to perform laser goniopuncture in 40-80% of cases to maintain filtration and the risk of postoperative iris incarceration. The purpose of this study is to assess the efficacy and safety profile in advanced open-angle glaucoma of a relatively new surgical technique designed to overcome this limitation: penetrating DS. SETTING: This was an investigator-initiated, prospective, interventional study, conducted at a single ophthalmology center in Kinshasa, Congo. The study was conducted in full compliance with the Declaration of Helsinki. METHODS: Fifty-one eyes (34 patients) with uncontrolled advanced primary open-angle glaucoma (visual field mean deviation<-10 dBs) were enrolled between October 2012 and June 2016. Age, gender, comorbidities (hypertension/diabetes), best-corrected visual acuity, topical medications, medicated and unmedicated intraocular pressure (IOP) were recorded. All patients underwent penetrating DS, during which, following standard dissection of the scleral flaps, the anterior chamber was penetrated through the trabeculo-Descemet membrane and an iridectomy was performed. Patients attended postoperative appointments at months 1, 3, 6 and 12. Surgical success was defined as a 20% reduction of IOP from baseline in conjunction with a 12-month unmedicated IOP≤12mmHg. RESULTS: The mean age was 64.5±14.0 years (44.1% female, 100% African). Mean IOP decreased from 20.2±6.1 (medicated) and 30.7±9.8mmHg (unmedicated) preoperatively to 12.1±4.1 at 12 months. Concomitantly, the number of topical medications decreased from 1.5±0.7 to 0.0. Complete surgical success was achieved in 64.7%. Four eyes (7.8%) were considered surgical failures due to uncontrolled IOP. None of the eyes lost light perception or required additional surgery. A significant association between surgical failure and hypertension was observed (HR=1.49; P=0.008). There were no intraoperative complications. Postoperatively, 4 bleb encapsulations (7.8%) and 1 iris incarceration (2%) were observed. CONCLUSIONS: The present study demonstrates that penetrating DS achieved similar efficacy and safety results to traditional non-penetrating DS. In addition, it showed a lower potential for intraoperative complications, which might be associated with a more benign surgical learning curve. Finally, the rates of serious postoperative complications (iris incarceration, choroidal effusion and hypotony) were significantly lower than in DS and trabeculectomy, and this technique does not require subsequent Nd: YAG laser goniopuncture to maintain filtration, making frequent follow-up visits less critical. In view of these findings, perforating deep sclerectomy could offer a viable option for glaucoma management in developing countries as well as worldwide.

Cost-effectiveness comparison between non-penetrating deep sclerectomy and maximum-tolerated medical therapy for glaucoma within the Brazilian National Health System (SUS) / Comparação de custo-efetividade entre a esclerectomia profunda não penetrante e a terapia clínica máxima tolerada para o glaucoma no Sistema Único de Saúde (SUS)

PURPOSE: Non-penetrating deep sclerectomy (NPDS) has emerged as a viable option in the surgical management of open-angle glaucoma. Our aim is to assess the cost-effectiveness of NPDS and to compare it to maximum medical treatment in a 5-year follow-up. METHODS: A decision analysis model was built. Surgical (NPDS) arm of the decision tree was observational (consecutive retrospective case series) and maximum medical treatment arm was hypothetical. Maximum medical therapy was considered a three-drug regimen (association of a fixed combination of timolol/dorzolamide [FCTD] and a prostaglandin analogue [bimatoprost, latanoprost or travoprost]). Cost-effectiveness ratio was defined as direct cost (US dollars) for each percentage of intraocular pressure (IOP) reduction. Horizon was 5 years and perspective is from the public health care service in Brazil (SUS). Incremental cost-effectiveness ratio (ICER) was calculated. RESULTS: Direct cost for each percentage of IOP reduction in 5 years (cost-effectiveness ratio) was US$ 10.19 for NPDS; US$ 37.45 for the association of a FCTD and bimatoprost; US$ 39.33 for FCTD and travoprost; and US$ 41.42 for FCTD and latanoprost. NPDS demonstrated a better cost-effectiveness ratio, compared to maximum medical therapy. The ICER was negative for all medical treatment options; therefore NPDS was dominant. CONCLUSIONS: Despite some limitations, NPDS was both less costly and more effective than maximum medical therapy. From the Brazilian public health perspective, it was the most cost-effective treatment option when compared to maximum medical therapy (FCTD and prostaglandin).

OBJETIVO: A esclerectomia profunda não penetrante (EPNP) é uma opção viável para o tratamento cirúrgico do glaucoma de ângulo aberto. O objetivo deste estudo é avaliar a relação custo-efetividade da EPNP e compará-la com terapia clínica máxima (TCM) em um acompanhamento de 5 anos. MÉTODOS: Um modelo de análise de decisão foi proposto comparando-se o tratamento cirúrgico (EPNP) versus a TCM. A avaliação da EPNP foi observacional retrospectiva de uma série consecutiva de casos e da TCM foi hipotética. A TCM foi considerada como o uso de três drogas (associação de uma combinação fixa de timolol/dorzolamida [CFTD] e um análogo de prostaglandina [bimatoprosta, latanoprosta ou travoprosta]). A relação custo-efetividade foi definida com o custo direto (em dólares) para cada porcentual de redução da pressão intraocular (PIO). A razão de custo-efetividade incremental (ICER) foi calculada. O seguimento foi de 5 anos e a perspectiva dos custos é do Sistema Único de Saúde (SUS). RESULTADOS: O custo direto para cada porcentual de redução da PIO ao final de 5 anos (relação custo-efetividade) foi de US$ 10,19 para a EPNP; US$ 37,45 para a CFTD + bimatoprosta; US$ 39,33 para CFTD + travoprosta; e US$ 41,42 para CFTD + latanoprosta. A EPNP apresentou uma melhor relação custo-efetividade, quando comparada com a TCM. O índice ICER foi negativo, portanto a EPNP foi a opção terapêutica dominante. CONCLUSÃO: A EPNP foi menos custosa e mais efetiva que a TCM. Do ponto de vista do SUS, ela foi a opção mais custo-efetiva, quando comparada com a TCM.

Resources use, costs and effectiveness of non-penetrating deep sclerectomy according to glaucoma stage / Utilização de recursos, custos e efetividade da esclerectomia profunda não penetrante de acordo com a gravidade do glaucoma

PURPOSE: To assess the resources use, costs and effectiveness of non-penetrating deep sclerectomy (NPDS). METHODS: A retrospective cohort of NPDS patients was analyzed. Eyes were stratified according to glaucoma severity into 3 groups: 1 (early), 2 (moderate) and 3 (severe). NPDS associated resources were based on the frequency of the following variables: surgical procedure (NPDS), intraoperative mitomycin C (MMC); 5-fluorouracil needling (5-FU); Nd:YAG laser goniopuncture; new filtering surgery and medications needed postoperatively. Costs were based on the value and prices of the Brazilian Public Health System and follow-up period was 5 years. Success rate: percentage of patients achieving an end-point intraocular pressure <18 mmHg (and least 20 percent reduction) without any medications. RESULTS: Percentage of patients using resources in groups 1, 2 and 3 was, respectively: 92.1 percent, 88.5 percent and 93.0 percent for MMC; 10.5 percent, 11.5 percent and 13.3 percent for 5-FU; 18.4 percent, 19.7 percent and 21.9 percent for goniopuncture and 13.2 percent, 24.6 percent and 27.3 percent for a new surgery. Mean number of glaucoma medications per patient at the end of follow-up was 0.42 in group 1 and 0.48 and 0.73 in groups 2 and 3, respectively. Mean NPDS direct cost was US$305.25, US$361.37 and US$390.09 in early, moderate and severe glaucoma, respectively. No differences were found in effectiveness according to glaucoma severity. CONCLUSION: There is a trend in the use of resources and costs in NPDS. The more advanced the glaucoma, the higher the need for resources and the higher the associated costs. NPDS effectiveness did not differ among different glaucoma stages.

OBJETIVO: Avaliar a utilização de recursos, os custos e a efetividade da esclerectomia profunda não penetrante (EPNP). MÉTODOS: Foi realizado um estudo retrospectivo consecutivo de olhos operados de glaucoma pela técnica de EPNP. Os olhos foram divididos em três grupos de acordo com a gravidade do glaucoma: 1 (inicial), 2 (moderado) e 3 (avançado). Os recursos considerados foram baseados nas seguintes variáveis: procedimento cirúrgico (EPNP), uso de mitomicina C (MMC) intraoperatória, agulhamento com 5-fluoruracil (5-FU), goniopuntura com Nd:YAG laser, nova cirurgia filtrante e medicações necessárias no pós-operatório. O cálculo dos custos foi baseado nos valores exercidos pelo Sistema Único de Saúde (SUS) no período de 5 anos. O sucesso foi considerado uma pressão intraocular final <18 mmHg (com pelo menos 20 por cento de redução) sem qualquer medicação anti-glaucomatosa. RESULTADOS: A utilização proporcional de recursos nos grupos 1, 2 e 3 foi, respectivamente: 92,1 por cento, 88,5 por cento e 93,0 por cento para MMC; 10,5 por cento, 11,5 por cento e 13,3 por cento para 5-FU; 18,4 por cento, 19,7 por cento e 21,9 por cento para goniopuntura e 13,2 por cento, 24,6 por cento e 27,3 por cento para nova cirurgia filtrante. O custo direto da EPNP foi de US$305,25 para os glaucomas iniciais; US$361,37 para os moderados e US$390,09 para os avançados. Não foi observada diferença na efetividade da cirurgia nos três grupos. CONCLUSÃO: Observou-se uma tendência na utilização dos recursos e no custo direto da EPNP. Quanto mais avançado o glaucoma, maior foi a necessidade de recursos e maiores foram os custos. A efetividade da EPNP não sofreu influência do estágio evolutivo do glaucoma.

Resources use, costs and effectiveness of non-penetrating deep sclerectomy according to glaucoma stage.

PURPOSE: To assess the resources use, costs and effectiveness of non-penetrating deep sclerectomy (NPDS). METHODS: A retrospective cohort of NPDS patients was analyzed. Eyes were stratified according to glaucoma severity into 3 groups: 1 (early), 2 (moderate) and 3 (severe). NPDS associated resources were based on the frequency of the following variables: surgical procedure (NPDS), intraoperative mitomycin C (MMC); 5-fluorouracil needling (5-FU); Nd:YAG laser goniopuncture; new filtering surgery and medications needed postoperatively. Costs were based on the value and prices of the Brazilian Public Health System and follow-up period was 5 years. Success rate: percentage of patients achieving an end-point intraocular pressure <18 mmHg (and least 20% reduction) without any medications. RESULTS: Percentage of patients using resources in groups 1, 2 and 3 was, respectively: 92.1%, 88.5% and 93.0% for MMC; 10.5%, 11.5% and 13.3% for 5-FU; 18.4%, 19.7% and 21.9% for goniopuncture and 13.2%, 24.6% and 27.3% for a new surgery. Mean number of glaucoma medications per patient at the end of follow-up was 0.42 in group 1 and 0.48 and 0.73 in groups 2 and 3, respectively. Mean NPDS direct cost was US$305.25, US$361.37 and US$390.09 in early, moderate and severe glaucoma, respectively. No differences were found in effectiveness according to glaucoma severity. CONCLUSION: There is a trend in the use of resources and costs in NPDS. The more advanced the glaucoma, the higher the need for resources and the higher the associated costs. NPDS effectiveness did not differ among different glaucoma stages.