ABSTRACT
ABSTRACT Bevacizumab, a monoclonal anti-vascular endothelial growth factor antibody, has been suggested as a potential healing therapeutic following glaucoma surgery. Here, we aimed to improve the bioavailability of bevacizumab when used as an adjunct therapy to non-penetrating deep sclerectomy (DS) by using a bevacizumab-methylcellulose mixture (BMM). Ten previously non-operated eyes in ten patients diagnosed with primary open angle glaucoma underwent DS with a subconjunctival injection of 0.3 ml of BMM (bevacizumab 3.75 mg incorporated into 4% methylcellulose) at the surgical site. Bevacizumab release was evaluated in vitro using size-exclusion high performance liquid chromatography (HPLC). Intraocular pressure (IOP), bleb morphology, corneal endothelial cell count (CECC), and complications were evaluated at 6 months after surgery. Using HPLC, bevacizumab was detected in BMM for up to 72 h. Moreover, all surgical blebs remained expanded with hyaline material during the first week. A significant IOP reduction (mean ± SD= -10.3 ± 5.4 mmHg, P<0.001) and diffuse blebs were observed at the final follow-up period. Although CECC was slightly reduced (-7.4%), no complications were observed. In conclusion, bevacizumab was released from BMM, and the use of this innovative mixture yielded good results following DS with no complications. Further studies are required to determine its efficacy prior to establishing BMM as an adjunct treatment for penetrating and non-penetrating glaucoma surgeries.
RESUMO O bevacizumabe (um agente anti-fator de crescimento endotelial vascular) tem sido sugerido como potencial modulador cicatricial na cirurgia do glaucoma. Este estudo objetivou melhorar a biodisponibilidade do bevacizumabe, investigando a viabilidade de uma nova mistura de bevacizumabe-metilcelulose (BMM) como terapia adjuvante para a esclerectomia profunda não-penetrante (DS). Dez olhos sem cirurgias prévias de 10 pacientes com glaucoma primário de ângulo aberto foram submetidos à DS associada à uma injeção subconjuntival de 0,3 ml da mistura de bevacizumabe-metilcelulose (bevacizumabe 3,75 mg incorporado em metilcelulose 4%) no sítio cirúrgico. A liberação de bevacizumabe foi avaliada in vitro através de cromatografia líquida de alta performance por exclusão de tamanho (HPLC). A pressão intraocular (PIO), a morfologia da ampola de filtração, a contagem de células endoteliais da córnea (CECC) e as complicações foram estudadas aos seis meses de seguimento. O bevacizumabe foi detectado a partir da mistura de bevacizumabe-metilcelulose por meio do HPLC até 72 horas. Além disso, todas as ampolas cirúrgicas permaneceram expandidas com material hialino durante a primeira semana. Uma redução significativa da pressão intraocular (média ± DP= -10,3 ± 5,4 mmHg, P<0,001) e ampolas difusas foram observadas ao final do período de seguimento. Embora a contagem de células endoteliais da córnea se mostrou discretamente diminuída (-7,4%), nenhuma complicação foi observada. Neste estudo, o bevacizumabe foi liberado da mistura de bevacizumabe-metilcelulose e o uso desta nova mistura se associou com bons resultados cirúrgicos e nenhuma complicação. Estudos futuros serão necessários para determinar sua eficácia, antes de se estabelecer a mistura de bevacizumabe-metilcelulose como um tratamento adjuvante às cirurgias penetrantes e não-penetrantes para o glaucoma.
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Angiogenesis Inhibitors/pharmacology , Bevacizumab/pharmacology , Glaucoma, Open-Angle/surgery , Methylcellulose/pharmacology , Angiogenesis Inhibitors/therapeutic use , Blister , Bevacizumab/therapeutic use , Chemotherapy, Adjuvant/methods , Drug Combinations , Drug Liberation , Feasibility Studies , Follow-Up Studies , Glaucoma, Open-Angle/drug therapy , Intraocular Pressure , Methylcellulose/therapeutic use , Pilot Projects , Prospective Studies , Slit Lamp , Wound Healing/drug effectsABSTRACT
Fundamento: el tratamiento quirúrgico a pacientes con glaucoma crónico primario y catarata sigue siendo un dilema para los oftalmólogos. Objetivo: evaluar los resultados posoperatorios de la esclerectomía profunda no perforante con mitomicina C y la facoemulsificación realizadas en dos tiempos en pacientes con glaucoma crónico primario y catarata. Métodos: estudio descriptivo prospectivo, en 200 pacientes que fueron operados mediante la esclerectomía profunda no perforante con mitomicina C e iridotomía periférica con Nd YAG láser previa, en un primer tiempo y facoemulsificación con implante del lente intraocular de PMMA, en un segundo tiempo. Se analizaron la agudeza visual con corrección, el comportamiento de la tensión ocular y de la bula de filtración, la relación excavación – papila; y las complicaciones intra y posoperatorias. Resultados: la agudeza visual de 0,4 en el preoperatorio mejoró a 0,7 al año. El 62 % de las ampollas de filtración se mantuvieron prominentes y funcionales. Luego de la facoemulsificación el 17 % de los ojos continuaron con el uso de medicamentos y el 83 % mantuvieron presiones intraoculares por debajo de 17 mmHg, sin tratamiento. Las complicaciones posoperatorias fueron: la iridociclitis moderada (74 %) y la opacidad capsular posterior al año (46 %). Hubo 18 ojos (9 %) con descompensación endotelial leve y transitoria.Conclusiones: la esclerectomía profunda no perforante con mitomicina C y la facoemulsificación en dos tiempos permiten obtener el control quirúrgico del glaucoma crónico primario y una buena visión.
Background: surgical treatment of patients with primary chronic glaucoma and cataract remains a dilemma for ophthalmologists. Objective: to assess the postoperative results of non-penetrating deep sclerectomy with mitomycin C and phacoemulsification performed in two stages in patients with primary chronic glaucoma and cataract. Methods: a prospective descriptive study was conducted in 200 patients who underwent non -penetrating deep sclerectomy with mitomycin C and Nd:YAG laser peripheral iridotomy in the first stage and phacoemulsification with intraocular PMMA lens implantation in the second stage. Corrected visual acuity, intraocular pressure and filtering blebs, cup-to-disc ratio and intra -and postoperative complications were analyzed. Results: visual acuity improved from 0.4 before surgery to 0.7 a year after surgery. Sixty-two percent of the filtering blebs remained prominent and functional. After phacoemulsification, 17 % of the eyes continued under medication and 83% maintained the intraocular pressure below 17 mmHg, without treatment. Postoperative complications included moderate iridocyclitis (74 %) and posterior capsular opacity after a year (46%). Eighteen eyes (9 %) developed mild and transient endothelial decompensation. Conclusions: non -penetrating deep sclerectomy with mitomycin C and phacoemulsification performed in two stages lead to the surgical management of primary chronic glaucoma and good vision.
ABSTRACT
PURPOSE: A microdevice for the treatment of refractory glaucoma is presented. The underlying concepts, its mechanisms of action and the surgical technique for implanting are explained and the results are analyzed. The microdevice was developed and the surgeries were performed at the Maldonado-Bas Eye Clinic (Cordoba, Argentina), under the rules established in the protocol approved by the provisions of the National Administration of Drugs, Food and Medical Technology 430/7. File No.:1-47-25-649-07-1. METHODS: In a prospective study, following the protocol, 16 eyes with refractory glaucoma were included and operated. Intraocular pressure <21mmHg with or without additional medication was considered successful. The follow-up was one year. Averages, percentages and their 95 percent confidence bands were calculated. Analysis of variance for repeated measures was used to compare averages. RESULTS: The average preoperative intraocular pressure was 32.81 mmHg, SD ± 10.94 mmHg in a range of 14 to 50 mmHg. The average post-surgical intraocular pressure at one year was 12.43 mmHg, SD ± 2.85 mmHg in a range of 7 to 19 mmHg. The difference between the pre-and post-surgery average intraocular pressure was 20.38 mmHg. The number of successes was 14 eyes (87.5 percent, confidence interval (CI) 95 percent 61.6 percent - 98.6 percent). The number of failures was two eyes (12.5 percent, CI 95 percent 1.43 percent - 38.4 percent). CONCLUSIONS: The results show that the microdevice is successful for the treatment of refractory glaucoma.
OBJETIVO: Se presenta un microdispositivo para el tratamiento del glaucoma refractario. Se explican los conceptos con los que fue desarrollado, su mecanismo de acción, la técnica quirúrgica para implantarlo y se analizan los resultados obtenidos. Realizado en la Clínica de ojos Maldonado-Bas (Córdoba- Argentina), bajo la reglamentación establecida en el protocolo aprobado por disposición de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica 430/7. Expediente:1-47-25-649-07-1. MÉTODOS: En un estudio prospectivo, según la reglamentación del protocolo se incluyeron e intervinieron 16 ojos con glaucoma refractario. Se consideró éxito presión intraocular <21mmHg con o sin medicación adicional. El seguimiento fue de un año. Se calcularon promedios, porcentajes y sus bandas de confianza del 95 por ciento según estuviera indicado. Para comparar promedios se empleó Análisis de la Varianza para mediciones repetidas. RESULTADOS: El promedio de la presión intraocular pre-quirúrgica fue de 32,81 mmHg, SD ± 10,94 mmHg con un rango entre 14 y 50 mmHg. La presión intraocular post-quirúrgica promedio al año fue de 12,43 mmHg, SD ± 2,85 mmHg con un rango entre 7 y 19 mmHg. La diferencia entre el promedio de la presión intraocular pre y pos-quirúrgica fue de 20,38 mmHg. El número de éxitos fue de 14 ojos (87,5 por ciento; IC95 por ciento 61,6 por ciento - 98,6 por ciento). El número de fracasos fue de dos ojos (12,5 por ciento; IC95 por ciento 1,43 por ciento - 38,4 por ciento). CONCLUSIONES: Los resultados demuestran que el microdispositivo es eficaz para el tratamiento del glaucoma refractario.
Subject(s)
Humans , Aqueous Humor , Drainage/instrumentation , Glaucoma/surgery , Drainage/methods , Follow-Up Studies , Intraocular Pressure , Prospective Studies , Tonometry, Ocular , Treatment OutcomeABSTRACT
A esclerectomia profunda não penetrante tem sido uma alternativa à trabeculectomia, pois tem como vantagem a redução da pressão intra-ocular (PIO), sem penetrar na câmara anterior. Desta forma, evitando descompressão brusca, câmara anterior rasa. Neste trabalho, descrevemos o caso de uma paciente, 53 anos, negra, com diagnóstico de glaucoma primário de ângulo aberto, com controle clínico insatisfatório e que foi submetida à esclerectomia profunda não penetrante. A paciente evoluiu com formação de goniossinéquia na região da esclerectomia, após uso inadvertido de colírio midriático no pós-operatório, levando ao aumento da PIO e conseqüente falência da cirurgia. O uso de colírio midriático no pós-operatório da esclerectomia profunda não está indicado, pois neste caso, ocasionou o insucesso da cirurgia.
Non-penetrating deep sclerectomy has been an alternative to trabeculectomy, because it has the advantage of reducing intraocular pressure (IOP), without penetrating the anterior chamber. Thus, it avoids a sudden decompression and a plain anterior chamber. In this paper, we described a case of a female patient, 53 years old, black, with diagnosis of open-angle primary glaucoma, with unsatisfactory clinical control and who was submitted to non-penetrating deep sclerectomy. The patient developed goniosynechiae at the site of the sclerectomy, after inappropriate use of mydriatic eye-drops during the postoperative period, leading to an increase of IOP and, therefore, failure of the surgery. The use of mydriatic eye-drops during the postoperative period of deep sclerectomy is not indicated, because in this case, it led to surgery failure.
Subject(s)
Female , Humans , Middle Aged , Anterior Chamber , Glaucoma, Open-Angle/surgery , Mydriatics/adverse effects , Sclerostomy/adverse effects , Tropicamide/adverse effects , Gonioscopy , Intraocular Pressure/drug effects , Mydriatics/administration & dosage , Ophthalmic Solutions , Tropicamide/administration & dosageABSTRACT
Relato do caso de um paciente com diagnóstico de glaucoma primário de ângulo aberto, que foi submetida a esclerectomia profunda em olho direito, com sucesso. No pós-operatório de 3 meses, o procedimento cirúrgico foi avaliado com biomicroscopia ultra-sônica (UBM) utilizando-se dois equipamentos distintos (UBM 840-Zeiss; UBM-VUMAX-Sonomed) com transdutores de 50 MHz. O método diagnóstico com biomicroscopia ultra-sônica pode ser usado como método não invasivo para avaliar a arquitetura interna ocular na topografia da esclerectomia profunda. Permite identificar as estruturas do segmento anterior, sua relação anatômica, bem como a membrana trabéculo-Descemet íntegra e o espaço intra-escleral. Biomicroscopia ultra-sônica demonstrou utilidade na avaliação pós-operatória do procedimento cirúrgico.
Case report of a woman with the diagnosis of primary open-angle glaucoma who was submitted to a successful surgical procedure of deep sclerectomy in the right eye. In the postoperative period, at month 3, the surgical procedure was evaluated with ultrasound biomicroscopy (UBM) utilizing two distinct equipments (UBM 840-Zeiss; UBM-VUMAX-Sonomed), with 50-MHz transducers. The diagnostic method of ultrasound biomicroscopy can be utilized as a non invasive method to evaluate the internal architecture of the eye at the topography of deep sclerectomy. It allows to identify the anterior segment structures, their anatomical relationship, and also the intact trabecular-Descemet membrane and the intrascleral space. Ultrasound biomicroscopy showed to be useful in evaluating postoperative status of the surgical procedure.
Subject(s)
Aged , Female , Humans , Glaucoma, Open-Angle , Microscopy, Acoustic/methods , Descemet Membrane/pathology , Descemet Membrane , Glaucoma, Open-Angle/pathology , Glaucoma, Open-Angle/surgery , Postoperative Period , SclerostomyABSTRACT
Nuestro propósito en este trabajo es evaluar la eficacia de la Mitomicina C como inhibidor fibroblástico en la esclerectomía profunda no perforante (EPNP). Se realizó EPNP en 40 ojos con glaucoma crónico primario; 20 sin Mitomicina C y 20 con aplicación tópica intraoperatoria de Mitomicina C (0,5 mg/mL) durante 5 min, evaluándose al 1, 6 y 12 meses. En la EPNP sin Mitomicina C la PIO se redujo de 27,40 ± 4,76 mmHg a 15,80 ± 2,50 mmHg requiriendo betabloqueadores 5 ojos (25 %) a diferencia (p=,0001) de una reducción de 27,35 ± 2,91 mmHg a 7,15 ± 1,67 mmHg sin necesidad de betabloqueadores; con ampolla de filtración extensa, pálida, transparente y avascular y escasas complicaciones como hifema y dehiscencia conjuntival segmentaria. La EPNP con Mitomicina C fue más efectiva en el control de la PIO y su monodosificación tópica transoperatoria bien tolerada por los pacientes.
We intend in this paper to assess the effectiveness of Mitomycin C as a fibroblastic proliferation inhibitor in the non-penetrating deep sclerostomy (NPDS). This procedure was performed in 40 eyes with primary chronic glaucoma, 20 of them were treated with intraoperative topycal Mitomycin C at 0,5 mg/mL for five minutes and 20 were not applied this drug. They were followed up and assessed one, six and twelve months after the surgery. In the NPDS without mitomycin C group, intraocular pressure was reduced from 27,40 ± 4,76 mmHg to 15,80 ± 2,50 mmHg, but 5 eyes required betablockers compared to a reduction from 27,35 ± 2,91 mmHg to 7,15 ± 1,67 mmHg without betablockers in the NPDS with Mitomycin C group, which presented and extensive, pale, transparent and avascular filtering ampulla and slight complications such as hyphema and dehiscence. The NPDS with mitomycin C was more effective in controlling intraocular pressure and transoperative topycal monodosage of this drug was well tolerated by the patients.