RESUMO
OBJECTIVES: Stereotactic radiation therapy (Oraya, OT) is available as a second line therapy for patients who, despite intensive anti-VEGF therapy for neovascular AMD, do not show an improvement in CNV. As OT is expensive (5,308 ), the short term economics for starting this therapy were investigated. METHODS: A short-term cost model was set up in MS Excel with a two year time horizon. On the basis of the data of the randomised, controlled INTREPID pivotal trial and current treatment practice in Germany, the costs were compared of conventional anti-VEGF therapy, with or without a single OT treatment. Patients with an active lesion after initial anti-VEGF therapy and a maximum lesion diameter ≤ 4 mm were included. Modeled cost components/aspects were direct savings from injection number, control follow-up examinations and aids, as well as anti-VEGF switches. Costs for Germany were employed and a univariate sensitivity analysis was performed to address the existing uncertainty. RESULTS: For the patients with a maximum AMD lesion diameter ≤ 4 mm and a macula volume > 7.4 mm(3), the INTREPID trial showed a mean reduction of 3.68 intravitreal injections for 16 Gy radiation versus sham over a time period of 2 years. These 3.68 IVM result in ~ 4,500 direct cost savings. Moreover, due to the higher response rate with 16 Gy radiation, the number of follow-up visits and aids can be reduced, which results in savings between 207 and 1,224 over 2 years. After radiation, fewer anti-VEGF switches for low or non-responders are expected, which is modeled to result in ~ 1.7 fewer injections over 2 years. Due to overall fewer injections, fewer endophthalmitis cases would be expected. However, endophthalmitis and microvascular abnormalities, which can be observed in a few cases, are associated with low or non-quantifiable costs in this cost-cost comparison model. In summary, cost reductions of between 6,400 and 8,500 are predicted in the model over two years, which have to be compared to the costs of a single application of OT. CONCLUSIONS: The short-term economic analysis shows that anti-VEGF therapy combined with OT results in savings above the costs for OT itself over a 2 year time horizon. Overall, the approach gives potential cost reductions, if the appropriate indication is followed.
Assuntos
Quimiorradioterapia/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Modelos Econômicos , Radiocirurgia/economia , Degeneração Macular Exsudativa/economia , Degeneração Macular Exsudativa/radioterapia , Adulto , Inibidores da Angiogênese/economia , Inibidores da Angiogênese/uso terapêutico , Quimiorradioterapia/estatística & dados numéricos , Simulação por Computador , Relação Dose-Resposta à Radiação , Feminino , Alemanha/epidemiologia , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Lesões por Radiação/economia , Lesões por Radiação/epidemiologia , Radiocirurgia/estatística & dados numéricos , Dosagem Radioterapêutica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Degeneração Macular Exsudativa/epidemiologiaRESUMO
BACKGROUND: The purpose of this study is to establish the correlation between functional and morphological aspects before and 12 months after macular hole surgery. METHODS: In this prospective, interventional, consecutive study 16 eyes of 16 patients were included. All eyes received a successful transconjunctival 23-gauge vitrectomy with ILM peeling after initial diagnosis and maximum duration of symptoms of two months. Preoperatively and 3, 6 and 12 months postoperatively determinations of best-corrected visual acuity (logMAR), a 10° microperimetry (MP-1) and a spectral-domain based optical coherence tomography (SD-OCT) examination were performed. The photoreceptor layer (inner and outer segment, IS/OS) was evaluated based on SD-OCT images and correlated with data assessed by microperimetry analysis in the foveal and parafoveal region. RESULTS: After three months a stabilisation of BCVA with regeneration of the IS/OS line, an improvement of the fixation behaviour and the macular sensitivity could be observed. A significant restitution of the IS/OS line was observed after 12 months. Best corrected visual acuity, mean overall macular sensitivity and fixation improved significantly within the twelve month observation period (p < 0.05). Comparison of patients with at least two lines of visual acuity gain with patients having less than two lines of visual acuity gain 12 months after surgery showed no statistically significant difference in regeneration of the IS/OS integrity in the fovea (p = 0.433), but a difference was seen in the parafoveal region. A postoperative visual acuity gain of at least two lines was significantly more often seen in eyes with postoperative continuous IS/OS line in the parafoveal sectors compared to eyes with persistent IS/OS defects (p < 0.02). CONCLUSION: Correlations of morphological and functional improvements can be observed after successful micro-invasive macular hole surgery. The extent of the preoperative IS/OS defect, particularly in the parafoveal region, is a good predictive parameter for the postoperatively obtained macular sensitivity. The prediction of the postoperative visual acuity should not be made on the basis of a single clinical, anatomic finding.
Assuntos
Macula Lutea/patologia , Macula Lutea/cirurgia , Recuperação de Função Fisiológica , Perfurações Retinianas/diagnóstico , Perfurações Retinianas/cirurgia , Transtornos da Visão/diagnóstico , Transtornos da Visão/prevenção & controle , Vitrectomia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Perfurações Retinianas/complicações , Estatística como Assunto , Resultado do Tratamento , Transtornos da Visão/etiologia , Acuidade VisualRESUMO
BACKGROUND: Over the past years, a significant progress in genetic, functional and imaging diagnostics in hereditary retinal diseases has been made. Optical coherence tomography (OCT) as well as fundus autofluorescence (FAF) allow for high-resolution, non-invasive imaging - from various perspectives - of retinal and choroidal layers of the posterior fundus. Both techniques have gained more and more significance in the diagnosis of hereditary retinal diseases. PATIENTS/METHODS: Of all patients presented in this review, extensive family history was taken and a clinical ophthalmological examination performed. OCT scans as well as FAF images were acquired and compared to results of other functional and molecular genetic tests in the context of each disease. RESULTS: The presented cases in this review addressing hereditary retinal diseases (Best's disease, Stargardt's disease, cone-rod dystrophy, retinitis pigmentosa, achromatopsia, and X-linked retinoschisis) show the significance of ophthalmic imaging (OCT + FAF) for a targeted diagnosis of hereditary retinal diseases. CONCLUSION: The described imaging techniques (OCT + FAF) are becoming more and more important in the diagnosis of hereditary retinal diseases. Due to increasing availability of the devices, earlier detection of typical morphological changes not seen in clinical fundoscopy is feasible.
Assuntos
Testes de Percepção de Cores , Eletrorretinografia , Angiofluoresceinografia , Testes Genéticos , Doenças Retinianas/diagnóstico , Doenças Retinianas/genética , Tomografia de Coerência Óptica , Adolescente , Criança , Pré-Escolar , Cromossomos Humanos X/genética , Defeitos da Visão Cromática/diagnóstico , Defeitos da Visão Cromática/genética , Feminino , Genótipo , Humanos , Lactente , Degeneração Macular/congênito , Degeneração Macular/diagnóstico , Degeneração Macular/genética , Masculino , Retinose Pigmentar/diagnóstico , Retinose Pigmentar/genética , Retinosquise/diagnóstico , Retinosquise/genética , Aberrações dos Cromossomos Sexuais , Doença de Stargardt , Distrofia Macular Viteliforme/diagnóstico , Distrofia Macular Viteliforme/genéticaRESUMO
BACKGROUND: The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. METHODS: In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. RESULTS: Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. DISCUSSION: By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner.
Assuntos
Ensaios Clínicos como Assunto/métodos , Internet , Oftalmologia/organização & administração , Projetos de Pesquisa , Software , Alemanha , Validação de Programas de ComputadorRESUMO
BACKGROUND: The aim of this study was to evaluate the fixation and other functional and morphological alterations in patients with diabetic macular oedema (DMO) under intravitreal ranibizumab therapy. PATIENTS AND METHODS: Thirty patients (39 eyes) with DMO with central involvement were included in this prospective study. Morphological (fluorescein angiography, OCT) as well as functional (visual acuity, microperimetry including fixation) parameters were analysed before and after three monthly intravitreal applications of ranibizumab. RESULTS: Best-corrected mean visual acuity (BCVA) increased significantly by 6.85 + 6.45 letters from 26.15 ± 13.83 to 33.03 ± 13.31 letters. Mean central retinal thickness and mean central retinal volume decreased significantly from 503.72 ± 143.78 µm, respectively (p < 0.001) before treatment to 387.05 ± 122.02 µm after the third intravitreal injection with ranibizumab. Mean retinal sensitivity obtained with microperimetry did not change significantly over the course of treatment. Mean fixation within 2° (4°) improved from 64.15 % (85.7 %) before treatment significantly to 70.15 % (91.5 %) after three intravitreal injections with ranibizumab. Mean fixation stability within 2° improved from 43.9 % before treatment significantly to 58.5 % after three intravitreal injections. CONCLUSION: DMO improved both morphologically with a significant reduction of central retinal thickness and volume and a significantly improved BCVA as well as fixation and fixation stability over the course of three monthly intravitreal injections with ranibizumab. Retinal sensitivity obtained in microperimetry did not change significantly over the course. Based on our observations we interpret and suggest fixation and fixation stability as an early functional parameter and prior to microperimetrically detectable changes of retinal sensitivity additional to BCVA during treatment of diabetic macular edema.
Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Fixação Ocular/efeitos dos fármacos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Transtornos da Visão/prevenção & controle , Inibidores da Angiogênese/administração & dosagem , Retinopatia Diabética/complicações , Feminino , Humanos , Injeções Intravítreas , Edema Macular/complicações , Masculino , Pessoa de Meia-Idade , Ranibizumab , Resultado do Tratamento , Transtornos da Visão/diagnóstico , Transtornos da Visão/etiologia , Acuidade Visual/efeitos dos fármacosAssuntos
Atrofia Óptica Hereditária de Leber/tratamento farmacológico , Ubiquinona/análogos & derivados , Adolescente , Adulto , Idoso , Estudos de Coortes , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Atrofia Óptica Hereditária de Leber/epidemiologia , Atrofia Óptica Hereditária de Leber/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Ubiquinona/farmacologia , Ubiquinona/uso terapêutico , Acuidade Visual/efeitos dos fármacos , Acuidade Visual/fisiologia , Adulto JovemAssuntos
Implante de Lente Intraocular/métodos , Lentes Intraoculares , Satisfação do Paciente , Complicações Pós-Operatórias/etiologia , Presbiopia/cirurgia , Refração Ocular , Transtornos da Visão/etiologia , Topografia da Córnea , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Desenho de Prótese , Falha de Prótese , Reoperação , Transtornos da Visão/diagnósticoRESUMO
BACKGROUND: Glaucoma is the second leading cause of blindness worldwide and in many cases cannot be adequately controlled with conservative treatment. MATERIALS AND METHODS: Schematic evaluation of various surgical techniques. RESULTS: Trabeculectomy is the gold standard of glaucoma surgery and requires close follow-up care. Novel, minimally invasive procedures are suitable for patients with moderately advanced, uncomplicated stages of the disease, whereas filtrating tube implants or cyclodestructive techniques are required in patients with complex glaucoma. CONCLUSION: Various surgical techniques are available and have their specific indication window for the glaucoma surgeon, depending on the severity, progression, and risk factors of the disease.
Assuntos
Traumatismos Oculares/prevenção & controle , Cirurgia Filtrante/métodos , Glaucoma/diagnóstico , Glaucoma/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Medicina Baseada em Evidências , Traumatismos Oculares/etiologia , Cirurgia Filtrante/efeitos adversos , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Posterior uveitis comprises a heterogeneous group of diseases with inflammatory alterations of the posterior fundus and is a common cause of visual impairment and blindness. The goal of this study was to evaluate the diagnostic value of wide-field fundus autofluorescence (FAF) in patients with non-infectious posterior uveitis and chorioretinal alterations. MATERIAL AND METHODS: In this study 73 eyes from 51 patients were included. Best-corrected visual acuity, wide-field color and FAF images achieved by a wide-field scanning laser opththalmoscope (SLO, Optomap P200Tx, Optos PLC, Dunfermline UK) and a full ophthalmological examination were obtained from each patient. A systematic analysis of chorioretinal alterations detected with FAF and color images was conducted followed by the evaluation of the diagnostic information of wide-field FAF compared to the clinical finding and wide-field color images. RESULTS: Of the 73 eyes included in the study 52 showed peripheral alterations. In 32 cases wide-field FAF images revealed a greater number and more extensive chorioretinal alterations than the corresponding wide-field color images of the posterior fundus. CONCLUSIONS: In this study wide-field FAF images showed more chorioretinal alterations than seen in funduscopy or in color SLO images. Therefore, wide-field FAF images offer important additional information for detection and documentation of peripheral and central chorioretinal alterations.
Assuntos
Aumento da Imagem/métodos , Microscopia Confocal/métodos , Microscopia de Fluorescência/métodos , Retina/patologia , Retinoscopia/métodos , Úvea/patologia , Uveíte Posterior/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecções Bacterianas/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Adulto JovemRESUMO
BACKGROUND: The goal of this retrospective study was to evaluate the development of visual acuity before and after recurrence treatment of neovascular age-related macular degeneration (AMD) in a university eye clinic with referring ophthalmologists. METHODS: Data from patients with recurrent neovascular AMD who initially had been treated for neovascular AMD and followed by referring ophthalmologists were analyzed. An intravitreal recurrence treatment with ranibizumab using the same PrONTO scheme as used in the "upload" phase followed. RESULTS: Mean best corrected visual acuity (BCVA) of all 100 patients included in the study was - 0.61 ± 0.33 LogMAR before treatment and improved to - 0.36 ± 0.24 LogMAR (p < 0.001) after "upload" therapy. Mean central retinal thickness (CRT) was 291.5 ± 85.3 µm before treatment and decreased to 200.1 ± 63.7 µm after "upload" therapy (p < 0.001). At the time of recurrence the mean BCVA was - 0.63 ± 0.33 LogMAR and improved significantly to - 0.52 ± 0.28 LogMAR (p < 0.001) after recurrence treatment. At the time of recurrence the mean CRT was 281.2 ± 94.4 µm and decreased significantly to 202.7 ± 59.9 µm after recurrence treatment (p < 0.001). CONCLUSIONS: Retreatment criteria according to the PrONTO scheme showed good morphological and functional results in the patients with recurrent neovascular AMD treated but seemed to be defined too broadly for everyday clinical use with an irreversible loss under those conditions in cases of a recurrent episode. Accordingly, the latest recurrence criteria of the DOG/BVA/DOC recommendations should be applied.
Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Transtornos da Visão/prevenção & controle , Acuidade Visual/efeitos dos fármacos , Degeneração Macular Exsudativa/tratamento farmacológico , Degeneração Macular Exsudativa/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/administração & dosagem , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ranibizumab , Estudos Retrospectivos , Prevenção Secundária , Resultado do Tratamento , Transtornos da Visão/diagnóstico , Transtornos da Visão/etiologia , Degeneração Macular Exsudativa/complicaçõesRESUMO
BACKGROUND: Intravitreal anti-VEGF (vascular endothelial growth factor) therapy with ranibizumab has been shown to be an effective therapeutic option for foveal diabetic macular edema (DME). This prospective study evaluated the functional and morphological retinal changes after intravitreal ranibizumab treatment. MATERIAL AND METHODS: A consecutive prospective series of DME patients treated with intravitreal ranibizumab were examined before and after 3 and 6 months of intravitreal ranibizumab therapy. Best-corrected visual acuity (BCVA) according to the ETDRS protocol, retinal thickness in the macular area and central retinal thickness (CRT) measured with spectral-domain optical coherence tomography (SD-OCT) was determined. In addition, microperimetric functional macular mapping was determined before therapy and 4 weeks after the third injection. RESULTS: A total of 41 eyes from 33 patients were evaluated. During the 6-month observational period patients received a mean number of 5.2 injections. The mean BCVA increased significantly from 26 ± 14 to 33 ± 13 letters 4 weeks after the third injection and to 34 ± 14 letters 6 months after starting the treatment. The mean CRT decreased significantly from 509 ± 147 µm to 385 ± 121 µm after the third injection and to 383 ± 110 µm after 6 months. After 3 injections, the thickness of the most prominent central retinal area was less than 445 µm in 68.3% of patients and after a further 3 months of treatment in 78.0%. CONCLUSION: The presented data demonstrate that intravitreal ranibizumab is effective for DME in everyday clinical practice and results are comparable to those of registration trials. After three initial injections significant structural and functional improvements were observed in a considerable number of patients.
Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/patologia , Edema Macular/tratamento farmacológico , Edema Macular/patologia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Inibidores da Angiogênese/administração & dosagem , Feminino , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Ranibizumab , Resultado do TratamentoRESUMO
At present there is no routinely available decontamination procedure in washer-disinfectors to allow the reliable inactivation and/or elimination of prions present on reusable surgical instruments. This means that is not possible to provide assurance for preventing iatrogenic transmission of prion diseases. We need effective procedures in prion decontamination that can be integrated into the usual routine of reprocessing surgical instruments. This article reports on the evaluation of an automated process designed to decontaminate prions in washer-disinfectors using a quantitative, highly sensitive in vivo assay for surface-adherent 22L prions. The automated process showed great advantages when compared with conventional alkaline cleaning. In contrast, the new process was as effective as autoclaving at 134 degrees C for 2h and left no detectable prion infectivity, even for heavily contaminated surfaces. This indicates a reduction of surface-adherent prion infectivity of >7 log units. Due to its compatibility with even delicate surgical instruments, the process can be integrated into the large scale reprocessing of instruments in a central sterile supply department. The system could potentially make an important contribution to the prevention of iatrogenic transmission of prions.